Medtech Matters

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 regard to?Does this help simplify the pathway to market for commonly used materials that have a proven record?The fact that we’re talking about “intact skin surface,” this wouldn’t apply to any type of wound care products, correct?With the nintinol-containing devices guidance, what’s the purpose behind that?Is this guidance primarily being put out due to the potential for an allergic reaction to nickel or is it more about the unique physical characteristics of Nitinol?What are the primary takeaways from these guidances device makers should keep in mind?There are also a number of references made. Following are links for mor

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 discussion of the company’s 10th anniversary and the achievements its had in that time. Specifically, we pose the following questions to him.    What is The Orthopaedic Implant Company and what is its niche within the medical device space?Last September, your firm partnered with Intermountain health systems. How did this come about and what was the goal of the arrangement?What have been the results of the partnership?How is OIC able to achieve such savings for a customer like Intermountain compared to other device manufacturers?OIC is celebrating 10 years within the orthopedic industry. What are some of the achieveme

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 as it only requires a camera on the patient’s side to capture the information. Specifically, we pose the following questions to him.    What is Binah.ai and what is your technology solution?As AI is still relatively new in being incorporated into medical technology, can you share your experience working with it?What has the pandemic done to the interest level in your technology?I’ve heard telemedicine has advanced in six months during the pandemic what was expected to take six years. How does such rapid adoption impact the industry?What aspects of telemedicine do you expect to remain post-pandemic?  Listen to this e

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 multiple function device as it relates to the FDA’s guidance?What’s the difference between a regulated medical device and a consumer product?How does something like a multiple function device differ from a combination product?What regulatory strategy suggestions do you have for dealing with this type of device?What concerns exist from a regulatory viewpoint if a sensor, such as a camera, is updated for non-regulated purposes? Will that impact the clearance of a regulated product that leverages that camera for sensing, such as a visual detection app that can detect skin cancer?What other significant takeaways from this guida

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 remind us what the BDP is? Why was it created? Who should consider it?How is the 510k pathway able to be used in conjunction with this program?How does the BDP differ from the STeP (or Safer Technologies Program)?So what’s “new” in the BDP? Why are we talking about it again?In what ways could the program be improved still?Listen to this episode and see what you think of the BDP and whether it could be for an upcoming product you are producing. 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 sfenske@rodmanmedia.com and we’ll see if we wan

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 episode. Listen to this episode and see what you think of the top five list or any of the other topics mentioned. 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 sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode. Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.Send us a textFor more medtech news and information, visit www.mpomag.com.

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, including:What are combination products? What are the different types?The FDA recently issued a new compliance program which included its approach to inspections for combination products. What exactly does that mean? What is the compliance program being referred to here?What are the most important details to manufacturers of combination products, whether drug/device or biologic/device?Does any of this represent a drastic change in how things were performed previously?What are the most important takeaways with regard to regulatory changes for manufacturers of combination products?Listen to this episode and see what you thin

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 nonbinding mean with regard to input or advice from the FDA?The nonbinding feedback we spoke about back in May 2019 had to do with 483s from site inspections. Where else does nonbinding feedback come into play with the FDA?Although the FDA’s feedback or recommendation may be nonbinding, is it always a good idea to follow the advice?What happens if you don’t follow nonbinding advice? Are you setting yourself up for a problem or a tougher “fight” with the FDA?What are the most important takeaways with regard to how a company should handle nonbinding feedback?Listen to this episode and see what you think of nonbinding fee

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 what real world evidence (RWE) is within the context of the FDA’s world?How was the agency viewing the use of real world evidence for a medical device’s regulatory pathway at the time?What does the actual use of real world evidence look like today?Why hasn’t real world evidence seen the implementation the agency was expecting or hoping to see? What are the challenges?Should medical device manufacturers be using RWE?What are the most important takeaways device manufacturers need to keep in mind with regard to the use of RWE?You can click here to listen to the aforementioned first podcast about real world evidence from 2

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 for certain types of devices or when using certain regulatory pathways or is it available to all device makers?Are there questions you shouldn’t ask during the pre-sub?What’s the most common mistakes you’ve heard companies made during their pre-sub?Will the FDA help a company determine what regulatory pathway to take during a pre-sub?Will the FDA give recommendations on things such as testing protocols a certain type of device should go through during a pre-sub?Is there any information you shouldn’t share with the FDA during a pre-sub? In other words, can being too transparent hurt you?What’s the most important thing for

