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 China that were deemed not to be used by the FDA. The other story is about a report indicating third-party testing lab data may be unreliable and, in some cases, falsified. Specifically, the following questions are addressed:

• Can you give some additional insights into each of these news items and explain how they are connected?
• Given the medtech universe and all the different types of devices it encompasses, a syringe seems somewhat low on the list of advanced devices. What can we learn from this device?
• If a basic device like a syringe cracks or doesn’t function properly, how realistic is it that the issue is reported to the manufacturer or FDA?
• If my device includes a syringe but it’s not manufactured by one of the companies that received a warning letter (or maybe it’s not even made in China), do I have anything to worry about?
• Do you have an example to help illustrate this?
• Looking beyond syringes, obviously virtually all device manufacturers rely on testing data. If the FDA is warning makers about third-party labs providing fabricated, duplicated, or otherwise unreliable data, what should companies do who use third-party testing labs?
• What are the takeaways?

Listen to this discussion and see what you think of these concerns regarding device safety. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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 for home users, risking misuse and patient harm. Can you please explain why this would be number one on the list? What’s the issue with usability?
• The second item on the list involves inadequate or onerous device cleaning instructions. So this isn’t really about cleaning protocols, but rather the instructions that indicate how the device should be cleaned. What’s the concern here?
• The fourth item is regarding the sustainability trend. Specifically, ECRI states this one as overlooked environmental impacts of patient care endanger public health. This is more of a product design issue, correct?
• Another hot topic item, number five calls out insufficient governance of AI used in medical technologies risks inappropriate care decisions. Is this indicating we should avoid relying too heavily on decisions indicated by AI and ensure clinician overview of findings?
• Still another hot button, cybersecurity issues ranks at number six on the list. Specifically, it is listed as ransomware targeting the healthcare sector remains a critical threat. This ties in directly to the significant efforts being put forth to ensure connected devices have a cybersecurity plan in place, correct?
• What are the takeaways?

Listen to this discussion and see what you think of these items on the list or what was missed and should have been on the list. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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 trial?
• Do you have suggestions on selecting an IRB? What I would want to look for and perhaps what I’d want to avoid?
• What information do I need to provide to the IRB for its review?
• What kind of timeline should I expect with the IRB review process?
• Do I have any recourse if the IRB review comes back not in my favor?
• What are the takeaways?

Listen to this discussion and see if you’ve gained insight for your next interaction with an IRB. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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 device to have reimbursement tied to it upon regulatory approval/clearance?
• What concerns did CMS have regarding the reimbursement portion of the BDP?
• This year, we’ve seen proposed legislation from Congress to force CMS to pay for devices that gain the BDP designation. What’s going on with these?
• Does the ridiculously low number of devices associated with the TCET demonstrate an underlying problem with all of this?
• What about the proposed “reasonable and necessary” caveat that’s also associated with the TCET? Do we need to clarify what this means or just replace it entirely?
• What are the takeaways?

Listen to this discussion and see how you feel about the latest proposed reimbursement plan. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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 device, we recently had a podcast on using a recalled device for a predicate. When they say “best practices,” are they suggesting avoiding doing that?
• What other best practices are tied to the predicate device selection?
• How do you gather clinical data on a device that’s not cleared or approved and just being submitted to the FDA?
• For what situations is the agency considering clinical data in a submission and why?
• For the third guidance, can you explain what this is? What are evidentiary expectations with implanted devices?
• What do these mean to you? What will they mean to medical device manufacturers?
• What are the takeaways?

