In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dave Anderson, president of Neuromodulation at Medtronic. He offers insights on the ways in which neuromodulation is being used to address a variety of conditions and diseases. He also covers trends within the space such as what is driving the growth. Anderson also discusses the incorporation of smart technologies into these systems and the benefits that offers. Specifically, the following questions are addressed.

• What exactly are we talking about when we say neuromodulation? What are some of the technologies and application areas?
• How fast is the neuromodulation space growing? What is driving that growth?
• Has the opioid crisis put a spotlight on device-delivered technologies for pain management?
• One of the most exciting aspects of medical technologies is the smart functionality they can offer. How is Medtronic using AI, patient data, and connectivity within the neuromodulation space?
• What’s ahead in neuromodulation? What can we expect to see from Medtronic in the coming year?

Listen to this episode and see what you think of Medtronic’s neuromodulation strategy. 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 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].

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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].

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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].

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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].

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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.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with David Fischel, CEO of Stereotaxis. He explains how his robotic surgical system works and what makes it unique from other systems on the market. He also speaks about the additional benefits that could be realized for interventional technology as a result of his system’s ability to “pull” the catether through the patient’s vasculature. Specifically, the following questions are addressed.

• What type of technology does Stereotaxis offer and what is the target clinical area?
• How does your system improve upon the traditional methods of performing interventional procedures?
• Many of my listeners are familiar with robotic systems as it relates to automation or minimally invasive surgical systems. How does your system compare to the more traditional thought of a robotic system?
• What is the learning curve for doctors seeking to learn how to use your system who are accustomed to more traditional procedures?
• What’s ahead for Stereotaxis? What’s on the horizon?

Listen to this episode and see what you think of the unique robotic surgical system from Stereotaxis. 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].

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Deepak Khuntia, chief medical officer and senior VP of Medical Affairs at Varian. He offers insights on the company’s FLASH technology* and the significant differences between it and other radiation treatment systems. Dr. Khuntia also provides information about a clinical trial taking place to better understand the effect the FLASH system has on surrounding tissue. Specifically, the following questions are addressed.

• You’re currently conducting a clinical trial on your FLASH therapy. Can you explain what the technology is and what it’s used for?
• How does this treatment compare with more traditional methods for addressing this condition?
• Are there future potential applications where the FLASH technology could be used?
• Is this the first clinical trial incorporating the technology? I’m curious as to the response/feedback from physicians.
• In terms of the Flash technology, or Varian on the whole, what’s ahead? What are the next steps?

Listen to this episode and see what you think of Varian’s FLASH technology. 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].

*Note: FLASH therapy is under development and is not available for commercial sale.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Moshe Safran, CEO of RSIP Vision U.S. He shares technology advancements and his thoughts about them as related to the imaging field. Of note is his comments on 3D reconstruction as well as the impact artificial intelligence is having on the space. Specifically, the following questions are addressed.

• What is RSIP Vision and what is your area of focus?
• Medical imaging technology is rapidly advancing in several ways. Let’s start with 3D reconstruction. How is this being used today and how is it transforming medical imaging?
• Imaging advancements are also impacting joint replacement procedures. What are the real innovations here and how are they enhancing treatment?
• How about the use of AI in image capture? What’s happening here to improve processes?
• What are the key takeaways in terms of using AI in medical technology? Why is it important?
• What’s ahead for RSIP? What can we expect or where is your focus?

Listen to this episode and see what you think of emerging imaging technology. 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].

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recent offering put out by the FDA in conjunction with the Medical Device Innovation Consortium and MITRE. It is a playbook for device makers to involve threat modeling of medical devices in its approach to cybersecurity. Best practices for addressing cybersecurity of medical devices is also covered. Specifically, the following questions are addressed:

• Can you start things off by explaining what Threat Modeling is?
• Regarding this playbook the FDA released, is this purely a type of best practices item or is this something that may have regulatory implications tied to it somewhere down the road?
• Why is the FDA putting such attention on cybersecurity in medical devices? Is this about patient safety?
• Are there currently regulatory requirements with regard to cybersecurity?
• What do you foresee happening with FDA and cybersecurity? Will there continue to be guidance and/or will it become a bigger part of a regulatory review?
• What are your suggestions or takeaways for device manufacturers when it comes to cybersecurity and the FDA?

You can download the playbook for Threat Modeling Medical Devices discussed in this podcast by clicking  HERE.

Listen to this episode and see what you think of the FDA’s interest in cybersecurity. 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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