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 news that tie into the safety of medical devices. First, a story regarding plastic syringes made in

Analyzing ECRI’s 2024 Top 10 Health Technology Hazards

Mar 19th, 2024 51m 35s

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 put out by ECRI, an independent authority on healthcare technology and safety, on their top 10 h

Examining Institutional Review Boards

Mar 6th, 2024 51m 11s

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at IRBs, or institutional review boards. We’re taking a look at what these are, how they relate to medical device approval

Reimbursing Breakthrough Designation Products

Jan 2nd, 2024 51m 18s

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the journey that’s occurred with regard to getting reimbursement tied to the FDA’s Breakthrough Designation Program (BDP). It

Strengthening the 510k Program

Dec 19th, 2023 38m 6s

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 FDA regarding the 510k regulatory pathway. The subject matter of the three were: best practices

Medical Device Manufacturing Recalls

Oct 3rd, 2023 46m 35s

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 recalls that are being tied back to manufacturing issues. The discussion explores the recall mechan

AI Predetermined Change Control Plan

Sep 19th, 2023 52m 17s

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 that explains how product sponsors can submit a predetermined change control plan for artifici

Can You Use a Recalled Device as a Predicate?

Jun 20th, 2023 53m 40s

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA policy regarding the use of a recalled device as a predicate in a 510k submission. Is it a good idea? What considerat

Leading Issues from FDA Inspections (or History Repeating Itself)

Apr 4th, 2023 46m 17s

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 that resulted from FDA inspections in 2022. The list is alarmingly similar to previous years and

To Regulate or Not to Regulate…LDTs, Part 2

Feb 7th, 2023 49m 18s

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue to discuss lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. How would FDA o

To Regulate or Not to Regulate…Lab Developed Tests, Part 1

Jan 31st, 2023 42m 3s

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 tests (LDTs) and whether or not the FDA should have the authority to regulate them. What would

What Happens When the EUA Period Ends?

Dec 13th, 2022 48m 8s

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 market under the FDA’s emergency use authorization (EUA). Once the EUA period ends, what happ

What Does 510k Exempt Actually Mean?

Nov 29th, 2022 50m 33s

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 “exempt” and what it means for medical device manufacturers. During this discussion, we look at the

How Can Off-Label Use Be Promoted?

Nov 15th, 2022 48m 46s

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 off-label use of a medical device. It would seem to go against FDA regulation to do so, but the

FDA's Intended Use Rule’s Relation to Labeling

Nov 1st, 2022 51m 5s

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 and how it impacts device labeling. It is also revealed how labeling can be used by medical devic

Gaining an Advantage Through Class II Special Controls

Oct 25th, 2022 47m 15s

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 part of the FDA’s regulatory requirements for Class II devices. During the conversation, the pu

FDA’s Refuse to Accept Policy for 510(k)s

Oct 18th, 2022 50m 36s

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 Refuse to Accept (RTA) as it relates to 510k submissions. Sadly, some companies are rejected due to

Initiating a Voluntary Medical Device Recall

Oct 11th, 2022 47m 21s

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine medical device recalls. More specifically, the focus of the discussion is on voluntary recalls, why they occur, and why compa

A Letter to File Deep Dive

Oct 4th, 2022 45m 24s

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 tool that companies can use for certain situations. But what are those situation and how do yo

Discussion of Neuromodulation Technology with Medtronic's Dave Anderson

May 31st, 2022 21m 7s

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dave Anderson, president of Neuromodulation at Medtronic. He offers insights on the ways in which neu

Humacyte’s Bioengineered Tissue Platform Technology

Mar 8th, 2022 27m 37s

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Juliana Blum, Co-founder and Executive Vice President of Corporate Development at Humacyte. She s

Koya Medical Restores Mobility for Compression Therapy Patients

Mar 1st, 2022 26m 58s

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Andy Doraiswamy, founder and CEO of Koya Medical. He highlights the benefits of his company’s compres

NeuroPace’s Aid in Tracking and Treating Epilepsy

Feb 22nd, 2022 20m

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Mike Favet, CEO of NeuroPace. He offers insights into how his technology helps those suffering with e

Aidoc Is Improving Patient Outcomes Through AI

Feb 15th, 2022 21m 25s

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Elad Walach, Co-Founder and CEO of Aidoc. He explains how artificial intelligence is being leveraged

Performing a Gap Analysis on FDA's Regulatory Protocols

Feb 8th, 2022 43m 38s

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 the agency’s regulatory oversight could be considered lacking. If the agency incorporated the hi