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 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 prov...

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 cardi...

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 probl...

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 off...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the FDA’s guidances on biocompatibility submissions and nitinol-containing devices. Although the two are separate guidance documents, we combine them into a single discussion. Specifically, we address a number of questions, including: What is the biocompatibility guidance in rega...

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Itai Nemovicher, CEO and founder of The Orthopaedic Implant Company. Nemovicher offers insights into what makes his company and its orthopedic technologies unique within the sector and how the company uses that to compete with larger players. There is also...

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with David Maman, CEO and co-founder of Binah. Maman shares information about his telehealth technology, which enables medical providers to get vital signs readings of patients before speaking with them through a video portal. The technology is platform agnostic...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the FDA’s guidance on Multiple Function Device Products. While the terminology can be somewhat confusing, the guidance, and more importantly, how manufacturers comply with it is relatively straightforward. Specifically, we address a number of questions, including: What is a multi...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss how the breakthrough designation program has changed since its inception. While the language of the program has not changes, FDA’s interpretation of it has shifted somewhat. Find out what’s “new” in this episode. Specifically, we address a number of questions, including: Can you...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we look back at a variety of the topics that have been covered in the past 49 episodes. We check out what were the top five most popular topics, while also inquiring about the omissions from the list. Did the episodes you find most interesting or valuable make the list? Find out in this epi...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the impact of a new compliance program with regard to inspections for combination products. The impact to the device manufacturers of this type of product is examined following an introduction to what combination products are. Specifically, we address a number of questions, inclu...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the term “nonbinding feedback” and what it means for medical device manufacturers. While the feedback comes from the FDA, it’s not mandatory that the feedback (or advice or recommendation) needs to be followed. Specifically, we address a number of questions, including: What does...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the use (or lack of use) of real world evidence. This discussion is a sort of update on the first Mike on Medtech podcast, which offered an introduction to real world evidence. Specifically, we address a number of questions, including: Can you please provide a quick refresher on...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the FDA’s pre-sub program and best practices for companies to consider prior to their scheduled appointment with the agency. Specifically, we address a number of questions, including: Can you please give a brief overview of what the FDA’s pre-sub program is? Is the pre-sub only f...

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Scott Whitaker, CEO and president of AdvaMed, the world’s largest medical technology association. He’s participating in the podcast to provide insight into the COVID-19 pandemic and the challenges the medical device industry has been facing as a result. Spe...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss recent coverage of a two-minute COVID-19 test that had miscommunicated obtaining emergency use authorization from the FDA. We look at actions the FDA is taking around these types of incidents and also about the potential issues with a relaxing of regulatory rules around certain p...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss questions raised by news of medical technology being rolled out to help battle the COVID-19 virus. Topics such as what Emergency Use Authorization means to how non-manufacturers of medical devices can now produce products for the effort such as ventilators. Specifically, we addre...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the concern surrounding the use of EtO for medical device sterilization. Questions have been raised as to the safety of the amount that’s been detected in the air around facilities that provide this type of sterilization process. Specifically, we address a number of questions, in...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the FDA’s pilot of an interactive 510(k) template called eSTAR (electronic Submission Template and Resource). This electronic template would be used by companies submitting a 510(k) application so as to try to avoid administrative rejection, one of the most common causes of submi...

In the second part of this Medtech Matters podcast series of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the FDA’s emphasis on human factors (or ergonomics or usability) testing. We mention what medical device manufacturers should be concerned with for less than satisfactory testing protocols, and how the FDA may not even be the worst thing they should be worried a...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the FDA’s emphasis on human factors (or ergonomics or usability) testing. Medical device manufacturers need to ensure they are not only satisfying this need, but also fulfilling any potential liability involved. Specifically, we address a number of questions, including: What is h...

In the second part of this two-part Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss change management with regard to how to address it with the FDA. The type of change and the overall implications of it to the functionality and efficacy of the device should dictate which route a company should take—letter-to-file or a Special 510k. Sp...

In this two-part Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss change management with regard to how to address it with the FDA. The type of change and the overall implications of it to the functionality and efficacy of the device should dictate which route a company should take—letter-to-file or a Special 510k. Specifically, we addr...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the FDA’s Safety and Performance Based 510k pathway, which offers a pathway for medical device manufacturers to use performance criteria in place of a predicate device for clearance. This option, previously known as an Abbreviated 510k, is only available for a select group of wel...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the FDA’s Special 510(k) program, which offers a pathway for medical device manufacturers making modifications to its own legally marketed device. It is a method for device makers to avoid the need to completely resubmit their device as a new device to the agency. Specifically, w...