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Document Versioning
Veeva SiteVault
/@VeevaSiteVault
Oct 13, 2021
This video provides an in-depth exploration of document versioning within Veeva SiteVault, Veeva's eRegulatory and eISF system designed for clinical research sites. The presenter outlines the critical need for robust document versioning in a regulated environment, explaining how the system manages updates to ensure clarity, maintain an audit trail, and prevent confusion regarding the most current version of a document. The tutorial systematically demonstrates the practical steps involved in updating documents, distinguishing between those in a draft state and those already in a steady (approved or final) state. The core mechanism discussed is the "stacking method," where all versions of a document are linked, clearly marking previous iterations as "superseded" while designating the latest approved version as "current approved" or "final." The video details the version numbering convention, where draft documents typically increment in 0.1 steps (e.g., 0.1, 0.2, 1.1, 1.2), and major approved versions are denoted by whole numbers (e.g., 1.0, 2.0). Specific scenarios necessitating versioning are highlighted, such as receiving updated ICF templates or protocols, making administrative changes like adding staff members, or updating monitor annotations that impact source or regulatory documents. The tutorial progresses through two main workflows for uploading new document versions. First, for documents in the draft state, users learn to "check out" the document, make necessary edits (either directly or externally), and then "check back in" or "upload new version" to increment the draft version. Second, for documents already in a steady state (e.g., 1.0), the process involves selecting "create draft" from the action menu. This can then lead to either copying the file from the current version for internal edits or uploading an entirely new file. The video emphasizes using the workflow and state change menu to formally approve documents, transitioning them from a draft version (e.g., 0.2) to a major approved version (e.g., 1.0 or 2.0). Finally, it showcases the "version history" section and the "compare versions" feature, allowing users to track changes and access previous iterations, even after they have been superseded. Key Takeaways: * **Purpose of Document Versioning:** Document versioning in Veeva SiteVault is crucial for maintaining a clear, auditable history of changes, preventing confusion about the most current document, and ensuring regulatory compliance in clinical research settings. * **Superseded vs. Current Versions:** The system automatically marks older versions as "superseded" when a new version is uploaded or approved, ensuring that only the "current approved" or "final" version is prominently displayed and used. * **Draft vs. Steady State Distinction:** Documents exist in two primary states: "draft" (not yet approved) and "steady state" (current, approved, or final). Workflows for updating documents differ based on their current state. * **Version Numbering Conventions:** Draft documents are typically noted by minor version increments (e.g., 0.1, 0.2, 1.1, 1.2), while approved documents receive major version numbers (e.g., 1.0, 2.0). * **Workflow for Draft Documents:** To update a document in a draft state, users can "check out" the document, make edits, and then "check back in" or "upload new version" to increment the draft number (e.g., from 0.1 to 0.2). * **Workflow for Steady State Documents:** For documents already approved, the process involves selecting "create draft" from the action menu. Users can then either "copy file from current version" for internal edits or "upload new file" if an entirely new document needs to replace the current one. * **Formal Approval Process:** Moving a document from a draft state (e.g., 0.2) to a major approved version (e.g., 1.0) requires utilizing the "workflow and state change menu" to select the appropriate approval method. * **Automated Version History:** Veeva SiteVault automatically populates a "version history" section under document information once a document has multiple versions, providing a comprehensive log of all changes. * **Compare Versions Feature:** The system offers a "compare versions" functionality via the action menu, allowing users to easily review the specific changes made between different iterations of a document. * **Access to Previous Versions:** Even after a document has been superseded, users can still access and view previous versions by clicking into them, though the system will clearly indicate that a newer steady-state version exists. * **Regulatory Compliance Support:** The robust versioning capabilities are essential for managing critical regulatory and clinical trial documents like Informed Consent Form (ICF) templates, study protocols, and FDA Form 1572s, ensuring auditability and adherence to GxP and 21 CFR Part 11 requirements. * **Operational Efficiency:** By standardizing document updates and providing clear version control, Veeva SiteVault helps clinical research sites streamline their eRegulatory and eISF processes, reducing manual errors and ensuring that all stakeholders are working with the most current information. Tools/Resources Mentioned: * Veeva SiteVault: An eRegulatory / eISF system specifically designed for clinical research sites. Key Concepts: * **Document Versioning:** The process of creating and managing multiple iterations of a document, tracking changes over time. * **Steady State:** Refers to documents that are current, approved, or final within the system. * **Draft State:** Refers to documents that are not yet approved and are still undergoing revisions. * **Superseded:** The status given to older versions of a document once a newer version has been approved or uploaded, indicating they are no longer the current active version. * **eRegulatory / eISF:** Electronic Regulatory / Electronic Investigator Site File systems, which manage essential documents for clinical trials digitally. * **Action Menu:** A context-sensitive menu within Veeva SiteVault providing options like "check out," "check in," "upload new version," "create draft," and "compare versions." * **Workflow and State Change Menu:** A system menu used to initiate and manage document approval processes, transitioning documents between different states (e.g., from draft to approved). Examples/Case Studies: * Updating ICF (Informed Consent Form) templates or study protocols. * Making changes due to staff member additions. * Updating monitor annotations that require a change to source or regulatory documents. * Revising FDA Form 1572 (Statement of Investigator) to add a new sub-investigator.
Healthcare Stocks and IPOs: Investing in Change??
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Oct 9, 2021
This video provides an in-depth exploration of the complexities and often misleading narratives surrounding healthcare stock investments and IPOs, using Privia Health as a primary case study. Dr. Eric Bricker, leveraging his extensive background as a physician, hospital finance consultant, and healthcare entrepreneur, highlights the pervasive confusion in quarterly earnings calls across the healthcare industry. He argues that despite his deep industry knowledge, understanding the true underlying economics and strategic direction of many healthcare companies from their public statements is exceedingly difficult, often due to a disconnect between stated goals and actual business practices. The presentation delves into the operational model of Privia Health, initially described as a "practice enablement company," which Dr. Bricker clarifies as an Independent Practice Association (IPA). He explains that IPAs serve as a confederacy for physician practices, primarily for administrative and billing purposes. Their core functions include negotiating better fee-for-service reimbursement rates from insurance carriers, facilitating collective purchasing and integration of Electronic Medical Records (EMRs), and professionalizing revenue cycle management (billing and collections) – areas where individual physician practices often struggle. This aggregation of small practices under a common tax ID provides them with increased negotiating power and operational efficiencies. Initially, Privia Health positioned itself around the promise of value-based care (VBC), focusing on primary care physicians in the DC/Maryland/Virginia area. The VBC model, particularly capitation, aimed to incentivize physicians to manage patient populations more effectively, reducing overall healthcare costs by preventing hospitalizations and specialist visits, thereby allowing practices to keep the savings. However, as the anticipated widespread adoption of ACOs (Accountable Care Organizations) and alternative payment models by commercial insurers and Medicare (CMMI) did not fully materialize, Privia pivoted its strategy. They began acquiring specialist practices, such as dermatologists, OB/GYNs, and surgeons, who predominantly operate on a fee-for-service basis and have little to no involvement in value-based care models. This strategic shift created a fundamental misalignment: Privia's IPO narrative centered on value-based care and cost reduction, while its actual economic engine became the expansion of fee-for-service, which inherently drives higher healthcare utilization and costs. Dr. Bricker concludes by warning investors that this kind of strategic obfuscation is not unique to Privia but is a common theme among major insurance carriers and other large healthcare companies, urging caution when investing in companies touting "change" that may not reflect their true financial incentives. Key Takeaways: * **Complexity of Healthcare Finance:** The healthcare industry's financial reporting and corporate communications are often intentionally vague and confusing, making it difficult even for industry veterans to discern the true underlying business models and economic drivers. * **Role of Independent Practice Associations (IPAs):** IPAs like Privia Health aggregate physician practices to achieve economies of scale and increased negotiating power, primarily focusing on administrative functions, EMR integration, revenue cycle management, and fee-for-service contracting. * **Operational Challenges for Physician Practices:** Small physician practices frequently struggle with efficient EMR implementation, effective revenue cycle management (billing and collections), and negotiating favorable reimbursement rates with insurance carriers, making them targets for IPA roll-ups. * **Value-Based Care (VBC) Mechanics:** VBC, particularly capitation, aims to put physicians at financial risk for their patient population's total cost of care, incentivizing proactive health management to reduce hospitalizations and specialist visits. * **Strategic Shift from VBC to Fee-for-Service (FFS):** The anticipated widespread adoption of VBC models (e.g., ACOs, alternative payment models) did not fully materialize in the commercial insurance sector, and government initiatives like CMMI scaled back their aggressive push, leading companies like Privia to pivot towards FFS models. * **Misalignment of IPO Narratives and Business Realities:** Healthcare companies often present an IPO or earnings narrative focused on innovative, cost-saving value-based care, while their actual growth and profitability are increasingly driven by traditional fee-for-service models that can lead to higher healthcare costs. * **Fee-for-Service Drives Higher Costs:** The inherent incentive of fee-for-service models is to perform more services at higher reimbursement rates, which directly contributes to increased healthcare utilization and overall costs, contrary to the goals of value-based care. * **Private Equity Roll-up Strategy:** The aggregation of numerous small, often struggling, physician practices (a "roll-up") is a classic private equity strategy to create larger entities with greater market power and operational efficiencies before taking them public. * **Importance of Understanding Underlying Economics:** Investors and industry stakeholders must look beyond corporate rhetoric and deeply analyze the actual economic drivers and operational strategies of healthcare companies to understand their true impact on healthcare costs and quality. * **Caution for "Investing in Change":** The video serves as a warning that companies touting "new" and "innovative" initiatives to lower healthcare costs might, in practice, be perpetuating or even exacerbating the existing fee-for-service system that drives costs higher. Key Concepts: * **Practice Enablement Company:** A term used to describe organizations that provide administrative, IT, billing, and contracting support to physician practices, often to help them navigate complex healthcare landscapes. * **Independent Practice Association (IPA):** A group of independent physicians who band together for administrative and contracting purposes, allowing them to negotiate collectively with insurance carriers and manage shared services. * **Value-Based Care (VBC):** A healthcare delivery model where providers are paid based on patient health outcomes, quality of care, and efficiency, rather than the volume of services provided. * **Capitation:** A payment arrangement where healthcare providers receive a fixed amount of money per patient per unit of time, regardless of how many services the patient uses. * **Accountable Care Organizations (ACOs):** Groups of doctors, hospitals, and other healthcare providers who come together voluntarily to give coordinated high-quality care to their Medicare patients. * **Alternative Payment Models (APMs):** Payment approaches that give added incentives to provide high-quality and cost-efficient care, often linked to VBC initiatives. * **Fee-for-Service (FFS):** A traditional payment model where providers are paid for each service they perform, such as a doctor's visit, test, or procedure. * **Revenue Cycle:** The entire process of managing claims processing, payment, and revenue generation from patient services. Examples/Case Studies: * **Privia Health:** Used as the central case study, illustrating a company that started with a value-based care narrative but shifted its strategy to primarily acquire fee-for-service specialist practices due to market realities, creating a disconnect between its public story and its underlying economic drivers.
Webinar: “Towards a Smooth Transition to ISO IDMP”
Asphalion
/@Asphalion.
Oct 4, 2021
This webinar provides an in-depth exploration of the transition to ISO IDMP (Identification of Medicinal Products) within the pharmaceutical industry, specifically focusing on the European Medicines Agency's (EMA) implementation strategy. The speakers, Ramon Hernandez and Lidia Canovas from Asphalion, begin by establishing the critical need for global standardization in defining and identifying medicinal products, moving beyond the current xEVMPD (External Vigilance Medicinal Product Dictionary) system. They introduce ISO IDMP as a series of global ISO standards that define product identification at various levels, from substances to the final medicinal product and even batches. The presentation delves into the foundational components of EMA's IDMP approach, primarily the SPOR portal, which comprises four master data services: Substances (SMS), Organizations (OMS), Referentials (RMS), and the future Product Master Services (PMS). A significant portion of the discussion is dedicated to the historical timeline of xEVMPD, its mandatory implementation in 2012, and the subsequent delays in ISO IDMP's rollout, attributed to factors like standard finalization and Brexit. The speakers highlight the release of the European Implementation Guidance (EIG) version 2.0 in February of the current year as the critical trigger for actual implementation deadlines. They illustrate the dramatic increase in data granularity required by IDMP, using the example of packaging information, which transforms from a simple text field in xEVMPD to a complex, structured object with multiple defined attributes in PMS. The webinar outlines a four-step implementation strategy for Marketing Authorization Holders (MAHs): understanding EMA's data requirements, assessing internal data availability and quality, defining internal processes and updating SOPs, and finally, strategizing to go "beyond compliance." The speakers emphasize that IDMP is not solely a regulatory affairs concern but a company-wide data management project requiring significant IT involvement and cross-departmental collaboration. They discuss the EMA's phased implementation plan, including the "Go-Live" for optional PMS submissions, followed by mandatory reporting for centralized and then non-centralized products. The process of data migration from xEVMPD to PMS by EMA is explained, along with the concept of "delta import" and "feedback loop" to maintain data synchronization. Practical case studies for companies with varying portfolio sizes and existing RIM (Regulatory Information Management) systems are presented, underscoring the need for tailored strategies, data audits, and potential system upgrades or new implementations to handle the new "Fire message" (FHIR standard) submissions. Key Takeaways: * **ISO IDMP Standardization:** ISO IDMP is a global initiative to standardize the identification of medicinal products, driven by ISO standards, and implemented in Europe through the EMA's European Implementation Guidance (EIG). This aims to create a unified, machine-readable definition of products across global pharma. * **SPOR as the Foundation:** EMA's SPOR portal is central to IDMP, comprising four master data services: SMS (Substance Management Service), OMS (Organization Management Service), RMS (Referential Management Service), and PMS (Product Master Services), which will be the new IDMP-compliant product database. * **Increased Data Granularity:** The transition to IDMP necessitates a significantly higher level of data granularity compared to xEVMPD. A prime example is packaging information, which evolves from a single descriptive text field to multiple structured objects defining materials, pack sizes, and unique identifiers (PCID). * **Phased EMA Implementation:** EMA's IDMP rollout is phased, with a "Go-Live" for optional PMS submissions (not before Feb 2022, as per the webinar's timeline, implying later in real-time), followed by mandatory reporting for centralized products (not before Feb 2023, implying later), and eventually for non-centralized products. * **Comprehensive Implementation Steps:** Companies must follow a structured approach: 1) Thoroughly understand EMA's data requirements from the EIG v2.0, 2) Conduct a gap analysis and data audit of existing internal data, 3) Redefine and update internal processes, SOPs, and data ownership, and 4) Develop a strategic approach that goes beyond mere compliance. * **Addressing Data Silos:** A major challenge is overcoming internal data silos, where product information is scattered across various departments (e.g., regulatory, marketing, production) and disparate systems (e.g., common databases, individual Excel files), leading to inefficiencies and data quality issues. * **FHIR Message Submissions:** The new standard for communicating product information to EMA's PMS will be the "Fire message" (based on the FHIR standard), replacing the XML format used for xEVMPD submissions. * **EMA Data Migration & Enrichment:** EMA will migrate existing xEVMPD data to PMS, but MAHs will be responsible for significant "enrichment" by providing the extensive new data fields required by IDMP that were not part of xEVMPD. * **Impact of xEVMPD Data Discrepancies:** The current xEVMPD "acknowledgement" process, where EMA can unilaterally alter submitted data, highlights existing data misalignment between industry and agency. These discrepancies will carry over to PMS if not proactively addressed through data reconciliation. * **Strategic Opportunity for RIM Systems:** Implementing or upgrading a Regulatory Information Management (RIM) system is presented as a strategic opportunity to consolidate all regulatory data, streamline workflows, and ensure IDMP compliance, offering benefits beyond basic regulatory adherence. * **Company-Wide Project:** IDMP implementation is not confined to regulatory affairs; it's a significant, company-wide data management and IT project requiring substantial time, investment, and cross-functional collaboration. * **Tailored Implementation Strategies:** Companies, especially those with large portfolios or without existing RIM systems, need to define specific strategies, which may include phased implementation (e.g., focusing on centralized products first), data migration plans, and decisions on whether to acquire new systems or enhance existing ones. * **External Support Options:** For companies lacking internal resources or expertise, externalizing services for PMS submission file preparation and SPOR maintenance is a viable option to ensure compliance and smooth transition. * **Streamlined Administrative Changes:** In the future, certain administrative variations (e.g., changes in manufacturer name or QPPV location) might be directly reported to PMS without requiring a full regulatory assessment, potentially reducing the administrative burden. **Tools/Resources Mentioned:** * **ISO Standards:** The foundational international standards for IDMP. * **EMA's European Implementation Guidance (EIG):** Specifically versions 2.0 and the anticipated 3.0, which detail EMA's approach to IDMP in Europe. * **SPOR Portal:** EMA's master data management portal for IDMP, encompassing SMS, OMS, RMS, and PMS. * **PMS (Product Master Services):** The future IDMP-compliant database at EMA. * **xEVMPD (External Vigilance Medicinal Product Dictionary):** EMA's current database for Article 57 data. * **FHIR (Fast Healthcare Interoperability Resources):** The standard for the new "Fire messages" used for submissions to PMS. * **eCTD (Electronic Common Technical Document):** The format for regulatory submissions that will incorporate Fire messages. * **RIM System (Regulatory Information Management System):** A key software solution for managing regulatory data and processes. **Key Concepts:** * **ISO IDMP (Identification of Medicinal Products):** A set of five international ISO standards defining how medicinal products should be identified and described globally, covering substances, pharmaceutical products, medicinal products, units of measurement, and controlled vocabularies. * **xEVMPD (External Vigilance Medicinal Product Dictionary):** The current EMA database (also known as the Article 57 database) that stores structured data about authorized medicinal products for pharmacovigilance and other regulatory activities. * **SPOR (Substances, Products, Organizations, Referentials):** EMA's master data management system designed to support IDMP implementation, providing centralized, authoritative sources for key regulatory data. * **PMS (Product Master Services):** The future component of SPOR that will serve as EMA's central database for IDMP-compliant medicinal product data, replacing xEVMPD. * **Fire Message (FHIR):** A standard for exchanging healthcare information electronically, adopted by EMA for submitting IDMP-compliant product data to PMS. * **EIG (European Implementation Guidance):** A document published by EMA that translates the global ISO IDMP standards into specific requirements and processes for implementation within the European Union. * **Delta Import & Feedback Loop:** Mechanisms during the IDMP transition period to ensure data synchronization between the existing xEVMPD database and the new PMS, allowing updates in one system to be reflected in the other. * **Regulatory Information Management (RIM) System:** An integrated software solution used by pharmaceutical companies to manage all aspects of their regulatory information, including product registrations, submissions, compliance, and master data. **Examples/Case Studies:** * **Packaging Data Transformation:** The webinar provided a detailed illustration of how a single "package description" text field in xEVMPD, containing free-text information about pack sizes and materials, will be replaced by a highly structured, object-oriented data model in IDMP. This new model requires defining separate objects for the box, blister, and manufacturer item (e.g., tablet), specifying materials, quantities, and generating unique identifiers (PCID) for each pack size. * **Siloed Data Management:** The speakers highlighted a common industry challenge where different departments (e.g., regulatory, marketing, production) and even individuals within those departments maintain product data in disparate systems, such as shared databases, individual Excel files, or documents. This fragmentation leads to difficulties in data access, quality, and timely updates, making IDMP compliance more arduous. * **Streamlining Administrative Variations:** An example was given of how IDMP might streamline certain administrative changes, such as a change in the Qualified Person for Pharmacovigilance (QPPV) location or a manufacturer's name. In the future, these might be directly reported to PMS via a Fire message without requiring a full regulatory assessment and eCTD submission, reducing the procedural burden on MAHs.
