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 Christophe Bancel, CEO of TISSIUM. He provides information about the incredible material technology his company offers, enabling a replacement for human tissue. Based on the mix of three polymers, the firm can vary the characteristics such that it can be used for muscle or a section of colon or some other soft tissue application. Specifically, the following questions are addressed.Your company specializes in tissue reconstruction using something called biomorphic programmable polymers. Can you explain what that is?What are the potential applications for this type of technology?So is this a raw material, a medical device, or a bit of both?Does the material completely breakdown as healing occurs or does some of it remain to aid with strength?What has occurred already with regard to market launch/regulatory reviews and what are the next stages for the company?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 Ken Miller, CEO of BioVentrix. He shares insights on how his technology helps to treat patients who have suffered from a heart attack and aren’t responding well to the traditional stent protocol. His solution helps bring the heart back to its normal size after the attack to prevent heart failure from the enlarged heart getting tired. Specifically, the following questions are addressed.Let’s start with an introduction to your company and its LIVE Therapy system. Can you tell us what that is and the treatment it offers?The FDA granted your technology a breakthrough device designation. What was that application process like?Have you seen a difference in how your submission is handled by the agency with the BDP designation compared to prior experience?Your system is currently involved in a clinical trial. What have been the results of that thus far?What is your anticipated

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Mike Daley, CEO of OrthogenRx. He speaks on the benefits of hyaluronic acid (HA) to address osteoarthritis as an alternative to pain medications and surgical replacement. The FDA, however, has recently changed its oversight of HA and is now treating it as if it were a drug instead of a device. Specifically, the following questions are addressed.Your company offers a hyaluronic acid treatment for osteoarthritis. Can you provide a brief explanation of that technology?For 20 years, hyaluronic acid was treated as a device by the FDA. Then in 2018, the agency questioned that classification and indicated it might be a drug? What impact does that have on a company like yours?Did the FDA give a reason for their change in thinking?Has there been any new decisions on this since the agency questioned the classification in 2018?More and more combination products are emerging and t

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a still relatively newer option for medical device manufacturers in gaining a priority status with their regulatory review. STeP (Safer Technologies Program) emphasizes devices that enhance safety (as opposed to efficacy as is the case with the Breakthrough Device Program). Specifically, the following questions are addressed:Can you please give us a brief overview of the program?How does this program compare and contrast to the breakthrough devices program?What’s been the latest updates to STeP?What should companies consider or be aware of if they are looking at participating in this program?Any additional comments or final thoughts on STeP?You can view the STeP guidance from the FDA by clicking here. Listen to this episode and see what you think of the STeP designation and if it is appropriate for a device you’re going to submit to the agency. If you’d like to share thoughts, ask questions,

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Peter Vranes, co-founder and co-CEO of the Australian company Nutromics. He offers insight on a platform technology that enables continuous molecular monitoring. Using continuous glucose monitoring as an example for the potential for the technology, Vranes explains how his technology is capable of tracking any target, not just glucose. Specifically, the following questions are addressed.Your company has developed a continuous molecular monitoring platform. What does that mean exactly?Most people are aware of why you need to monitor glucose especially for diabetics but why seek to measure anything other than glucose continuously?How is your technology different from continuous glucose monitors already on the market?What is your first intended market for the technology and why did you choose it?Does the platform lend itself to be expanded to monitor other items such as w

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Jennifer Meade, president of the breast and skeletal health division at Hologic. She offers insight on the company’s recent acquisition activity as well as its partnership involving artificial intelligence. Meade also speaks to the importance of AI within Hologic technology and its efforts to encourage greater patient compliance. Specifically, the following questions are addressed.You were promoted to the position of president of the breast and skeletal health division in August of last year. What are your top priorities for your segment of Hologic in 2021 and beyond?Hologic didn’t waste time this year with an acquisition just a few days after the ball dropped on the new year. Can you speak to the reason behind the Somatex acquisition and where you see this fitting into your larger plan?It was announced last year that Hologic was working with RadNet on an artificial in

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Maninder Bedi, founder and chief medical officer of Optimize EP, and Ravi Kartan, president and CEO of the same firm. They speak about the importance of their solution for physicians to save time reviewing EP monitoring reports. They also speak to the machine learning algorthms that are employed within the software to enable a more effective offering. Specifically, the following questions are addressed.Let’s start with a little bit of an introduction to the EP process. How is data associated with an EP captured, reviewed and analyzed currently?How is Optimize EP and your See-Arm software attempting to change this?Since this is collecting remote monitoring data, I’m guessing this isn’t a solution intended for a hospital or healthcare environment exclusively? This is used for patients with monitoring technology on their person at home?Is the software compatible with

