< Back to conference archives
Archive
2022 MedCon Sessions
The premier medical device conference driving the speed of innovation.
Early Morning Sessions
9:30 a.m. – 10 a.m.
CONNECT in early
Take this time to log in early and check your connection.
10:00 a.m. – 10:20 a.m.
welcome to medcon 2022
Moderator
Speakers
10:20 a.m. – 11:05 a.m.
CDRH’s Strategic Direction for 2022
Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health (CDRH), will provide an update on FDA’s priorities and strategic direction for the medical device industry. The session will highlight Center activities that continue to promote device safety, efficacy, quality, access, and innovation.
Moderator
Speakers
11:05 a.m. – 11:15 a.m. Break
Mid-Morning Sessions
11:15 a.m. – 12:15 P.m.
Update from ORA’s Office of Medical Products and Office of Medical Device and Radiological health
The Office of Regulatory Affairs’ (ORA) Office of Medical Products and Radiological Health houses all medical device and radiological health investigators across the country. Dr. Elizabeth Miller, Associate Commissioner of the Office of Medical Products and Anne Reid, Acting Program Director of the Office of Medical Devices and Radiological Health will provide an update on ORA’s key initiatives, strategic priorities, and inspectional approaches to the medical device industry.
Moderator
speakers
12:15 p.m. – 12:45 p.m. lunch
Afternoon Sessions
12:45 p.m. – 1:45 p.m.
Medical Device User Fee Amendments (MDUFA) V Update
Learn about the commitments that will affect every device company.
moderator
Speaker
1:45 p.m. – 2:45 p.m.
FDA Proposed QMSR – Updating 21 CFR 820 to Harmonize with ISO 13485:2016
On February 24, 2022, FDA published the Draft Proposed Rulemaking for the new “Quality Management System Regulation” (QMSR) with comments due by May 24, 2022.
- CDRH will provide an update on the proposed rule from an FDA perspective.
- Hear the analysis of the proposed rule from industry and ISO TC 210 International Committee experts.
- Join in open discussions on questions, concerns, and how to submit public comments.
moderator/SPEAKER
Speaker
2:45 p.m. – 2:55 p.m. Break
Day 1 Tracks
Pick from three track options.
2:55 p.m. – 3:55 p.m.
IMDRF Good Regulatory Review Practices: How to Make Single Review a Reality
Do you market your products in more than one jurisdiction? Do you seek globally harmonized regulatory requirements that reduce regulatory redundancy and support patient access to medical devices? The Medical Device Single Review Program (MDSRP), once implemented, will support earlier patient access to devices by enabling a single regulatory premarket review across multiple regulatory jurisdictions. Hear from CDRH on what they have been doing in collaboration with other regulators participating in the International Medical Device Regulators Forum (IMDRF) to help move international device regulatory submissions into a “single review” process. This session also provides industry’s perspective on the importance of a globally harmonized regulatory requirements, including potential challenges.
Moderator
speakers
3:55 p.m. – 4:00 p.m.
break
4:00 p.m. – 5:00 p.m.
CDRH Premarket Program Updates
Listen to FDA Leadership from the Office of Product Evaluation and Quality provide updates to current ongoing novel programs at FDA including: eSTAR, transitioning from Emergency Use Authorizations, SteP, the submissions progress tracker, and the Breakthrough Device Program. Also, get up-to-date information on recent trends of Premarket Submissions data and information regarding premarket submission appeals and the least burdensome flag.
moderator
speaker
2:55 p.m. – 3:55 p.m.
Current Perspectives on Lifecycle Risk Management
Explore, with this panel of experts, the current landscape of Risk Management and ISO 14971 implementation, including EN harmonization. This discussion will also traverse lifecycle management of use-related risks and discuss considerations and best practices for the transition of risk management activities from pre-market to post market.
Moderator/speaker
- Shannon Hoste, Senior Director of Human Factors and Regulatory Strategy, Agilis Consulting Group
speakers
- Taylor Dieringer, MEDIceptEd Bills, Edwin Bills, Consultant
3:55 p.m. – 4:00 p.m.
break
4:00 p.m. – 5:00 p.m.
The Connected Journey of Data, Metrics, KPIs and CAPA
Does your firm use metrics and Key Performance Indicators (KPIs) to make CAPA decisions? Learn how data sources, metrics and KPIs interrelate and their relationship to CAPA. Using examples, the speakers will demonstrate the importance of setting triggers based on risk data to incorporate into CAPA decision making to achieve consistency in escalation to the improvement process.
- Discuss data sources and how to determine triggers.
- Explore utilizing risk data and other quantitative historical data to establish triggers.