Patient Trust in Healthcare: 84% Trust Doctors, 33% Health Insurance Companies
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Oct 3, 2021
This video provides an in-depth exploration of patient and doctor trust within the healthcare system, drawing insights from a January 2021 survey conducted by the American Board of Internal Medicine (ABIM). Dr. Eric Bricker, the presenter, uses the survey data to highlight significant disparities in trust levels across various healthcare entities, including nurses, doctors, government, pharmaceutical companies, health insurance companies, and hospitals. The core purpose of the video is to argue that understanding these trust dynamics is fundamental for driving any meaningful change in healthcare, as trust (ethos) is the prerequisite for persuasion and action. The presentation details patient trust levels, revealing that nurses and doctors command the highest levels of confidence, with 85% and 84% trust respectively. Hospitals also receive a relatively high trust rating from patients at 72%. However, trust significantly diminishes when it comes to the government (56%), pharmaceutical companies (34%), and health insurance companies (33%). This stark contrast underscores a foundational challenge for sectors like pharmaceuticals and health insurance in engaging with the patient population. Dr. Bricker then shifts to doctor trust, presenting even more striking figures. While doctors overwhelmingly trust other doctors (94% within their practice, 85% outside), their trust in hospital executives is surprisingly low at 53%. More critically for the pharmaceutical industry, only 47% of doctors trust pharmaceutical companies, a figure lower than the general public's trust in the government regarding health matters. Trust in health insurance companies plummets to an abysmal 19% among doctors. Dr. Bricker emphasizes that according to the ancient Greek model of persuasion (ethos, pathos, logos), credibility and trust (ethos) must be established first, followed by empathy (pathos), before logic (logos) can be effectively applied. Without this foundational trust, efforts to drive change or influence behavior are largely futile. The video concludes by asserting that entities with low trust, such as health insurance companies, cannot realistically be the drivers of patient or doctor behavior change. Instead, any successful initiative for change must originate from or be channeled through highly trusted sources, primarily nurses and doctors for patients, and other doctors for physicians. This perspective offers a critical lens through which to view strategies for commercial operations, patient engagement, and professional education within the pharmaceutical and life sciences sectors, highlighting the imperative of building or leveraging existing trust. Key Takeaways: * **High Trust in Healthcare Professionals:** Patients exhibit very high levels of trust in nurses (85%) and doctors (84%), positioning these professionals as the most credible sources within the healthcare ecosystem. * **Low Patient Trust in Key Industry Players:** Patient trust in pharmaceutical companies (34%) and health insurance companies (33%) is remarkably low, indicating a significant hurdle for these sectors in direct patient engagement and communication. * **Doctor Trust Dynamics:** Doctors place extremely high trust in their peers (94% for those in their practice, 85% for those outside), suggesting that peer influence is a powerful mechanism for driving change among physicians. * **Pharmaceutical Industry's Trust Deficit with Doctors:** Only 47% of doctors trust pharmaceutical companies, a critical insight for pharma firms aiming to influence prescribing behavior or introduce new therapies. This low trust necessitates indirect or highly credible communication strategies. * **Extremely Low Doctor Trust in Insurers:** Doctors' trust in health insurance companies is exceptionally low at 19%, making insurers highly ineffective as agents of change for physician behavior. * **Foundational Role of Trust in Persuasion:** Drawing on the ancient Greek model of ethos, pathos, and logos, the video underscores that trust (ethos) is the absolute prerequisite for effective persuasion and driving any form of behavior change. * **Implications for Driving Healthcare Change:** Entities with low trust, such as health insurance companies, are unlikely to be successful drivers of patient or doctor behavior change. Efforts to change behavior must leverage or build upon existing trusted relationships. * **Strategic Communication for Pharma:** Given the low trust in pharmaceutical companies by both patients and doctors, strategies for commercial operations, medical affairs, and patient education must prioritize building credibility or working through highly trusted intermediaries like physicians and nurses. * **Leveraging Trusted Channels:** To influence patient behavior, engaging through nurses and doctors is paramount. To influence doctor behavior, peer-to-peer communication and endorsement from other trusted physicians are likely the most effective approaches. * **Challenge for Hospital Executives:** The low trust of doctors in hospital executives (53%) indicates potential internal friction and challenges in implementing top-down initiatives within hospital systems. * **Data-Driven Understanding of Ecosystem:** The survey data provides a concrete, quantitative understanding of the trust landscape, which is essential for any organization operating in or supporting the pharmaceutical and life sciences industries to design effective solutions and strategies. Tools/Resources Mentioned: * **ABIM Foundation/NORC Survey:** The video references a survey conducted by the American Board of Internal Medicine (ABIM) in January 2021, with data sourced from NORC (National Opinion Research Center at the University of Chicago). The specific source PDF link is provided in the video description: https://www.norc.org/PDFs/ABIM%20Foundation/20210520_NORC_ABIM_Foundation_Trust%20in%20Healthcare_Part%201.pdf Key Concepts: * **Ethos, Pathos, Logos:** An ancient Greek model of persuasion. * **Ethos:** Refers to the speaker's credibility or trustworthiness. The video emphasizes this as the foundational element for persuasion. * **Pathos:** Relates to appealing to the audience's emotions or empathy. * **Logos:** Involves using logic and reason to persuade. The video highlights that logic is only effective after ethos and pathos have been established.
RegTalks about Regulatory Information Management Systems (RIMS)
Asphalion
/@Asphalion.
Oct 1, 2021
This video directly addresses Regulatory Information Management Systems (RIMS) within the pharmaceutical and life sciences industries, a core area for companies seeking to optimize operations and maintain regulatory compliance. **Summary:** The "RegTalks" video, featuring Lidia Canovas from Asphalion and Frank Dickert from EXTEDO, provides an in-depth exploration of Regulatory Information Management Systems (RIMS) and their increasing importance in the pharmaceutical and life sciences sectors. The speakers define RIMS as comprehensive solutions for master product data management, regulatory activity tracking, and integrated document management, serving as a crucial "single source of truth." A central theme is the significant industry transition from xEVMPD to the complex ISO IDMP standard, which necessitates robust RIMS to handle increased data transmission and regulatory compliance. The discussion highlights how RIMS enhance operational efficiency by replacing fragmented manual systems, improve impact assessment capabilities, and are applicable across various regulated fields beyond human medicines, including animal health and medical devices. Furthermore, the video emphasizes that RIMS benefit a wide array of departments beyond regulatory affairs, such as quality, clinical, manufacturing, and supply chain, and stresses the indispensable role of experienced implementation partners in successfully deploying these complex systems. **Key Takeaways:** * **RIMS as a Foundational Compliance System:** Regulatory Information Management Systems (RIMS) are critical enterprise solutions for the life sciences, providing a "single source of truth" for master product data, regulatory activities, and integrated document management, essential for ensuring regulatory compliance and operational efficiency. * **IDMP Transition Drives RIMS Adoption:** The impending transition to the ISO IDMP standard is a major catalyst for RIMS implementation, as it significantly increases data complexity and submission requirements, necessitating sophisticated systems to manage and submit data effectively, often integrated with eCTD submissions. * **Broad Organizational Impact:** RIMS are not exclusive to regulatory affairs but serve a wide range of departments across a life sciences company, including quality, clinical, manufacturing, marketing, and supply chain, by providing centralized access to regulatory information, thereby improving cross-functional decision-making and impact assessment. * **Beyond Human Medicines:** The utility of RIMS extends beyond human pharmaceuticals to other regulated sectors such as animal health, consumer health, and medical devices (e.g., for IVDR/MDR compliance), indicating a broader market need for robust regulatory data management solutions. * **Criticality of Implementation Expertise:** Successful RIMS deployment, especially in the context of IDMP compliance, requires knowledgeable external implementation partners who can provide technical support, guide necessary process changes, and leverage deep industry experience to ensure optimal system configuration and user adoption.
What is Trials Methodology?
HRB-TMRN HRB-TMRN
/@hrb-tmrnhrb-tmrn6411
Oct 1, 2021
This video provides an in-depth exploration of randomized trials and the critical discipline of 'trials methodology.' It begins by establishing the universal importance of good health and healthcare, emphasizing that well-informed decisions are paramount for individuals. The findings of research studies, particularly randomized trials, are presented as an essential ingredient in empowering people to make these health decisions. The video then delves into the core mechanism of randomized trials, explaining how treatments are assigned randomly (often by computer) rather than by medical professionals or participants, to ensure unbiased group formation and reliable results. The presentation meticulously explains the concept of randomization, highlighting its purpose in creating groups with characteristics that are as similar as possible, such as age, gender, and ethnicity. This methodological rigor ensures that any observed differences in outcomes between groups can be confidently attributed to the treatment being tested, rather than to pre-existing variations among participants. The video underscores the profound impact of randomized trials, noting their role in testing new medicines, diagnosing conditions, developing treatments, and ultimately saving lives by identifying the most effective interventions for specific conditions or patient populations. A significant portion of the video is dedicated to introducing 'trials methodology' as a distinct field of study. This discipline focuses on continuously evaluating and improving how clinical trials are planned, conducted, and how their findings are shared. It encourages researchers to question existing practices and seek better ways to execute trials. For instance, trials methodology addresses practical challenges like making participation more relevant and easier for patients and doctors. This involves considering the optimal amount and format of information provided to potential participants, who should invite them, when contact should be made, and what support is necessary for informed decision-making. The video provides a concrete example of trials methodology in action by discussing how researchers are exploring innovative ways to present trial information, such as using video formats instead of traditional written materials, to help patients make more informed choices. Furthermore, trials methodology plays a crucial role in determining the most important 'outcomes' to measure in a trial—those aspects that patients, health professionals, and researchers agree are most relevant for a particular condition. The increasing involvement of patients and the public in trials methodology research is highlighted as a key trend, ensuring that the design and execution of trials are aligned with the needs and perspectives of those directly affected. Key Takeaways: * **Foundation of Informed Healthcare Decisions:** Randomized trials are presented as a cornerstone of evidence-based healthcare, providing essential findings that enable individuals to make well-informed decisions about their health and treatment options. * **Mechanism and Purpose of Randomization:** Randomization involves assigning treatments randomly to participants, typically by computer, to create groups with highly similar characteristics. This crucial step ensures that any observed differences in results are attributable to the treatment itself, not to confounding factors among participants. * **Definition of Trials Methodology:** Trials methodology is an academic discipline focused on systematically studying and improving the processes of planning, conducting, and disseminating the findings of randomized trials, constantly seeking better and more efficient approaches. * **Patient-Centric Trial Design:** A core aspect of trials methodology involves making trial participation more accessible and relevant for patients. This includes optimizing the information provided, the timing of contact, and the support offered to help individuals make informed decisions about joining a trial. * **Optimizing Information Delivery:** Researchers are actively investigating more effective ways to convey trial information to potential participants, such as utilizing video formats over traditional written materials, to enhance comprehension and facilitate informed consent. * **Importance of Relevant Outcome Measures:** Trials methodology helps define and standardize the "outcomes" measured in a trial—the specific aspects of health or disease that are assessed to determine treatment efficacy. These outcomes are ideally agreed upon by patients, health professionals, and researchers to ensure their relevance. * **Patient and Public Involvement:** There is a growing emphasis on involving patients and the public directly in trials methodology research. This collaboration ensures that trial designs and processes are patient-centered and address the real-world concerns and priorities of those affected by medical conditions. * **Impact on Medical Advancement:** Randomized trials are instrumental in testing new medicines and treatments, improving diagnostic methods, and developing strategies to prevent and manage medical conditions, ultimately contributing to saving lives and enhancing public health. * **Continuous Improvement Cycle:** Trials methodology fosters a continuous cycle of evaluation and refinement, prompting researchers to constantly question existing practices and innovate in areas such as participant recruitment, data collection, and result sharing. Key Concepts: * **Randomised Trials:** A type of research study where participants are randomly assigned to different treatment groups (e.g., new medicine vs. placebo or standard care) to objectively assess the effectiveness and safety of interventions. * **Randomisation:** The process of assigning participants to treatment groups by chance, typically using a computer, to minimize bias and ensure that groups are as similar as possible in all characteristics except for the treatment received. * **Trials Methodology:** A field of study dedicated to understanding, evaluating, and improving the methods used to design, conduct, analyze, and report randomized trials, with the goal of enhancing their efficiency, relevance, and reliability. * **Outcomes:** The specific health-related events, measures, or changes that are assessed in a clinical trial to determine the effects of an intervention. These can include symptoms, quality of life, disease progression, or survival rates.
