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 health technology hazards for 2024. The full list is available at the organization’s website, which is at www.ecri.org. Specifically, the following questions are addressed: What is ECRI and what is the purpose of this list? Number one on the list is medical devices for the home. Specifically, they indicate medical devices may pose usability challenges f ..read more

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 approvals, and why they are important. Specifically, the following questions are addressed: Could you please explain what an IRB or institutional review board is? If I’m a device maker and am looking to conduct a clinical trial for one of my devices, do I need IRB approval? Are there situations in which I would not need an IRB approval prior to a clinical tria ..read more

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’s been planned, called off by CMS, put into proposed legislation, but we still don’t have a definitive solution. Specifically, the following questions are addressed: Can you please explain what the Breakthrough Device Designation program is? When did the reimbursement component come into play with regard to the BDP? Why is it important for a BDP devic ..read more

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 for selecting a predicate device, the need for clinical data in a submission, and evidentiary expectations with implanted devices. Specifically, the following questions are addressed: Can you please provide a brief explanation of the 510k pathway? Why is the agency attempting to strengthen the program? What is their ultimate goal? With the predicate d ..read more

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 considerations are there for doing so? Specifically, the following questions are addressed: First, would you please explain the various levels of a recall as it relates to a medical device and what each level means? Can you quickly remind us of how a predicate device is used in a 510k submission? Given we’ve laid the groundwork, can you now please explain how a ..read more

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 the discussion explores why that’s the case. The discussion also centers around ways device manufacturers can avoid making many of these same mistakes that get other companies into trouble with the agency. Specifically, the following questions are addressed: Can run through the top reasons for 483s and warning letters? Can you provide some examples of ..read more

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 this type of oversight do to the need for speed with these types of tests? Would FDA supervision make things safer and also avoid future situations like the Theranos debacle? Specifically, the following questions are addressed between the two parts of this podcast presentation: Can you start today’s conversation by explaining why we’ve selected this to ..read more

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 happens to these products? As President Biden has already declared the pandemic to be over, this timeframe will be approaching quickly. Specifically, the following questions are addressed: Could you please explain what an EUA is within the regulatory context of the pandemic? Under whose authority is the pandemic deemed over such that the status of devices ..read more

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 there are acceptable methods that can be utilized that essentially promote the off-label use. Specifically, the following questions are addressed: Since this discussion came out of the last podcast on intended use, can you give a very quick summation of that rule? Can you speak to the relationship between intended use and off-label use? When it comes to a ..read more

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 device OEMs as a competitive advantage. Specifically, the following questions are addressed: Could you please explain exactly what we mean by labeling, and further, clarify the difference between high level and low level labeling? How can labeling, both high level and low level, be used as a strategic advantage? Could you please explain the difference betwe ..read more