Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the 483s medical device manufacturing facilities received in 2020. The list comes from the FDA and points to trends among device manufacturers that the quality systems companies have in place may not be used adequately. Actions to take to avoid such concerns in the future are addressed as well as best practices device makers should consider. Specifically, the following questions are addressed:

• If every company is required to have a quality management system in place, how does this happen?
• Is there something to be said about the FDA’s numbers given how many companies are registered with the FDA for the manufacture of medical devices?
• So if CAPA, complaint handling, and design controls represent approximately a third of the 483s issued in 2020, what are the other two thirds.
• What are your tips and suggestions for companies to avoid these types of citations?
• Do you think the pandemic had any impact on these numbers? Were some companies ill-prepared for a virtual inspection with the FDA?

Listen to this episode and see what you think of the top 483s in 2020. 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 episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Roxie Mooney, the CEO and Healthcare Commercialization Strategist of Legacy DNA. She shares a number of best practices for companies determining their pathway to market for a new medical device. She also shares ideas and strategies for how medical device manufacturers can better leverage marketing channels to target a specific audience. Specifically, the following questions are addressed.

• What is Legacy DNA and how are you helping medical device manufacturers?
• What’s the biggest or most common mistake you see with regard to a company’s market strategy?
• What are some of your best suggestions for getting to market and gaining market share?
• How did the pandemic disrupt device manufacturers’ pathway to market?
• Do you anticipate any lasting changes with regard to a firm getting to market or do you expect an eventual return to business as usual?

Listen to this episode and see what you think of the suggestions provided and how they could affect your market startegy. 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 Dr. Greg Nicola, the chief medical officer at NeuTigers. He shares information about the firm’s involvement with Princeton University and the neural networks they are leveraging for use in the medical space. Further, he discusses why the use of this technology on edge devices is a differentiator for AI. Specifically, the following questions are addressed.

• What is NeuTigers?
• What is meant by shrinking AI?
• How is this being used within the healthcare space?
• Do you have real world examples of it being used?
• What are the next steps for this technology within healthcare? Do you have other clinical areas on your radar that you’d like to address?

Listen to this episode and see what you think of the NeuTigers, neural networks, and the use of AI on edge devices. 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 Giovanni Di Napoli, president of Gastrointestinal at Medtronic. He shares insights on several of Medtronic’s gastrointestinal diagnostic devices, including the Pillcam—a pill-sized camera a patient swallows to gain views of the digestive tract. The device provides an alternative to a colonoscopy as a first-step procedure. Additionally, Di Napoli gives information about the capabilities of the AI-driven GI Genius technology. Specifically, the following questions are addressed.

• What types of medical technology does Medtronic offer through its Gastrointestinal unit?
• Let’s focus specifically on the Pillcam. What is this technology and is it an alternative to a colonoscopy?
• Given the movement to expand telehealth we are seeing as one result of the pandemic, how does this align with the functionality and benefits of the Pillcam?
• Why is Medtronic teaming up with Amazon around the Pillcam at home program and what are the goals of this collaboration?
• What is GI Genius and how does it tie to the Pillcam?
• Any chance you can give us any type of scoop on the next steps for the GI Genius technology?

Listen to this episode and see what you think of the industry’s response to the need for COVID diagnostics. 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 Chris Hagen, vice president of the global COVID-19 task force and marketing for Beckman Coulter. He addresses a number of issues around the COVID-19 pandemic, from challenges with the ramp-up of production to securing needed supplies from a supply chain under stress. Hagen also speaks to the federal government’s response and how it affected diagnostic manufacturers. Specifically, the following questions are addressed.

• For those who don’t know what Beckman Coulter is, can you give a brief introduction?
• How has Beckman Coulter contributed to the fight against COVID-19?
• What was it like for a firm like Beckman Coulter to scale up manufacturing to meet the incredible demand for COVID-19 diagnostics?
• What was the impact of all those tests on the diagnostic infrastructure, such as the processing labs, and were the manufacturers able to aid with this portion in any way?
• How is the federal government trying to increase testing capability and what’s the impact on manufacturers?
• For Beckman Coulter, what are the lessons learned from the pandemic that you can carry forward?