Veeva Vault Training
Albert Jhonson
/@albertjhonson5031
Sep 29, 2021
This video provides a foundational overview of a Veeva Vault training course, outlining the comprehensive curriculum designed to familiarize users with this cloud-based content management solution. The speaker details the various modules and functionalities that will be covered, emphasizing Veeva Vault's superiority in storing documents in a structured manner compared to other cloud solutions. The training is structured to guide participants from basic navigation and user interface understanding to advanced administrative tasks, configurations, and deployment processes, making it suitable for individuals seeking to master the platform for life science industry applications. The course begins with an introduction to the Veeva Vault user interface, including the home page, and then progresses into fundamental operations such as user creation, document creation, editing, and annotation. It covers how documents are displayed within the home directory, leading into the generation of reports and dashboards for data visualization and operational insights. A significant portion of the training is dedicated to the administration section, which delves into business administration, log management, user and group creation, and detailed configurations. This administrative focus ensures that participants understand not only how to use the system but also how to manage and customize it to meet specific organizational needs. Further into the curriculum, the training explores advanced concepts like object and document lifecycles, workflows, and deployment processes. It meticulously breaks down each module, starting with an overview of Veeva Vault, followed by basic navigation and search/filtering techniques. Document operations, including adding, copying, and versioning, are covered in detail, alongside security profiles and mail notifications. The course culminates in an in-depth look at configurations, specifically addressing document types, document fields, and the intricate design of document and object workflows, which are crucial for maintaining regulatory compliance and operational efficiency within the life sciences sector. Key Takeaways: * **Veeva Vault as a Cloud-Based Content Management Solution:** The training positions Veeva Vault as a superior cloud solution for structured document storage and management, highlighting its benefits over generic cloud platforms, particularly for the life sciences industry. * **Comprehensive UI and Navigation Understanding:** Participants will gain a thorough understanding of the Veeva Vault user interface, including the home page, and learn essential navigation techniques to efficiently locate and interact with content. * **Core Document Management Operations:** The course covers critical document operations such as creation, editing, annotation, and versioning, which are fundamental for maintaining accurate and controlled documentation within regulated environments. * **User and Group Administration:** A key focus is placed on user creation, group management, and security profiles, ensuring that administrators can effectively control access and permissions within the Veeva Vault system. * **Reporting and Dashboard Capabilities:** The training includes modules on generating reports and creating dashboards, enabling users to extract actionable insights from their data and monitor key operational metrics. * **In-depth Configuration Management:** The curriculum extensively covers configurations, including the setup of document types, document fields, and the intricate design of document and object lifecycles, which are vital for tailoring the system to specific business processes and regulatory requirements. * **Workflow Automation and Management:** A significant portion of the training is dedicated to understanding and implementing document and object workflows, which are essential for automating processes, ensuring compliance, and streamlining content review and approval cycles. * **Business Administration and Operational Logs:** The course delves into business administration tasks and the management of system logs, providing insights into auditing, troubleshooting, and maintaining the health of the Veeva Vault environment. * **Deployment and System Settings:** Participants will learn about the deployment process for changes within Veeva Vault and how to manage overall system settings, crucial for system maintenance and updates. * **Security and Compliance Focus:** While not explicitly detailed in the transcript, the emphasis on structured content management, user/group security, lifecycles, and workflows inherently supports regulatory compliance (e.g., GxP, 21 CFR Part 11) by ensuring data integrity and auditability. * **Practical Skill Development:** The course is designed to provide practical skills for end-users and administrators alike, moving from basic usage to advanced system configuration and management, enabling efficient utilization of Veeva Vault in a professional setting. **Tools/Resources Mentioned:** * **Veeva Vault:** A cloud-based content management solution specifically designed for the life sciences industry. **Key Concepts:** * **Cloud-Based Solution:** Refers to software and services that run on the Internet instead of locally on your computer, offering scalability, accessibility, and reduced infrastructure overhead. * **Content Management:** The process of organizing, storing, and managing digital content, including documents, images, and other media, throughout its lifecycle. * **Document Lifecycle:** The various stages a document goes through from creation to archiving or deletion, often involving review, approval, and version control. * **Object Lifecycle:** Similar to document lifecycle but applied to specific data objects within the system, defining their states and transitions. * **Workflows:** Automated sequences of tasks or processes that guide content through various stages, ensuring consistency, compliance, and efficiency. * **User Interface (UI):** The visual part of a computer application or website that allows users to interact with it. * **Reports and Dashboards:** Tools for visualizing data and presenting key information in an understandable format, aiding in decision-making and performance monitoring. * **Configurations:** The settings and parameters that define how a software system operates, allowing customization to specific organizational needs.
Employee Demographics - Why Amazon Care Will Fail
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Sep 19, 2021
This video provides an in-depth exploration of why employer-sponsored healthcare initiatives, specifically Amazon Care, may struggle to achieve widespread impact due to fundamental differences in employee demographics and associated healthcare costs. Dr. Eric Bricker, the speaker, begins by establishing that the three top diagnostic categories driving employee health plan spend are musculoskeletal conditions (primarily osteoarthritis), cardiovascular diseases (heart attacks, strokes, diabetes), and cancer. He then posits that age is the single greatest risk factor and driver of costs for all these conditions, as bodies naturally deteriorate with age, leading to increased health issues. The speaker supports this claim with specific data from Health Affairs, illustrating a dramatic increase in per-person per-year healthcare costs with age: from $3,628 for under 18s to $18,424 for those 65 and older. He highlights that working populations over 44 years old cost almost double those under 44. This foundational understanding of age as the primary cost driver sets the stage for his critique of Amazon Care. He contrasts the median age of employees in various industries, noting that "older" industries like government (45.6 years), manufacturing (44.4 years), education (43.9 years), and transportation (43.9 years) have median ages significantly above the national average of 42.5 years. Conversely, Dr. Bricker points out that major tech companies like Facebook (28 years), Google (30 years), Apple (31 years), Amazon (31 years), and Microsoft (33 years) have significantly younger workforces. He argues that for these tech giants, employee healthcare is often a "hobby" rather than an "existential threat" because their young, relatively healthy employees incur much lower healthcare costs. Consequently, solutions developed within this context, such as Amazon Care, are designed for a demographic that doesn't face the severe healthcare cost challenges plaguing older industries. The video concludes by suggesting that true innovation and change in employer-sponsored healthcare will emerge from organizations with an "existential threat" – those with older employee populations and consequently higher healthcare burdens, such as state governments, municipalities, school systems, and manufacturing firms. Key Takeaways: * **Age is the Primary Driver of Healthcare Costs:** The video emphatically states that age is the greatest risk factor for the top three diagnostic categories driving employee health plan spend: musculoskeletal, cardiovascular, and cancer. As employees age, their bodies are more prone to these conditions, leading to significantly higher healthcare expenditures. * **Significant Cost Discrepancy by Age Group:** Healthcare costs per person per year escalate dramatically with age. For instance, individuals aged 45-64 cost nearly double those aged 19-44, demonstrating that older workforces inherently incur much higher healthcare expenses. * **Industry Demographics Impact Healthcare Spend:** There's a stark contrast in median employee ages across industries. "Older" industries like government, manufacturing, education, and transportation have median ages significantly above the national average, leading to higher underlying healthcare problems and costs. * **Tech Companies Have a Unique Healthcare Advantage:** Major tech companies (e.g., Facebook, Google, Amazon) boast significantly younger workforces (median ages in the late 20s to early 30s). This demographic advantage means their employees are generally healthier and incur substantially lower healthcare costs. * **Healthcare as a "Hobby" vs. "Existential Threat":** For tech companies with young employees, healthcare costs are often manageable, making it a "hobby" or a perk rather than a critical financial burden. In contrast, for industries with older workforces, healthcare costs can become an "existential threat" to their financial viability. * **Amazon Care's Demographic Mismatch:** Amazon Care, developed for Amazon's young employee base (median age 31), is fundamentally misaligned with the demographics of most other industries facing severe healthcare cost problems. Solutions designed for a young, healthy population are unlikely to be effective or scalable for older, sicker populations. * **Where True Healthcare Innovation Emerges:** Genuine innovation in employer-sponsored healthcare is more likely to originate from organizations facing an "existential threat" from high healthcare costs. These are typically industries with older workforces, such as state and local governments, school systems, and manufacturing companies. * **Examples of Progressive Organizations:** The video cites examples like the State of Montana and the manufacturing company Serigraph as organizations that have successfully implemented changes to address their employee healthcare problems due to their significant "itch" (high costs). * **The "Itch and Scratch" Analogy:** The speaker uses the analogy of an "itch" (poor employee health and high costs) and a "scratch" (healthcare solutions). He argues that tech companies lack a major "itch," thus their "scratches" (solutions) may not be robust enough for those with a severe "itch." * **Technology Adoption Life Cycle in Healthcare:** The video implicitly touches upon the technology adoption life cycle, suggesting that early adopters and pragmatists in industries with high healthcare costs are the ones driving significant change, rather than those without a compelling need. * **Healthcare is Not a Monolith:** Employer-sponsored health plans are highly diverse, primarily due to the varying age and health profiles of employee populations. Solutions must be tailored to these demographic realities, rather than assuming a one-size-fits-all approach. * **Focusing the Mind with Existential Threats:** The speaker emphasizes that "nothing focuses the mind better than an existential threat." This implies that organizations facing severe financial pressure from healthcare costs are more motivated to find and implement truly transformative solutions. Tools/Resources Mentioned: * **Health Affairs:** Cited as a source for healthcare costs by age. * **Bureau of Labor Statistics (BLS):** Cited as a source for employee age by industry. * **Business Insider:** Cited as a source for tech company employee age. * **"16 Lessons in the Business of Healing":** A book by Dr. Bricker, mentioned as a resource for viewers. Key Concepts: * **Employee Demographics:** The statistical characteristics of a workforce, particularly age, which the video highlights as a critical determinant of healthcare costs. * **Healthcare Spend Drivers:** The underlying factors that contribute to the overall cost of healthcare, with age identified as the most significant. * **"Itch and Scratch" Analogy:** A framework used to explain the relationship between a problem (the "itch" of poor health and high costs) and its corresponding solution (the "scratch" of healthcare interventions). * **Technology Adoption Life Cycle:** A sociological model describing the adoption or acceptance of a new product or innovation, applied here to the adoption of healthcare solutions by different types of organizations. Examples/Case Studies: * **Amazon Care:** Used as the central example of a healthcare initiative developed within a demographic context (young tech employees) that the speaker argues makes it unsuitable for broader application. * **State of Montana:** Highlighted as a progressive organization that successfully addressed its state employee health problem, likely due to having an older workforce and thus a significant "itch." * **Serigraph:** A manufacturing company whose CEO wrote a book about solving healthcare, presented as another example of an organization driven by necessity to innovate. * **Cities, Municipalities, and School Systems:** Mentioned as organizations in states like Colorado and Wisconsin that have implemented on-site or near-site clinics due to high healthcare costs, demonstrating localized innovation.
Health Insurance Carrier Earnings Calls: Learn Their TRUE Strategy
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Sep 12, 2021
This video provides an in-depth exploration of the true strategic priorities of major health insurance carriers in the United States, as revealed through their Q2 2021 investor earnings calls. Dr. Eric Bricker analyzes the conference calls of industry giants like UnitedHealth Group, CVS Health, Cigna, and Anthem, aiming to uncover what these companies communicate to their investors as their primary drivers of growth and profitability. The analysis highlights a significant divergence between the perceived focus of these carriers and their actual financial strategies, particularly concerning employer-sponsored health plans versus government programs and Pharmacy Benefit Managers (PBMs). The core finding of the video is that the primary growth engines for these large health insurance carriers are government programs, specifically Medicare Advantage and Medicaid managed care, and an increase in script counts for their PBM businesses. Dr. Bricker points out that every single one of these companies emphasized these two areas as their sources of growth. Conversely, there was a striking absence of any mention of employer-sponsored health plans as a growth driver. This creates a disconnect, as the digital health sector, fueled by significant venture capital and private equity investment (e.g., $14 billion in 2020), is heavily focused on creating innovative solutions for employer health plans. The speaker contrasts the market capitalization of digital health innovators like Teledoc with that of established carriers, suggesting missed opportunities for the latter if they were truly focused on innovation in the employer space. Dr. Bricker explains this apparent contradiction by characterizing health insurance carriers as "fast-followers" rather than true innovators. He recounts a personal experience where a large carrier admitted to copying successful solutions from smaller, agile companies. This strategy allows them to offer "just good enough" services to retain employer clients without investing heavily in R&D for this segment. The video further reveals that carriers strategically utilize employer-sponsored plans to negotiate less favorable PPO network discounts with hospital systems. These PPO contracts, while not optimal for employers, enable the carriers to secure much lower HMO allowed amounts, which they then leverage for their more profitable Medicare Advantage and Medicaid managed care members. The speaker underscores the financial motivation, noting that the margin on a Medicare Advantage beneficiary is significantly higher ($1600 per year) than that for an employer-sponsored plan member ($800 per year), making government programs both faster-growing and more profitable. The video concludes by advising employers to listen to the investor calls of their health insurance carriers to understand their genuine priorities. This insight is critical for any entity operating within the broader healthcare ecosystem, including pharmaceutical and life sciences companies, as the strategic decisions of major payers directly influence market access, drug utilization, and commercial success. By understanding where these carriers derive their growth and profit, other industry players can better anticipate market shifts and align their own strategies. Key Takeaways: * **Primary Growth Drivers for Health Insurance Carriers:** Major health insurance carriers like UnitedHealth Group, CVS Health, Cigna, and Anthem primarily derive their growth from government programs (Medicare Advantage and Medicaid managed care) and increased prescription script counts for their integrated PBM businesses (e.g., OptumRx, Caremark, Express Scripts). * **Employer Plans are Not a Growth Priority:** Despite significant market activity, employer-sponsored health plans are explicitly not considered a source of growth by these large carriers in their investor communications. This indicates a strategic de-prioritization of this segment. * **Disconnect in Innovation Investment:** There's a stark contrast between the carriers' lack of focus on employer plans and the substantial venture capital and private equity investment ($14 billion in 2020) pouring into digital health companies specifically creating innovative solutions for employer-sponsored health plans. * **"Fast-Follower" Strategy:** Health insurance carriers tend to be "fast-followers" rather than innovators, preferring to copy successful digital health solutions developed by smaller, agile companies. Their goal is to offer "good enough" services to retain employer clients, not to lead innovation in this space. * **Strategic Use of Employer Plans:** Carriers leverage their employer-sponsored health plans to negotiate PPO network discounts with hospital systems that are "not so hot" for employers. This allows them to secure much lower HMO allowed amounts, which are then utilized for their more profitable Medicare Advantage and Medicaid managed care members. * **Higher Profitability of Government Programs:** Medicare Advantage beneficiaries yield significantly higher profit margins (approximately $1600 per person per year) compared to members on employer-sponsored health plans (approximately $800 per person per year). This financial incentive drives the carriers' strategic focus. * **Implications for Pharmaceutical Commercial Operations:** The emphasis on PBM script counts as a growth driver directly impacts pharmaceutical companies. Understanding this priority is crucial for optimizing market access strategies, drug utilization, and overall commercial success within the pharmaceutical and life sciences sectors. * **Market Access Strategy Context:** For pharmaceutical companies, understanding the payer landscape, particularly the financial drivers of major health insurance carriers and PBMs, is essential for developing effective market access and reimbursement strategies for their products, especially concerning government programs like Medicare Advantage and Medicaid. * **Data-Driven Strategic Insights:** The video highlights the value of analyzing public financial statements and investor calls to uncover the true strategic priorities of key players in the healthcare ecosystem, providing actionable intelligence for other stakeholders. * **Understanding Payer Behavior:** Pharmaceutical and life sciences firms need to recognize that large payers prioritize segments with higher growth and profitability. This understanding should inform how they engage with these payers for product placement, formulary inclusion, and patient access initiatives. Key Concepts: * **Medicare Advantage:** A type of Medicare health plan offered by a private company that contracts with Medicare to provide all your Part A and Part B benefits. * **Medicaid Managed Care:** A system where states contract with managed care organizations (MCOs) to provide healthcare services to Medicaid beneficiaries. * **PBM (Pharmacy Benefit Manager):** A third-party administrator of prescription drug programs for commercial health plans, self-insured employer plans, Medicare Part D plans, the Federal Employees Health Benefits Program, and state government employee plans. * **PPO (Preferred Provider Organization):** A type of health plan where you pay less if you use providers in the plan's network. * **HMO (Health Maintenance Organization):** A type of health insurance plan that usually limits coverage to care from doctors who work for or contract with the HMO. * **Digital Health:** The convergence of digital technologies with health, healthcare, living, and society to enhance the efficiency of healthcare delivery and make medicine more personalized and precise. Examples/Case Studies: * **Health Insurance Carriers:** UnitedHealth Group (with OptumRx PBM), CVS Health (with Caremark PBM), Cigna (with Express Scripts PBM), and Anthem (with its own PBM). * **Digital Health Company:** Teledoc, cited for its significant market capitalization ($22.6 billion) as an example of successful innovation in digital health, contrasting with the carriers' slower adoption.
