Medtech Matters
Episodes
Triaging Your QMS: Considerations Based on the New QMSR
17 Apr 2026
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the FDA’s recently im...
A Deep Dive into E&L and Biocomp Testing
11 Mar 2026
Contributed by Lukas
In this Medtech Matters podcast episode, sponsored by Nelson Labs, we’re discussing the importance of E&L (extractables and leachables) and bioc...
Planning for FDA Shutdowns Now and in the Future
27 Oct 2025
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the government shutdown...
Should Wellness Products Come with a Warning?
11 Sep 2025
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re speaking about a recent Editor’s...
3 Most Common Premarket (Postmarket?) Review Issues FDA Sees
25 Jun 2025
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re highlighting comments made by FDA ...
Why Are One-Third of MAUDE Reports a Problem?
10 Jun 2025
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing MAUDE safety reports an...
FDA Guidance on Off-Label Communication, Part 2
30 May 2025
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re continuing our conversation on off...
FDA Guidance on Off-Label Communication, Part 1
30 May 2025
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re speaking about off-label communica...
Development Considerations for OTC Medtech, Part 2
23 Jan 2025
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re continuing our conversation about ...
Development Considerations for Over-the-Counter Medtech, Part 1
23 Jan 2025
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing over-the-counter (OTC) ...
Device Descriptions in Regulatory Submissions
07 Jan 2025
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing a common part of a regu...
Regulatory Ramifications Due to the Presidential Election
26 Nov 2024
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at the potential implicati...
Regulatory Considerations with an Assisted Suicide Machine
20 Nov 2024
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re drawing inspiration from an item I...
Predetermined Change Control Plans, Part 2
24 Sep 2024
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue speaking on the topic of prede...
Predetermined Change Control Plans, Part 1
24 Sep 2024
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA’s recent guidance doc...
What is a CAPA and How Do You Best Use It?
03 Sep 2024
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re focusing in on a regulatory piece ...
You Got a 483 from the FDA. Now what?
22 Aug 2024
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing what the process should...
Revisiting Real-World Evidence
18 Jun 2024
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re revisiting real-world evidence (RW...
The Most Dangerous Devices to Hit the Market
11 Jun 2024
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re taking a look at several devices t...
Headline-Generating Medical Device Safety Concerns
02 May 2024
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re reviewing a few stories in the new...
Analyzing ECRI’s 2024 Top 10 Health Technology Hazards
19 Mar 2024
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at the latest annual list ...
Examining Institutional Review Boards
06 Mar 2024
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at IRBs, or institutional ...
Reimbursing Breakthrough Designation Products
02 Jan 2024
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the journey that’s occurred w...
Strengthening the 510k Program
19 Dec 2023
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at guidances published by F...
Medical Device Manufacturing Recalls
03 Oct 2023
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at the recent rise in recal...
AI Predetermined Change Control Plan
19 Sep 2023
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at a guidance from the FDA ...
Can You Use a Recalled Device as a Predicate?
20 Jun 2023
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA policy regarding the us...
Leading Issues from FDA Inspections (or History Repeating Itself)
04 Apr 2023
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the 483s and warning letters th...
To Regulate or Not to Regulate…LDTs, Part 2
07 Feb 2023
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue to discuss lab developed tests...
To Regulate or Not to Regulate…Lab Developed Tests, Part 1
31 Jan 2023
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the debate over lab developed t...
What Happens When the EUA Period Ends?
13 Dec 2022
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at what happens to products on the...
What Does 510k Exempt Actually Mean?
29 Nov 2022
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s use of the word “...
How Can Off-Label Use Be Promoted?
15 Nov 2022
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at how a company can promote the o...
FDA's Intended Use Rule’s Relation to Labeling
01 Nov 2022
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s Intended Use rule a...
Gaining an Advantage Through Class II Special Controls
25 Oct 2022
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the Special Controls that are p...
FDA’s Refuse to Accept Policy for 510(k)s
18 Oct 2022
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s policy known as Ref...
Initiating a Voluntary Medical Device Recall
11 Oct 2022
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine medical device recalls. More sp...
A Letter to File Deep Dive
04 Oct 2022
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a deep dive on the letter to file ...
Humacyte’s Bioengineered Tissue Platform Technology
08 Mar 2022
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. Jul...
Koya Medical Restores Mobility for Compression Therapy Patients
01 Mar 2022
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 Andy Do...
NeuroPace’s Aid in Tracking and Treating Epilepsy
22 Feb 2022
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 Mike Fa...
Aidoc Is Improving Patient Outcomes Through AI
15 Feb 2022
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 Elad Wa...
Performing a Gap Analysis on FDA's Regulatory Protocols
08 Feb 2022
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we highlight a number of areas in which th...
Stereotaxis’ Robotic Surgery System for Interventional Procedures
01 Feb 2022
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 F...
Fighting Tumors with Varian’s FLASH Technology
27 Jan 2022
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. Dee...
