- Please Note: this conference will NOT be held in-person, but virtually instead
- Conference held in Eastern Time Zone
- The schedule is subject to change, so please check back for updates.
- The education sessions will be recorded and made available to registered attendees after the conference.
Monday, October 18, 2021
10:30 a.m.-10:45 a.m. - Welcome & Introductions, AAMI/BSI Staff
10:45 a.m.-11:15 a.m. - Opening Keynote - Ensuring the Safety and Effectiveness of Medical Devices Across the Product Lifecycle, Dr. Jeffrey Shuren, Office of the Center Director of the Center for Devices and Radiological Health at the FDA
- The FDA’s Total Product Life Cycle (TPLC) approach promotes and enhances the safety and effectiveness of medical devices by strengthening CDRH’s focus on the device life cycle, from device design and development to real-world use.
It also ensures transparency, efficiency, and agility of CDRH’s regulatory oversight by making communication and information sharing across CDRH easier. This is critical for ensuring that authorized devices remain safe and effective
once on the market and to inform future device modifications that are subject to premarket review.
- Dr. Shuren will describe how the FDA is working to ensure the safety and effectiveness of medical devices across a product’s entire lifecycle—a daunting challenge in an era of rapid change and technological advancement.
11:15 a.m.-12:15 p.m. - FDA Regulatory Update 1 - Update on the activities and programs of the FDA Center for Devices and Radiological Health, Barbara Zimmerman, Deputy Director, FDA/ORP; Angie Krueger, FDA; Michael Hoffman, FDA
- The presenters will provide updates on select activities and initiatives of the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, including the MDUFA IV independent Assessment, the COVID response and lessons
learned, and the COVID transition plan.
12:15 p.m.-1:00 p.m. - Navigating the Pandemic...Ensuring Continuity of Patient Care, Linda Ricci, Director, Division of All Hazard Response, Science and Strategic Partnerships, FDA; Abby Pratt, Senior Vice President, Global Strategy & Analysis, AdvaMed; Diane Wurzburger, Executive Regulatory Affairs, Developed Markets & Global Strategic Policy, GE Healthcare
- The panel will review the challenges the Covid-19 pandemic posed for the medical device sector, review the efforts of regulators, industry and clinicians to respond to those challenges, and discuss future actions the industry may consider to prepare
for the next critical event or pandemic.
1:00 p.m.-1:45 p.m. - Virtual Networking Break
1:45 p.m.-2:30 p.m. - Patient Engagement in Standards and Regulations and the Science of Patient Input, Dr. Jesse Ehrenfeld, MD, MPH, AMA Board of Trustees, Medical College of Wisconsin; Dr. Michelle Tarver, MD, PhD, Deputy Director, FDA/CDRH/OST
- Dr. Tarver and Dr. Ehrenfeld will review the importance of real-world patient perspectives in medical product development and will examine the FDA’s efforts to achieve more meaningful patient engagement in regulatory discussions as well
as discuss how this engagement can be promoted during the creation of standards.
2:30 p.m.-3:15 p.m. - FDA Regulatory Update 2 - Digital Health Center of Excellence, Bakul Patel, Director, Digital Health Center of Excellence, FDA
- Bakul Patel will review the FDA’s digital health programs and the work of the Digital Health Center of Excellence and will provide updates on related FDA initiatives (e.g., software, AI, health IT, etc.)
Tuesday, October 19, 2021
10:30 a.m.-11:15 a.m. - Update on the European Medical Device Regulations and IVD MDR, Richard Bancroft, BSc, Science & Technical Director, STERIS Corporation; Erica Conway, Head of Notified Body-IVD, BSI
- Richard Bancroft will provide an update on the EU Medical Device Regulation, in particular the status of International Standards harmonization to the MDR. Erica Conway will provide an update on the upcoming implementation of the In vitro Diagnostics
Regulation and the priorities from year one until the end of the transition.
11:15 a.m.-12:00 p.m. - Update on the Developing Regulatory Regime in the United Kingdom, Dr. Camilla Fleetcroft, Devices Regulatory Affairs Group Manager, UK MHRA; Dr. Eamonn Hoxey, PhD, FR Pharm S, Director, EV Hoxey, LTD
- Dr. Fleetcroft will present on the status of the U.K. Medicines and Healthcare products Regulatory Agency post-Brexit regulatory regime for medical devices and then Dr. Fleetcroft and Dr. Hoxey will converse on the implications for and perspectives
12:00 p.m.-12:45 p.m. - IMDRF Update and the Future of Global Efforts to Harmonize Regulatory Regimes, Melissa Torres, FDA/CDRH
- Melissa Torres will provide an update on the International Medical Devices Regulatory Forum and other global efforts to promote the harmonization of medical device regulation.
12:45 p.m.-1:30 p.m. - Virtual Networking Break
1:30 p.m.-2:15 p.m. - Spotlight on the Medical Device Regulatory Coalition and the USAID COVID-19 Medical Device Regulatory Convergence Project and the Coalition for Regulatory Convergence, Medtech Sector, Steven Bipes, Vice President, Global Strategy & Analysis, Advamed; Sandra Ligiad Gonzalez, Executive Secretary of the Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector
- Mr. Bipes will address AdvaMed’s work on global medical device regulatory convergence within the geographic regions of Latin America and Africa. Within this context, he will address AdvaMed’s advocacy for Good Regulatory Practices
(GRP) including the use of international standards to minimize Technical Barriers to Trade (TBT). Mr. Bipes will also present on the USAID COVID-19 Medical Device Regulatory Convergence Project (MDRC) and related capacity building with industry
and National Regulatory Authorities.