FDA Pharmaceutical Industry Ties
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Sep 6, 2021
This video, presented by Dr. Eric Bricker of AHealthcareZ, delves into the intricate and often problematic financial and personnel ties between the U.S. Food and Drug Administration (FDA) and the pharmaceutical industry it is tasked with regulating. Drawing insights from a 2021 New York Times opinion piece by Farhad Manjoo, Dr. Bricker explores two primary areas of potential conflict of interest: the FDA's funding model and the "revolving door" phenomenon where regulators transition to industry roles. The overarching purpose is to highlight systemic issues that may compromise the FDA's impartiality and, consequently, drug safety for patients, prompting a discussion on how physicians should approach prescribing newly approved medications. The speaker details a significant shift in FDA funding that occurred in 1992, where the agency began collecting fees directly from pharmaceutical companies to cover the salaries of FDA employees. This arrangement, which includes "performance guarantees" from the FDA related to the speed of drug reviews, creates a direct financial link between the regulator and the regulated, raising concerns about "regulatory capture." Dr. Bricker emphasizes that this model means the industry itself funds the very body designed to oversee it, inherently creating grounds for a conflict of interest that could prioritize speed of approval over thoroughness or safety. Further exacerbating these concerns is the "revolving door" phenomenon, where FDA personnel, particularly those involved in drug approval, leave their government positions to take up more lucrative roles within the pharmaceutical industry. The video cites an example of over 13 cancer drug reviewers making this transition. A particularly egregious case highlighted is that of Curtis Wright, the FDA regulator specifically responsible for Oxycontin, who subsequently left the FDA to work for Purdue Pharma, the manufacturer of Oxycontin and a central figure in the opioid epidemic. These instances suggest a potential for regulators to be overly lenient in the approval process, possibly with an eye toward future employment opportunities within the industry. The consequences of these ties are illustrated by a troubling statistic: one-third of drugs approved by the FDA between 2000 and 2010 were later found to have safety problems during Phase 4 post-market surveillance. In response to these systemic issues, Dr. Bricker shares a practical recommendation from his residency training at Johns Hopkins: physicians might consider waiting five years after a new drug's approval before prescribing it, especially if other proven and safe alternatives exist. This allows for more extensive real-world data collection and identification of issues missed in initial clinical trials, as seen with drugs like Vioxx, Avandia, and Zelnorm. While acknowledging exceptions for critical medications with no alternatives, such as the COVID vaccine, the video concludes with a strong call for fundamental changes to the FDA's funding and operational structure to restore public trust and ensure unbiased regulation. Key Takeaways: * **FDA Funding Model Conflict:** Since 1992, the FDA has received funding directly from pharmaceutical companies to pay employee salaries, creating a direct financial tie and potential conflict of interest, as the regulated industry funds its regulator. * **Performance Guarantees:** In exchange for industry funding, the FDA reportedly offered "performance guarantees" related to the speed of drug reviews, suggesting a prioritization of efficiency that could compromise thoroughness. * **High Incidence of Post-Approval Safety Issues:** A significant concern is that one-third of drugs approved by the FDA between 2000 and 2010 were later found to have safety problems during Phase 4 post-market surveillance, indicating potential gaps in the initial approval process. * **The "Revolving Door" Phenomenon:** Many FDA regulators transition to high-paying jobs within the pharmaceutical industry after their tenure, raising ethical questions about potential leniency during their regulatory roles. * **Egregious Example of Conflict:** The case of Curtis Wright, the FDA regulator for Oxycontin, who later worked for Purdue Pharma, serves as a stark illustration of how the "revolving door" can lead to severe conflicts of interest with public health consequences. * **Physician's Prudent Prescribing Strategy:** A recommendation from Johns Hopkins suggests physicians consider waiting five years after a new drug's approval before prescribing it, allowing for more robust post-market safety data to emerge. * **Importance of Phase 4 Surveillance:** This waiting period emphasizes the critical role of Phase 4 post-market surveillance in identifying adverse effects or safety issues that may not be apparent during pre-market clinical trials. * **Historical Precedents for Caution:** Past examples like Vioxx (increased cardiovascular risk), Avandia (poor cardiovascular outcomes), and Zelnorm (liver function problems) underscore the historical basis for exercising caution with newly approved medications. * **Exceptions for Unmet Needs:** The strategy of waiting five years is not absolute; in situations where no other effective treatment options exist (e.g., the COVID vaccine), the immediate use of new drugs may be justified, balancing risks and benefits. * **Broader Regulatory Context:** When evaluating critical new drugs, especially in global health crises, considering approvals by multiple international regulatory agencies can provide an additional layer of validation beyond the FDA's assessment. * **Call for Systemic Reform:** The video advocates for fundamental changes to the FDA's funding and operational structure to eliminate conflicts of interest, enhance regulatory independence, and rebuild public trust in drug approval processes. Tools/Resources Mentioned: * New York Times article by Farhad Manjoo (September 2, 2021) * AHealthcareZ video on Regulatory Capture * AHealthcareZ video on Stages of Drug Approval Key Concepts: * **Regulatory Capture:** A form of political corruption that occurs when a regulatory agency, created to act in the public interest, instead advances the commercial or political concerns of special interest groups that dominate the industry or sector it is charged with regulating. * **Post-Market Surveillance (Phase 4):** The ongoing monitoring of a drug's safety and effectiveness after it has been released to the market and is being used by the general public. This phase is crucial for detecting rare or long-term side effects that may not have been observed during clinical trials. * **Conflict of Interest:** A situation in which a person or organization has a vested interest—financial, personal, or otherwise—that could potentially bias their judgment or actions in a professional or official capacity. * **Quid Pro Quo:** A favor or advantage granted or expected in return for something. In this context, it refers to the implied exchange of industry funding for faster drug review times or future job opportunities. Examples/Case Studies: * **Curtis Wright and Oxycontin:** The FDA regulator responsible for Oxycontin who later took a job with Purdue Pharma, the drug's manufacturer, illustrating a direct "revolving door" conflict. * **Vioxx:** A pain medication found to increase cardiovascular and stroke risk after its approval. * **Avandia:** A diabetes medication found to increase poor cardiovascular outcomes post-approval. * **Zelnorm:** An IBS medication taken off the market due to problems with liver function. * **COVID Vaccine:** Cited as an example of a critical new drug where immediate use was justified due to the lack of alternatives and global pandemic circumstances, despite broader concerns about FDA processes.
portatour® route planner for Veeva CRM – demo video
portatour®
/@portatour
Sep 1, 2021
This video provides an in-depth exploration of portatour®, an artificial intelligence route planning system designed to integrate seamlessly with Veeva CRM for pharmaceutical field representatives. The primary purpose of the video is to demonstrate how this solution helps reps achieve their cycle plan goals, optimize their schedules, minimize driving time, and ultimately increase customer visits. It highlights the inefficiencies of manual planning and positions portatour as a user-friendly, automated solution that leverages AI to enhance commercial operations within the life sciences sector. The video begins by outlining the common challenges faced by field reps, such as Robert Rep, who struggle to manually plan visits to Healthcare Professionals (HCPs) while adhering to cycle plan goals, prioritizing accounts, and minimizing driving distances. It illustrates how traditional planning methods are time-consuming and often result in missed targets despite significant effort. Portatour addresses this by reading critical data directly from Veeva CRM, including customer addresses, cycle plan targets, achieved calls, last call dates, remaining calls, saved appointments, and office best times. An artificial intelligence algorithm then analyzes this information to select optimal customers for each day, considering geographical proximity and historical traffic data, to generate highly efficient routes. The core output of portatour is the "magic calendar," where these optimized call suggestions are automatically written back into the Veeva CRM calendar. This feature intelligently distributes remaining calls throughout the cycle plan, taking into account existing appointments and filling any gaps, ensuring reps have a complete and optimized schedule. The solution maintains a user-friendly experience by allowing reps to continue working within their familiar Veeva CRM mobile environment. Furthermore, the video introduces "portatour anywhere," a web-based interface that provides reps with a visual map of their territory, color-coding customers based on visit urgency (green for recently visited, yellow for due, red for overdue), allowing for quick strategic oversight and route adjustments. The video concludes by detailing the simple deployment process for portatour within an existing Veeva CRM environment. This involves an initial analysis of the Veeva installation, followed by installation as a managed solution and collaborative configuration based on the client's business strategy. A pilot project with a limited number of reps is recommended for initial rollout. The pricing model is presented as Software-as-a-Service (SaaS), with ongoing costs per user per month and one-time costs for the base license and rollout project. The video emphasizes a clear return on investment, stating that portatour pays off by optimizing mileage by more than two percent or achieving two additional calls per month, with expected performance increases of up to 25%. Key Takeaways: * **AI-Powered Route Optimization:** Portatour is an artificial intelligence system specifically designed to automate and optimize route planning for pharmaceutical field reps using Veeva CRM, significantly reducing manual planning effort. * **Seamless Veeva CRM Integration:** The system directly reads essential data from Veeva CRM, such as customer addresses, cycle plan targets, call history, and existing appointments, and writes optimized schedules back into the Veeva CRM calendar, ensuring a cohesive workflow. * **Enhanced Cycle Plan Achievement:** By automatically prioritizing and scheduling calls based on cycle plan goals and customer urgency, portatour helps reps consistently meet their targets and visit more customers. * **Minimized Driving Time and Increased Efficiency:** The AI algorithm considers geographical proximity and historical traffic data to create the most efficient routes, minimizing driving time and enabling reps to conduct more calls per day. * **"Magic Calendar" for Automated Schedules:** Reps receive a pre-populated, optimized weekly schedule directly within their Veeva CRM calendar, which intelligently distributes remaining calls and fills gaps, simplifying their daily planning. * **User-Friendly Experience:** Field reps continue to operate within their familiar Veeva CRM mobile interface, making the portatour connector a non-disruptive and intuitive solution. * **Visual Territory Management:** The "portatour anywhere" web application provides a visual map of the rep's territory, color-coding customers by visit urgency (green, yellow, red), allowing for quick strategic overview and identification of high-priority visits. * **Strategic Deployment Process:** Rolling out portatour involves an initial analysis of the existing Veeva CRM installation, installation as a managed solution, collaborative configuration, and a recommended pilot project for smooth adoption. * **Clear Return on Investment (ROI):** The solution is presented with tangible ROI metrics, indicating it pays off by optimizing mileage by over two percent or enabling two additional calls per rep per month, with potential performance increases of up to 25%. * **SaaS Pricing Model:** Portatour is offered as a Software-as-a-Service, including all updates and support, with ongoing per-user monthly costs and one-time costs for the base license and the initial rollout project. * **Free Admin/Supervisor Accounts:** A notable benefit is that administrative and supervisor accounts are free, reducing overall licensing costs for the organization. * **Focus on Pharma Field Reps:** The solution is specifically tailored for the unique needs of pharmaceutical field representatives, addressing challenges related to HCP visits and cycle plan management in a regulated environment. Tools/Resources Mentioned: * Veeva CRM * portatour® (AI route planning system) * portatour® anywhere (web-based map interface) Key Concepts: * **Cycle Plan:** A strategic plan in Veeva CRM defining how often specific Healthcare Professionals (HCPs) need to be visited based on priority and potential. * **AI Algorithm:** The core intelligence of portatour that analyzes various data points to optimize call schedules and routes. * **Geographic Optimization:** The process of planning routes to minimize driving distances and time between customer visits. * **Managed Solution:** A deployable package in Veeva CRM that allows for easy installation and management of the portatour connector. * **SaaS (Software as a Service):** A software licensing and delivery model in which software is licensed on a subscription basis and is centrally hosted.
GE Healthcare: Jeff Immelt's Autobiography Reveals Why Zero Growth
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Aug 29, 2021
This video provides an in-depth exploration of GE Healthcare's stagnant growth over a decade, using insights from former GE CEO Jeff Immelt's autobiography, "Hot Seat." Dr. Eric Bricker, the speaker, uses GE Healthcare as a case study to illustrate how established business models can become significant barriers to innovation and adaptation within the broader healthcare industry. The analysis delves into the underlying economic drivers that prevent large organizations from embracing new technologies and market shifts, ultimately leading to missed opportunities and underperformance compared to more agile competitors. The core of the video's argument centers on GE Healthcare's business model, which relies on selling medical devices like CT scanners, MRI machines, and ventilators at cost, and then generating the vast majority of its profit from subsequent service contracts for maintenance and repairs. This model, while historically profitable, creates a perverse incentive: improving product efficiency or durability directly reduces the lucrative service revenue. Immelt's attempt to counter this with "GE Digital," an initiative aimed at leveraging the Internet of Things (IoT) to make GE devices more efficient and easier to service, was met with internal resistance and eventually abandoned because it threatened the existing revenue streams. Dr. Bricker extends this specific example to a broader critique of large, bureaucratic organizations within healthcare, including hospitals and Pharmacy Benefit Managers (PBMs). He argues that many are "married to their old business models"—such as fee-for-service in hospitals or commission-based structures in PBMs—making it incredibly difficult for them to pivot towards patient-centered care, prevention, or other innovative approaches. The video contrasts GE Healthcare's stagnation with the rapid growth of newer, technology-focused companies like Health Catalyst (software analytics), Teledoc (virtual visits), and Veeva Solutions (cloud computing for biopharma), highlighting how GE missed opportunities to acquire or develop similar capabilities, leading to a significant loss of market capitalization and relevance in emerging healthcare sectors. Key Takeaways: * **Business Model as an Innovation Barrier:** GE Healthcare's reliance on service contracts for maintenance and repairs created a disincentive for developing more durable or efficient medical devices. This illustrates how an established revenue model can actively hinder product innovation and digital transformation efforts. * **Organizational Resistance to Change:** Jeff Immelt's "GE Digital" initiative, aimed at improving product efficiency through IoT, failed due to internal organizational revolt. This highlights the profound challenge large, established companies face when attempting to disrupt their own profitable, albeit outdated, business practices. * **Economic Models Drive Behavior:** The video emphasizes that the underlying economic business model of an organization ultimately dictates its actions and priorities. In healthcare, this means that despite discussions of patient-centeredness or prevention, the fee-for-service model often ensures that revenue generation from procedures and treatments prevails. * **Stagnant Growth in Established Giants:** GE Healthcare experienced near-zero growth (0.69% CAGR) over a decade, significantly underperforming competitors like Medtronic (7% CAGR). This demonstrates the severe consequences of failing to adapt and innovate in a dynamic industry. * **Missed Opportunities in Emerging Technologies:** GE Healthcare failed to capitalize on the rise of new healthcare technology companies. It missed opportunities to acquire or develop capabilities in areas like software analytics (Health Catalyst), virtual care (Teledoc), and cloud computing for biopharma (Veeva Solutions), all of which achieved substantial market capitalization during GE's stagnant period. * **The Rise of Agile Innovators:** Companies like Health Catalyst ($2.7B market cap), Teledoc ($22.8B market cap), and Veeva Solutions ($50B market cap) emerged and thrived by focusing on software, data, and cloud-based solutions, demonstrating the market's demand for innovative, technology-driven healthcare services. * **Veeva Solutions as a Benchmark:** The explicit mention of Veeva Solutions, founded in 2007 and achieving a $50 billion market capitalization by 2021 through cloud computing for the biopharma industry, underscores the immense value created by specialized, digitally native solutions in the life sciences sector. * **Challenges for Large Bureaucratic Organizations:** The video concludes that large, bureaucratic organizations often struggle to break from their past and adapt to new market realities, even when leadership recognizes the need for change. This suggests that innovation is more likely to come from outside these established structures. * **Implications for Career Choices:** For individuals aspiring to drive significant change in healthcare, the speaker advises against working for large, established healthcare companies, suggesting that their inherent resistance to change makes impactful innovation difficult from within. * **The Power of Data and Analytics:** The success of Health Catalyst highlights the growing importance of software analytics for hospital systems, a domain where traditional hardware manufacturers like GE Healthcare failed to establish a strong presence. * **Transparency from Retired Leaders:** Jeff Immelt's autobiography is presented as a valuable source of candid insights, as retired leaders are often more forthright about organizational challenges and failures than when they are actively in their roles. **Tools/Resources Mentioned:** * **"Hot Seat" by Jeff Immelt:** Autobiography of the former CEO of GE. * **Bloomberg.com:** Financial news and data source. * **Veeva.com:** Website for Veeva Solutions. * **Macrotrends.net:** Financial data website (used for Medtronic revenue). * **Statista.com:** Statistics portal (used for GE Healthcare revenue). **Key Concepts:** * **Compound Annual Growth Rate (CAGR):** A measure of the annual growth rate of an investment over a specified period longer than one year. * **Planned Obsolescence:** The practice of designing products to have a limited lifespan, often to encourage repeat purchases or service contracts. In this context, it refers to the disincentive to create highly durable products. * **Fee-for-Service:** A payment model in healthcare where services are unbundled and paid for separately, often criticized for incentivizing volume over value or prevention. * **Internet of Things (IoT):** A network of physical objects embedded with sensors, software, and other technologies for the purpose of connecting and exchanging data with other devices and systems over the internet. * **P/E Ratio (Price-to-Earnings Ratio):** A valuation ratio of a company's current share price compared to its per-share earnings. **Examples/Case Studies:** * **GE Healthcare's Stagnation:** Revenue growth of only 0.69% CAGR from $16.9B (2010) to $18.1B (2020), compared to Medtronic's 7% CAGR during the same period. * **GE Capital's Unwinding:** The financial crisis of 2008-2009 decimated GE Capital, a banking division that constituted half of GE's revenue, leading to its eventual divestment. * **Failure of GE Digital:** An initiative to improve the efficiency of GE's industrial products through IoT, which was abandoned due to internal resistance from divisions reliant on service contract revenue. * **Success of Health Catalyst:** A software analytics company for hospital systems, achieving a $2.7 billion market capitalization. * **Success of Teledoc:** A virtual visit company, achieving a $22.8 billion market capitalization. * **Success of Veeva Solutions:** A cloud computing provider for the biopharma industry, founded in 2007 and achieving a $50 billion market capitalization.
