Medtech Matters
Technology
About
A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.
Episodes
- FDA's Third-Party Review Program
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re discussing the FDA’s third-party review program. This option is available for certain 510k reviews. It is performed through…
- Triaging Your QMS: Considerations Based on the New QMSR
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re discussing the FDA’s recently implemented QMSR. It went into effect on February 2nd and replaced 21 CFR Part 820. The regula…
- A Deep Dive into E&L and Biocomp Testing
In this Medtech Matters podcast episode, sponsored by Nelson Labs , we’re discussing the importance of E&L (extractables and leachables) and biocompatibility testing for a variety of medical devices. The pair from Nelson Labs—Audrey Turley…
- Planning for FDA Shutdowns Now and in the Future
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re discussing the government shutdown and its potential impact on medical device manufacturers and their submissions. This shut…
- Should Wellness Products Come with a Warning?
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 Letter I wrote for MPO that gave reasons why placing a warning label on wellness devices ab…
- 3 Most Common Premarket (Postmarket?) Review Issues FDA Sees
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re highlighting comments made by FDA representatives at an event about the most common premarket review issues they see in subm…
- Why Are One-Third of MAUDE Reports a Problem?
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re discussing MAUDE safety reports and taking a look at what the issues are with them. More specifically, we’re digging in to f…
- FDA Guidance on Off-Label Communication, Part 2
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re continuing our conversation on off-label communication. In this part, we’re examining the downside or negative aspects of th…
- FDA Guidance on Off-Label Communication, Part 1
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re speaking about off-label communication. More specifically, we’re reviewing a recent guidance from the FDA that offers insigh…
- Development Considerations for OTC Medtech, Part 2
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re continuing our conversation about over-the-counter (OTC) medical devices. If you haven’t already enjoyed part 1 of the discu…
- Development Considerations for Over-the-Counter Medtech, Part 1
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re discussing over-the-counter (OTC) devices and aspects developers need to keep in mind for these devices. A variety of topics…
- Device Descriptions in Regulatory Submissions
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 regulatory submission—the device description. While this element may seem to be straightforwar…
- Regulatory Ramifications Due to the Presidential Election
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re looking at the potential implications for the medical device regulatory sector as a result of the U.S. presidential election…
- Regulatory Considerations with an Assisted Suicide Machine
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 wrote about recently in one of my MPO editor’s letters . Specifically, I’m referring to t…
- Predetermined Change Control Plans, Part 2
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we continue speaking on the topic of predetermined change control plans. Potential scenarios for their use are discussed, examples…
- Predetermined Change Control Plans, Part 1
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we examine the FDA’s recent guidance documents regarding predetermined change control plans (PCCP). The first guidance addresses P…
- What is a CAPA and How Do You Best Use It?
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 that’s been mentioned numerous times with regard to other topics we’ve discussed. This epi…
- You Got a 483 from the FDA. Now what?
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re discussing what the process should be for a company once they receive a 483 or warning letter from the FDA. Best practices,…
- Revisiting Real-World Evidence
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re revisiting real-world evidence (RWE), which is a topic that’s been getting some attention. So today, we’re going to look at…
- The Most Dangerous Devices to Hit the Market
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 that unfortunately ended up being quite dangerous even though they made it to the market an…
- Headline-Generating Medical Device Safety Concerns
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 m…
- Analyzing ECRI’s 2024 Top 10 Health Technology Hazards
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 to…
- Examining Institutional Review Boards
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 ap…
- Reimbursing Breakthrough Designation Products
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 (BD…
- Strengthening the 510k Program
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 pra…
- Medical Device Manufacturing Recalls
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…
- AI Predetermined Change Control Plan
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 ar…
- Can You Use a Recalled Device as a Predicate?
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 cons…
- Leading Issues from FDA Inspections (or History Repeating Itself)
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 yea…
- To Regulate or Not to Regulate…LDTs, Part 2
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…
- To Regulate or Not to Regulate…Lab Developed Tests, Part 1
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…
- What Happens When the EUA Period Ends?
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, wha…
- What Does 510k Exempt Actually Mean?
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…
- How Can Off-Label Use Be Promoted?
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, b…
- FDA's Intended Use Rule’s Relation to Labeling
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…
- Gaining an Advantage Through Class II Special Controls
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,…
- FDA’s Refuse to Accept Policy for 510(k)s
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…
- Initiating a Voluntary Medical Device Recall
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…
- A Letter to File Deep Dive
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…
- Humacyte’s Bioengineered Tissue Platform Technology
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.…
- Koya Medical Restores Mobility for Compression Therapy Patients
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 co…
- NeuroPace’s Aid in Tracking and Treating Epilepsy
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 w…
- Aidoc Is Improving Patient Outcomes Through AI
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 lever…
- Performing a Gap Analysis on FDA's Regulatory Protocols
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…
- Stereotaxis’ Robotic Surgery System for Interventional Procedures
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with David Fischel, CEO of Stereotaxis. He explains how his robotic surgical system works and what ma…
- Fighting Tumors with Varian’s FLASH Technology
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Deepak Khuntia, chief medical officer and senior VP of Medical Affairs at Varian. He offers…
- RSIP Vision’s Diagnostic Imaging Advancements
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Moshe Safran, CEO of RSIP Vision U.S. He shares technology advancements and his thoughts about t…
- FDA’s Cybersecurity Playbook
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 the FDA in conjunction with the Medical Device Innovation Consortium and MITRE. It is a pl…
- Video Capture of Surgery with Theator
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Tamir Wolf, CEO and Co-Founder of Theator. He discusses his company and why capturing a vide…
- GE Healthcare’s Chief Digital Officer’s 2022 Predictions
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Amit Phadnis, chief digital officer at GE Healthcare. He makes several predictions for the new y…