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 Elad Walach, Co-Founder and CEO of Aidoc. He explains how artificial intelligence is being leveraged to assist radiologists in diagnosing conditions that weren’t originally even being sought. The Aidoc software constantly runs in the background of the imaging system to examine all patient scans without any further direction or commands. Specifically, the following questions are addressed.

• Can you please tell us what Aidoc is and what your focus is?
• How much time is saved for a radiologist in leveraging Aidoc versus the more traditional review method?
• What is the accuracy level with detection and how does it compare to the average for human error?
• Can this system function as a training or educational tool just as well as being a clinical tool?
• What’s next for Aidoc?

Listen to this episode and see what you think of Aidoc's ability to scan beyond the original condition. 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 highlight a number of areas in which the agency’s regulatory oversight could be considered lacking. If the agency incorporated the highlighted ideas from this podcast, might it smooth the pathway to market for some products? Might it enhance communication with the FDA? Could they be welcome additions? Specifically, the following questions are addressed:

• Can you please take a minute to explain why we are dedicating an episode to what’s missing from regulatory and quality systems?
• First topic on the list is communicating with the FDA. Do we need a Wellness Device registration, wellness pre-sub, or wellness device database?
• What about a catch-up 510k and letter to file pre-sub?
• How about a pre-sub for manufacturing issues or to resolve 483s and/or warning letters?
• Let’s jump to regulatory pathway. Is a pathway needed that provides a de novo like version of the PMA?
• Staying in this realm, what about the idea of having substantial equivalence in the Class III and PMA realm?
• What are today’s takeaways in what we may be missing in regulatory and quality systems?

Listen to this episode and see what you think of these regulatory ideas. 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 David Fischel, CEO of Stereotaxis. He explains how his robotic surgical system works and what makes it unique from other systems on the market. He also speaks about the additional benefits that could be realized for interventional technology as a result of his system’s ability to “pull” the catether through the patient’s vasculature. Specifically, the following questions are addressed.

• What type of technology does Stereotaxis offer and what is the target clinical area?
• How does your system improve upon the traditional methods of performing interventional procedures?
• Many of my listeners are familiar with robotic systems as it relates to automation or minimally invasive surgical systems. How does your system compare to the more traditional thought of a robotic system?
• What is the learning curve for doctors seeking to learn how to use your system who are accustomed to more traditional procedures?
• What’s ahead for Stereotaxis? What’s on the horizon?

Listen to this episode and see what you think of the unique robotic surgical system from Stereotaxis. 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. Deepak Khuntia, chief medical officer and senior VP of Medical Affairs at Varian. He offers insights on the company’s FLASH technology* and the significant differences between it and other radiation treatment systems. Dr. Khuntia also provides information about a clinical trial taking place to better understand the effect the FLASH system has on surrounding tissue. Specifically, the following questions are addressed.

• You’re currently conducting a clinical trial on your FLASH therapy. Can you explain what the technology is and what it’s used for?
• How does this treatment compare with more traditional methods for addressing this condition?
• Are there future potential applications where the FLASH technology could be used?
• Is this the first clinical trial incorporating the technology? I’m curious as to the response/feedback from physicians.
• In terms of the Flash technology, or Varian on the whole, what’s ahead? What are the next steps?

Listen to this episode and see what you think of Varian’s FLASH 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].

*Note: FLASH therapy is under development and is not available for commercial sale.

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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 Moshe Safran, CEO of RSIP Vision U.S. He shares technology advancements and his thoughts about them as related to the imaging field. Of note is his comments on 3D reconstruction as well as the impact artificial intelligence is having on the space. Specifically, the following questions are addressed.

• What is RSIP Vision and what is your area of focus?
• Medical imaging technology is rapidly advancing in several ways. Let’s start with 3D reconstruction. How is this being used today and how is it transforming medical imaging?
• Imaging advancements are also impacting joint replacement procedures. What are the real innovations here and how are they enhancing treatment?
• How about the use of AI in image capture? What’s happening here to improve processes?
• What are the key takeaways in terms of using AI in medical technology? Why is it important?
• What’s ahead for RSIP? What can we expect or where is your focus?

