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Mike on Medtech: Changing Pathway to Market?

Mike on Medtech: Changing Pathway to Market?

Sean Fenske and Mike Drues discuss the changing MDR for CE mark and its impact on the “first to market” route companies take.

By Sean Fenske, Editor-in-Chief04.25.18
In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the April issue of MPO. Click here to read that Letter. In it, I reach out to a number of industry experts on regulatory strategies and compliance to ask about a number of changes happening worldwide. One of the primary topics is the European MDR and how its transformation will affect companies’ strategies for the launch of their product. Specifically, the potential of the U.S. to become a “first to market” target going forward versus what has been an EU/CE mark first strategy for quite some time. Having his own comments on this topic, I posed similar questions to Mike during this episode to get his insights and what shifts he saw as potential outcomes of the MDR changes.

During the discussion, there is mention of a previous podcast topic—the Alternative 510(k). Click here to listen to that podcast.

Listen to this episode and see if you agree with our thoughts on the subject. If you’d like to share those opinions with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can perhaps discuss them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or you can download the MP3 file, load it onto your player of choice, and listen at your convenience.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

Click here to review other episodes of Mike on Medtech.
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