Regulatory Ramifications Due to the Presidential Election

Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at the potential implications for the medical device regulatory sector as a result of the U.S. presidential election. This recording took place two weeks following the election results. In addition, we speak about some recurring themes that are not exclusive to the election, such as the impact of regulatory on innovation. Specifically, the following questions are addressed:

• Based on the fact things can continue to change, why discuss this now?
• Would it be possible to eliminate the FDA? What might replace it?
• Is there too much regulation of medical devices? Or is it just the opposite—too little? What’s the sweet spot?
• There are some who believe the more regulation we have, the less innovation that’s possible. Do you agree? Are these directly impacted by each other?
• Is it possible to separate regulation and politics?
• Other than AdvaMed, which said it was looking forward to working with the new administration for what that’s worth, why isn’t the FDA or industry speaking about the possible eliminations at FDA?
• Do you agree that safety and efficacy should NOT be a function of politics?
• Without naming specific people, who is the type of person you’d want heading HHS or the FDA?
• Does this discussion have implications related to reimbursement or CMS?
• If you were serving as a regulatory consultant for a company looking at what’s potentially coming down the road, how would you advise them today?
• Any final thoughts on what’s important for this discussion/topic?

Listen to this discussion and see if you agree with our assessments. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to

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