Listen to this episode and see what you think of the industry’s response to the need for COVID diagnostics. 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 guidelines issued by the European Commission on the reprocessing of devices indicated by the manufacturer as beings single-use. Liability is brought up, as well as concerns such as material compatibility with reprocessing protocols with devices not intended to be used more than once. We also discuss measures device manufacturers should take if there’s a chance of their single-use devices being reprocessed to avoid patient injury. Specifically, the following questions are addressed:

• If a company states a device is single-use, how is it OK for a regulatory agency to override that indication and say it is OK to reprocess the device for at least one more use?
• Don’t we encounter specific material or device concerns that could arise with such a blanket guidance? What reprocessing system is safe to use and won’t have material incompatibility issues?
• How would the quality/design control requirements (design inputs) differ? I mean, if the design engineer is developing a single-use device, one would think he or she wouldn’t have to follow the same protocols as they would for a reprocessed device.
• Does this guidance mean developers of single-use devices have to test their device for multi-use and reprocessing?
• Are there limitations on this guidance? Are there certain types of single-use devices that the guidance does not permit to be reprocessed?
• If a patient is harmed by a reprocessed device, who is liable? The device maker, the regulatory agency, or the reprocessor?
• Does this guidance reflect a need for a new definition of single-use?

Listen to this episode and see what you think of the European Commission issuing these guidelines. 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 episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Shaka Bahadu, the COO and co-founder of Cipher Skin. He explains how his mesh measures movement and how it could be of value to physical therapists treating patients following surgery or injury. In addition, the mesh enables the attachment of additional sensors that could be used to measure pulse, oxygen level, and other important data points. Specifically, the following questions are addressed.

• Could you please provide an explanation of your company Cipher Skin, and really, more specifically, the Cipher Mesh technology?
• What are the application areas for this technology within the healthcare space?
• I understand the Department of Defense is even interested in the technology. Anything you can talk about there?
• Do you foresee future applications where this could be implanted? Perhaps in an application that measures motion of the lungs or heart?
• What are the next steps for you and Cipher Skin?

Listen to this episode and see what you think of Cipher Skin and Cipher Mesh. 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 Clive Smith, founder and CEO of Thinklabs. He gives an explanation of what his digital stethoscope is, how it works, and why it’s proved beneficial during the pandemic. Further, there’s a detour into a larger discussion on digital health, its evolving role in healthcare, and how we can expect it to develop going forward. Smith also tells us how digital health is like self-driving cars! Specifically, the following questions are addressed.

• Would you mind starting us off with a brief introduction of what Thinklabs is and tell us a little about your digital stethoscope product?
• How has the Thinklabs One digital stethoscope been used to help during the COVID-19 pandemic?
• With the rapid growth of telehealth, how might your digital stethoscope be used in this type of healthcare environment?
• Does the price point of your system enable it to be used in a number of homes or is there a different type of use case you envision?
• Would this technology have a value to medical device manufacturers conducting clinical trials?

Listen to this episode and see what you think of the Thinklabs One digital stethoscope. 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 Guy Harchen, VP Client Strategy at FreeMind Group. He provides an explanation of what non-dilutive funding is and why its so attractive to medical device firms. We also get into his vision of the future of digital health and how it will dramatically change how healthcare functions. His views on the pace of that change, however, are particularly interesting. Specifically, the following questions are addressed.

• What is the FreeMind Group and what do you do?
• What is non-dilutive funding?
• From your perspective, why does digital health matter?
• Is the U.S. government interested in the growth of digital health? Why?
• What do you expect to happen with digital health post-pandemic?

Listen to this episode and see what you think of non-dilutive funding and/or digital health. 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 recent issues impacting the proposed reimbursement for products that have been granted breakthrough device status from the FDA. With talk of too many devices being given BDP status along with the fact that a newly cleared device can still be viewed as experimental, the reimbursement policy is going through some additional review. Specifically, the following questions are addressed:

• Can you please explain the details of the BDP reimbursement policy that was being proposed?
• Can you provide some specifics on what’s driving this reevaluation of the policy?
• As I mentioned in the introduction, are there too many devices gaining BDP status? I mean, as we’ve discussed in the past, the fact that 510k devices are even eligible for a breakthrough designation seems ridiculous. What’s your opinion on this?
• What’s meant by the comments regarding a newly approved or cleared device being unproven?
• How is this policy reevaluation impacting medical device companies and their regulatory strategies?

Listen to this episode and see what you think of the BDP reimbursement delay and if changes could impact your regulatory strategy. 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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For more medtech news and information, visit https://www.mpomag.com.