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 Chen Levin, CEO of XACT Robotics. She offers insights on the capabilities of the XACT ACE Robotic System that enables a doctor to identify a target in the body and the robot to reach the target. The robot can make adjustments should the target move due to the movement of tissue during the procedure. The robot can be used for ablation, biopsy, or drug delivery. Specifically, the following questions are addressed.

• Can you please briefly explain the current problem with trying to diagnose a suspicious tumor that’s too small or hard to reach?
• How does the XACT ACE robot help with this challenge?
• What type of vision system is being used by the robot to visualize the tissue?
• How does the robot track the tissue even if it moves during the procedure?
• How many of these are being implemented? How many of these are out on the market?
• Are there other applications for this type of technology that are either in development or could see market soon?

Listen to this episode and see what you think of this robotic navigation 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 episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Christophe Bancel, CEO of TISSIUM. He provides information about the incredible material technology his company offers, enabling a replacement for human tissue. Based on the mix of three polymers, the firm can vary the characteristics such that it can be used for muscle or a section of colon or some other soft tissue application. Specifically, the following questions are addressed.

• Your company specializes in tissue reconstruction using something called biomorphic programmable polymers. Can you explain what that is?
• What are the potential applications for this type of technology?
• So is this a raw material, a medical device, or a bit of both?
• Does the material completely breakdown as healing occurs or does some of it remain to aid with strength?
• What has occurred already with regard to market launch/regulatory reviews and what are the next stages for the company?

Listen to this episode and see what you think of these programmable polymers. 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 Ken Miller, CEO of BioVentrix. He shares insights on how his technology helps to treat patients who have suffered from a heart attack and aren’t responding well to the traditional stent protocol. His solution helps bring the heart back to its normal size after the attack to prevent heart failure from the enlarged heart getting tired. Specifically, the following questions are addressed.

• Let’s start with an introduction to your company and its LIVE Therapy system. Can you tell us what that is and the treatment it offers?
• The FDA granted your technology a breakthrough device designation. What was that application process like?
• Have you seen a difference in how your submission is handled by the agency with the BDP designation compared to prior experience?
• Your system is currently involved in a clinical trial. What have been the results of that thus far?
• What is your anticipated timeline for the system to gain regulatory approval and see a market launch?

Listen to this episode and see what you think of the BioVentrix Live Therapy 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].

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 Mike Daley, CEO of OrthogenRx. He speaks on the benefits of hyaluronic acid (HA) to address osteoarthritis as an alternative to pain medications and surgical replacement. The FDA, however, has recently changed its oversight of HA and is now treating it as if it were a drug instead of a device. Specifically, the following questions are addressed.

• Your company offers a hyaluronic acid treatment for osteoarthritis. Can you provide a brief explanation of that technology?
• For 20 years, hyaluronic acid was treated as a device by the FDA. Then in 2018, the agency questioned that classification and indicated it might be a drug? What impact does that have on a company like yours?
• Did the FDA give a reason for their change in thinking?
• Has there been any new decisions on this since the agency questioned the classification in 2018?
• More and more combination products are emerging and those that interact with the body or breakdown and deliver a pharmaceutical agent. What could the FDA’s actions with regard to hyaluronic acid mean for companies of those types of products?

Listen to this episode and see what you think of the FDA’s revised stance on this 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].

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 a still relatively newer option for medical device manufacturers in gaining a priority status with their regulatory review. STeP (Safer Technologies Program) emphasizes devices that enhance safety (as opposed to efficacy as is the case with the Breakthrough Device Program). Specifically, the following questions are addressed:

• Can you please give us a brief overview of the program?
• How does this program compare and contrast to the breakthrough devices program?
• What’s been the latest updates to STeP?
• What should companies consider or be aware of if they are looking at participating in this program?
• Any additional comments or final thoughts on STeP?

You can view the STeP guidance from the FDA by clicking here.

Listen to this episode and see what you think of the STeP designation and if it is appropriate for a device you’re going to submit to the agency. 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 Peter Vranes, co-founder and co-CEO of the Australian company Nutromics. He offers insight on a platform technology that enables continuous molecular monitoring. Using continuous glucose monitoring as an example for the potential for the technology, Vranes explains how his technology is capable of tracking any target, not just glucose. Specifically, the following questions are addressed.