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Linnea Burman, Vice President & General Manager, Enabling Technologies: Cranial & Spinal Technologies at Medtronic. She speaks about the company’s interest in Mazor Robotics and why they made the acquisition. Burman also speaks about the evolving robotic surgical landscape as well as what’s ahead for Medtronic within the space. Specifically, the following questions are addressed.    Let’s start with the significant news Medtronic made a couple years ago when they purchased Mazor. What’s the latest with that robotic surgical technology?What was it about Mazor that made it such an attractive target to Medtronic?While the Mazor is indicated for orthopedic surgery, there’s been talk of Medtronic’s initiatives for a soft tissue robotic surgical solution. Can you speak to that at all?The da Vinci aside, the soft tissue space for robotic surgery seems to be a longer d

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss one of the most talked about regulatory elements of the last ten months—emergency use authorizations (or EUAs). The conversation is about what they are, when they are used, and, perhaps most importantly, what happens when the emergency is deemed over. Specifically, the following questions are addressed:Can you provide a full explanation of the EUA and when it is used?What happens to products that have received an EUA to get to market during the pandemic once the emergency is deemed over?How does an EUA fit within a company’s regulatory strategy?Can a company use real-world evidence from a product’s time on the market as a result of an EUA in its regulatory submission for that product?For companies that have been granted an EUA, what are the most important things to keep in mind as we hopefully get closer to the end of the pandemic?Listen to this episode and see what you think of EUAs and whet

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Nadine Hachach-Haram, the founder and CEO of Proximie. Her firm enables clinicians to collaborate from anywhere in the world. The solutions is hardware agnostic and enables connections in remote regions with low internet functionality. Specifically, the following questions are addressed.    Can you please tell us about your company and what it’s doing to the traditional surgical environment?Does your company provide all the hardware and software components to enable the connection?Is the hardware and software required on both ends?One unique thing I noticed about your technology is that it operates on weaker internet connections. Why was that an important factor and important to you?What’s the reaction from surgeons to the system?  Listen to this episode and see what you think of Proximie and the capabilities it enables for surgical consults and collaboration. If y

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Liane Teplitsky, vice president and worldwide general manager of robotics at Zimmer Biomet. She provides some background on how we arrived at where we are today, what’s driving the robotic surgery movement, what the latest with the company’s Rosa system is, and what’s ahead. Specifically, we pose the following questions to him.    What’s the latest with Zimmer Biomet and the Rosa system?Why have robotic surgical technologies exploded in the orthopedic space?What’s been the overall reception by surgeons to these systems?How is data informatics playing a role in robotic surgical systems?With the incorporation of AI and machine learning, are we at the early stages of physician-assisted surgeries, where the robot is doing more of the procedure and the surgeon is supervising?  Listen to this episode and see what you think of Zimmer Biomet’s strategy for robotic surgery. If

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a number of the priorities Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH), has mentioned in recent presentations. The agency had also laid out several priorities in a document a few years ago to be acted upon from 2018 through 2020, which has now been extended to 2021. Specifically, we address a number of questions, including:What are the important priorities for CDRH in 2021?Tracking of submissions and electronic templatesDecentralized clinical trials with CDER and CBERFeedback from patients through new Collaborative Communities forumDigital Health Center of ExcellenceHow will the COVID-19 pandemic impact these priorities and CDRH operations moving forward?What’s been the impact on non-COVID devices? Are new devices still being developed or being reviewed by the agency?What about the impact of politics and the new incoming administration?Listen to this

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Jesse Wheeler, head of MedTech and Analytics at Draper, a not-for-profit engineering innovation company. He explains what organization does and how its projects can help to improve medical devices. His latest project involves the development of an ECG sensing technology that does not require contact with the patient. Specifically, we pose the following questions to him.    First can you tell us a little about Draper and what you do?I understand you’re developing a noncontact sensor to replace traditional ECG technology. How does it work and why could it be a better alternative?Beyond the hospital, where could technology such as this enable ECG monitoring?Are there additional applications possible leveraging this technology?What are the obstacles remaining to getting this technology to market?  Listen to this episode and see what you think of Draper and its non-cont

