Medtech Matters

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Steven LeBoeuf, founder of Valencell. He provides insights on his company’s biomedical sensors, which can be incorporated into many different types of technologies, from fitness clothing to bracelets to footware. Specifically, the following questions are addressed.What is Valencell? What does the company do?Why is wearable biomedical sensing important?Can this technology be used to sense other biometrics?What types of applications are you incorporating these sensors into? Can you share any of your partners and share what they are doing specifically?What’s next for you and Valencell? What’s ahead five to ten years from now?Listen to this episode and see what you think of wearable biomedical sensing technology. 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 us

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at recently proposed legislation regarding in vitro diagnostics and lab developed tests. The previous version of the Verifying Accurate, Leading-edge IVCT Development Act or VALID, which was proposed just before the pandemic, split the industry with the AACC and ACLA not supportive of it, while AdvaMed and CAP were in favor of the proposed legislation. Specifically, the following questions are addressed:First, can you clarify what an IVD and LDT is and what the differences are?How are these currently regulated or how were they regulated?Why is there a call for changes to the regulatory process for these tests.Why is this proposal so divisive to the industry and these organizations?The last time this was proposed, it never even went to a vote. Will this version see the same fate or might this one have a little more support behind it given how important testing was during the pandemic?Listen to th

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Julie Kemink, COO at LifeSource. She speaks to the technologies being used within organ donation, primarily for transport and preservation. She also offers insights on upcoming technologies such as the use of drones, bioprinting of organs, and tracking solutions. Specifically, the following questions are addressed.What is LifeSource?As more of an end user of medical devices for transplant and organ donation, can you speak to the transition you’ve seen of those technologies?I understand you’re exploring the use of drones for the transport of organs. Can you tell me a bit of what’s happening there?What about bioprinting of organs? What are you seeing with that?I understand you’re also looking at tracking technologies for organs. What is the objective there?What about technologies used to monitor a transplant following the surgical procedure? Why is that needed?What more

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we dig into a story about an Italian firm that reportedly falsified information related to sterilization certificates going back as far as 2016. On June 2, 2021, the FDA published a letter to industry regarding the firm Steril Milano. In the letter, the agency stated it was working with a number of manufacturers and other partners to determine the scope of medical devices affected and contact any potentially impacted firms. Specifically, the following questions are addressed:How does this happen?Is there anything a device manufacturer can do to verify whether information from their sterilization provider has been falsified?If this happened to a device manufacturer whose products were used within healthcare facilities and a problem occurred, does this open them up to a liability lawsuit.This seems like a situation where the agency would be just as interested in working with the device manufacturer to res

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Adam Powell, a partner at Knobbe Martens. He provides clarification on what qualifies as a trade secret. He also shares best practices for companies who hire an employee from a direct competitor to avoid any potential legal issues or concerns. Specifically, the following questions are addressed.What is a trade secret?What are some of the methods companies should be using to protect confidential information?What should a company do if an employee took confidential information?What should a company do if they hire an employee from a competitor?Where is the line drawn between trade secret and acquired experience? What about implementing best practices?Listen to this episode and see what you think of trade secrets. 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 us a

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Bill Hunter, the CEO of Canary Medical. He offers additional information about the company’s ‘smart’ implant technology. He provides insight on the benefits of orthopedic implants that can communicate with physicians on the implant’s status as well as how the patient is doing with recovery postoperative. Specifically, the following questions are addressed.Can you start by telling me what Canary Medical does?Are you planning to market smart implants and devices from your company or will your device work with other manufacturers’ offerings?Why has it taken so long for device manufacturers to offer smart implant technologies even though they’ve been discussed for years?What’s next after orthopedic implants?How long before we start seeing connectivity within any type of device that is implanted into the body, regardless of size, location, or purpose?Listen to this epis

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Arnaud Rosier, the CEO and founder of Implicity. He offers insights on his company’s technology, which enables the remote monitoring of implanted cardiac devices. Dr. Rosier speaks about working with the device makers as well as the physicians using his software. He also speaks to the value of remote monitoring during the pandemic. Specifically, the following questions are addressed.Why did you create Implicity and what does the company do?Do you partner with device makers or are you able to collect the data without their buy-in?What are the challenges with remote monitoring and did we see more emerge during the pandemic?What needs to happen within the reimbursement space before remote monitoring and data management solutions are likely to change?How do you respond to concerns over data privacy with a solution like yours?Listen to this episode and see what you thin