- Reiterate the importance of communication within the organization and up to management.
Moderator
- Aaron Dunbar, Director of Corporate Quality Systems, Boston Scientific Corporation
speakers
- Amanda Rucker, Cook MedicalKatie Crawford, Boston Scientific Corporation
2:55 p.m. – 3:55 p.m.
Cybersecurity: Holistic Strategies to Mitigate and Manage Risk
Cybersecurity is a key enabler within our healthcare systems to protect the privacy and safety for patients as well as the business continuity of providers. Successful strategies for cybersecurity require a high degree of collaboration across multiple stakeholders with shared responsibility. Learn from this panel of industry experts some key areas to consider.
Moderator
- Kim Trautman, Managing Director and Vice President, MEDIcept Inc.
speakers
- Carlos Arglebe, Siemens Healthineers
- Arnab Ray, Abbott
- Dan Lyon, Global Director of Product Security, Boston Scientific Corporation
- Arnab Ray, Abbott
3:55 p.m. – 4:00 p.m.
break
Global developments in regulating AI based medical devices
4:00 p.m. – 5:00 p.m.
AI almost seems too hot to handle. Many active devices will see an AI component supporting them in the future, following the earlier steps of getting them all ‘connected’. This time the regulations are gearing up in speed with the technical development in the market. US, EU, China and more countries are adding legislation and guidance for AI in general and for medical devices in specific. This panel will bring some of the latest insights from around the world, and will support the discussion on how to best approach global regulatory approvals in this exciting field of development.
Moderator
- Gert Bos, Executive Director and Partner, Qserve Group
speakers
- Koen Cobbaert, Senior Manager – Quality, Standards & Regulations, Philips
- Eric Henry, King & Spalding
- Yu Zhao, Founder & President, Bridging Consulting LLC
- Arnab Ray, Abbott
Early Morning Sessions
9:30 a.m. – 10 a.m.
COnnect in early
Take this time to log in early and check your connection.
Day 2 Tracks
Pick from three track options.
10:00 a.m. – 11:30 a.m.
Biocompatibility and Premarket Submissions
Listen to a panel of experts discuss the current challenges of addressing biocompatibility issues for premarket submissions. Hear FDA leaders discuss expectations for medical device biocompatibility testing to be included in Premarket Notifications. Test lab experts will present trends and areas of concern observed while performing tests to support submissions. Finally, join in the discussion as industry leaders share experiences with recent FDA submissions as well as best practices in the inclusion of biocompatibility in preparation of Technical Files.
Moderator
speakers
11:30 a.m. – 11:40 A.m.
break
11:40 a.m. – 12:40 p.m.
How Does FDA Regulate Accessories to Medical Devices?
Is your product’s performance supported, supplemented, and/or augmented by an accessory? Then it may be classified as an accessory that requires premarket notification or approval. Hear from CDRH and Industry on medical device accessory determination, classification, and pathways for clearance or approval.
Moderator
speakers
10:00 a.m. – 11:00 a.m.
FDA Digital Health Software Precertification (Pre-Cert) Pilot
The Software Precertification (Pre-Cert) Pilot, as outlined in the FDA’s Digital Health Innovation Action Plan, will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices developed by manufacturers who have demonstrated a robust culture of quality and organizational excellence, and who are committed to monitoring real-world performance of their products once they reach the U.S. market. Brendan O’Leary, Acting Director, FDA / CDRH Digital Health Center of Excellence will provide an overview of the pilot and its continued development. Industry representatives will also share their perspectives of the pilot.
Moderator
speakers
11:00 a.m. – 11:40 a.m.
What Cloud Computing Teaches Us About the Future of the Validated State
The cloud endows software with incredible speed, flexibility and power. How can we harness that power for our medical device software while remaining compliant? And how can we apply best practices from the cloud to our broader interoperable MedTech world? Orthgonal’s Randy Horton and Philips’ Pat Baird co-chaired a team to create the groundbreaking consensus report on operating medical device software on cloud computing, AAMI CR510:2021. That consensus report has set the stage for AAMI TIR #115, currently in the works, that will provide more detailed guidance on how we can use cloud computing in the operation of medical devices.
Moderator
speakers
11:40 a.m. – 12:40 p.m.
break
10:00 a.m. – 11:00 a.m.
UK MHRA and Swiss Medic Medical Device Registrations – Are you in compliance?