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a variety of ways in which medical device manufacturers communicate with the FDA. Mike provides best practices he’s used and also shares stories from his own experience interacting with the agency for real-world projects. Specifically, we address a number of questions, including:Let’s review the more common or well-understood methods of communicating with the FDA.Regulatory submissionResponse to inspection or 483Pre-sub meetingSocial mediaLetter to fileWhat other methods are there outside of those?How has communication been handled during the pandemic?Can you share best practices when communicating with the FDA? Dos and don’ts?What ways would you like to see established for communication with the FDA?Listen to this episode and see what you think of communication with the FDA and if there are methods you could use which you aren’t. If you’d like to share thoughts, ask questions, or have a sugg

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Joe Mullings, chairman and CEO of The Mullings Group—a talent acquisition firm focused on medtech—and host of the web series TrueFuture. As someone who works with leading medtech manufacturers and travels the world to explore regions where new medtech is being developed, Mullings was able to provide an interesting viewpoint on what’s got him excited and how lessons learned from the pandemic could help the industry. Specifically, we pose the following questions to him.    Through your various ventures, you’re exposed to quite a bit of emerging medtech. What has you most excited and why?How are these new technologies impacting the types of people the medtech industry is hiring?Are you getting interest for medtech talent from non-traditional industry players? With the pandemic, we saw companies like GM and Tesla partnering with medical device firms to produce critical pro

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Bruce Lichorowic, President and CEO of Galen Robotics. The company is developing a robotic surgical system, like other medical device manufacturers, but has interesting plans on how it will roll it out to the market. The system will not require a capital investment from hospitals. Specifically, we pose the following questions to him.    There are a number of medtech companies developing or marketing robotic surgical solutions. What makes the Galen Robotics system unique?Is neurosurgery an emerging area for robotic surgery?What is digital surgery as a service?What has been the feedback from hospitals and surgeons regarding digital surgery as a service?What’s the timeframe for you launch of this service?  Listen to this episode and see what you think of Galen Robotics and their “subscription” plan. If you’d like to share thoughts, ask questions, or suggest a future parti

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Kevin Goodwin, CEO of EchoNous. The company offers a portable, point-of-care ultrasound solution that provides real-time views of the heart, lungs, and abdomen. With significant computing power driving it, but only weighing eight ounces, the technology provides a stark contrast to traditional cart-based systems. Specifically, we pose the following questions to him.    Please tell me about EchoNous and what makes your ultrasound technologies unique?Why is point-of-care ultrasound so important for healthcare, especially right now during the pandemic?What have been the challenges in developing this type of ultrasound system?What impact does AI have on the system and the level of care it enables?What’s next for EchoNous?  Listen to this episode and see what you think of EchoNous. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Ma

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Mark Toland, who was previously the CEO of Corindus, and Rick Anderson, who was formerly the WorldWide Franchise Chairman at J&J. They are now both on the board at Cardiologs. They talk about what interested them in the company, the important role cardiovascular diagnostics play in the battle against heart disease, and the impact of artificial intelligence on the device performance. Specifically, we pose the following questions to them.    What is Cardiologs and what attracted you to the organization?What does this influx of AI-powered technologies mean for healthcare?Are the challenges associated with reimbursement when it comes to AI-based technologies being addressed?What challenges are still inhibiting the growth of this technology segment?What is the response from caregivers and physicians? Are they ready to adopt AI-based technologies?  Listen to this 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. Sham Dholakia, senior VP of medical affairs and clinical operations at CareDx. Dr. Dholakia talks about the technologies his company provides to best match donated organs with the patients who so desperately need them. Since current methods detect problems with an organ match after the transplant, CareDX is trying to proactively prevent this from occurring. Specifically, we pose the following questions to him.    What is CareDx and what is the technology you offer?What are the challenges with transplants and how does your technology address them?What have been the challenges in the development of your technology?What are the “smart” aspects of your technology?  Listen to this episode and see what you think of CareDX and its technologies. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sf

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Justin Barad, orthopedic surgeon and founder of Osso VR. Barad shares insights on the advantages of leveraging virtual reality technologies for the simulation of surgical procedures for training, introducing new products, and other applications. He also offers his thoughts on the influx of new, “smart” technologies that are encompassing the traditional implants in orthopedics. Specifically, we pose the following questions to him.    Please tell us about Osso VR and specifically, your virtual reality based surgical training platform?I’ve definitely seen a shift in orthopedics even within the last five years where sensors, virtual and augmented reality, robotics, and other non-traditional orthopedic advancements are impacting this sector. As both a surgeon and a medical device professional, what’s your impression of this influx of new innovations?How do these technologie