• Your company has developed a continuous molecular monitoring platform. What does that mean exactly?
• Most people are aware of why you need to monitor glucose especially for diabetics but why seek to measure anything other than glucose continuously?
• How is your technology different from continuous glucose monitors already on the market?
• What is your first intended market for the technology and why did you choose it?
• Does the platform lend itself to be expanded to monitor other items such as white blood cell count or perhaps a disease?
• You’re developing a smart patch to serve as a carrier for the platform. When are you looking to launch that and what will the functions of the patch be?
• Is this technology only suitable for in hospital use?

Listen to this episode and see what you think of this platform for continuous molecular monitoring. 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 Jennifer Meade, president of the breast and skeletal health division at Hologic. She offers insight on the company’s recent acquisition activity as well as its partnership involving artificial intelligence. Meade also speaks to the importance of AI within Hologic technology and its efforts to encourage greater patient compliance. Specifically, the following questions are addressed.

• You were promoted to the position of president of the breast and skeletal health division in August of last year. What are your top priorities for your segment of Hologic in 2021 and beyond?
• Hologic didn’t waste time this year with an acquisition just a few days after the ball dropped on the new year. Can you speak to the reason behind the Somatex acquisition and where you see this fitting into your larger plan?
• It was announced last year that Hologic was working with RadNet on an artificial intelligence-based initiative. Can you tell me more about that?
• How is Hologic leveraging AI in other areas and technologies?
• Does Hologic see opportunities at the technology or device level to help increase compliance with regular breast cancer screenings?

Listen to this episode and see what you think of Hologic’s approach to addressing women’s breast 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].

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 Dr. Maninder Bedi, founder and chief medical officer of Optimize EP, and Ravi Kartan, president and CEO of the same firm. They speak about the importance of their solution for physicians to save time reviewing EP monitoring reports. They also speak to the machine learning algorthms that are employed within the software to enable a more effective offering. Specifically, the following questions are addressed.

• Let’s start with a little bit of an introduction to the EP process. How is data associated with an EP captured, reviewed and analyzed currently?
• How is Optimize EP and your See-Arm software attempting to change this?
• Since this is collecting remote monitoring data, I’m guessing this isn’t a solution intended for a hospital or healthcare environment exclusively? This is used for patients with monitoring technology on their person at home?
• Is the software compatible with any technology that’s being used to capture the data or does it only work with certain partners?
• Does the software have any impact on the patient in terms of what they need to do?
• Can you speak to the algorithms that are incorporated into the software and what they enable? Do they help with diagnosis or detection of a problem?
• What is the availability status of this technology? Regulatory approvals? On the market?

Listen to this episode and see what you think of Opitmize EP’s software solution for remote patient monitoring data. 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 Linnea Burman, Vice President & General Manager, Enabling Technologies: Cranial & Spinal Technologies at Medtronic. She speaks about the company’s interest in Mazor Robotics and why they made the acquisition. Burman also speaks about the evolving robotic surgical landscape as well as what’s ahead for Medtronic within the space. Specifically, the following questions are addressed.  
  

• Let’s start with the significant news Medtronic made a couple years ago when they purchased Mazor. What’s the latest with that robotic surgical technology?
• What was it about Mazor that made it such an attractive target to Medtronic?
• While the Mazor is indicated for orthopedic surgery, there’s been talk of Medtronic’s initiatives for a soft tissue robotic surgical solution. Can you speak to that at all?
• The da Vinci aside, the soft tissue space for robotic surgery seems to be a longer development cycle compared to orthopedics. Do you have any insight why this seems to be the case?
• While current robotic surgical systems are very exciting, we’re only at the early stages of development. Without giving away all the secrets, where do you see this technology headed? 

 Listen to this episode and see what you think of Medtronic’s current and future robotic surgical solution initiatives. 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 one of the most talked about regulatory elements of the last ten months—emergency use authorizations (or EUAs). The conversation is about what they are, when they are used, and, perhaps most importantly, what happens when the emergency is deemed over. Specifically, the following questions are addressed:

• Can you provide a full explanation of the EUA and when it is used?
• What happens to products that have received an EUA to get to market during the pandemic once the emergency is deemed over?
• How does an EUA fit within a company’s regulatory strategy?
• Can a company use real-world evidence from a product’s time on the market as a result of an EUA in its regulatory submission for that product?
• For companies that have been granted an EUA, what are the most important things to keep in mind as we hopefully get closer to the end of the pandemic?

Listen to this episode and see what you think of EUAs and whether your firm needs to take action as a result of one of your products having one. 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.