In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at ways in which medical device manufacturers can benefit from a commercial strategy standpoint through the leveraging of its regulatory strategy. Knowing how to make the regulatory process more challenging to help prevent “me too” products to reach the market can be a commercial advantage for medtech firms. Specifically, the following questions are addressed:

• First, why don’t we begin with you describing exactly what you mean when you say a company’s regulatory strategy? And is that strategy company-wide or does a regulatory strategy change with each product?
• Who should be involved with the creation of a regulatory strategy if anyone beyond the regulatory representative?
• So how does the regulatory strategy and commercial strategy intertwine?
• What benefits can be realized from this approach?
• Would you please provide some real world example to further help illustrate the relationship between the two when it’s successful?
• What should be the most important considerations for medical device firms to keep in mind regarding their commercial strategy when identifying their regulatory strategy?

In addition, several previous podcasts were mentioned. To listen to those, click on the podcast title below.

Breakthrough Designation Program Update—Mike on Medtech
Beyond 510(k)/PMA: Breakthrough Devices Program—Mike on Medtech
Breakthrough Designation Program—Mike on Medtech
Reimbursement Debate Over FDA Breakthrough Device Designation

De Novo Final Rule—Mike on Medtech
Beyond 510(k)/PMA: De Novo 101—Mike on Medtech

Listen to this episode and see what you think of the intermingling of regulatory and commercial strategy. 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 address your ideas/inquiries/suggestions in a future episode.

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