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Medtech Matters - Podcast

Medtech Matters

A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.

Tech News Business News Technology
Update frequency
every 8 days
Average duration
31 minutes
Episodes
154
Years Active
2017 - 2025
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Beyond 510(k)/PMA—Safer Technologies Program

Beyond 510(k)/PMA—Safer Technologies Program

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the brand new (in fact, yet-to-be-launched) Safer Technologies Program (click to…

00:24:35  |   Wed 16 Oct 2019
Benefit-Risk Determinations

Benefit-Risk Determinations

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss two recently issued FDA guidance documents. As they can be coupled together, we …

00:23:40  |   Mon 16 Sep 2019
Mike on Medtech: Beyond 510(k)/PMA—Breakthrough Devices Program

Mike on Medtech: Beyond 510(k)/PMA—Breakthrough Devices Program

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the still relatively new Breakthrough Devices Program (click to review the guida…

00:28:36  |   Tue 06 Aug 2019
Beyond 510(k)/PMA—De Novo 101

Beyond 510(k)/PMA—De Novo 101

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the third most commonly used (although still substantially less than the 510(k) …

00:24:06  |   Tue 02 Jul 2019
Mike on Medtech: The NYT Editorial Board Statement

Mike on Medtech: The NYT Editorial Board Statement

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the subject of my latest Editor’s Letter, which appeared in the June issue of MP…

00:25:06  |   Mon 17 Jun 2019
The Alternative Summary Reporting Program

The Alternative Summary Reporting Program

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recently announced cancellation of the FDA’s alternative summary reporting p…

00:25:54  |   Fri 24 May 2019
Do we need a pre-sub for 483s? (Part 2)

Do we need a pre-sub for 483s? (Part 2)

In the second part of this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue our discussion of a recently released guidance from the FDA,…

00:23:45  |   Thu 09 May 2019
Do we need a pre-sub for 483s?

Do we need a pre-sub for 483s?

In the first part of this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recently released guidance from the FDA, “Nonbinding Feedb…

00:23:47  |   Thu 09 May 2019
FDA's Material Evaluation

FDA's Material Evaluation

In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s letter from March 15, which provided a statement from FDA Commissioner Scott Gottlieb, M.D., a…

00:23:16  |   Tue 02 Apr 2019
510k Modernization

510k Modernization

In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s announcement of their effort to modernize the 510(k) regulatory pathway. This podcast is an ex…

00:18:54  |   Fri 25 Jan 2019
Personalized Healthcare

Personalized Healthcare

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 q…

00:22:43  |   Thu 03 Jan 2019
My Holiday Wish List (Part 1)

My Holiday Wish List (Part 1)

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 November/December issue of MPO, My Holiday Wish List (fo…

00:21:27  |   Tue 04 Dec 2018
Regulating the Practice of Medicine

Regulating the Practice of Medicine

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 October issue of MPO, Regulating the Practice of Medicin…

00:25:22  |   Fri 26 Oct 2018
The Bleeding Edge, Part 3

The Bleeding Edge, Part 3

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we conclude our conversation on the Netflix documentary, The Bleeding Edge. The documentary…

00:30:30  |   Wed 26 Sep 2018
The Bleeding Edge, Part 2

The Bleeding Edge, Part 2

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue a discussion that will span several parts. The conversation is centered around …

00:30:05  |   Fri 07 Sep 2018
The Bleeding Edge, Part 1

The Bleeding Edge, Part 1

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we begin a discussion that will span several parts. The conversation is centered around the…

00:28:30  |   Wed 05 Sep 2018
Breakthrough Designation Program

Breakthrough Designation Program

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a relatively new FDA regulatory review option—the Breakthrough Designation Progr…

00:24:32  |   Fri 10 Aug 2018
15 Tips for Getting New Products Through FDA

15 Tips for Getting New Products Through FDA

In this Medtech Matters podcast 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 an…

00:24:00  |   Tue 03 Jul 2018
Voice-Enabled Medtech

Voice-Enabled Medtech

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the May issue of MPO, The Power of M…

00:23:21  |   Thu 17 May 2018
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