QMS Software Overview of The Lean Machine - Quality, Risk, and Material Management
Total Lean Management Software
/@totalleanmanagementsoftwar8554
Aug 21, 2021
This video provides an in-depth overview of "The Lean Machine," an all-in-one Quality Management Software (QMS) solution designed to help businesses optimize resource utilization, manage risks, and ensure continuous improvement. The presenter, David, highlights how the software addresses the critical need for organizations to get and stay organized, orchestrating resources effectively to satisfy customers and drive sales, while simultaneously identifying and mitigating risks that could otherwise squander efforts. The core message emphasizes that an effective QMS is vital for business success, and The Lean Machine is engineered to enhance this system through user-friendly, comprehensive, and integrated functionalities. The presentation systematically walks through the software's key attributes, starting with its ease of implementation and intuitive user interface. It then delves into the comprehensive nature of the system, which comprises 26 modules covering quality, risk, and material management workflows. A significant focus is placed on the system's integration capabilities, demonstrating how various modules interlink to provide a holistic view of operations, from inventory management integrated with approved parts and suppliers to document control linked with ISO standards for auditor review. The speaker underscores the importance of visible accountability, achieved through user-specific dashboards that consolidate assignments and prioritize tasks with color-coded alerts. Further, the video details the robust support structure, including direct technical assistance from the development team, and advanced communication features like integrated email alerts and server-side escalation systems. The Lean Machine's ability to integrate with existing ERP systems is presented as a major advantage, allowing quality-related data to be leveraged from enterprise-wide systems. Custom development is offered as a flexible solution for unique business requirements, ensuring the software can adapt to specific organizational needs. Finally, the presentation addresses affordability through flexible pricing and a companion web app, and critically, highlights the software's strong validation support for medical device customers, boasting a 100% success rate in first-time registration audits and a commitment to evolving with regulatory standards like ISO 9001:2015. Key Takeaways: * **Strategic Resource Management:** The Lean Machine helps businesses intelligently use limited resources (time, money, knowledge, employee motivation) by getting organized, staying organized, and orchestrating tasks towards customer satisfaction and sales, while proactively managing risks. * **User-Friendly Design:** The software is designed for ease of use and rapid implementation, featuring a consistent interface across its 26 modules, with simple navigation, filtering capabilities, and tabbed record views. * **Comprehensive Modular System:** It offers a wide array of modules covering quality, risk, and material management, allowing companies to incorporate necessary quality principles, eliminate waste, and drive continuous improvement. * **Integrated Workflows:** The system provides deep integration between modules, such as linking inventory with approved parts/suppliers and inspection plans, or connecting document control to specific ISO sections for streamlined auditing and compliance. * **Visible Accountability:** User dashboards centralize assignments, linking users directly to their tasks. Priority information is color-coded based on age and system configuration, ensuring nothing falls through the cracks and critical tasks are addressed promptly. * **Robust Communication and Escalation:** An integrated email system automates communication points, such as alerting reviewers for document approvals. A server-based alerts and escalation system sends targeted emails to users based on dashboard categories, enhancing inter-user communication for quality system tasks. * **ERP System Integration:** The Lean Machine can integrate with existing ERP systems, allowing for the import of data (e.g., PO numbers) to enrich quality processes, providing robust solutions for quality-side data management that many ERPs lack. * **Custom Development Flexibility:** The vendor offers custom development projects to add unique functionalities requested by customers, often implementing minor changes free of charge and significant efforts for a modest project fee, ensuring the software evolves with user needs. * **Affordable and Scalable Pricing:** Pricing is structured to be affordable, including all modules with permission settings to control user access. Volume discounts are available, and a companion web app offers access to released documents and training sign-offs for a larger user base, reducing the need for full desktop licenses. * **Critical Validation Support for Regulated Industries:** For medical device customers, the software provides comprehensive validation documentation sets, including pre-written test protocols and online tutorials, which are robust enough to satisfy auditors and can be executed with risk-appropriate effort. * **High Audit Success Rate:** The Lean Machine boasts a 100% success rate at first-time registration audits and has successfully navigated countless customer installations, often receiving compliments from auditors who appreciate its effectiveness. * **Commitment to Evolving Standards:** The software is continuously updated to address new regulatory requirements, such as the dedicated module for risk and opportunity requirements introduced in ISO 9001:2015, ensuring ongoing compliance. * **Direct Technical Support:** Technical support is provided directly by the development team, which serves as a strong motivator for getting features right before release and ensures faster resolution of technical issues by actual experts. Tools/Resources Mentioned: * The Lean Machine QMS * ERP Systems * Active Directory Key Concepts: * **Quality Management System (QMS):** A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. * **Risk Management:** The process of identifying, assessing, and controlling risks to an organization's capital and earnings. * **Material Management:** The process of planning, organizing, and controlling the flow of materials from their initial purchase through internal operations to the final product. * **Continuous Improvement:** An ongoing effort to improve products, services, or processes. * **ISO 9001:2015:** An international standard for quality management systems, which includes requirements for risk and opportunity management. * **Software Validation:** The process of ensuring that software meets its intended use and user requirements, particularly critical in regulated industries like medical devices and pharmaceuticals.
Deviations in QMS Software - The Lean Machine
Total Lean Management Software
/@totalleanmanagementsoftwar8554
Aug 19, 2021
This video provides an in-depth exploration of deviations within a Quality Management System (QMS) software, specifically showcasing "The Lean Machine." The presenter begins by defining a deviation as any departure from standard procedures or specifications that results in non-conforming material or processes, or an unusual event with the potential to impact product quality, system integrity, or personal safety. The core message emphasizes the critical importance of managing these deviations for compliance with Good Manufacturing Practices (GMP) and for fostering continuous improvement, particularly for FDA-regulated companies like those in the pharmaceutical sector. The discussion elaborates on the necessity of recording deviations in a formal deviation report. Such reports are required whenever there's a departure from methods or controls specified in manufacturing documents, material control documents, Standard Operating Procedures (SOPs), or when out-of-specification (OOS) results are confirmed. Furthermore, any event suggesting a real or potential quality-related problem, or even a noticeable trend requiring further investigation, mandates a deviation report. The video stresses that all batch production deviations—whether planned or unintended, covering manufacturing, equipment, operations, distribution, procedures, systems, and record-keeping—must be reported and investigated for corrective and preventive action (CAPA), irrespective of the final batch disposition. The video then transitions into a demonstration of "The Lean Machine" software's deviation module, positioning it as a tool that addresses the quality system requirement listed under ISO 9001: 10.2.2 for documenting non-conformances. The software allows for extensive customization of description fields and offers configurable layout options (e.g., three-field or five-field modes). The presenter highlights the straightforward workflow, where assigned deviations appear on users' dashboards, facilitating efficient management. A key design philosophy of "The Lean Machine" is its flexibility, enabling companies to use it at a minimum level of detail while still ensuring robust quality system procedures and aiding in the prevention of audit findings. Further features of the deviation module are explored, including optional links to affected procedures or parts, and two distinct options for trend analysis—one dedicated to the deviation module and another integrated with corrective actions, allowing for combined reporting. The system also supports configurable review processes, such as the ability to force at least one additional reviewer before a deviation is signed off and closed. Reporting capabilities are comprehensive, offering individual deviation reports, main menu trend reporting, and module-specific reporting screens with a variety of filters. These filters enable insightful data analysis, including the ability to report on deviations from different company locations, thus providing a holistic view of quality performance. Key Takeaways: * **Definition and Impact of Deviations:** A deviation is a critical departure from established procedures or specifications that can lead to non-conforming materials or processes, or an unexplained event with potential negative impacts on product quality, system integrity, or personnel safety, making its management crucial for GMP compliance and continuous improvement. * **Mandatory Reporting Scenarios:** Deviation reports are essential for documenting any departure from specified methods, controls, SOPs, confirmed out-of-specification (OOS) results, or any event indicating a real or potential quality problem, including the identification of adverse trends. * **Comprehensive Scope for Reporting:** All batch production deviations, encompassing all manufacturing facilities, equipment, operations, distribution procedures, systems, and record-keeping, must be reported and thoroughly investigated for Corrective and Preventive Actions (CAPA). * **Independence from Batch Disposition:** The requirement for a deviation report is absolute, regardless of the final disposition of the batch; even if a batch is rejected, the deviation must still be formally documented. * **QMS Compliance and ISO Standards:** Effective deviation management is a fundamental component of a Quality Management System (QMS), directly addressing requirements such as ISO 9001: 10.2.2, which mandates the documentation of non-conformances, their nature, subsequent actions, and results. * **Integrated Non-Conformance Management:** Robust QMS software, like "The Lean Machine," facilitates comprehensive non-conformance management by linking deviation modules with other related modules such as corrective actions, rejected materials, and customer feedback. * **Customization for Operational Fit:** QMS software should offer extensive customization options for data fields and layout configurations (e.g., three-field or five-field modes) to ensure it aligns precisely with a company's specific operational needs and desired level of detail. * **Streamlined Workflow and Accountability:** A well-designed deviation module provides a straightforward workflow, assigning deviations to responsible individuals and displaying them on dashboards for efficient tracking, completion, and approval, enhancing accountability. * **Mitigation of Audit Findings:** Implementing sound quality system procedures through comprehensive deviation management software is a proactive measure that helps companies avoid audit findings by ensuring proper documentation, investigation, and resolution of non-conformances. * **Advanced Trend Analysis Capabilities:** The ability to conduct trend analysis, either specifically for deviations or in combination with corrective actions, is vital for identifying recurring issues, understanding root causes, and driving strategic continuous improvement initiatives. * **Configurable Review and Reporting:** QMS systems should support flexible review processes, such as requiring multiple reviewers before sign-off, and offer diverse reporting functionalities, including individual reports, main menu trend reports, and module-specific screens with filters for location-based analysis, providing actionable insights. **Tools/Resources Mentioned:** * **The Lean Machine:** A Quality Management System (QMS) software demonstrated in the video for managing deviations and other non-conformances. **Key Concepts:** * **Deviation:** A departure from standard procedures or specifications, leading to non-conforming material/processes or an unusual event impacting quality, system integrity, or safety. * **Non-conformance:** A non-fulfillment of a requirement, often documented through deviation reports. * **Out-of-Specification (OOS) Results:** Test results that fall outside the established acceptance criteria for a product or process. * **Good Manufacturing Practice (GMP):** A system for ensuring that products are consistently produced and controlled according to quality standards. * **Corrective and Preventive Action (CAPA):** A system for investigating and correcting non-conforming products or processes (corrective action) and preventing their recurrence (preventive action). * **Quality Management System (QMS):** A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. * **ISO 9001: 10.2.2:** A specific clause within the ISO 9001 standard that outlines requirements for documenting information about non-conformances, subsequent actions, and results of corrective actions. * **Document Management System:** A system used to store, manage, and track electronic documents and electronic images of paper-based information.
What is a Medical Device (per the EU Medical Device Regulations)?
GreenSoft Technology, Inc.
/@GreenSoftTechnology
Aug 16, 2021
This video provides an in-depth exploration of what constitutes a "medical device" under the European Medical Device Regulations (EU MDR), which became mandatory for producers on May 26, 2021. The speaker's main purpose is to clarify the precise definition of a medical device, emphasizing the manufacturer's intended purpose, and to highlight key inclusions and exclusions to help companies ensure their products are compliant with the EU MDR framework. The presentation begins by establishing a broad definition: a medical device is any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used alone or in combination for human beings for one or more specific medical purposes. The video then systematically details these four crucial medical purposes that bring an item into scope: diagnosing, preventing, monitoring, predicting, or treating a disease or other ailment; diagnosing, monitoring, treating, or otherwise addressing an injury or a disability; investigating, replacing, or modifying the anatomy of a site or a physiological or pathological process or state in the body; and examining blood, tissue, or other specimens derived from the human body. A significant point of emphasis for the speaker is the explicit inclusion of "software" in the definition. This means that applications, such as an iPhone app that provides a risk analysis for headaches based on user input, are now considered medical devices and must comply with the stringent EU MDR processing. The video also clarifies that while products primarily using pharmacological, metabolic, or immunological means (i.e., pharmaceuticals) are not medical devices, devices that assist in their delivery or function (e.g., an insulin dispenser) are. Furthermore, specific items like birth control devices, fertility treatment devices, and those designed for cleaning, disinfection, or sterilization are explicitly listed as medical devices. The discussion also highlights that the regulation applies only to devices for human beings, excluding veterinary equipment. The video proceeds to provide practical examples to illustrate the breadth of the definition, such as pacemakers for modifying physiological processes, limb replacements for modifying anatomy, and home blood sugar monitors for in vitro examination of specimens. Finally, it lists several categories explicitly excluded from the EU MDR scope, including in vitro diagnostic medical devices (covered by IVDR), medicinal products, human blood and blood products, and food. A critical nuance is provided regarding products containing excluded substances: while the substance itself may not be a medical device, the overall product incorporating it could still be if its primary function aligns with the medical device definition. The speaker maintains a clear, illustrative approach, breaking down complex regulatory language into actionable insights for producers. Key Takeaways: * The EU MDR broadly defines a medical device as any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer for human beings for specific medical purposes. This "intended purpose" is the primary determinant of its regulatory status. * An item falls under the medical device definition if its intended purpose is to diagnose, prevent, monitor, predict, or treat a disease or ailment; diagnose, monitor, treat, or address an injury or disability; investigate, replace, or modify anatomy or physiological/pathological processes; or examine human body specimens. * **Crucially, software is explicitly included in the definition of a medical device.** This implies that AI solutions, chatbots, or other custom software developed by IntuitionLabs.ai for diagnostic, monitoring, or therapeutic purposes in the life sciences sector could be classified as medical devices and require EU MDR compliance. * Products whose primary intended action is achieved by pharmacological, metabolic, or immunological means (e.g., pharmaceuticals like insulin) are generally excluded from the medical device definition. However, devices that dispense or assist in the use of such products (e.g., an insulin dispenser) are considered medical devices. * Specific items like birth control devices, fertility treatment devices, and those designed for cleaning, disinfection, or sterilization of medical devices are explicitly listed as medical devices under EU MDR. * The EU MDR applies only to devices intended for *human beings*, meaning veterinary equipment is outside its scope. * Examples such as pacemakers (modifying heart rate), limb replacements (modifying anatomy), and home blood sugar monitors (in vitro examination) illustrate the diverse range of products that qualify as medical devices beyond direct disease treatment. * Several categories are explicitly excluded from EU MDR, including in vitro diagnostic medical devices (covered by IVDR), medicinal products, human blood and blood products, plasma, and cosmetic products (if covered by cosmetics regulation). Food is also excluded. * Manufacturers must carefully assess products that contain excluded substances (e.g., animal tissues). While the substance itself may not be a medical device, the overall product incorporating it could still be if its primary function meets the medical device definition. * The video emphasizes that understanding the nuances of the EU MDR definition is essential for medical device producers to ensure their products are compliant, avoiding potential regulatory pitfalls. Tools/Resources Mentioned: * GreenSoft Technology, Inc. (the channel and a provider of environmental regulation solutions) * greensofttech.com/data-services/eu-medical-device-regulation-mdr (GreenSoft's online solution for EU MDR) * greensofttech.com/videos (GreenSoft's video library) Key Concepts: * **EU MDR (European Medical Device Regulations):** The comprehensive regulatory framework governing the placing on the market and putting into service of medical devices in the European Union. * **Medical Device:** A broad term encompassing a wide array of items, including software, intended for specific medical purposes in humans, as defined by the manufacturer. * **Intended Purpose:** The manufacturer's stated objective for a product, which is the foundational element in determining if it is a medical device and its subsequent classification and regulatory pathway. * **Software as a Medical Device (SaMD):** Software that, by its intended purpose, fulfills the definition of a medical device, regardless of the platform it runs on (e.g., a smartphone app). * **IVDR (In Vitro Diagnostic Medical Devices Regulation):** A separate EU regulation specifically for devices used to examine specimens derived from the human body outside the body (in vitro). * **Pharmacological, Metabolic, or Immunological Means:** The primary modes of action for medicinal products, which differentiate them from medical devices under EU MDR. Examples/Case Studies: * **Insulin Dispenser vs. Insulin:** The dispenser is a medical device, while the insulin itself is a medicinal product. * **iPhone App for Headaches:** An app that provides a risk analysis for headaches based on user input is cited as an example of software qualifying as a medical device. * **Pacemaker:** Used as an example of a device that modifies a physiological process, thereby falling under the medical device definition. * **Limb Replacement:** An example of a device that replaces or modifies anatomy, qualifying it as a medical device. * **Home Blood Sugar Monitor:** A handheld electronic device for diabetics that examines blood specimens, illustrating a device for in vitro examination.