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Hanan Ben-Asher, the COO of PixCell Medical. He shares his ideas on the healthcare value of gaining access to rapid blood test diagnostics. Without requiring a full laboratory to obtain results, his testing protocol would enable point-of-care blood testing to take place anywhere. Specifically, the following questions are addressed.What is PixCell and what does the company do?During the pandemic, we got a perfect example of why diagnostics are so important. Did we learn why rapid diagnostics are even more important?What are the technologies that are enabling more rapid diagnostics?How are AI and machine vision being incorporated into diagnostics?Why do we need to expand the use of blood testing and make it more accessible?Listen to this episode and see what you think of the benefits of rapid blood testing. If you’d like to share thoughts, ask questions, or suggest a fut

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Anthony Fernando, the president and CEO of Asensus Surgical. He talks about his company’s Senhance robotic surgical system and how it stands apart from competitors. In addition, he discusses the integration of artificial intelligence and machine learning within robotic surgical technologies. Specifically, the following questions are addressed.Your company offers the Senhance Surgical System. Can you tell me what that is?We’re seeing an emergence of robotic surgical systems in healthcare. What differentiates the Senhance System?What role is AI and machine learning playing in robotic surgical systems?I mentioned the emergence of robotic surgical solutions we are seeing. Why is that? What’s driving this segment?What’s ahead for robotic surgical systems? Where is this sector headed in five years?Listen to this episode and see what you think of the Senhance system. If you’d

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the 483s medical device manufacturing facilities received in 2020. The list comes from the FDA and points to trends among device manufacturers that the quality systems companies have in place may not be used adequately. Actions to take to avoid such concerns in the future are addressed as well as best practices device makers should consider. Specifically, the following questions are addressed:If every company is required to have a quality management system in place, how does this happen?Is there something to be said about the FDA’s numbers given how many companies are registered with the FDA for the manufacture of medical devices?So if CAPA, complaint handling, and design controls represent approximately a third of the 483s issued in 2020, what are the other two thirds.What are your tips and suggestions for companies to avoid these types of citations?Do you think the pandemic had any impact o

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Roxie Mooney, the CEO and Healthcare Commercialization Strategist of Legacy DNA. She shares a number of best practices for companies determining their pathway to market for a new medical device. She also shares ideas and strategies for how medical device manufacturers can better leverage marketing channels to target a specific audience. Specifically, the following questions are addressed.What is Legacy DNA and how are you helping medical device manufacturers?What’s the biggest or most common mistake you see with regard to a company’s market strategy?What are some of your best suggestions for getting to market and gaining market share?How did the pandemic disrupt device manufacturers’ pathway to market?Do you anticipate any lasting changes with regard to a firm getting to market or do you expect an eventual return to business as usual?Listen to this episode and see

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Greg Nicola, the chief medical officer at NeuTigers. He shares information about the firm’s involvement with Princeton University and the neural networks they are leveraging for use in the medical space. Further, he discusses why the use of this technology on edge devices is a differentiator for AI. Specifically, the following questions are addressed.What is NeuTigers?What is meant by shrinking AI?How is this being used within the healthcare space?Do you have real world examples of it being used?What are the next steps for this technology within healthcare? Do you have other clinical areas on your radar that you’d like to address?Listen to this episode and see what you think of the NeuTigers, neural networks, and the use of AI on edge devices. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Giovanni Di Napoli, president of Gastrointestinal at Medtronic. He shares insights on several of Medtronic’s gastrointestinal diagnostic devices, including the Pillcam—a pill-sized camera a patient swallows to gain views of the digestive tract. The device provides an alternative to a colonoscopy as a first-step procedure. Additionally, Di Napoli gives information about the capabilities of the AI-driven GI Genius technology. Specifically, the following questions are addressed.What types of medical technology does Medtronic offer through its Gastrointestinal unit?Let’s focus specifically on the Pillcam. What is this technology and is it an alternative to a colonoscopy?Given the movement to expand telehealth we are seeing as one result of the pandemic, how does this align with the functionality and benefits of the Pillcam?Why is Medtronic teaming up with Amazon around the

