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 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.

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 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.

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 the options for a device maker upon the rejection of a submission?What are today’s takeaways with regard to Refuse to Accept guidance from the FDA?Listen to this episode and see if you better understand how to avoid a Refuse to Accept rejection. 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.

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 recall is reached?What are the most important takeaways companies need to keep in mind about voluntary recalls?Listen to this episode and see if you better understand voluntary recalls. 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.

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 where using a letter to file could result in an adverse effect to what was intended?When it comes to a letter to file, what are the most important takeaways for listeners to keep in mind?Listen to this episode and see if you better understand the point of the letter to file and when to use it. 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.

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 [email protected].

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 restored. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at [email protected].

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 future participant for Medtech Matters, please reach out to me at [email protected].

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 you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at [email protected].

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 the highlighted ideas from this podcast, might it smooth the pathway to market for some products? Might it enhance communication with the FDA? Could they be welcome additions? Specifically, the following questions are addressed:Can you please take a minute to explain why we are dedicating an episode to what’s missing from regulatory and quality systems?First topic on the list is communicating with the FDA. Do we need a Wellness Device registration, wellness pre-sub, or wellness device database?What about a catch-up 510k and letter to file pre-sub?How about a pre-sub for manufacturing issues or to resolve 483s and/or warning letters?Let’s jump to regulatory pathway. Is a pathway needed that provides a de novo like version of the PMA?Staying in this realm, what about the idea of having substantial equivalence in the Class III and PMA realm?What are today’s takeaways in what we may be missing in regulatory and quality systems?Listen to this episode and see what you think of these regulatory ideas. 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.