Digital health, artificial intelligence (AI), machine learning and more – these concepts continue to create a sensation in the Medtech world.
FDA published last month Guidance on a Clinical Decision Support (CDS) Program. It helped clarify what constitutes and what does not constitute a medical device. Early last year, the agency published a Default Change Control Plan (PCCP) To help build an organizational structure for this technology.
These topics and more have stimulated interesting comments on the panel in MedTech Conference at AdvaMed in Boston today.
The painting offered views across all corners of the space. Dr. Yuri Maricic, Chief Marketing Officer and Head of Development at Pear Therapeutics, presented ideas from the developer of Digital Therapies. Brendan O’Leary, acting director of the Food and Drug Administration’s Center of Excellence for Digital Health, provided the regulatory perspective.
Cybil Roehrenbeck, partner at Hogan Lovells, provided ideas on the payback side. Cassie Shearer, Senior Director of Digital Health Policy and Regulatory Strategy at Medtronic, provided an industry perspective. The session was moderated by Diane Johnson, Senior Director, Strategic Organization, MD&D at Johnson & Johnson.