Organizational impacts of regulatory change and business benefits


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Michelle Lott, RAQA Director, Xeridiem

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Organizational impacts of regulatory change and business benefits

  1. 1. Organizational Impacts of Regulatory Change and Business Benefits BIOMEDevice San Jose December 4 2013 Michelle Lott RA / QA Director
  2. 2. Candlestick Park Stadium – Copyright 2013 Michelle Lott
  3. 3. Key Players 49ERS SIDELINE CHARGERS CHARGERS SIDELINE Copyright 2013 Michelle Lott
  4. 4. Customer Customer Food and Drug Administration (FDA) European Commission Miscellaneous Copyright 2013 Michelle Lott
  5. 5. PIP ISO Patient Harm Guidance Customer Customer NE CP Food and Drug Administration (FDA) European Union (EU) BOEING Miscellaneous Copyright 2013 Michelle Lott
  6. 6. FDA Prioritized medical device guidance documents that the Agency intends to publish in FY 2013 ("A-list") Final Guidance Topics Refuse to Accept (RTA) Policy for 510(k) Submissions Acceptance and Filing Review for Premarket Approval Applications Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies In Vitro Companion Diagnostic Devices Design Considerations for Pivotal Clinical Investigations for Medical Devices De Novo Classification Process (Evaluation of Automatic Class III Designation) The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications CDRH Appeals Processes Medical Device Classification Product Codes The Pre-Submission Program and Meetings with FDA Staff Mobile Medical Applications eCopy Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents Draft Guidance Topics Distinguishing and Reporting Medical Device Recalls from Product Enhancements Types of Communication During the Review of Medical Device Submissions FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations Appropriate Use of Voluntary Consensus Standards in Premarket Submissions Copyright 2013 Michelle Lott
  7. 7. FDA Device guidance documents that the Agency intends to publish, as the Agency’s guidance-development resources permit each in FY 2013 ("B-list") Final Guidance Topics Finalizing existing draft guidance documents. Draft Guidance Topics Benefit-Risk Determinations in Premarket Notifications (510(k)s) Direct to Consumer (DTC) Genetic Testing: IVDs Transfer of Ownership of a Premarket Notification (510(k)) - Questions and Answers Custom Devices Copyright 2013 Michelle Lott
  8. 8. Not to mention … • Medical device tax • MDD recast – – – – – Qualified Person Requires unannounced audits Code of ethics for Notified Bodies Change in definitions on device classification Proposing change from “directive” to “regulations” so they can be changed easier and faster. Copyright 2013 Michelle Lott
  9. 9. Copyright 2013 Michelle Lott
  10. 10. Copyright 2013 Michelle Lott
  11. 11. ISO Argentina Guidance Singapore Israel Miscellaneous Copyright 2013 Michelle Lott Customer Customer Food and Drug Administration (FDA) European Union (EU)
  12. 12. Internal Key Players Player Role CEO and Executive Management Owner Coach Recruiter VP or Director of RAQA Offensive Coordinator Quality Engineer/ Regulatory Specialist Quarter Back Design and Manufacturing Engineers Copyright 2013 Michelle Lott Linebacker Fullback Tackle Guard
  13. 13. European Union (EU) ISO Guidance Singapore Israel Customer Customer FDA Argentina PENALTY Miscellaneous • Non Approval • Recall • Reputation Copyright 2013 Michelle Lott
  14. 14. European Union (EU) Respect DR Optimize DR Argentina Patient Harm FDA FUN Guidance Customer Customer ISO Singapore Israel Personal Accountability Miscellaneous Copyright 2013 Michelle Lott Integrity
  15. 15. So what can you do? • Do be aware of changing expectations – Write a gap analysis – Write justifications for “not applicable” requirements – it’s not obvious – Ask the agency – Create culture of empowerment • Don’t fight it – Your cheese has moved - trust your RA/QA group – Be creative finding solutions – simple solutions do exist – Look for existing tools that help you demonstrate how requirements are fulfilled Copyright 2013 Michelle Lott
  16. 16. Benefits of Keeping Up with Change • Increased safety and efficacy – Reduced cost of complaints and recalls – Opportunity to increase market share when competitor has recall • Better meet patient/ market needs – Usability studies ensure product meets market needs prior to launch – First release of product more quickly adopted by market without numerous design iterations • Products get to market faster – Company makes money sooner • Products stay on market longer – Build company reputation for product quality and reliability Copyright 2013 Michelle Lott
  17. 17. Your Vision. Designed. Delivered. Copyright 2013 Michelle Lott