Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss many of the concerns and issues involved with the off-label use of a medical device. Further, we talk about the advertising and promotion of such use, what’s permitted, and what will get a company in trouble. Specifically, the following questions are addressed:

• What is off-label use as it relates to a medical device?
• What are the limitations of off-label use? Where is the real line between what’s allowed and what’s not?
• How are off-label use and real-world evidence connected?
• Can a device manufacturer advertise off-label use without going to jail?
•  How might FDA’s view of advertising off-label use change in the future?

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.

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

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the differences between materials and biomaterials, biocompatibility, biofriendly, biostable, and bioabsorbable. Specifically, the following questions are addressed:
 

• What’s the difference between a material and a biomaterial?
• What’s the difference between a biocompatible material versus a biofriendly material?
• How is a biostable material different from a bioabsorable/biodegradable materials?
• Do bioabsorables pose additional challenges?
• Do the regulatory rules for biomaterials differ from the ones that are currently followed for more traditional materials?
• What’s your response to companies who would rather not attempt to introduce a new material (or biomaterial) to the regulatory approval process?

Check out the guidance mentioned in this podcast—ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."

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.

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

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the impact 3D printing has made on the current medical device industry, the challenges that are restricting greater use, and a couple of examples of bleeding edge applications that will likely play a substantial role in medtech and healthcare very soon. Always an interesting topic, this podcast likely represents only the first of a series of discussions that center around 3D printing in healthcare.

Check out the video mentioned in this podcast where we discuss the FDA’s additive manufacturing guidance.

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.

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

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the significance of reimbursement as it relates to product development. Not all medical device designers and engineers make the necessary connections between these two seemingly unrelated topics. In reality, however, the two need to be considered carefully alongside regulatory issues to ensure a delicate balance among all three is discovered. At that point, product development should begin in earnest.

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.

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

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recent Editor's Letter that appeared in the March 2017 issue of MPO. In it, I wrote about a blog Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, authored regarding findings of recent hospital inspections as related to medical device reporting. Suffice to say, changes are needed with regard to the reporting of incidents by those involved in healthcare. How might we resolve the issue? Listen to this episode to hear what suggestions are made.

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.

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

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use of real world evidence in the medical device approval process, which has gained much attention lately due to several reasons. It was specifically mentioned in the 21st Century Cures Act and it was also the topic of a recently released FDA Guidance document (PDF). Further, we seek to gain some additional insights on what real world evidence actually is, why it matters to medical device manufacturers, and how they might be able to make efficient use of it.

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 Fan Mail

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