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 Russ Johannesson, CEO of Glooko. He speaks about the advantages remote monitoring offers to both physicians of diabetics as well as the patients themselves. He also offers insights into how his solution is used in conjunction with other device makers’ technologies. Specifically, the following questions are addressed.

• What is Glooko and what do you do?
• Does your solution work across all vendor technologies or are you partnered with select companies?
• Given you were offering this technology prior to the pandemic, what did you learn about the use of the technology during the pandemic when people needed remote capabilities?
• What are the next stages for advancement? Do you have functionality you’re working on incorporating?
• What’s ahead? Where will Glooko be in five to ten years?

Listen to this episode and see what you think of remote monitoring of diabetes. 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. Steven LeBoeuf, founder of Valencell. He provides insights on his company’s biomedical sensors, which can be incorporated into many different types of technologies, from fitness clothing to bracelets to footware. Specifically, the following questions are addressed.

• What is Valencell? What does the company do?
• Why is wearable biomedical sensing important?
• Can this technology be used to sense other biometrics?
• What types of applications are you incorporating these sensors into? Can you share any of your partners and share what they are doing specifically?
• What’s next for you and Valencell? What’s ahead five to ten years from now?

Listen to this episode and see what you think of wearable biomedical sensing technology. 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 look at recently proposed legislation regarding in vitro diagnostics and lab developed tests. The previous version of the Verifying Accurate, Leading-edge IVCT Development Act or VALID, which was proposed just before the pandemic, split the industry with the AACC and ACLA not supportive of it, while AdvaMed and CAP were in favor of the proposed legislation. Specifically, the following questions are addressed:

• First, can you clarify what an IVD and LDT is and what the differences are?
• How are these currently regulated or how were they regulated?
• Why is there a call for changes to the regulatory process for these tests.
• Why is this proposal so divisive to the industry and these organizations?
• The last time this was proposed, it never even went to a vote. Will this version see the same fate or might this one have a little more support behind it given how important testing was during the pandemic?

Listen to this episode and see what you think of the proposed testing regulations. 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 Julie Kemink, COO at LifeSource. She speaks to the technologies being used within organ donation, primarily for transport and preservation. She also offers insights on upcoming technologies such as the use of drones, bioprinting of organs, and tracking solutions. Specifically, the following questions are addressed.

• What is LifeSource?
• As more of an end user of medical devices for transplant and organ donation, can you speak to the transition you’ve seen of those technologies?
• I understand you’re exploring the use of drones for the transport of organs. Can you tell me a bit of what’s happening there?
• What about bioprinting of organs? What are you seeing with that?
• I understand you’re also looking at tracking technologies for organs. What is the objective there?
• What about technologies used to monitor a transplant following the surgical procedure? Why is that needed?
• What more is needed from medical device manufacturers for this healthcare segment?

Listen to this episode and see what you think of trade secrets. 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 dig into a story about an Italian firm that reportedly falsified information related to sterilization certificates going back as far as 2016. On June 2, 2021, the FDA published a letter to industry regarding the firm Steril Milano. In the letter, the agency stated it was working with a number of manufacturers and other partners to determine the scope of medical devices affected and contact any potentially impacted firms. Specifically, the following questions are addressed:

• How does this happen?
• Is there anything a device manufacturer can do to verify whether information from their sterilization provider has been falsified?
• If this happened to a device manufacturer whose products were used within healthcare facilities and a problem occurred, does this open them up to a liability lawsuit.
• This seems like a situation where the agency would be just as interested in working with the device manufacturer to resolve the problem. What’s it like working with the FDA in this type of situation?
• What recommendations would you make to a manufacturer who had used this sterilization provider?

Listen to this episode and see what you think of this sterilization situation. 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 Adam Powell, a partner at Knobbe Martens. He provides clarification on what qualifies as a trade secret. He also shares best practices for companies who hire an employee from a direct competitor to avoid any potential legal issues or concerns. Specifically, the following questions are addressed.

• What is a trade secret?
• What are some of the methods companies should be using to protect confidential information?
• What should a company do if an employee took confidential information?
• What should a company do if they hire an employee from a competitor?
• Where is the line drawn between trade secret and acquired experience? What about implementing best practices?

Listen to this episode and see what you think of trade secrets. 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. Bill Hunter, the CEO of Canary Medical. He offers additional information about the company’s ‘smart’ implant technology. He provides insight on the benefits of orthopedic implants that can communicate with physicians on the implant’s status as well as how the patient is doing with recovery postoperative. Specifically, the following questions are addressed.

• Can you start by telling me what Canary Medical does?
• Are you planning to market smart implants and devices from your company or will your device work with other manufacturers’ offerings?
• Why has it taken so long for device manufacturers to offer smart implant technologies even though they’ve been discussed for years?
• What’s next after orthopedic implants?
• How long before we start seeing connectivity within any type of device that is implanted into the body, regardless of size, location, or purpose?

Listen to this episode and see what you think of the remote monitoring of cardiac 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 Dr. Arnaud Rosier, the CEO and founder of Implicity. He offers insights on his company’s technology, which enables the remote monitoring of implanted cardiac devices. Dr. Rosier speaks about working with the device makers as well as the physicians using his software. He also speaks to the value of remote monitoring during the pandemic. Specifically, the following questions are addressed.

• Why did you create Implicity and what does the company do?
• Do you partner with device makers or are you able to collect the data without their buy-in?
• What are the challenges with remote monitoring and did we see more emerge during the pandemic?
• What needs to happen within the reimbursement space before remote monitoring and data management solutions are likely to change?
• How do you respond to concerns over data privacy with a solution like yours?

Listen to this episode and see what you think of the remote monitoring of cardiac 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 Hanan Ben-Asher, the COO of PixCell Medical. He shares his ideas on the healthcare value of gaining access to rapid blood test diagnostics. Without requiring a full laboratory to obtain results, his testing protocol would enable point-of-care blood testing to take place anywhere. Specifically, the following questions are addressed.

• What is PixCell and what does the company do?
• During the pandemic, we got a perfect example of why diagnostics are so important. Did we learn why rapid diagnostics are even more important?
• What are the technologies that are enabling more rapid diagnostics?
• How are AI and machine vision being incorporated into diagnostics?
• Why do we need to expand the use of blood testing and make it more accessible?

Listen to this episode and see what you think of the benefits of rapid blood testing. 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 Anthony Fernando, the president and CEO of Asensus Surgical. He talks about his company’s Senhance robotic surgical system and how it stands apart from competitors. In addition, he discusses the integration of artificial intelligence and machine learning within robotic surgical technologies. Specifically, the following questions are addressed.

• Your company offers the Senhance Surgical System. Can you tell me what that is?
• We’re seeing an emergence of robotic surgical systems in healthcare. What differentiates the Senhance System?
• What role is AI and machine learning playing in robotic surgical systems?
• I mentioned the emergence of robotic surgical solutions we are seeing. Why is that? What’s driving this segment?
• What’s ahead for robotic surgical systems? Where is this sector headed in five years?

Listen to this episode and see what you think of the Senhance system. 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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For more medtech news and information, visit https://www.mpomag.com.