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Mike on Medtech: 15 Tips for Getting New Products Through FDA

Mike on Medtech: 15 Tips for Getting New Products Through FDA

Mike Drues provides insight to Sean Fenske on what he's learned about getting devices through the FDA over the last 15 years.

By Sean Fenske, Editor-in-Chief07.03.18
In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue the 15 year anniversary theme that ran throughout the June 2018 issue of MPO and within my lastest Editor’s Letter that appeared in that issue, The More Things Change... (click to read that Letter). In it, I take a look back at the very beginnings of MPO and see what topics were relevant then that still resonate today within the magazine and industry. Given that theme, in this podcast, we discuss lessons learned from the last 15 years of getting products through the FDA and into the market. The 15 “best practices” (or at least factors to keep in mind during the development of a new product) are provided to help ensure a smoother ride through the regulatory approval or clearance process. Following is a quick list of these 15 tips along with the timestamps in case you are interested in hearing only a few (but hopefully, you stick around to gain insights on all 15). Expanding on each of these, Mike Drues provides his “lessons learned” for each.

Mike Drues’ 15 Tips for Getting a New Product Through the FDA

1. This is a poker game in every sense—(00:56)
2. Consider regulatory from the beginning—(01:57)
3. Employ a competitive regulatory strategy—(03:22)
4. Use label expansions to your advantage—(05:00)
5. No submission should ever be rejected—(07:05)
6. Communicate early and often with FDA—(08:52)
7. Don't treat FDA as your enemy—(11:10)
8. Don’t be the regulatory police—(13:40)
9. Think globally—(16:40)
10. Don’t reinvent the wheel—(17:33)
11. Don't just copy others—(18:33)
12. Know all your options—(19:32)
13. Don’t be myopic about risk—(19:44)
14. New is not necessarily your friend—(20:30)
15. Design your label like you design your device—(21:50)

Listen to this episode and see if anything could use further explanation or you still have questions about any of the tips. If you’d like to share thoughts and comments 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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