Listen to this episode and see what you think of emerging imaging 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 discuss a recent offering put out by the FDA in conjunction with the Medical Device Innovation Consortium and MITRE. It is a playbook for device makers to involve threat modeling of medical devices in its approach to cybersecurity. Best practices for addressing cybersecurity of medical devices is also covered. Specifically, the following questions are addressed:

• Can you start things off by explaining what Threat Modeling is?
• Regarding this playbook the FDA released, is this purely a type of best practices item or is this something that may have regulatory implications tied to it somewhere down the road?
• Why is the FDA putting such attention on cybersecurity in medical devices? Is this about patient safety?
• Are there currently regulatory requirements with regard to cybersecurity?
• What do you foresee happening with FDA and cybersecurity? Will there continue to be guidance and/or will it become a bigger part of a regulatory review?
• What are your suggestions or takeaways for device manufacturers when it comes to cybersecurity and the FDA?

You can download the playbook for Threat Modeling Medical Devices discussed in this podcast by clicking  HERE.

Listen to this episode and see what you think of the FDA’s interest in cybersecurity. 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. Tamir Wolf, CEO and Co-Founder of Theator. He discusses his company and why capturing a video record of a surgery is beneficial to physicians. He speaks to the educational advantages that can be realized and also talks about the legal implications of using his technology in a malpractice suit. Specifically, the following questions are addressed.

• Can you please provide a brief overview of Theator?
• Is this technology used for surgical training, surgical planning, or both?
• Does this technology function in real time or is it only outside of the OR?
• What if a surgeon was sued for a mistake during a surgical procedure. Could this technology be used as evidence?
• What’s next for Theator? Where is the company headed?

Listen to this episode and see what you think of capturing surgeries on video with Theator. 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 Amit Phadnis, chief digital officer at GE Healthcare. He makes several predictions for the new year about how technology will impact the delivery of healthcare. Topics of discussion include the reduction of burnout among healthcare workers, continued integration and understanding of AI, reduction of healthcare inequalities, acceleration of telehealth, and other related areas. Specifically, the following questions are addressed.

• You have a number of predictions for 2022 that I’d like to explore. Let’s start with a continued emergence of innovations to reduce burnout. Why are these important and do you have examples of some more recent ones?
• Talk to me about physicians become more particular about AI. Are they overwhelmed or beginning to recognize what’s valuable and what’s not?
• Another prediction you have is that technology will help the workforce reduce healthcare inequalities. What does that mean?
• The pandemic resulted in an incredible acceleration of telehealth. How will we grow from that and find the real value play for it?
• You say that precision health will revolutionize healthcare delivery. What does that mean specifically?
• In what other ways do you see AI and other advanced medical technologies making an impact in 2022?

Listen to this episode and see what you think of Phadnis’ predictions of healthcare and technology in 2022. 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 Andrew Ekdahl, worldwide president of joint reconstruction at DePuy Synthes. He offers insight on the company’s approach to knee replacement, blending a number of technologies to achieve a restoration. Ekdahl also speaks to the impact newer innovations, such as robotic-assisted surgical technologies and data driven solutions, have on knee implants. Specifically, the following questions are addressed.

• I understand DePuy is taking a different approach to total knee replacement. Instead, it’s being looked at as knee restoration. Can you explain what that is and why the differentiation in language?
• How is data driven technologies being used to help with this mission?
• What’s happening in terms of implant development? Are the implants changing to meet with this effort?
• To further enhance this mission to restore the knee, how is personalized medicine (a term we hear often) playing a role here?
• How does this effort meet with the needs (and wants) of surgeons? Is this speeding up surgical procedures?
• What about the instrumentation? Any changes and/or advancements in that space?
• What is this leading to? Where is DePuy headed in terms of the knee, joints, or the larger orthopedic space?

Listen to this episode and see what you think of DePuy's knee restoration strategy. 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 Kathy Lee-Sepsick, founder and CEO of Femasys. She provides an overview of how the company’s technology is helping women who are dealing with infertility. She also speaks about a device that enables a non-surgical means of permanent birth control. Specifically, the following questions are addressed.

• Can you please start off by giving us a little insight on what Femasys is?
• So your technologies are at both end of the spectrum, addressing infertility and also helping to prevent pregnancy. Can you talk a bit about the FemaSeed and how it different from other available infertility technologies?
• What is FemBlock and how does it work?
• What is FemVue and how did it change the current standard for this type of medicine?
• What’s next for Femasys? Where is the firm headed?

Listen to this episode and see what you think of the women’s health technologies from Femasys. 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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