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 achievements the company has accomplished during that time?
• What’s next for OIC? What’s on the horizon? 

 Listen to this episode and see what you think of OIC 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 [email protected].
 
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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 episode and see what you think of the technology and the capabilities it offers to telehealth solutions. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at [email protected].
 
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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 guidance must manufacturers keep in mind?

Listen to this episode and see what you think of the Multiple Function Device Products guidance and whether it could affect 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 [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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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 [email protected] 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.

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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 [email protected] 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.

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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 think of this guidance and determine if it impacts your company and your products. 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 [email protected] 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.

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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 feedback as well as how your company has reacted to it in the past. 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 [email protected] 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.

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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 2017.

Listen to this episode and see what you think of the use of real world evidence and whether it’s something your company should be looking to use for your next label expansion. 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 [email protected] 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.

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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 a company to keep in mind with regard to a pre-sub?

There is also mention of the first podcast from 2017 where the pre-sub program was introduced and discussed. Click here to listen to that presentation.

Listen to this episode and see what you think of the eSTAR pilot program. 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 [email protected] 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.

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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 device manufacturing supply chain? Have they mobilized in step with the OEMs to enable the manufacture of these critical products?
• Looking ahead, do you think the medical device supply chain will shift geographies and some of it will emerge more prominently within the U.S.? 

 Listen to this episode and see what you think of the concerns brought up regarding the effort against COVID-19. If you’d like to share thoughts, ask questions, or would like to suggest a future participant for Medtech Matters, please reach out to me at [email protected].
 
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.

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