{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fd8d074a1-fdab-4718-a8ea-a956bf7904d1","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"15 Habits of Highly Effective Regulatory Professionals","description":"Quality and regulatory professionals in the medical device industry have to deal with a lot.\n\nIn this episode, Mike Drues of Vascular Sciences shares 15 of his highly effective habits and tips to help you lead your organization.\n\nYou have an opportunity and obligation to explain the current regulatory structure in the industry - embrace it, don\u2019t resist it!\n\nSOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE:\n\n\u25cf Poker Game: Relationship between a company and the FDA is like a poker game; even if someone understands the regulations, doesn\u2019t mean they win\n\n\u25cf Think Globally: Startups and new companies make the mistake of not considering international regulatory strategies; satisfy needs of various places\n\n\u25cf Consider Regulatory from the Beginning: It\u2019s never too early to think about regulatory in product development lifecycle; minimize burdens and problems\n\n\u25cf Don\u2019t Reinvent the Wheel: When it comes to clinical trials, data, and real-world evidence - can they be justified, even if the FDA asks for them?\n\n\u25cf Competitive Regulatory Strategy: If you follow in somebody else\u2019s footsteps, you\u2019ll never go anywhere new\n\n\u25cf Don\u2019t Just Copy Others: Lots of sheep in medical device industry who take the path of least resistance; not aware of their options\n\n\u25cf Know All of Your Options: Know about available options, as well as the advantages and disadvantages of each, to get your medical device on the market\n\n\u25cf Don\u2019t be Myopic About Risk: All conventional risk approaches are limiting; some aspects of risk are important to consider but not addressed in them\n\n\u25cf New is Not Necessarily Your Friend: If you think you\u2019re working on a newer, novel device, you\u2019re probably not: Regulation? Guidance? Reimbursement?\n\n\u25cf Use Label Expansions to Your Advantage: Tempting to bring a product with all the bells and whistles to market, but higher likelihood of being unsuccessful\n\n\u25cf Design Your Label Like You Design Your Device: Spend time and money on label design; use all tools available to express your message\n\n\u25cf No Submission Should Ever be Rejected: 75% of first-time 510(ks)s are rejected; minimize or eliminate rejections through advanced communication with agency\n\n\u25cf Communicate Early and Often with FDA: It\u2019s not the FDA\u2019s job to tell you what to do; tell, don\u2019t ask and lead, don\u2019t follow\n\n\u25cf Don\u2019t Treat FDA or Other Regulatory Agency as Your Enemy: Don\u2019t approach agency as beta tester or with minimum done to get it to sign-off on a product\n\n\u25cf Don\u2019t be the Regulatory Police: Don\u2019t tell a company what they can\u2019t do, but what they can do; don\u2019t let regulation hold you back","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/eb9d3d29-c812-4e66-b48e-80df33fd8feb/2bd7620f-7a5d-488c-8363-c26e5ec56954.jpg"}