Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we take a look at guidances published by FDA regarding the 510k regulatory pathway. The subject matter of the three were: best practices for selecting a predicate device, the need for clinical data in a submission, and evidentiary expectations with implanted devices. Specifically, the follo...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we take a look at the recent rise in recalls that are being tied back to manufacturing issues. The discussion explores the recall mechanism itself and then move to the details behind the numbers. Finally, a strategy for mitigating risk is shared to help manufacturers avoid the potential for...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we take a look at a guidance from the FDA that explains how product sponsors can submit a predetermined change control plan for artificial intelligence and machine learning technologies. These are critical as these types of software evolve over time to enhance the benefits they bring. Speci...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we examine the FDA policy regarding the use of a recalled device as a predicate in a 510k submission. Is it a good idea? What considerations are there for doing so? Specifically, the following questions are addressed: First, would you please explain the various levels of a recall as it rela...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we look at the 483s and warning letters that resulted from FDA inspections in 2022. The list is alarmingly similar to previous years and the discussion explores why that’s the case. The discussion also centers around ways device manufacturers can avoid making many of these same mistakes tha...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we continue to discuss lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. How would FDA oversight impact quality and timeliness of care? How do LDTs relate to what happened with Theranos? Specifically, the following questions are addressed betw...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we look at the debate over lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. What would this type of oversight do to the need for speed with these types of tests? Would FDA supervision make things safer and also avoid future situations like th...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we look at what happens to products on the market under the FDA’s emergency use authorization (EUA). Once the EUA period ends, what happens to these products? As President Biden has already declared the pandemic to be over, this timeframe will be approaching quickly. Specifically, the follo...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we look at the FDA’s use of the word “exempt” and what it means for medical device manufacturers. During this discussion, we look at the relationship between 510k exempt and Class of device. Specifically, the following questions are addressed: Could you please explain what 510k exempt actua...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we look at how a company can promote the off-label use of a medical device. It would seem to go against FDA regulation to do so, but there are acceptable methods that can be utilized that essentially promote the off-label use. Specifically, the following questions are addressed: Since this...

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 furt...

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. Sp...

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 a...

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 fo...

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 ari...

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...

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 K...

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...

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 imagi...

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 welc...

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...

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 informati...

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. Specifica...

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 d...

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Tamir Wolf, CEO and Co-Founder of Theator. He discusses his company and why capturing a video record of a surgery is beneficial to physicians. He speaks to the educational advantages that can be realized and also talks about the legal implications of us...