Value-Based Care Happened 40 Years Ago... Medicare's Prospective Payment System Explained
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Aug 15, 2021
This video provides an in-depth exploration of the historical implementation and impact of Medicare's Prospective Payment System (PPS) in the 1980s, framing it as an early and highly effective form of value-based care. Dr. Eric Bricker, the speaker, begins by establishing the context of healthcare reimbursement prior to PPS, where Medicare paid hospitals a "cost-plus" percentage of their expenses, leading to unsustainable cost escalation. He then details how the PPS, implemented between 1983 and 1986 under a bipartisan effort, fundamentally shifted this model to a fixed payment per Diagnosis Related Group (DRG), regardless of the patient's length of stay. This change incentivized hospitals to manage resources more efficiently for specific conditions like pneumonia or hip fractures, effectively introducing a form of capitation at the individual admission level. The presentation meticulously outlines the significant outcomes of PPS implementation. Data points reveal a 17% decrease in the average length of hospital stay for Medicare beneficiaries and a 3.5% reduction in admissions and discharges. A notable example cited is the shift of 300,000 cataract surgeries annually from inpatient to universally outpatient procedures, driven purely by the change in reimbursement, not clinical necessity. Interestingly, readmission rates remained unchanged, suggesting that earlier discharges did not compromise patient safety in this regard. While 30-day post-admission mortality slightly increased by 0.6 percentage points, Dr. Bricker attributes this to a sicker patient mix being admitted, as less complex cases (like cataract surgeries) were no longer admitted, thus removing low-mortality cases from the inpatient pool. Financially, PPS dramatically slowed Medicare inflation, reducing the annual payment increase rate from 10.1% to 5.7%. Beyond the direct financial and operational impacts, the video highlights crucial changes in clinical practice and broader healthcare dynamics. Hospitals, now incentivized by fixed payments, developed better inpatient care coordination, involving multidisciplinary teams of nurses, case managers, and therapists to optimize patient flow and discharge planning for Medicare patients. This improved process, initially developed for Medicare, had a "spillover effect" on commercial insurance plans, leading to an acceleration in outpatient services for commercially insured individuals as hospitals applied their newly optimized outpatient infrastructure across all patient populations. Dr. Bricker concludes by contrasting the rapid and profound changes achieved by PPS in three years with the minimal impact of the Affordable Care Act (ACA) over eleven years. He attributes this disparity to the increased economic size of the healthcare industry (10% of the economy in the 80s vs. 18% today) and its greater lobbying power, suggesting that significant systemic, government-led change is less likely today, urging organizations to drive their own internal changes. Key Takeaways: * **Historical Precedent for Value-Based Care:** Medicare's Prospective Payment System (PPS) in the 1980s served as an early and effective model of value-based care, demonstrating that shifting payment incentives can drive significant operational changes in healthcare. * **Shift from Cost-Plus to Fixed Payments:** PPS moved from reimbursing hospitals a percentage of their costs to a fixed amount per Diagnosis Related Group (DRG), regardless of length of stay, effectively introducing capitation at the admission level. * **Significant Operational Efficiency Gains:** The implementation of PPS led to a 17% decrease in the length of hospital stays and a 3.5% reduction in admissions/discharges for Medicare beneficiaries, driven by financial incentives for efficiency. * **Impact on Clinical Practice:** Hospitals improved inpatient care coordination and discharge planning for Medicare patients, utilizing multidisciplinary teams to optimize patient flow and resource allocation. * **Shift to Outpatient Services:** Payment changes directly influenced the move of procedures like cataract surgeries from inpatient to outpatient settings, demonstrating how reimbursement models can dictate care delivery locations. * **Financial Savings for Payers:** Medicare's annual payment increase rate to hospitals was nearly halved from 10.1% to 5.7% after PPS implementation, proving its effectiveness in controlling healthcare inflation. * **Outcomes and Patient Safety:** While readmission rates remained unchanged, a slight increase in 30-day post-admission mortality was observed, attributed to a sicker inpatient population after less complex cases moved to outpatient settings. * **Spillover Effect on Commercial Insurance:** The operational efficiencies and outpatient infrastructure developed for Medicare patients under PPS were subsequently applied to commercially insured patients, accelerating the increase in outpatient services across the board. * **Difficulty of Systemic Change Today:** The speaker posits that the healthcare industry's increased economic size (18% of the economy today vs. 10% in the 80s) and lobbying power make large-scale, government-mandated systemic changes much harder to implement effectively compared to the 1980s. * **Call for Internal Organizational Change:** Given the perceived inertia at the governmental level, organizations within the healthcare ecosystem are encouraged to proactively drive their own changes and efficiencies rather than waiting for top-down systemic reforms. Tools/Resources Mentioned: * **AHealthcareZ.com:** The channel's website for healthcare finance educational videos and newsletters. * **16 Lessons in the Business of Healing:** Dr. Bricker's book. * **Steve Brill's Book 'America's Bitter Pill':** Referenced for insights into the healthcare industry's influence on government. * **NCBI and Princeton University Articles:** Academic sources cited for data and analysis on PPS. Key Concepts: * **Prospective Payment System (PPS):** A method of reimbursement in which Medicare payment for hospital inpatient services is a fixed amount per diagnosis, regardless of the actual cost or length of stay. * **Diagnosis Related Groups (DRGs):** A classification system that categorizes patients into groups based on diagnosis, procedures, age, and other factors, used to determine the fixed payment amount under PPS. * **Value-Based Care:** A healthcare delivery model where providers are paid based on patient health outcomes, rather than the volume of services provided. The video frames PPS as an early, albeit unnamed, form of this. * **Cost-Plus Reimbursement:** A payment model where providers are reimbursed for their costs plus an additional percentage, which can incentivize higher spending. * **Capitation:** A payment arrangement where a healthcare provider is paid a fixed amount per patient per period of time, regardless of how many services the patient uses. PPS applied this concept at the individual admission level.
Veeva Vault AUI
LPW Talk Time and Learning
/@lpwtalktimeandlearning4213
Aug 6, 2021
This video provides an in-depth overview of the upcoming Veeva Vault Action User Interface (AUI) update, detailing its new look and feel, release schedule, and the critical steps organizations need to take for a smooth transition. The presenter emphasizes that Veeva has given Vault a "new facelift," resulting in a more modern, streamlined interface designed to enhance user experience and efficiency by keeping frequently accessed workflows readily available. This update is presented as more than just a cosmetic change, aiming to make the system easier and more intuitive for users. The core of the AUI update involves significant changes to navigation and interaction elements. Specifically, the traditional action menu will be replaced by a more contemporary ellipses icon, streamlining the visual interface. Furthermore, numerous common Vault actions, document actions, and object actions will be represented by new, modern icons, all contributing to a more intuitive and efficient user experience. The video highlights that these changes are intended to simplify user interaction and improve overall productivity within the Veeva Vault environment. Regarding the rollout, Veeva has scheduled a general release for the Action UI on August 6th, at which point the feature will be visible to all users if activated. However, customers have the flexibility to delay their adoption of the new interface until December 3rd. Regardless of the chosen timeline, the video stresses the imperative for organizations to prepare adequately. Key preparation steps include carefully selecting an adoption timing that aligns with internal operational needs, developing a robust communication plan to inform employees about the upcoming changes, and critically, refreshing all existing training materials, including videos and e-learning modules, to reflect the new interface. The speaker's company, LPW Training, positions itself as a partner in this transition, viewing the UI update as an opportune moment to not only update but also streamline and modernize existing training programs to match the new visual and functional experience of Veeva Vault. Key Takeaways: * **Significant UI Overhaul:** Veeva Vault is undergoing a major user interface update called Action UI, which introduces a modern, streamlined look and feel designed to improve user experience and operational efficiency. * **Enhanced User Experience Focus:** The primary goal of the AUI is to make the system easier and more efficient to use by keeping frequently accessed workflows a click away and updating visual cues. * **Key Interface Changes:** Specific UI modifications include the replacement of the traditional action menu with an ellipses icon and the introduction of several new, modern icons for common Vault, document, and object actions. * **Flexible Adoption Timeline:** Organizations have two main options for adopting the AUI: an early general release on August 6th, or a delayed adoption option until December 3rd, allowing companies to choose the timing that best suits their internal readiness. * **Mandatory Preparation:** Regardless of whether an organization chooses early or delayed adoption, comprehensive preparation is essential to ensure a smooth transition and minimize disruption to user workflows. * **Strategic Timing Selection:** A critical first step in preparation is to carefully select the adoption timing that aligns with the company's operational schedule, resource availability, and change management capacity. * **Robust Communication Plan:** Developing and executing a clear communication plan is vital to inform employees about the upcoming changes, manage expectations, and facilitate user acceptance of the new interface. * **Critical Training Material Refresh:** All existing training materials, including videos and e-learning modules, must be updated to reflect the new screens, icon placements, and overall look and feel of Veeva Vault AUI to ensure users receive accurate and effective guidance. * **Opportunity for Training Modernization:** The AUI update presents a unique opportunity for companies to not just update, but also to streamline and modernize their entire Veeva Vault training program, aligning it with current best practices in learning and development. * **External Support Available:** Specialized firms like LPW Training offer assistance with various aspects of the AUI transition, including help with communication strategies, refreshing current training materials, and reimagining comprehensive Vault training programs. Tools/Resources Mentioned: * Veeva Vault * Action UI (AUI) Key Concepts: * **Action UI (AUI):** The new user interface for Veeva Vault, characterized by a modern, streamlined design and updated icons. * **Early Adopter:** Refers to organizations that choose to implement the Veeva Vault AUI immediately upon its general release on August 6th. * **Delayed Adoption:** Refers to organizations that opt to postpone the implementation of the Veeva Vault AUI until December 3rd, allowing for more preparation time. * **Communication Plan:** A structured strategy for informing employees about upcoming system changes, managing expectations, and providing necessary support. * **Training Materials Refresh:** The process of updating existing instructional content (e.g., videos, e-learns) to accurately reflect changes in a software's user interface and functionality.
Doctor Specialties That Have Power at Hospital Systems
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Aug 1, 2021
This video provides an in-depth exploration of the financial power dynamics within major hospital systems, identifying specific physician specialties that drive the majority of hospital revenue and influence. Dr. Eric Bricker, Chief Medical Officer of a Value-Based Care Company, frames the discussion by recounting an offer to become a Chief Medical Officer of Value-Based Care at a top hospital system, immediately questioning the actual influence such a role could wield given the established financial incentives. He posits that the administration of hospital systems maintains a highly symbiotic relationship with particular physician groups, not based on medical necessity alone, but primarily on their ability to generate high-margin services. The core of the video details how Orthopedics, Neurosurgery (specifically spine), Cardiology, and Oncology are the "royalty" within hospital systems. These specialties are highlighted for performing complex, high-cost procedures on commercially insured patients, such as knee and hip surgeries, spine surgeries, cardiac cath lab procedures, nuclear stress tests, and inpatient chemotherapy. These services are presented as the primary drivers of hospital growth and profitability. Hospitals, therefore, go to great lengths to attract and retain these specialists, offering incentives like co-owned ambulatory surgery centers and facility fee sharing to ensure their continued presence and productivity. In contrast, other specialties like ENT, Urology, Vascular Surgery, Ophthalmology, and OB/GYN are categorized as mid-tier, often dealing with lower-paying Medicare or Medicaid populations, or performing procedures that yield less significant margins. Specialties such as Psychiatry, Primary Care Physicians, ER physicians, and Radiologists are deemed to hold minimal power, often seen as cost centers or easily replaceable. A significant portion of the video is dedicated to explaining why value-based care (VBC) models inherently conflict with this established fee-for-service financial structure. Dr. Bricker argues that VBC, by design, "betrays" the high-margin specialties by reducing patient volume and procedure counts. This reduction occurs through mechanisms like increased referrals to physical therapy by primary care physicians, decreased complex imaging, fewer emergency room visits, and more effective cancer screening leading to earlier-stage diagnoses that require less intensive (and less profitable) treatments like chemotherapy. The speaker concludes that the vast majority of hospital systems are unwilling to adopt VBC widely because it directly undermines the financial stability provided by these high-margin specialties. A rare successful example of VBC implementation involved hospitals paying these specialists *more* to perform *fewer* procedures, essentially buying them out of the fee-for-service model to align incentives. Key Takeaways: * **Financial Drivers of Hospital Power:** The true power dynamics within hospital systems are dictated by physician specialties that generate high-margin revenue, primarily Orthopedics, Neurosurgery (spine), Cardiology, and Oncology. * **High-Margin Procedures:** These dominant specialties drive profitability through expensive procedures like knee/hip surgeries, spine surgeries, cardiac cath lab interventions, nuclear stress tests, and inpatient chemotherapy, especially when performed on commercially insured patients. * **Hospital Incentives for Specialists:** Hospitals actively court and retain high-margin specialists by offering significant incentives, including co-ownership opportunities in ambulatory surgery centers and sharing facility fees to ensure their continued loyalty and productivity. * **Hierarchy of Influence:** A clear hierarchy exists where high-margin specialists are treated as "royalty," while specialties like Psychiatry, Primary Care, and Emergency Room physicians hold minimal sway, often viewed as cost centers or easily replaceable. * **Value-Based Care Conflict:** Value-Based Care (VBC) models fundamentally conflict with the fee-for-service incentives of high-margin specialties by aiming to reduce patient volume and procedure counts through preventative care and conservative treatments. * **Impact of VBC on Procedure Volume:** VBC initiatives lead to decreased complex imaging, increased utilization of physical therapy, and fewer ER visits, directly impacting the revenue streams of orthopedic, neurosurgery, and cardiology departments. * **Oncology Revenue Implications:** In oncology, VBC's emphasis on early cancer screening results in detecting earlier-stage cancers (e.g., DCIS, pre-cancerous polyps) that often do not require chemotherapy, thereby reducing high-margin treatment volumes for oncologists. * **Hospital Resistance to VBC:** Most hospital systems are reluctant to fully embrace VBC because it directly threatens the financial viability and profitability derived from their high-margin, fee-for-service specialties. * **Cost of VBC Transition:** A rare successful strategy for transitioning high-margin specialists to VBC involves paying them *more* to perform *fewer* procedures, effectively compensating them for lost fee-for-service revenue to align with value-based goals. * **Intermountain Health Case Study:** The experience at Intermountain Health with its patient-centered medical home demonstrated a tangible reduction in imaging, orthopedic/neurosurgery procedures, and ER visits, validating the volume-reduction effect of VBC. * **Strategic Implications for Life Sciences:** Pharmaceutical and medical device companies must understand these hospital financial dynamics and physician power structures to effectively tailor their commercial strategies, market access approaches, and product messaging when engaging with high-value specialties and hospital systems. * **Commercial Operations Insight:** For commercial operations, recognizing which specialties are critical revenue drivers for hospitals can inform sales targeting, resource allocation, and partnership strategies, especially when considering the potential shifts introduced by value-based care. * **Regulatory and Operational Challenges:** The inherent conflict between fee-for-service profitability and value-based care goals presents significant operational and potentially regulatory challenges for hospitals, impacting how new technologies and treatments are adopted. **Key Concepts:** * **High-Margin Specialties:** Physician groups (Orthopedics, Neurosurgery Spine, Cardiology, Oncology) that generate substantial profit for hospitals due to expensive procedures performed on commercially insured patients. * **Fee-for-Service (FFS):** A traditional payment model in healthcare where providers are reimbursed for each service they perform, incentivizing higher volumes of care. * **Value-Based Care (VBC):** A healthcare delivery model where providers are paid based on patient health outcomes, quality of care, and cost-efficiency, rather than the volume of services. * **Commercially Insured Patients:** Patients covered by private health insurance plans, which typically offer higher reimbursement rates to hospitals and providers compared to government programs like Medicare or Medicaid. * **Ambulatory Surgery Centers (ASCs):** Outpatient facilities where surgical procedures are performed, often co-owned by hospitals and physicians to share facility fees and increase profitability. **Examples/Case Studies:** * **Intermountain Health:** The video references Intermountain Health's "third-generation patient-centered medical home" as a real-world example where the implementation of value-based care principles led to a measurable decrease in imaging, orthopedic/neurosurgery procedures, and ER visits, illustrating the direct impact of VBC on procedure volume.
