Artificial intelligence and machine learning technologies are enabling medical devices to provide important insights to clinicians as they gather data generated during healthcare delivery. The U.S. Food and Drug Administration has identified earlier disease detection, more accurate diagnosis, and development of personalized diagnostics and therapeutics as opportunities for high-value applications.
Early detection can be a game changer for diseases such as cancer or Alzheimer’s, enabling patients to receive life-saving therapies sooner, but other applications such as interpreting MRI images or improving medication adherence are also benefiting from AI and ML. This 60-minute Webinar from the editors of Medical Design Briefs reviews the pathway to integrating this technology successfully.
In this Webinar, attendees will get:
- A process overview of the Total Product Lifecycle approach for Machine Learning (ML) and an overview of pre-market assurance of safety and effectiveness
- Process details of good ML practices; dataset selection and management; model training, tuning and evaluation; and addressing overfitting in ML models
- Clarity on which AI uses the FDA regulates: Multiple surveys indicate up to a quarter of companies do not know whether AI they use in medicine is FDA regulated.
- An understanding of FDA expectations on bias and transparency: These are unique and evolving requirements for all uses of AI, and FDA is honing its approach to regulating these aspects.
- An understanding of the technical considerations of bias, inclusion, and open-data sharing in the use of AI/ML in medical devices
- An explanation of the double-edged sword of AI and ML in medical devices as it relates to healthcare consumerism
- Details to make AI explainable: Where technical and data standards can have significant impact on driving stakeholder (patient, physician, regulatory, etc.) trust in the use of these applications
An audience Q&A follows the technical presentation.
Carrie Hetrick, DDS, Director of Regulatory and Clinical Affairs, Sterling Medical Devices
Dr. Carrie Hetrick leads the regulatory, clinical, and quality programs at Sterling Medical Devices as the company’s Director of Regulatory and Clinical Affairs. In this role, she helps companies navigate challenges in product development while establishing appropriate clinical, regulatory, and compliance structures during each stage of development. Carrie has more than 25 years of experience in medical technology, focusing on the intersection of technology, regulation, and healthcare, and has led numerous quality-management and business-process improvement/management measures. A seasoned subject matter expert in taking new products from R&D to market, she has used her regulatory and clinical expertise to aid in hundreds of successful regulatory submissions and clinical trials in the U.S. and Europe. Carrie is also experienced in leading early and late-stage cross-functional medical product development programs, directing activities and teams for all phases of design controls, and creating collaborative alliances. She holds a bachelor’s degree in biology from Pacific Lutheran University, a master’s degree in advanced biotechnology, regulatory science, from Johns Hopkins University, and a Doctor of Dental Surgery degree from the University of Colorado Health Science Center School of Dentistry.
Bradley Merrill Thompson, J.D., Regulatory Attorney, Artificial Intelligence, Epstein Becker Green, P.C.
Bradley Merrill Thompson is a Shareholder in the law firm of Epstein Becker Green, P.C., in the firm’s Washington, D.C., office, where he counsels software, medical device, and drug companies on a range of FDA regulatory issues and leads the firm’s Artificial Intelligence practice. He also serves as Chairman of the Board and Chief Data Scientist of EBG Advisors Inc., a consultancy affiliated with the law firm, which takes a multidisciplinary approach to helping health care and life sciences companies navigate the regulatory obstacles they face. Bradley has served as Counsel to the Continua Health Alliance and as General Counsel to the Combination Products Coalition, Health Regulatory Coalition, the Clinical Decision Support Coalition, and AI Startups in Health Coalition. He has taught food and drug law at Indiana University School of Law and has served as Co-Chair of the Food & Drug Law Committee of the American Bar Association and the Medical Device Committee of Food and Drug Law Institute. Bradley holds bachelor’s and master’s degrees from the University of Illinois at Urbana-Champaign, a master’s degree in applied data science from the University of Michigan, and a juris doctorate from the University of Michigan Law School.
Maria Palombini, Director, IEEE SA Healthcare & Life Sciences Practice
Maria leads the IEEE SA Healthcare & Life Sciences Practice, working with a global community of stakeholder volunteers who are committed to establishing trust and validation in tools and technologies that will change the approach to discover therapies, deliver care, and ultimately enable a sustainable and universal quality of care for all. Maria is the founder of DisruptiveRx, an information gateway that addresses the critical need for pharmaceutical and life sciences executives to connect innovation with business strategy to re-think the process of the drug development and distribution value chain. She has extensive experience in building global media brands in multiple industry sectors. She holds bachelor’s degrees from Rutgers College and an M.B.A. from Rutgers Graduate School of Business at Rutgers University.
Amanda Hosey, Editor, SAE Media Group