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Chris Hagen, vice president of the global COVID-19 task force and marketing for Beckman Coulter. He addresses a number of issues around the COVID-19 pandemic, from challenges with the ramp-up of production to securing needed supplies from a supply chain under stress. Hagen also speaks to the federal government’s response and how it affected diagnostic manufacturers. Specifically, the following questions are addressed.For those who don’t know what Beckman Coulter is, can you give a brief introduction?How has Beckman Coulter contributed to the fight against COVID-19?What was it like for a firm like Beckman Coulter to scale up manufacturing to meet the incredible demand for COVID-19 diagnostics?What was the impact of all those tests on the diagnostic infrastructure, such as the processing labs, and were the manufacturers able to aid with this portion in any way?How is the

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the guidelines issued by the European Commission on the reprocessing of devices indicated by the manufacturer as beings single-use. Liability is brought up, as well as concerns such as material compatibility with reprocessing protocols with devices not intended to be used more than once. We also discuss measures device manufacturers should take if there’s a chance of their single-use devices being reprocessed to avoid patient injury. Specifically, the following questions are addressed:If a company states a device is single-use, how is it OK for a regulatory agency to override that indication and say it is OK to reprocess the device for at least one more use?Don’t we encounter specific material or device concerns that could arise with such a blanket guidance? What reprocessing system is safe to use and won’t have material incompatibility issues?How would the quality/design control requirements

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Shaka Bahadu, the COO and co-founder of Cipher Skin. He explains how his mesh measures movement and how it could be of value to physical therapists treating patients following surgery or injury. In addition, the mesh enables the attachment of additional sensors that could be used to measure pulse, oxygen level, and other important data points. Specifically, the following questions are addressed.Could you please provide an explanation of your company Cipher Skin, and really, more specifically, the Cipher Mesh technology?What are the application areas for this technology within the healthcare space?I understand the Department of Defense is even interested in the technology. Anything you can talk about there?Do you foresee future applications where this could be implanted? Perhaps in an application that measures motion of the lungs or heart?What are the next steps for

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Clive Smith, founder and CEO of Thinklabs. He gives an explanation of what his digital stethoscope is, how it works, and why it’s proved beneficial during the pandemic. Further, there’s a detour into a larger discussion on digital health, its evolving role in healthcare, and how we can expect it to develop going forward. Smith also tells us how digital health is like self-driving cars! Specifically, the following questions are addressed.Would you mind starting us off with a brief introduction of what Thinklabs is and tell us a little about your digital stethoscope product?How has the Thinklabs One digital stethoscope been used to help during the COVID-19 pandemic?With the rapid growth of telehealth, how might your digital stethoscope be used in this type of healthcare environment?Does the price point of your system enable it to be used in a number of homes or is there

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Guy Harchen, VP Client Strategy at FreeMind Group. He provides an explanation of what non-dilutive funding is and why its so attractive to medical device firms. We also get into his vision of the future of digital health and how it will dramatically change how healthcare functions. His views on the pace of that change, however, are particularly interesting. Specifically, the following questions are addressed.What is the FreeMind Group and what do you do?What is non-dilutive funding?From your perspective, why does digital health matter?Is the U.S. government interested in the growth of digital health? Why?What do you expect to happen with digital health post-pandemic?Listen to this episode and see what you think of non-dilutive funding and/or digital health. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recent issues impacting the proposed reimbursement for products that have been granted breakthrough device status from the FDA. With talk of too many devices being given BDP status along with the fact that a newly cleared device can still be viewed as experimental, the reimbursement policy is going through some additional review. Specifically, the following questions are addressed:Can you please explain the details of the BDP reimbursement policy that was being proposed?Can you provide some specifics on what’s driving this reevaluation of the policy?As I mentioned in the introduction, are there too many devices gaining BDP status? I mean, as we’ve discussed in the past, the fact that 510k devices are even eligible for a breakthrough designation seems ridiculous. What’s your opinion on this?What’s meant by the comments regarding a newly approved or cleared device being unproven?How is this

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Chen Levin, CEO of XACT Robotics. She offers insights on the capabilities of the XACT ACE Robotic System that enables a doctor to identify a target in the body and the robot to reach the target. The robot can make adjustments should the target move due to the movement of tissue during the procedure. The robot can be used for ablation, biopsy, or drug delivery. Specifically, the following questions are addressed.Can you please briefly explain the current problem with trying to diagnose a suspicious tumor that’s too small or hard to reach?How does the XACT ACE robot help with this challenge?What type of vision system is being used by the robot to visualize the tissue?How does the robot track the tissue even if it moves during the procedure?How many of these are being implemented? How many of these are out on the market?Are there other applications for this type of techno