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 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 technologies impact the way we care for patients?
• From your point of view, what has the pandemic revealed about the orthopedic industry? Beyond the negative impact on surgical procedures, are there lessons to learn that we can use going forward?
• Is the rapid adoption of telehealth going to have a significant impact on orthopedics? 

 Listen to this episode and see what you think of Osso VR 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 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 more information on those items.

• Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin (Draft, Oct, 2020)
• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" [Finalized Sept, 2020]
• Final Guidance: Technical Considerations for NonClinical Assessment of Medical Devices Containing Nitinol (Oct 15, 2020; draft issued April 2019)
• Mike on Medtech: FDA's Material Evaluation (April 2, 2019)
• Mike on Medtech: Biomaterials, Biocompatibility, and Bioabsorbable (July 25, 2017)

 Listen to this episode and see what you think of these two guidance documents and whether they 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.

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 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].
 
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 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].
 
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 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.

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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For more medtech news and information, visit https://www.mpomag.com. 

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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For more medtech news and information, visit https://www.mpomag.com. 

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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For more medtech news and information, visit https://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 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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For more medtech news and information, visit https://www.mpomag.com. 

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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For more medtech news and information, visit https://www.mpomag.com. 

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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For more medtech news and information, visit https://www.mpomag.com.