Looking Forward, What you Should Know about Veeva and the Vault Platform
NetworkPharma
/@networkpharmatv
Jul 21, 2021
This video provides an in-depth exploration of the future direction and key enhancements coming to the Veeva Vault Platform, specifically focusing on PromoMats. Presented by Jon Fisher, Senior Program Manager at Veeva Systems, the session, part of a MedComms Forum, aims to equip medical communications professionals with essential knowledge about upcoming features and evolving customer usage patterns. Fisher outlines Veeva's vision for PromoMats as an end-to-end content solution, moving beyond its traditional role as a review and approval tool to encompass the entire content lifecycle from creation and collaboration to digital asset management, publishing, and insights. The presentation details the evolution of content management, emphasizing the journey towards a "transformative" state characterized by data-driven, dynamic, and personalized content across all channels, with PromoMats serving as the single source of truth. A significant portion of the discussion is dedicated to PromoMats' capabilities as a Digital Asset Management (DAM) solution. Fisher defines DAM not just as technology, but as a business process for organizing, storing, retrieving, and managing rights for digital assets, categorized into components (individual elements), composites (final tactics), and references. He highlights specific DAM features like rights management, auto image renditions, a robust API for integrations, and content performance dashboards, explaining how these features streamline workflows for agencies and clients. A major strategic focus for Veeva is the introduction and adoption of Modular Content. Fisher explains that this initiative, accelerated by customer needs during the COVID-19 pandemic, aims to enable faster content creation and significantly reduce Medical, Legal, and Regulatory (MLR) review times. Modular content involves creating channel-agnostic, pre-approved content blocks that can be quickly recombined to build new assets. The roadmap for modular content includes enhancements to module creation, approval processes, API updates for integration with content authoring solutions like Adobe Experience Manager, and future capabilities for faster, risk-based MLR review based on the proportion of pre-approved content used. The video concludes by detailing upcoming user interface (UI) changes, referred to as "Action UI," designed to modernize the platform, improve productivity, and simplify user experience through fewer clicks and enhanced navigation. Key Takeaways: * **PromoMats as an End-to-End Content Solution:** Veeva PromoMats is evolving beyond a simple review and approval tool to become a comprehensive platform supporting the entire content lifecycle, from strategy and creation to publishing and optimization, serving as a single source of truth. * **Digital Asset Management (DAM) Capabilities:** PromoMats offers robust DAM functionalities for organizing, storing, and retrieving digital assets. This includes managing rights and permissions, creating auto image renditions for various channels, and providing a powerful API for system integrations. * **Streamlined Agency Workflows:** Agencies will increasingly be required to upload source files (e.g., InDesign files) into PromoMats, enabling automatic recognition and linking of component assets, and will leverage PromoMats' component libraries to reuse approved assets, thereby increasing efficiency and reducing recreation time. * **Automated Digital Publishing:** A newer feature allows for automatic publishing of approved content to the web, generating a persistent URL. This ensures that all digital channels (emails, websites, social media) always reflect the latest approved version and enables immediate content takedown if necessary. * **InDesign Auto Linking for Efficiency:** The platform supports InDesign auto-linking, allowing creative teams to upload an entire InDesign package. PromoMats automatically generates a viewable rendition and identifies/links all component assets within the file, streamlining the upload and reuse of creative elements. * **Brand Portal for Content Discovery:** Brand Portal (or Medical Portal in MedComms) provides a user-friendly interface for sharing and discovering content with different audiences, such as global affiliates, sales teams, or for training purposes, effectively replacing disparate shared drives or internal communication portals. * **Strategic Shift to Modular Content:** Veeva is heavily investing in modular content, driven by customer demand to accelerate content creation and reduce lengthy MLR review cycles (which can range from 30 to 100 days). This approach uses channel-agnostic, pre-approved content blocks. * **Modular Content Process and Roadmap:** The modular content strategy involves preparing modules (assembling approved assets with rules), using modules (manual or integrated via API with authoring tools), and enabling faster MLR review (visualizing approved vs. new content, leading to risk-based reviews). Key releases in 2021 focused on module creation, API updates, and linking for MLR. * **User Interface Modernization (Action UI):** Upcoming UI changes aim to provide a more modern, intuitive, and productive user experience. Enhancements include a redesigned layout, prominent notifications, an action bar for frequently used actions, a consolidated document info panel, and a simplified annotation toolbar with persistent filters. * **Value-Added Features, Not Extra Costs:** All discussed innovations, including DAM features, modular content capabilities, and UI updates, are enhancements to the existing Veeva PromoMats product and do not require additional licenses or payments, underscoring Veeva's commitment to continuous product improvement. * **Proactive Adoption and Training:** Customers and agencies are encouraged to proactively engage with Veeva's communication and training programs (e.g., certification, partner programs, in-app notifications) to prepare for the upcoming changes, particularly the mandatory Action UI rollout by December. **Tools/Resources Mentioned:** * Veeva Vault Platform * PromoMats (Veeva's content management solution) * MedComms Networking / NetworkPharma.tv (Host/Organizer) * Zoom.us (Meeting platform) * LinkedIn (Speaker's contact method) * Adobe Experience Manager (Example of a content authoring solution that can integrate with Veeva modules) * InDesign (Adobe software for creative design, specifically mentioned for auto-linking) **Key Concepts:** * **Digital Asset Management (DAM):** A business process and technology solution for organizing, storing, and retrieving digital assets, and managing their rights and permissions. * **Modular Content:** The strategy of creating pre-approved, channel-agnostic content blocks that can be quickly recombined to build various digital assets, aiming to increase efficiency and reduce review times. * **MLR (Medical, Legal, Regulatory) Review:** The crucial approval process in life sciences for all promotional and medical content to ensure compliance with industry regulations. * **Action UI:** Veeva's term for its modernized user interface, designed for improved aesthetics, efficiency, and user experience. * **Component Assets:** Individual elements (e.g., images, text blocks, logos) that make up a larger piece of content. * **Composite Assets:** Final, complete pieces of content or tactics (e.g., a visual aid, an email, a website page). * **References:** Supporting scientific or regulatory documentation linked to content. * **Brand Portal / Medical Portal:** A feature within Veeva Vault that allows for curated sharing and discovery of content with specific audiences in a user-friendly manner.
Fireside Chat Series: Managing Updates and Re-Training - Video 5 of 7
Veeva Systems Inc
/@VeevaSystems
Jul 21, 2021
This video, part of Veeva Systems' "Fireside Chat Series," features Kent Malmros, Senior Director of Vault Training at Veeva Systems, and Graham O'Keeffe, Founder and CEO of Learnaboutgmp. The discussion centers on the critical and often challenging process of managing updates and ensuring timely retraining for e-learning content libraries, particularly within the highly regulated life sciences industry. Malmros initiates the conversation by highlighting Veeva's entry into the training technology space, driven by the historical difficulty and cost associated with connecting regulated document management systems with third-party learning management systems (LMS) to ensure automatic and compliant retraining on updated control documents. This challenge extends beyond internal documents to external e-learning libraries, such as an "introduction to GMP course," which also require diligent management and retraining triggers when content changes. O'Keeffe then details Learnaboutgmp's multi-faceted approach to keeping their e-learning libraries current and aligned with evolving regulations, guidelines, and standards. His methodology involves a three-phased strategy: first, an in-house QA team dedicated to monitoring and tracking regulatory updates relevant to their course library; second, monthly consultations with subject matter experts (SMEs) who are inherently abreast of industry changes; and third, weekly calls with clients to proactively understand upcoming regulatory shifts and industry needs. He cites the example of the new EU Medical Device Regulation (EU MDR), for which Learnaboutgmp began production of an online program eight months in advance, demonstrating a proactive stance driven by direct client engagement. This consultative approach, particularly the consistent weekly client contact, is presented as a unique and highly effective strategy, contrasting with the more isolated content update processes often seen in other e-learning providers. The conversation further explores the communication aspect of content updates. O'Keeffe explains that Learnaboutgmp utilizes internal communication mechanisms to inform clients about course updates, regulatory changes, and which specific courses have been affected. This agile communication, coupled with responsive customer service, ensures that clients are not only aware of changes but also understand how to process them and identify who needs to be retrained. The speakers emphasize that having up-to-date, expert content is only valuable if customers know it exists and how to effectively deploy it. The agility and strong communication capabilities in redeploying new assets are highlighted as critical differentiators, ensuring customers can quickly adapt to regulatory shifts and maintain compliance. The discussion concludes by hinting at future topics, such as managing updates for smaller micro-learning assets, underscoring the ongoing complexity of content lifecycle management in regulated environments. Key Takeaways: * **The Challenge of Regulated E-Learning Updates:** Life sciences companies face significant hurdles in managing updates and retraining for e-learning content, especially when it's tied to industry regulations. Historically, connecting regulated document management systems with third-party LMS for automated, compliant retraining has been costly and time-consuming, a problem Veeva aims to solve with its training technology. * **Proactive Regulatory Monitoring is Essential:** Effective content providers in regulated industries must employ proactive strategies to monitor regulatory changes. Learnaboutgmp, for instance, uses an in-house QA team and monthly SME consultations to stay abreast of updates to regulations, guidelines, and standards, ensuring content remains current. * **Client-Centric Content Strategy Drives Relevance:** Engaging directly with clients on a consistent basis (e.g., weekly calls) is crucial for understanding their evolving needs and anticipating major regulatory shifts. This allows content providers to proactively develop or update training programs, as demonstrated by Learnaboutgmp's early development of an EU MDR program based on client input. * **Importance of Deep Subject Matter Expertise:** Content providers must possess or have access to deep subject matter expertise to ensure their e-learning materials are accurate, current, and compliant with the latest industry standards and regulations, which is a key differentiator for quality. * **Agile Content Development and Deployment Capabilities:** The ability to quickly update and republish new versions of e-learning courses is essential for maintaining compliance in dynamic regulatory environments. This agility extends to the proactive development of new programs in anticipation of significant regulatory changes. * **Robust Communication Mechanisms for Updates are Critical:** It's not enough to simply update content; providers must have clear internal communication mechanisms to inform clients about changes, including which regulations have been affected and which courses have been revised. This ensures clients know what has changed and why. * **Guidance on Retraining Triggers and Implementation:** Content providers should assist customers in understanding how to process updates, who should be retrained, and when. This backend support is critical for customers to effectively utilize updated content for compliance purposes and manage their workforce training. * **Customer Service as a Key Differentiator:** Responsive customer service that provides instant feedback and facilitates quick changes is vital in a fast-moving regulatory environment. This enables clients to reach out and get immediate support regarding content updates and deployment, enhancing the overall value proposition. * **The Value of Up-to-Date and Actionable Content:** Expert, up-to-date content is only valuable if customers are aware of its existence and know how to effectively use and deploy it within their organization. Strong communication capabilities are hyper-critical for ensuring content translates into actionable compliance. * **Anticipating Major Regulatory Shifts with Clients:** Successful content providers work collaboratively with clients to identify and prepare for major regulatory changes, such as the EU MDR, ensuring workforces are trained and ready before new regulations come into effect to avoid operational disruptions and maintain market access. Tools/Resources Mentioned: * **Veeva Vault Training:** A specific product from Veeva Systems designed to manage training within regulated industries, highlighted as a solution for connecting regulated document management with learning management systems. * **Learning Management System (LMS):** A general term for software applications used to administer, document, track, report, and deliver educational courses or training programs. Key Concepts: * **Regulated Document Management System:** A system used by organizations in regulated industries (e.g., life sciences) to control and manage documents that are subject to regulatory requirements, ensuring compliance and auditability. * **GMP (Good Manufacturing Practice):** A system of quality standards that ensures products are consistently produced and controlled according to quality standards, minimizing risks in pharmaceutical production. * **EU MDR (European Union Medical Device Regulation):** A comprehensive regulation governing the production and distribution of medical devices in the EU, emphasizing higher safety and performance standards. * **SLA (Service Level Agreement):** A contractual commitment between a service provider and a customer outlining the expected level of service, including aspects like content updates and delivery timelines. * **Micro-learning Assets:** Small, focused units of learning content designed for quick consumption and addressing specific learning objectives, mentioned as a future topic for continuous updates. Examples/Case Studies: * **EU Medical Device Regulation (EU MDR):** Learnaboutgmp proactively started developing an online training program for the EU MDR approximately eight months before its implementation, based on ongoing discussions with multinational medical device companies. This demonstrates how client engagement drives the anticipation and preparation for significant regulatory changes. * **Introduction to GMP Course:** This is used as a specific example of an e-learning library course that requires regular updates and triggered retraining when its content changes due to evolving regulations, highlighting the ongoing challenge of content lifecycle management.
Interactive Content for MedComms
NetworkPharma
/@networkpharmatv
Jul 21, 2021
This video provides an in-depth exploration of interactive and functional content for Medical Communications (MedComms), specifically focusing on its application for Medical Science Liaisons (MSLs) within the Veeva ecosystem. James Harper, Managing Director of 28b, begins by setting the context of the evolving landscape for HCP engagement, particularly post-COVID-19, which has accelerated the need for multi-channel and remote interaction strategies. He emphasizes how platforms like Veeva CRM and CLM (Closed-Loop Marketing) can empower MSLs to deliver more impactful engagements with Key Opinion Leaders (KOLs) and stakeholders by leveraging data-driven content. Harper meticulously breaks down the Veeva universe, narrowing the focus to Veeva Vault, CRM, and CLM. He explains the critical concept of Veeva Vault as a "single source of truth" for compliant content, detailing the workflow from content creation and approval in PromoMats/MedComs to its deployment on MSL iPads via the CRM. A core methodology discussed is Closed-Loop Marketing, where data collected from MSL-stakeholder interactions (e.g., slides shown, responses to questions) feeds back into the system to inform and optimize future content. This iterative process allows for continuous improvement and personalization of scientific discussions, moving beyond static presentations to dynamic, responsive content. The presentation draws significant parallels and lessons from the commercial pharmaceutical world, where functional content has been more widely adopted. Harper cites data indicating a substantial improvement (up to 71%) in positive engagement outcomes when interactive sales aids are used, especially those that encourage customer input. He then transitions to demonstrating practical examples of functional content, genericized for confidentiality, which are suitable for field medical teams. These include interactive discussion guides for understanding clinical pathways (e.g., ADHD patient journey), tools for market access discussions (e.g., drug comparisons, cost analyses), and dynamic data visualizations for exploring study results. The overarching goal is to enable MSLs to have bespoke, insightful conversations that meet the specific needs of their stakeholders while simultaneously gathering valuable intelligence. Key Takeaways: * **Veeva as a Central Ecosystem:** Veeva Vault serves as the "single source of truth" for all approved medical and commercial content, ensuring compliance and consistency across various channels and field teams. * **CRM/CLM for MSLs:** Customer Relationship Management (CRM) and Closed-Loop Marketing (CLM) principles, traditionally associated with sales, are equally vital for MSLs to understand KOLs, personalize interactions, and track engagement data, moving beyond simple call reports. * **Post-COVID Engagement Shift:** The pandemic has drastically accelerated the shift towards virtual and hybrid engagement models, with a significant majority of HCPs now preferring a mix of virtual and in-person meetings, necessitating robust digital content strategies. * **Empowering the Multi-Channel MSL:** Veeva platforms enable MSLs to orchestrate diverse engagements, including face-to-face, remote meetings (Veeva Engage), compliant emails, virtual congresses, and directing stakeholders to online educational resources. * **Value of Functional Content:** Interactive and functional content significantly enhances engagement, leading to better outcomes. Data from commercial teams shows a 71% improvement in "good sell outcomes" when engaging sales aids are used, a principle transferable to medical discussions. * **Data-Driven Content Optimization:** The closed-loop system allows for the collection of granular data (e.g., slides viewed, customer input) from interactions, which can then be analyzed to refine content, making it more relevant and impactful over time. * **Interactive Discussion Guides:** Examples include tools for assessing KOL priorities (e.g., patient groups for a new pediatric license), exploring clinical pathways (e.g., ADHD referral steps), and facilitating market access discussions with dynamic cost/opportunity analyses. * **Dynamic Data Visualization:** Content can incorporate real-time, interactive data visualizations of study results, allowing MSLs and KOLs to collaboratively explore complex scientific information in an engaging manner, rather than relying on static screenshots. * **Insights and Intelligence Gathering:** Functional content can be designed to subtly gather insights from stakeholders through interactive questions or pathways, providing valuable intelligence on treatment preferences, referral patterns, and unmet needs. * **Dashboards for Stakeholder Understanding:** Veeva can provide MSLs with dashboards that offer deeper insights into their stakeholders' preferences and engagement history, enabling more bespoke and effective future interactions. * **Content Personalization:** Leveraging data from interactions and optional surveys (Veeva Surveys), content can be tailored to individual stakeholder needs, ensuring that the most appropriate scientific information is presented. * **Modular Digital Publishing:** A future trend involves creating pre-approved, modular components of content that can be flexibly assembled and deployed across various channels, streamlining content creation and ensuring consistency. * **MedComms Agencies' Opportunity:** MedComms agencies have a significant opportunity to move beyond traditional deliverables and embrace the creation of data-driven, interactive content for platforms like Veeva, contributing directly to measurable engagement outcomes. **Tools/Resources Mentioned:** * **Veeva:** Veeva Vault, Veeva CRM, Veeva CLM, Veeva Engage, Veeva Surveys, PromoMats, MedComs. * **Tableau:** Mentioned as an external tool for data analysis and business intelligence. * **Amazon Web Services (AWS):** Where Veeva Vault instances are hosted. * **iPad:** The primary device for field teams to deliver Veeva content. * **Doctors.net, Accenture, Cross Health, Stem Healthcare:** Sources for market data and insights. **Key Concepts:** * **Functional Content:** Content designed not just to inform but to facilitate interaction, gather data, and drive specific outcomes or discussions. * **Closed-Loop Marketing (CLM):** A marketing strategy where customer interaction data is collected, analyzed, and used to refine subsequent marketing efforts and content, creating a continuous feedback loop. * **Customer Relationship Management (CRM):** A system and strategy for managing an organization's interactions with current and potential customers, primarily focusing on improving business relationships. * **Medical Science Liaison (MSL):** A field-based scientific expert who builds relationships with KOLs and other healthcare professionals to exchange scientific and medical information. * **Single Source of Truth:** A concept referring to a data storage principle where all data is stored in one place, ensuring consistency and accuracy across all applications and users. * **Multi-channel MSL:** An MSL capable of engaging with stakeholders across various digital and in-person channels, adapting to their preferences. * **Modular Digital Publishing:** An approach to content creation where content is broken down into smaller, reusable, pre-approved modules that can be combined and deployed across different platforms and channels. **Examples/Case Studies:** * **Calcium Bone Replacement Therapy:** An example illustrating how interactive content can assess a customer's (HCP's) prioritization of patient groups (e.g., pediatrics vs. adults) and their approach to treatment (lifestyle advice vs. medication), allowing for tailored discussions and data collection on trends. * **ADHD Clinical Pathway (Minecraft-style):** A heavily genericized example of a self-led interactive tool used by medical teams and at conferences to understand clinicians' referral pathways and steps, providing comparative data (national average, guidelines) in return for their input. * **Market Access Discussions:** An interactive tool designed to help CCG (Clinical Commissioning Group) or clinical directors visualize costs, opportunities, and compare different drugs based on patient profiles, with the ability to share the generated insights via email. * **Opioid Misuse (Public Affairs):** A dynamic presentation visualizing statistics on opioid misuse, allowing for country comparisons, used to drive discussions and gather insights on areas of interest. * **Data Exploration for Study Results:** An interactive visualization tool that allows MSLs and clinicians to collaboratively explore clinical outcomes and background information from various studies, moving beyond static charts to dynamic data representation.
