{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F0c3f42b3-bc88-4a66-bcb4-8db5992db64f","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"<iframe style=\"width: 100%; height: 200px;\" title=\"Medical Device Product Development Project Management Best Practices with Peter Sebelius\" frameborder=\"0\" scrolling=\"no\" allow=\"clipboard-write\" seamless src=\"http://player.captivate.fm/episode/0c3f42b3-bc88-4a66-bcb4-8db5992db64f\"></iframe>","title":"Medical Device Product Development Project Management Best Practices with Peter Sebelius","description":"Another brilliant mind joins us today on the Global Medical Device Podcast. Peter Sebelius is the founder of Gantus.com and today we\u2019ll talk medical device product development and project management. \n\nPeter 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. \n\nToday we\u2019ll 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?\n\n\u201cMedical device product development is far from a straight line.\u201d  - Jon Speer\n\nKnowing when to turn on the design controls is a delicate balance. Design controls should be a framework - they don\u2019t necessarily need to stifle the creative process. It doesn\u2019t have to be restrictive.\n\n\u201cIt was never intended in product management or design control to be changing technical solutions fundamentally while you\u2019re in that process.\u201d - Peter Sebelius\n\nToday we\u2019ll talk about:\n\n- Can you be lean?\n- Finding the right balance with design controls\n- Using \u201cTBDs\u201d\n- Project Management and Design Controls as \u2018best practices\u2019\n- \u201cGuide for the Project Management Body of Knowledge\u201d\n- \u201cShared responsibility is no responsibility\u201d\n\n\u201cYou can\u2019t write something down that you haven\u2019t thought through well.\u201d - Peter Sebelius\n\nPeter suggests that project managers should learn more about qualitative management and regulatory affairs. Make sure you know what\u2019s good enough.\n\nPeter provides online training on risk management, project management and design control. You can find him and learn more at gantus.com.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/952641f8-ec7f-4d97-8bec-a422589904c1/125bd218-bae7-4c66-a633-4e1a0762256b.jpg"}