Medtech Matters
Episodes
Organ Donation Matching
02 Nov 2020
Contributed by Lukas
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Sha...
Virtual Reality for Surgery
28 Oct 2020
Contributed by Lukas
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Justin ...
Biocompatibility and Nitinol Guidances
26 Oct 2020
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s guidances on biocom...
Economical Orthopedic Implants
22 Oct 2020
Contributed by Lukas
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Itai Ne...
Vital Signs Monitoring Via Telehealth Interface
20 Oct 2020
Contributed by Lukas
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with David M...
Multiple Function Device Products
16 Sep 2020
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s guidance on Multipl...
Breakthrough Designation Program Update
28 Aug 2020
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss how the breakthrough designatio...
50th Episode: A Look Back
10 Aug 2020
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look back at a variety of the topics th...
Combination Products Update
08 Jul 2020
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the impact of a new compliance ...
Binding vs. Nonbinding FDA Feedback
10 Jun 2020
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the term “nonbinding feedback...
Real World Evidence Revisited
14 May 2020
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use (or lack of use) of rea...
FDA Pre-Sub Best Practices
24 Apr 2020
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s pre-sub program and...
Scott Whitaker of AdvaMed on Medtech's Response to COVID-19
17 Apr 2020
Contributed by Lukas
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Scott W...
COVID-19, Part 2
08 Apr 2020
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss recent coverage of a two-minute...
COVID-19, Part 1
01 Apr 2020
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss questions raised by news of med...
EtO Sterilization Concerns
30 Mar 2020
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the concern surrounding the use...
FDA's eSTAR Program
03 Mar 2020
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s pilot of an interac...
Human Factors/Usability, Part 2
03 Feb 2020
Contributed by Lukas
In the second part of this Medtech Matters podcast series of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s e...
Human Factors/Usability, Part 1
03 Feb 2020
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s emphasis on human f...
Change Management, Part 2
20 Jan 2020
Contributed by Lukas
In the second part of this two-part Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss cha...
Change Management, Part 1
20 Jan 2020
Contributed by Lukas
In this two-part Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss change management with...
Safety and Performance Based 510k
05 Dec 2019
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s Safety and Performa...
The Special 510k Program
13 Nov 2019
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s Special 510(k) prog...
Beyond 510(k)/PMA—Safer Technologies Program
16 Oct 2019
Contributed by Lukas
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-...
Benefit-Risk Determinations
16 Sep 2019
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss two recently issued FDA guidanc...
Mike on Medtech: Beyond 510(k)/PMA—Breakthrough Devices Program
06 Aug 2019
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the still relatively new Breakt...
Beyond 510(k)/PMA—De Novo 101
02 Jul 2019
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the third most commonly used (a...
Mike on Medtech: The NYT Editorial Board Statement
17 Jun 2019
Contributed by Lukas
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...
The Alternative Summary Reporting Program
24 May 2019
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recently announced cancella...
Do we need a pre-sub for 483s? (Part 2)
09 May 2019
Contributed by Lukas
In the second part of this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue our discuss...
Do we need a pre-sub for 483s?
09 May 2019
Contributed by Lukas
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 ...
FDA's Material Evaluation
02 Apr 2019
Contributed by Lukas
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 stat...
510k Modernization
25 Jan 2019
Contributed by Lukas
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 t...
Personalized Healthcare
03 Jan 2019
Contributed by Lukas
In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the impact of personalized medicine on the medical devi...
My Holiday Wish List (Part 2)
11 Dec 2018
Contributed by Lukas
This is part 2 of a two-part podcast series. If you haven't listened to the first portion yet, click here to first listen to that part.In this ep...
My Holiday Wish List (Part 1)
04 Dec 2018
Contributed by Lukas
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 Novem...
Regulating the Practice of Medicine
26 Oct 2018
Contributed by Lukas
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 Octob...
The Bleeding Edge, Part 3
26 Sep 2018
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we conclude our conversation on the Netfli...
The Bleeding Edge, Part 2
07 Sep 2018
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue a discussion that will span se...
The Bleeding Edge, Part 1
05 Sep 2018
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we begin a discussion that will span sever...
Breakthrough Designation Program
10 Aug 2018
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a relatively new FDA regulatory...
15 Tips for Getting New Products Through FDA
03 Jul 2018
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue the 15 year anniversary theme ...
Voice-Enabled Medtech
17 May 2018
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter th...
Changing Pathway to Market?
25 Apr 2018
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter th...
3D Printing Healthcare at the Point of Care
23 Mar 2018
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter th...
Quality vs. Regulatory
02 Mar 2018
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss two terms that are sometimes us...
The 'New' Alternative 510k
29 Jan 2018
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recently announced alternativ...
Regulatory Approval Pathway for Biomaterials
02 Jan 2018
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss what the implementation of a re...
Pre-Sub with the FDA
06 Nov 2017
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use of an FDA pre-sub (or p...
Human Factors
09 Oct 2017
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use of human factors (or er...
MDUFA IV and Its Impact on Medtech Innovation
07 Sep 2017
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the passage of MDUFA IV and the...
Off-Label Use
25 Aug 2017
Contributed by Lukas
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...
Biomaterials, Biocompatibility, and Bioabsorbable
24 Jul 2017
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the differences between materia...
3D Printing in Healthcare
05 Jun 2017
Contributed by Lukas
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...
Reimbursement for Engineers
05 May 2017
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the significance of reimburseme...
Device Incident Reporting
30 Mar 2017
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recent Editor's Letter t...
Real World Evidence
24 Feb 2017
Contributed by Lukas
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 ...