2024 MedCon Workshop
this year’s theme
AI/ML Enabled Medical Devices from a Quality & Regulatory Perspective: an Interactive Workshop
As the number of Artificial Intelligence and Machine Learning (AI/ML)-enabled medical devices cleared by FDA approaches 1,000, the challenges associated with incorporating this technology are still significant. The level of understanding around AI/ML fundamental concepts in the industry is still very low; regulatory frameworks are not yet designed to take advantage of the greatest benefits of AI/ML, and there are many barriers to trust in these technologies to safely and effectively diagnose and treat patients (e.g., bias, transparency, explainability).
This daylong workshop aligns attendees on vocabulary and concepts and includes a hands-on session that takes a simple AI algorithm and moves it through the training, testing, and tuning process. The workshop will also include:
An overview of current and future regulatory trends in AI/ML-enabled medical devices
The impact of AI/ML on Quality and Regulatory functions
Technology, intended use, and trustworthiness challenges that the medical device industry and regulators must address
A case study walking attendees through development, submission, clearance, and deployment of an AI/ML-enabled medical device
workshop Facilitators
Cassie Scherer
Medtronic
Erez Kaminski
Ketryx
Eric Henry
King & Spalding
Jason Brooke
Brooke & Associates
Mandar karhade
Citingale
Yarmela Pavlovic
Medtronic
APRIL 23, 2024 — MedCon Workshop Agenda
9:00 a.m. – 10:00 a.m.
Intro
- Welcome and Introduction to the Workshop
- Brief Overview of AI in the Medical Devices Industry (technologies and use cases)
- Key AI Concepts (machine learning, natural language processing, computer vision)
Speakers
Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
Erez Kaminski, CEO & Founder, Ketryx
10:00 a.m. – 10:45 a.m.
Regulatory Landscape for AI in Medical Devices
- Overview of current and future regulatory frameworks (U.S. and global) for medical devices
Speaker
Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
10:45 a.m. – 11:00 a.m.
Break
11:00 a.m. – 12:00 noon
Quality Assurance with AI in Medical Devices
- Medical device AI/ML use cases
- Role of AI supporting the QMS
- Role of AI in enhancing quality control processes (manufacturing)
- Addressing challenges and opportunities in compliance
- AI and safety risk management
Speaker
Jason Brooke, Attorney & Managing Member, Brooke & Associates
12:00 noon – 1:00 p.m.
Lunch
1:00 p.m. – 2:00 p.m.
Future Trends and Challenges
- Emerging trends in AI for medical devices and their regulatory impact
- Bias
- Transparency/explainability
- Nutrition labels
- Assurance labs
- Other anticipated regulatory challenges and potential solutions for AI/ML
Speakers
Yarmela Pavlovic, VP Global Regulatory Affairs, Strategy & Policy, Medtronic
Cassie Scherer, Senior Director U.S. Regulatory and Global Digital Health Policy, Medtronic
2:00 p.m. – 3:00 p.m.
Interactive Session: Building an AI-Enabled Medical Device Overview
- Overview of a sample medical device project
- Hands-on demo using AI tools
Speaker
Mandar Karhade, Founder, Citingale
3:00 p.m. – 3:15 p.m.
Break
3:15 p.m. – 4:00 p.m.
Case Studies: Successful Implementation of AI in Medical Devices
- Real-world examples of AI integration in medical devices
- Highlighting positive outcomes in terms of efficiency and compliance
- Lessons learned and best practices from these cases
Speaker
Erez Kaminski, CEO & Founder, Ketryx
4:00 p.m. – 4:30 p.m.
Conclusion and Networking
- Recap of key takeaways
- Opportunities for further learning and collaboration
Speaker
Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
