Today on the Global Medical Device Podcast we have a very interesting and highly debated topic for you around research vs. development for medical device companies. We’ll challenge some conventional wisdom on the subject and dig into when ‘R’ should end and ‘D’ begin. Our guest on the show today is David Amor, a medtech/biotech consultant and mobile health entrepreneur. David is the founder of Medgineering, a consultancy specializing in implementing new quality systems, design control processes, and risk management for both startups and larger companies. Recently David also launched QuickConsult, an online consulting platform that pairs up medtech experts with startups or large companies. The online consulting model allows clients to work with the consultants of their choice who will help them understand their specific quality and regulatory needs. The subject of today’s episode is loosely based on a well written and thoughtful article David authored a few months back titled, “When does the ‘R’ end and the ‘D’ begin for medical device companies?” Jon and David touch upon a lot of the points in that post (which I encourage you to go read after listening to today’s episode) and really dig into why the conventional wisdom regarding ‘R’ and ‘D’ in medical device product development is often wrong. Specifically, today Jon and David get into: -Why should you start design controls early in development? -Are your thoughts about research wrong? -Will doing design controls early slow you down? -When do design controls ACTUALLY start? -How to view design controls as more than a paperwork heavy process. -The shift in traditional R&D roles. -What outcomes you should be focused on BEFORE research.