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 pro

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 gu

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

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 discuss

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

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 the

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 IV

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

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

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

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 medical device manufacturer promoting the off-label use of a device, how can that happen without raising a red flag with the FDA?To what degree can a promotion take place? Could it be an advertisement, collateral material provided to a doctor, or messaging from a sales person? Or all of the above?Can you share a couple real-world examples of acceptable off-label promotion?Where is the cut-off? In other words, what should com

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 between intended use and indications for use?What is this intended use rule and why is it important to medical device manufacturers?What is meant by manufacturer's objective intent?Do you have examples you can provide?What are the most important takeaways with all of this for medical device manufacturers?Listen to this episode and see how Intended Use affects your device labeling. If you’d like to share thoughts, ask question

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 purpose of these Special Controls is presented. Additionally, ways to use these regulatory requirements to gain a competitive advantage is also discussed. Specifically, the following questions are addressed:Would you please explain what we mean by Special Controls? What are they, and how and when are they used?What makes these “special”?Would you mind providing some real-world examples of Special Controls?How do Special Controls vary based on the regulatory pathway? In other words, how are they different from 510k vs a de novo?With regard to Special Controls, what are the most important takeaways to keep in mind?Listen to this episode and see if you can leverage Special Controls to gain a competitive advantage. If you’d like to share thoughts, ask questions, or have a sug

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 Refuse to Accept as many as three times, which is a completely avoidable problem. Specifically, the following questions are addressed:Please start with an explanation of the FDA’s review process. What happens after the agency receives a submission?This is the third Refuse to Accept guidance from FDA. Can you provide an overview of all three and explain how they should be used?What was the agency’s goal in releasing these guidance documents?Do you have examples you can share of submissions rejected on RTA review?The agency has tried to modernize with the offering of some etools. Can you explain what these are and what advantages and disadvantages there are to using them?How should a medical device manufacturer view these documents and how should they use them?What are t

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 companies need to be ready to conduct a recall. The FDA’s involvement with a recall is also presented as well as what “recall ready” means. Specifically, the following questions are addressed:Can you start by explaining what a voluntary recall is and why or when it’s used?Is there any differences in the process for a voluntary recall across any of FDA’s categories, such as pharma, medical device, food, etc.?Is there a non-voluntary recall (or one that is ordered)? If so, how is that different?The FDA states a company within a product distribution chain needs to be “recall ready.” What does this mean?What are the steps in a voluntary recall?Is the FDA involved in a voluntary recall beyond being notified? If so, how?How do you ensure everyone who needs to be contacted about a

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 you know when it’s appropriate to use this pathway? Also, how do you ensure you are using a letter to file correctly so as to avoid challenges that could arise with the FDA? Specifically, the following questions are addressed:While we’ve mentioned letter to file a number of times in other podcasts, can you please take a minute to explain exactly what a letter to file is and when it should be used?Why is a letter to file important?When does a medical device company submit a letter to file to the FDA?Does the FDA provide any guidance on a letter to file or offer a template to use for it?What goes into a Letter to file?Can you provide some real-world examples of when to consider using a letter to file versus not using one? Does the type of change matter?Are there situations

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 speaks to the technology behind their regenerative solution and how it can be leveraged as a technology platform to fulfill a variety of bioengineered tissue needs. Specifically, the following questions are addressed.What is Humacyte and tell us a bit about your technology?What are the applications for bioengineered tissue?Obviously without giving away trade secrets, can you tell us a bit about how it is fabricated?What were the major challenges that needed to be overcome to develop this?What’s ahead for Humacyte?Listen to this episode and see what you think of the company’s bioengineered tissue technology platform. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.Send u

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 compression therapy solution, which can be accomplished while the patient remains mobile and active. Specifically, the following questions are addressed.What is Koya Medical and what is your clinical focus area?You recently gained clearance for the Dayspring Lite. What is this and how does it differ from the Dayspring?Is this device only used to address lymphedema in cancer patients or can it be used to treat other conditions that could benefit from compression therapy?What is the feedback from patients? Have you had patients who went through more traditional treatments to address lymphedema and then used the Dayspring and can compare the two?What’s next for Koya Medical?Listen to this episode and see what you think of compression therapy technology that enables mobility to be

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 epilepsy. In addition, he provides an explanation of the firm’s nSight Platform. Finally, he talks about the partnership with another organization focused on epilepsy and how it integrates with his firm’s technologies. Specifically, the following questions are addressed.Can you please explain what the focus of your company NeuroPace is?What is the nSight Platform and how does it lead to a better treatment protocol for patients with epilepsy?Why have you partnered with Seizure Tracker?With the three of these systems combined and working together, what is the impact to those with epilepsy?What’s next for NeuroPace? What are the next steps?Listen to this episode and see what you think of these epilepsy solutions. If you’d like to share thoughts, ask questions, or suggest a

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 to assist radiologists in diagnosing conditions that weren’t originally even being sought. The Aidoc software constantly runs in the background of the imaging system to examine all patient scans without any further direction or commands. Specifically, the following questions are addressed.Can you please tell us what Aidoc is and what your focus is?How much time is saved for a radiologist in leveraging Aidoc versus the more traditional review method?What is the accuracy level with detection and how does it compare to the average for human error?Can this system function as a training or educational tool just as well as being a clinical tool?What’s next for Aidoc?Listen to this episode and see what you think of Aidoc's ability to scan beyond the original condition. If