Medtech Matters

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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

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 on the market under EUAs become a concern?
• How will the FDA handle these EUA products?
• What should companies be doing now if they want to keep their products on the market after the EUAs expire?
• Are there any considerations companies should keep in mind with an EUA product?
• Are there any reasons a company may not want an EUA product to go through a full regulatory review?
• What are the most important takeaways with all of this for medical device manufacturers?

Listen to this episode and see if the end of EUAs impacts your company. 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.

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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 relationship between 510k exempt and Class of device. Specifically, the following questions are addressed:

• Could you please explain what 510k exempt actually means?
• Are all Class I medical devices exempt and all Class II devices not exempt?
• What’s the difference between Class I exempt and Class II exempt?
• What is the difference between general controls and special controls? How are these relevant to exempt status?
• Could you give some examples of products that are Class I exempt and explain why they are afforded that status?
• Now could you do the same for Class II products that are exempt and give reasons why?
• What are the most important takeaways with all of this for medical device manufacturers?

Listen to this episode and see how 510k exempt may affect your company’s products and future regulatory submissions. 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.

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