Listen to this discussion and let us know what you think of any or all of these guidances. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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 mechanism itself and then move to the details behind the numbers. Finally, a strategy for mitigating risk is shared to help manufacturers avoid the potential for recalls. Specifically, the following questions are addressed:

• Before we get into the reasons around why, can give a very brief overview of what exactly a device recall is?
• Medical device recalls aren’t new, so why are we taking a closer look at them today?
• Should we have been able to see this coming? Was this foreseeable?
• Are all of these recalls, or really any recalls, equal in terms of how serious they are?
• Can you explain what is meant by faulty manufacturing? Are machines making bad parts and it’s not being recognized?
• Who’s job is it to set the specs?
• Why the sudden increase? In 2022, recalls hit their lowest level in a decade. So what changed that now in 2023, they are at such a high level?
• Moving forward, what could we do/should we do to mitigate these risks and minimize residual risk for devices in the future?
• What are the takeaways?

Listen to this discussion and see if you feel more comfortable about avoiding a recall. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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 artificial intelligence and machine learning technologies. These are critical as these types of software evolve over time to enhance the benefits they bring. Specifically, the following questions are addressed:

• Can you please give a brief overview of what an AI or ML product is?
• Can you explain how this product can, quote evolve, as the FDA puts it?
• Now can you cover what a predetermined change control plan is and how it relates to the AI/ML product in this discussion?
• So why is this important? Why is it important to enable an AI or ML device to evolve?
• Can you offer real world examples of how this all works?
• What are the takeaways? Or in this instance, perhaps you could reiterate the most important tasks a company needs to keep in mind for their AI/ML products.

Listen to this discussion and see if you think this guidance addresses the issues associated with AI/ML. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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 recalled device can be used as a predicate device?
• Is there any argument that can be made for having it be valid to use a Class 1 recall device as a predicate?
• Do you think a recall should invalidate a device from being used as a predicate? Or, would you ever suggest a recalled device to a client to be used as a predicate?
• I know some have argued for a “cap” to a device being used as a predicate, for example, nothing older than 10 years. Should there be a minimum amount of time a device should be on the market in clinical use to be able to be used as a predicate?
• What are the most important takeaways?

Listen to this discussion and see if you think using a recalled device as a predicate is a good regulatory strategy. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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 CAPA problems and offer suggestions for avoiding them?
• Like CAPAs, design controls accounted for more than 12% of the list. Can you provide examples of these violations and suggestions on how to avoid them?
• Third among the top was complaint handling, almost 11% of all violations. Do you have examples of these and tips for avoiding them?
• Are these top three problems really identical to what we’ve seen in previous years? Are these the same mistakes again?
• What are the most important takeaways with regard to today’s discussion?

Listen to this discussion and see if you might be vulnerable to a 483 upon your next inspection. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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 oversight impact quality and timeliness of care? How do LDTs relate to what happened with Theranos? 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 topic for today’s discussion? Has there been an update to this debate?
• What is an LDT?
• Why do labs develop their own LDTs?
• Can you provide a couple of examples of LDTs?
• Currently, are LDTs regulated? Why and who is involved?
• You mentioned LDTs are low risk, but are LDTs truly low risk? What do you mean?
• Is there precedent we can examine for using enforcement discretion to not regulate LDTs?
• What is the relationship between LDTs and Theranos?
• What is your recommendation for companies developing LDTs and/or IVDs?
• Do you have suggestions for improving the status quo with regard to LDTs?
• What are the important takeaways from this discussion manufacturers should keep in mind?

Listen to this two-part discussion and see how FDA oversight of LDTs could affect your company’s products. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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 topic for today’s discussion? Has there been an update to this debate?
• What is an LDT?
• Why do labs develop their own LDTs?
• Can you provide a couple of examples of LDTs?
• Currently, are LDTs regulated? Why and who is involved?
• You mentioned LDTs are low risk, but are LDTs truly low risk? What do you mean?
• Is there precedent we can examine for using enforcement discretion to not regulate LDTs?
• What is the relationship between LDTs and Theranos?
• What is your recommendation for companies developing LDTs and/or IVDs?
• Do you have suggestions for improving the status quo with regard to LDTs?
• What are the important takeaways from this discussion manufacturers should keep in mind?

Listen to this two-part discussion and see how FDA oversight of LDTs could affect your company’s products. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.