In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the impact of personalized medicine on the medical device sector. Specifically, we address a number of questions, including:

• As far as we’re concerned with regard to the medical device industry, what is personalized medicine?
• For the few devices that have been “personalized” for an individual, how has the FDA handled their approval process?
• What are the challenges to pursuing personalized medicine given the current regulatory environment as it relates to finished devices?
• What are the most significant changes that would need to occur within the regulatory environment to enable the review and approval of personalized medicine technologies?
• What is the impact on the manufacturing side with regard to regulating protocols involved with the development of personalized medicine technologies (for example, additive manufacturing and 3D printing)?

There was also reference made to a previous podcast on the topic of regulating the practice of medicine. This relates to the use of additive manufacturing technologies within the healthcare space, such as fabricating an implant right in the OR. Click here to listen to that podcast.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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 at [email protected] and we’ll try to respond in an upcoming Mike on Medtech podcast.

Send us a text

For more medtech news and information, visit https://www.mpomag.com.