Another brilliant mind joins us today on the Global Medical Device Podcast. Peter Sebelius is the founder of Gantus.com and today we’ll talk medical device product development and project management. Peter is a certified PM and has vast experience in the industry and extensive knowledge of medical device standards. He is also a member of the joint working groups on ISO 13485 and Iso 14971. Today we’ll talk about lean management and agile as it applies to the development of medical devices. Can you be lean and compliant at the same time? “Medical device product development is far from a straight line.” - Jon Speer Knowing when to turn on the design controls is a delicate balance. Design controls should be a framework - they don’t necessarily need to stifle the creative process. It doesn’t have to be restrictive. “It was never intended in product management or design control to be changing technical solutions fundamentally while you’re in that process.” - Peter Sebelius Today we’ll talk about: - Can you be lean? - Finding the right balance with design controls - Using “TBDs” - Project Management and Design Controls as ‘best practices’ - “Guide for the Project Management Body of Knowledge” - “Shared responsibility is no responsibility” “You can’t write something down that you haven’t thought through well.” - Peter Sebelius Peter suggests that project managers should learn more about qualitative management and regulatory affairs. Make sure you know what’s good enough. Peter provides online training on risk management, project management and design control. You can find him and learn more at gantus.com.