As of May 2021, with the effectiveness of the EU MDR, the CE mark will no longer be extending to three countries: United Kingdom, Switzerland, and Turkey. To market in these countries, medical device manufacturers must have new Authorized Representatives, registrations, and additional requirements. This session will cover deadlines for registration and appointment of Authorized Representatives as well as up-to-date information on specific requirements for the UK and Switzerland. Recognize the need to stay tuned to upcoming UK MHRA publications of new medical device regulations that will not be the same as the EU MDR or EU IVDR scheduled for the UK in 2023. Learn about the nuances of Northern Ireland and the Republic of Ireland. Understand what you need to know about marketing your products in Switzerland.
Moderator
speakers
11:00 a.m. – 11:1o a.m.
break
11:10 a.m. – 12:4o p.m.
EU MDR and EU IVDR: Latest Guidance and Developments
Notified body, industry and service provider will come together to bring an overview of current developments in the field of EU MDR and EU IVDR. New guidance will be explained, and general updates will be provided. The audience will be engaged in discussion centering around several examples of core regulatory issues.
Moderator
speakers
12:40 p.m. – 1:10 p.m. Break
Afternoon Sessions
1:10 p.m. – 2:10 p.m.
Supply Chain and Medical Device Shortages – Navigating a Challenging Situation
Have you experienced challenges due to supply chain disruptions and product shortages? This session will provide FDA and industry perspective on past experience, lessons learned during the COVID public health emergency, and how government and industry can partner to identify issues before they become problems in the future.
Moderator
speakers
2:10 p.m. – 2:20 p.m. Break
2:20 p.m. – 3:35 p.m.
Software Bill of Materials (SBOM): An Essential Tool Supporting Cybersecurity Risk Management across the Healthcare Ecosystem
Cybersecurity issues such as ransomware plague the healthcare ecosystem and one major contributor to the sector’s vulnerability is failure to keep software components updated to address emerging vulnerabilities. In 2017, the WannaCry ransomware outbreak that crippled over 70,000 devices across the National Health Service hospitals in the UK and Scotland was possible due to inability to identify and patch a Microsoft Windows vulnerability (MS17-010). The problem is complex and significant risk still exists today. Executive Order 14028, issued on May 12, 2021, specifically calls out SBOM and its value in an effort to improve the Nation’s Cybersecurity and help address this specific problem. Have you wondered why Software Bill of Materials (SBOM) should be important to your company? What is the benefit of disclosing your SBOM? Why do some regulatory jurisdictions strongly recommend it? Join this session to understand the importance of SBOM for your medical device’s security and quality. Industry and FDA experts will provide an update on regulatory and market expectation, invaluable insight on best practices for implementing SBOM, and current efforts to advance international regulatory convergence on medical device cybersecurity.
Moderator
speakers
3:35 p.m. – 3:45 p.m.
Closeout / Wrap-up for Day
Early Morning Sessions
9:30 a.m. – 10 a.m.
CONNECT in early
Take this time to log in early and check your connection.
10:00 a.m. – 11:20 a.m.
EU MDR Implementation: First Lessons Learned
Join us as a panel of experts provide core elements of learning from the first phase of the EU MDR implementation. Explore what worked well, where have they surprised each other, and what is not easy to implement or review.
Moderator
speakers
11:20 a.m. – 11:50 a.m. Break
Mid- Morning Sessions
11:50 a.m. – 1:50 P.m.
Investigator Insights
Every year at MedCon, Investigators share insight on inspection trends observed. The FDA sends veteran device investigators to “tell it like it is” from their perspective. Use this friendly forum to prepare today for tomorrow.
Moderator
speakers
1:50 p.m. – 2:00 p.m. Break
Afternoon Sessions
2:00 P.m. – 3:00 P.m.
Unique Device Identifiers – AccessGUDID.
Are you where you should be?
In this session, the FDA will provide an overview of the Unique Device Identification (UDI) System, its benefits, and the latest information on implementation timelines and extensions. Insights on how UDI is covered during FDA inspections and what medical device manufacturers should expect will also be shared. Industry representatives will also share their perspectives of the FDA’s UDI System, UDI requirements from other geographies, and managing the differences in applicable requirements.
Moderator
speakers
3:00 P.m. – 3:45 P.m.
ASSESSING AND IMPROVING DEVICE SAFETY & PERFORMANCE THROUGH ADVERSE EVENT SURVEILLANCE
Adverse event information is one of several data elements that industry and FDA consider in monitoring medical device performance in the real world. This session will focus on Medical Device Reporting (MDR) and related programs, to provide updates on policy process and systems made by FDA in recent months. FDA and industry representatives will provide perspective on a variety of topics, as well as best practices and anticipated developments in this space.
Moderator
Facilitators
3:45 P.m. – 4:00 P.m.
CLOSE OUT / EVENT WRAP-UP
In 2022, this conference was co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.