RSIP Vision’s Diagnostic Imaging Advancements
25 Jan 2022
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 Moshe S...
FDA’s Cybersecurity Playbook
20 Jan 2022
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recent offering put out by th...
Video Capture of Surgery with Theator
18 Jan 2022
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. Tam...
GE Healthcare’s Chief Digital Officer’s 2022 Predictions
13 Jan 2022
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 Amit Ph...
DePuy Synthes Strives for Knee Restoration
11 Jan 2022
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 Andrew ...
Femasys Targets Fertility and Women’s Health
06 Jan 2022
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 Kathy L...
Front Line’s COBRA-OS Helps Prevent Bleed Out
04 Jan 2022
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. Ash...
Pristine Surgical’s Single-Use Endoscopes
14 Dec 2021
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 Bryan L...
Discussing Spine with Medtronic's Carlton Weatherby
30 Nov 2021
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 Carlton...
Aligning Regulatory and Commercial Strategies
16 Nov 2021
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at ways in which medical device ma...
Medtech Manufacturing at the U.S.-Mexico Border
09 Nov 2021
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 Jackie ...
Surgical Instrumentation Update from Ethicon
02 Nov 2021
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 Tom O’...
De Novo Final Rule
26 Oct 2021
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the final rule recently announc...
Options with an Overly Burdensome FDA
19 Oct 2021
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the options available to a medi...
Molli Surgical's Breast Tumor Marker
14 Sep 2021
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. Faz...
Three Systems of Risk
07 Sep 2021
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the three systems of risk as th...
Glooko’s Remote Patient Monitoring for Diabetics
31 Aug 2021
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 Russ Jo...
Valencell’s Wearable Biomedical Sensors
24 Aug 2021
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. Ste...
Regulating IVDs and LDTs
10 Aug 2021
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at recently proposed legislation r...
LifeSource Discusses Organ Donation Technologies
04 Aug 2021
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 Julie K...
Facility Falsified Sterilization Data
27 Jul 2021
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we dig into a story about an Italian firm ...
Knobbe Martens Talks Trade Secrets
20 Jul 2021
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 Adam Po...
Canary Medical’s ‘Smart’ Implants
13 Jul 2021
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. Bil...
Implicity’s Cardiac Device Remote Monitoring
06 Jul 2021
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. Arn...
PixCell's Rapid Blood Test Diagnostics
29 Jun 2021
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 Hanan B...
Discussing Asensus Surgical’s Senhance Robotic Surgical System
17 Jun 2021
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 Anthony...
Top 483s of 2020
08 Jun 2021
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the 483s medical device manufac...
Legacy DNA’s Market Strategy Advice
25 May 2021
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. Rox...
NeuTigers’ Edge-Based AI for Healthcare
19 May 2021
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. Gre...
Medtronic's Pillcam and GI Genius
11 May 2021
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 Giovann...
COVID Diagnostics from Beckman Coulter
04 May 2021
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 Chris H...
Single-Use Device Reprocessing
27 Apr 2021
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the guidelines issued by the Eu...
A Biomechanics Measuring Mesh
22 Apr 2021
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...
A Digital Stethoscope & Digital Health
13 Apr 2021
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 Clive S...
Non-Dilutive Funding
06 Apr 2021
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 Guy Har...
BDP Reimbursement Delay
30 Mar 2021
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recent issues impacting the...
Robotic-Driven Percutaneous Procedures
23 Mar 2021
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 Chen Le...
Biomorphic Programmable Polymers
16 Mar 2021
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 Christo...
Treating Hearts Post-Attack
09 Mar 2021
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 Ken Mil...
FDA’s Ambiguity on Hyaluronic Acid
02 Mar 2021
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 Mike Da...
Update on FDA's STeP Designation
26 Feb 2021
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a still relatively newer option...
Continuous Molecular Monitoring
23 Feb 2021
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 Peter V...
Hologic’s Breast Health Happenings
16 Feb 2021
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 Jennife...
Optimizing Remote Electrophysiology Monitoring
09 Feb 2021
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. Man...
Medtronic's Robotic Surgery Status
02 Feb 2021
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 Linnea ...
Emergency Use Authorizations
26 Jan 2021
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss one of the most talked about re...
Surgeons Scrubbing In Virtually
19 Jan 2021
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. Nad...
Talking Robotics with Zimmer Biomet
12 Jan 2021
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 Liane T...
CDRH 2021 Priorities
08 Jan 2021
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a number of the priorities Dr. ...
A Non-Contact ECG Sensor
05 Jan 2021
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. Jes...
Communicating with the FDA
15 Dec 2020
Contributed by Lukas
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a variety of ways in which medi...
Talking Medtech with Joe Mullings
08 Dec 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 Joe Mul...
A Robotic Surgery Subscription
01 Dec 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 Bruce L...
Point-of-Care Ultrasound
24 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 Kevin G...
AI-Enabled Cardiac Diagnostics
18 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 Mark To...