- Ms. González will address the work of the Inter-American Coalition that brings together the Medtech associations of the Western Hemisphere promoting Good Regulatory Practices and Medical Technology Regulatory Convergence. She will review
the Coalition’s engagement as principal implementing partner for the USAID COVID-19 Medical Device Regulatory Convergence Project (MDRC) and provide a summary of Coalition initiatives and MDRC activities by country.
2:15 p.m.-3:00 p.m. - Spotlight on India and Efforts to Promote the use of International Standards, Abby Pratt, Senior Vice President, Global Strategy & Analysis, Advamed; Leslie McDermont, Senior Director-International Development, American National Standards Institute; Scott Colburn, CAPT, USPHS, Director, Standards and Conformity Assessment Program, FDA/CDRH/OST/DARSS/S-CAP
- Recently, India has pursued a policy of adopting indigenous product specific standards for medical devices which could prevent India consumers from accessing state-of-the-art medical technology that provides the safest and most effective treatment
for medical conditions. The panel will review these developments and India’s emergent regime for regulating medical devices. The panel will also discuss the ongoing efforts of various organizations (AdvaMed, AAMI, ANSI and FDA) to encourage
harmonization of those regulations with IMDRF guidelines and essential principles as well as to promote the adoption of international medical standards by India . Finally, ANSI will provide information on their efforts to partner with the
Bureau of Indian Standards (BIS) to provide direct training and technical workshops to support these efforts.
Wednesday, October 20, 2021
10:30 a.m.-11:00 a.m. - Closing Keynote - Consumer Facing Health AI: Ensuring the Safety and Effectiveness of Personal Health Devices and Technologies, Dr. Jesse Ehrenfeld, MD, MPH, AMA Board of Trustees, Medical College of Wisconsinr
- The continued growth and availability of digital health AI tools poses challenges for both regulators and consumers. While regulators pursue balance in the need to ensure safety, reliability, and availability of medical devices and software, consumer
confidence has grown for both regulated and unregulated products. How should regulators and standards organizations address the expectations that consumers have that the health information they seek and AI tools they use are accurate and reliable,
when a growing number of consumer facing digital tools are unregulated by the FDA or other regulatory bodies? In this session, Dr. Ehrenfeld, a dual board certified anesthesiologist and informaticist who serves on the AMA Board of Trustees,
will review case examples and provide a physicians perspective on this looming challenge.
11:00 a.m.-11:45 a.m. - UDIs Requirements and Opportunities for Global Harmonization, Lena Cordie-Bancroft, BSI
- Lena Cordie-Bancroft will provide an update on the status of and comparison of UDI regulations globally and review key considerations and best practices for companies developing a sustainable, global UDI program.
11:45 a.m.-12:15 p.m. - Standards and Regulation for Combination Products, Jon Cammack, Chief Quality & Compliance Officer, Nevakar; John Weiner, Associate Director FDA Office of Combination Products, FDA
- Jon Cammack and John Weiner will report on AAMI’s efforts to identify standards and education needed to support combination products and the growing number of pharma-medical device companies, as well as on the ongoing work of the AAMI Combination
Products Committee and the revision of AAMI TIR48, Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products.
12:15 p.m.-1:00 p.m. - Cybersecurity Update - Managing Medical Device Cybersecurity in an Increasing Complex and Hostile Environment, Michael McNeil, Senior Vice President and Global CISO, McKesson; Michelle Jump, Global Regulatory Advisor-Medical Device Cybersecurity, MedSec
- Michael McNeil and Michelle Jump will discuss the increasing cyber threat to medical devices and networks and the ongoing regulatory and standards efforts to address them.
1:00 p.m.-1:45 p.m. - Virtual Networking Break
1:45 p.m.-2:30 p.m. - Cloud Computing for Medical Devices and Medical Device Quality Systems, Randy Horton, VP of Solutions and Partnerships, Orthogonal; Pat Baird, Regulatory Head of Global Software Standards, Philips; Bernhard Kappe, CEO, Orthogonal
- The panel will discuss the new AAMI Consensus Report, AAM CR 510, Appropriate use of cloud computing for quality systems and medical devices and plans to develop it further into a AAMI Technical Information Report, followed by a discussion of the
various new approaches to managing ongoing change of validated processes.
2:30 p.m.-3:15 p.m. - Artificial Intelligence - Developing standards and requirements for artificial intelligence and algorithm change protocols, Shawn Forrest, FDA; Pat Baird, Regulatory Head of Global Software Standards, Philips; Rob Turpin, BEng, Head of Sector (Healthcare), BSI
- The panel will review AAMI and BSI’s plans to publish an AAMI Technical information Report/BSI Standard on risk management for medical devices incorporating AI as well as the anticipated development of international AI medical device standards.
3:15 p.m.-3:30 p.m. - Closing Remarks