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. Specifically, we ask him about the following questions.    We are hearing about the medical device industry mobilizing to support the healthcare professionals treating those with COVID-19. Overall, is the medical device industry keeping up and where are the greatest challenges being encountered?What are medtech firms telling you the real pain points are they are facing?Can you share your thoughts on the companies who are partnering with medical device manufacturers who aren’t accustomed to manufacturing under the FDA (e.g., Ford and Tesla)? What are the major concerns here?How has the response been from the medical devi

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 products during this pandemic. Specifically, we address a number of questions, including:We saw a 2-minute COVID-19 test being reported on that incorrectly claimed to have Emergency Use Authorization. The company claimed a misunderstanding. What should companies be doing to ensure they don’t make this mistake as well?Is there a concern of future misunderstandings from companies seeking to help, but not accustomed to working with the FDA?Does a company who has gained an EUA for a new device still need to seek a traditional regulatory pathway for approval/clearance?What does the FDA’s relaxing of regulatory rules mean to

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 address a number of questions, including:What is coronavirus?We’re hearing quite a bit about Emergency Use Authorization, primarily around tests for COVID-19. What does that mean exactly?Does EAU lower the regulatory burden compared to other pathways to market?To address the need for ventilators, companies like Ford and GM are changing over production to help. How does this happen when the FDA has likely never stepped foot into these facilities?With all the rushed approvals/clearances of new medical supplies, is there a concern regarding safety?What is the situation for companies with existing devices (already on market) t

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, including:How common is EtO for sterilization?How does it compare to other methods?Why is it used so frequently?What are the problems with EtO?Do you expect EtO to go away?What is the “root cause” of this problem? Could it have been avoided?What type of regulatory pathway requires a notification to the FDA for a change of sterilization process?What is the FDA’s EtO sterilization pilot program for changing vendors?What are the most important takeaways from this issue for medical device manufacturers?Several references were mentioned during this podcast and you can locate those items by clicking on each one.FDA Website: E

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 submission rejection. Specifically, we address a number of questions, including:What is the eSTAR program?What is the goal of this program?What is FDA seeking from companies interested in participating in the trial?For what types of devices/510(k) submissions can eSTAR be used and which types can it not be used?What does the form ask for?Is FDA offering incentives to encourage manufacturers to use eSTAR?What challenges do you foresee with this template? Has the FDA neglected to consider anything?If this template goes into effect, do you expect it to speed up 510(k) submissions and/or the processing of them?Would you encour

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 about. Specifically, we address a number of questions, including:  Are there certain areas of human factors the FDA is emphasizing or paying closer attention to? Do you have suggestions or real-world examples on how a company may perform human factors testing? How does human factors testing for a medical device differ based on where the product is intended to be used (for example, in the home versus in a hospital room or used by a physician versus the patient directly)? What type of trouble with the FDA can a company get into for not accomplishing human factors testing in a satisfactory manner? What are the key takeawa

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 human factors as it relates to medical device development?Were human factors always required by the FDA?What is the difference between human factors testing and a clinical trial?What types of medical devices are required to go through human factors validation testing?If you’d like to review the FDA’s Human Factors guidance document before listening to this podcast, you can find it by clicking here. Listen to this episode and see what you think of the FDA’s human factors requirements. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmed

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. Specifically, we address a number of questions, including:What is change management and why is it important?How does a company or regulatory individual decide when to handle the change internally, such as via a letter-to-file, vs. notifying the FDA with a special 510k or PMA supplement?Does it matter what type of change is being made? And I have a list of examples. Perhaps we can take these one at a time?Aesthetic change, such as color or size of a font?Design change, such as the shape or size of the device?Material change, such as the replacement of one material with another or the combination of two materials?Labeling

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 address a number of questions, including:What is change management and why is it important?How does a company or regulatory individual decide when to handle the change internally, such as via a letter-to-file, vs. notifying the FDA with a special 510k or PMA supplement?Does it matter what type of change is being made? And I have a list of examples. Perhaps we can take these one at a time?Aesthetic change, such as color or size of a font?Design change, such as the shape or size of the device?Material change, such as the replacement of one material with another or the combination of two materials?Labeling change, such as mo

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 well-understood devices that meet FDA-identified performance criteria to demonstrate the device is as safe and effective as a legally marketed device. Specifically, we address a number of questions, including:What is the Safety and Performance 510k?How does it differ from other variations of the 510k, such as the traditional version or the Special 510k?When should a manufacturer consider using this 510k?How does using performance criteria differ from citing a predicate device?Is this simply another way to get “me too” products to market quicker or is there more to it than that?Is this a incentivized way to have companies