Content Landscape and the Vault Platform (PromoMats and MedComms)
NetworkPharma
/@networkpharmatv
Jul 21, 2021
This video provides an in-depth exploration of Veeva's Vault platform, specifically focusing on PromoMats and MedComms, and their critical role in the medical communications (MedComms) industry. The session begins with Jon Fisher, Senior Program Manager at Veeva Systems, setting the stage by presenting real-world data on the evolving content landscape within life sciences. He highlights the significant shift to digital content and the increasing volume of assets managed, underscoring Veeva's vision to enhance speed to market, scalability, and intelligence in content operations. Following the presentation, a panel of MedComms agency specialists shares practical experiences and challenges in utilizing the Vault platform, offering valuable insights from the agency perspective. Fisher details Veeva's strategic approach to content management, emphasizing three core pillars: speed, scale, and intelligence. Speed is addressed through initiatives like modular content, aiming to streamline creation and approval processes. Scale focuses on global content leverage, enabling local markets to easily adapt existing materials. Intelligence involves data-driven content, utilizing analytics to track approval times, review cycles, and benchmark performance against industry peers. He presents compelling data, such as an 80% increase in content year-over-year and an average approval time of 21 days for 300,000 assets, demonstrating the platform's impact and the industry's rapid pace. The presentation then delves into the distinct roles of PromoMats for promotional content and MedComms for medical affairs content, explaining how these "sister products" ensure regulatory compliance by creating a "firewall" between different content types while offering tailored configurations and roadmaps. The video further elaborates on the specific features and benefits of both PromoMats and MedComms. PromoMats is positioned as the single source of truth for promotional materials, facilitating real-time collaboration, integration with Office 365 for collaborative authoring, and advanced features like Auto Claims Linking. This innovative feature automatically annotates content by matching it against an approved claims library, significantly reducing manual referencing efforts. PromoMats also supports content distribution to Veeva CRM and other digital channels via Brand Portal and Digital Publishing, with robust reporting and "Standard Metrics" for performance analysis. MedComms, on the other hand, centralizes scientific content for medical affairs, offering features like Medical Inquiry Management to streamline case handling and content fulfillment. The panel discussion provides a crucial real-world perspective, with agency representatives discussing the nuances of client-specific customizations, the importance of clear Standard Operating Procedures (SOPs), the challenges of managing reference libraries across multiple agencies, and the value of Veeva's support channels. They collectively affirm the platform's utility while highlighting areas for improved communication and standardization in implementation. Key Takeaways: * **Explosive Digital Content Growth:** The life sciences industry experienced an 80% increase in content year-over-year, with a 3.5x shift towards digital over print, underscoring the urgent need for efficient digital content management solutions. * **Veeva's Vision for Content Management:** Veeva aims to increase speed to market by 75% through modular content for faster creation, global scalability for content reuse, and data-driven intelligence for process optimization and benchmarking. * **PromoMats as a Central Hub:** Veeva PromoMats serves as the single source of truth for promotional content, managing review, approval, and distribution to various channels including Veeva CRM, websites, and social media, ensuring regulatory compliance. * **Auto Claims Linking for Efficiency:** This feature allows for the creation of a claims library, automatically linking content within documents to approved references, potentially cutting down manual annotation time by 25-50% for agencies. * **Data-Driven Performance Insights:** PromoMats' "Standard Metrics" feature tracks key performance indicators like review cycles and approval times, enabling customers to analyze their processes and benchmark against industry peers. * **MedComms for Medical Affairs:** Veeva MedComms provides a dedicated platform for scientific and medical content, creating a crucial "firewall" between promotional and medical materials to maintain compliance and tailored workflows for medical affairs teams. * **Streamlined Medical Inquiry Management:** MedComms includes a specialized feature for managing medical inquiries, allowing medical affairs teams to handle cases, fulfill requests with existing content, or flag the need for new content creation. * **Extensive Partner Ecosystem:** Veeva integrates with a broad network of technology partners (e.g., Adobe Experience Manager, Salesforce Marketing Cloud) to ensure seamless content flow from approval in Vault to various digital channels. * **Customization and SOP Importance:** While Veeva platforms are highly customizable, agencies face challenges due to varying client implementations and SOPs, highlighting the need for clear, harmonized procedures across all stakeholders. * **Veeva's Continuous Evolution:** Veeva commits to three major product releases annually, incorporating customer feedback and innovation, as evidenced by ongoing UI refreshes and new features like modular content. * **Agency Role and Feedback:** Agencies are considered primary users of Veeva platforms, and their feedback is actively sought for future roadmap development, emphasizing the importance of direct communication with Veeva. * **Real-time Collaboration:** The platforms facilitate real-time collaboration, allowing reviewers and team members to work on content from anywhere, including collaborative authoring for Office 365 documents within PromoMats. * **Digital Publishing for Dynamic Content:** PromoMats' digital publishing feature automatically updates URLs with the latest approved versions of content (e.g., SM PC/PI), ensuring that external channels always display current, compliant information without manual intervention. **Tools/Resources Mentioned:** * Veeva Vault Platform * Veeva PromoMats * Veeva MedComms * Veeva CRM (Commercial CRM and Medical CRM) * Brand Portal (within PromoMats) * Medical Portal (within MedComms) * Office 365 (for collaborative authoring integration) * Adobe Experience Manager (as an example of a technology partner integration) * Salesforce Marketing Cloud (as an example of a technology partner integration) **Key Concepts:** * **Modular Content:** An approach to content creation and management where content is broken down into smaller, reusable modules, designed to increase speed and consistency across various outputs. * **Auto Claims Linking:** A feature in PromoMats that automates the annotation of claims in a document by matching them against an approved claims library, linking them to supporting references. * **Standard Metrics:** A feature in PromoMats that automatically tracks key metrics for content approval processes, such as review cycles and approval times, allowing for internal analysis and industry benchmarking. * **Medical Inquiry Management:** A feature within MedComms that centralizes the process of receiving, managing, and fulfilling medical inquiries from healthcare professionals. * **Single Source of Truth:** The concept that all content, especially regulated content, should reside in one authoritative system (like Veeva Vault) to ensure consistency, compliance, and easy access. * **Content Partner Team:** Veeva's team dedicated to supporting agencies and freelancers in effectively using Veeva's content and multi-channel platforms. * **Technology Partner Team:** Veeva's team that works with other technology providers to create integrations between Veeva products and external systems (e.g., CMS, campaign tools).
Infosys Interview For 2 Years Experience || Veeva Vault Developer || Veeva Interview Experience
The Corporate Guys
/@TheCorporateGuys
Jul 19, 2021
This. Understanding the technical intricacies, configuration, and domain-specific applications of Veeva Vault, as detailed in the interview, isai in developing integrated solutions and providing expert consulting. This video details a candidate's interview experience for a Veeva Vault Developer position at Infosys, highlighting the technical and functional expertise required for such a role within the life sciences domain. The discussion covers the candidate's background working extensively with Veeva Vault in pharma and clinical projects, the multi-round interview process, and the specific types of questions encountered, which heavily focused on Veeva Vault configuration, security, and scenario-based problem-solving. Key Takeaways: * **Veeva Vault Technical Depth:** The interview questions underscore the necessity of deep technical knowledge in Veeva Vault, particularly regarding access control, lifecycle and workflow configurations, security permissions (profiles, licenses), custom objects, and administrative functions. * **Life Sciences Domain Expertise:** The candidate's experience and the interview's focus emphasize that practical application of Veeva Vault is predominantly within the life sciences (pharma, clinical), requiring domain-specific understanding for project execution, including migrations. * **Scenario-Based Problem Solving:** Interviewers heavily relied on scenario-based questions to assess practical problem-solving skills related to Veeva Vault functionalities (e.g., restricting user access, handling project deadlines, client interactions), indicating a need for applied knowledge beyond theoretical concepts. * **Agile and Client Management Skills:** The inclusion of questions on Agile methodology and client interaction highlights the importance of modern project management practices and soft skills for successful delivery in Veeva Vault projects. * **Pervasiveness of Veeva Vault:** The candidate's career progression within major IT service providers (Cognizant, Infosys) consistently working on Veeva Vault projects reinforces its widespread adoption and critical role in the pharmaceutical and life sciences sectors. * **Confidence from Knowledge:** The advice for aspiring candidates stresses that strong command over one's core technology and domain knowledge is the foundation for building confidence, which is crucial for effective interview performance.
Machine Learning for Population Health
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Jul 19, 2021
This video provides an in-depth exploration of machine learning (ML) applications in population health, demystifying the concept for a general audience. Dr. Eric Bricker begins by establishing a clear distinction between traditional, human-programmed "if-then" algorithms and true machine learning, where software autonomously learns and generates its own rules. He emphasizes that "real AI" lies in this self-learning capability. The presentation then pivots to a practical application, showcasing ClosedLoop.ai, an Austin-based startup that won the prestigious CMS AI Challenge, beating out 300 other organizations including IBM and the Mayo Clinic, for its prowess in applying ML to population health data. The core purpose of applying machine learning in population health, as highlighted in the video, is to significantly improve the identification of high-risk individuals who are most likely to benefit from targeted interventions. This contrasts sharply with historical "predictive analytics" methods, which have proven largely ineffective in accurately pinpointing the small percentage of people (e.g., 5%) who drive a disproportionate amount of healthcare costs or adverse outcomes. ClosedLoop.ai's approach leverages ML to overcome these limitations, enabling health plans and systems to proactively intervene with individuals at high risk of complications, ER visits, or hospitalizations, thereby improving health outcomes and optimizing resource allocation. The video further delves into three crucial aspects that make machine learning effective and trustworthy in a healthcare context. First, **explainability** is paramount; ML models cannot be black boxes, as healthcare professionals need to understand *why* a particular individual is flagged for intervention to build trust and ensure effective action. Second, **addressing bias** is critical, as historical health data often contains inherent biases related to demographics, income, or race, which ML models must be explicitly programmed to counteract. Third, ML's ability to handle **messy data** is a significant advantage, as it can infer insights (e.g., a diabetes diagnosis from insulin prescriptions, even without an ICD-10 code) in a way that traditional algorithms or human analysis often struggle with. A compelling case study of ClosedLoop.ai's COVID-19 Vulnerability Index demonstrates these principles in action, showing how ML can rapidly identify individuals at high risk of severe COVID-19 complications, leading to practical interventions like home delivery of groceries and prescriptions. Finally, the discussion touches upon the transformative impact of the COVID-19 pandemic on ML in population health, particularly in two areas: speed and implementation. The pandemic underscored the need for rapid model development, with ClosedLoop.ai creating their COVID-19 index in a single weekend due to an existing platform. More profoundly, the video identifies the "limiting reagent" for wider ML adoption not as the software or data, but as the **ability to persuade and consult** with organizations to effectively integrate and apply these solutions. This highlights a critical gap in translation and implementation, emphasizing the need for strong consulting and sales capabilities to bridge the divide between advanced ML technology and its practical application in healthcare settings. Key Takeaways: * **Machine Learning vs. Traditional Algorithms:** Machine learning distinguishes itself by enabling software to autonomously learn and create its own "if-then" rules, unlike traditional algorithms that rely on human-programmed instructions. This self-learning capability is considered the hallmark of "real AI." * **Purpose of ML in Population Health:** The primary goal is to accurately predict individuals who are at high risk of adverse health outcomes (e.g., hospitalizations, ER visits, complications) so that targeted, proactive interventions can be implemented. * **Ineffectiveness of Historical Predictive Analytics:** Traditional methods of identifying high-risk populations have proven largely ineffective, often failing to accurately pinpoint the small percentage of individuals responsible for a majority of healthcare costs or negative outcomes. * **Importance of Explainability:** For machine learning models to be trusted and utilized by healthcare professionals (nurses, physicians), their predictions cannot be black boxes. The rationale behind identifying a high-risk individual must be explainable and transparent. * **Explicitly Addressing Bias:** Healthcare data inherently contains biases related to demographics, socioeconomic status, and other factors. ML models must be designed and programmed to explicitly identify and mitigate these biases to ensure equitable and accurate predictions across all populations. * **Handling Messy Data:** Machine learning excels at making sense of imperfect or "messy" healthcare data. It can infer conditions or risks even when complete or perfectly coded data is absent, such as identifying diabetes from insulin prescriptions without an official ICD-10 code. * **Case Study: COVID-19 Vulnerability Index:** ClosedLoop.ai developed an index using 21 measures (demographics, chronic conditions, utilization data) to predict with 80% sensitivity who would be at high risk of severe COVID-19 complications if infected. * **Practical Interventions:** Based on the COVID-19 Vulnerability Index, health plans implemented real-world interventions for high-risk individuals, including arranging grocery deliveries and ensuring home delivery of prescription medications to minimize exposure risks. * **Speed of ML Development:** With an established platform and framework, machine learning projects can be developed rapidly, as demonstrated by the COVID-19 index being created in a single weekend, enabling quick responses to emerging health challenges. * **The Limiting Factor is Consulting and Persuasion:** The primary barrier to wider adoption and implementation of machine learning in population health is not the software, the data, or even the programming skill. Instead, it's the ability to effectively persuade and consult with organizations (health plans, hospitals, employers) on how, when, and why to apply these solutions. * **Opportunity for Consulting Firms:** The identified "limiting reagent" highlights a significant opportunity for consulting and sales professionals to bridge the gap between advanced ML capabilities and organizational implementation, translating technical solutions into practical value. Key Concepts: * **Machine Learning (ML):** A subsegment of AI where computer software can create and improve algorithms on its own, learning from data without explicit programming of "if-then" statements. * **Population Health:** An approach to health that aims to improve the health outcomes of a group of individuals, including the distribution of such outcomes within the group. * **Predictive Analytics:** The use of data, statistical algorithms, and machine learning techniques to identify the likelihood of future outcomes based on historical data. * **Explainability (in ML):** The ability to understand and interpret how a machine learning model arrives at its predictions or decisions, crucial for trust and adoption in critical fields like healthcare. * **Bias (in ML):** Systematic and repeatable errors in a computer system that create unfair outcomes, such as favoring or disfavoring certain groups of people. * **Messy Data:** Imperfect, incomplete, or inconsistently formatted data that often requires significant effort to clean and prepare for analysis. Examples/Case Studies: * **ClosedLoop.ai:** A company based in Austin, Texas, specializing in applying machine learning to population health data. They won the CMS AI Challenge, beating out 300 other organizations including IBM, the Mayo Clinic, and Deloitte. * **COVID-19 Vulnerability Index:** A machine learning model created by ClosedLoop.ai to identify individuals at high risk of severe complications if they contracted COVID-19. This index was used by institutions like Johns Hopkins, the University of Texas Medical Branch, and Einstein. * **Interventions for High-Risk Individuals:** A New York City health insurance plan used the COVID-19 Vulnerability Index to identify high-risk members and arranged for groceries and prescription medications to be delivered to their homes, helping them avoid exposure to the virus.