Medtech Matters

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 o

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 t

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, o

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 expe

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

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 parti

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 inequal

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) playin

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 sh

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Asha Parekh, a biomedical engineer and CEO of Front Line Medical. She explains how the COBRA-OS can stop internal bleeding to prevent patients from dying due to loss of blood. She also explains how the technology differs from current treatment methods. Specifically, the following questions are addressed.Can you please start by telling us a little about Front Line Medical Technologies and your COBRA-OS technology?How does the COBRA-OS technology differ from other available solutions?When is the COBRA-OS used? Is this used in a hospital or in an emergency situation at the scene (of say an accident)?Can you share some of the stats associated with this technology? In other words, how does it measure up to other technologies in survival rate, success rate, etc.?What’s next for Front Line Medical Technologies?Listen to this episode and see what you think of Front Line’s

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Bryan Lord, CEO and co-Founder of Pristine Surgical. He provides a number of reasons why disposable endoscopes should be indicated for medical procedures. Lord also highlights some of the challenges with reusable scopes and how single-use solutions help to eliminate them. Specifically, the following questions are addressed.Let’s start with a quick overview of what Pristine Surgical is about. Can you tell us about the company and technology?Why have there been such problems with the cleaning and sterilization of endoscopes?I understand safety in terms of instrument cleaning shortcomings, but has COVID had an impact as well?Do you encounter questions regarding durability and/or functionality of single-use scopes? If so, how do you address them?When compared to reusable scopes, are there any tasks that can’t be performed with a single-use scope?Are the images and videos a

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Carlton Weatherby, vice president and general manager of Spine and Biologics at Medtronic. He provides insight on why the organization acquired Mazor and Titan Spine, the strategy for the division to address more of the care continuum, and how trends are being addressed such as AI, data, and MIS. Specifically, the following questions are addressed.Medtronic has made two interesting acquisitions in the Spine space. Can you tell us what made Mazor and Titan Spine attractive targets?Medtronic has demonstrated an interest in providing a solution for the entire care chain in other therapy areas, such as in diabetes. Is Spine headed in a similar direction?As you know, minimally invasive in spine is the trend. How is Medtronic addressing this?Another significant trend in medtech is the incorporation of data and artificial intelligence. What is Medtronic doing in these areas w

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at ways in which medical device manufacturers can benefit from a commercial strategy standpoint through the leveraging of its regulatory strategy. Knowing how to make the regulatory process more challenging to help prevent “me too” products to reach the market can be a commercial advantage for medtech firms. Specifically, the following questions are addressed:First, why don’t we begin with you describing exactly what you mean when you say a company’s regulatory strategy? And is that strategy company-wide or does a regulatory strategy change with each product?Who should be involved with the creation of a regulatory strategy if anyone beyond the regulatory representative?So how does the regulatory strategy and commercial strategy intertwine?What benefits can be realized from this approach?Would you please provide some real world example to further help illustrate the relationship between the two w

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Jackie Butler, director of BIO El Paso – Juarez, and Philip Morton, product development lab manager at MCA. They offer insights on how strong the region has been in supporting medical device manufacturers and how their organizations is only building upon that foundation. They explain the benefits of the organizations and the services they provide—free of charge—to U.S.-based companies. Specifically, the following questions are addressed.What is Bio El Paso?Can you tell me what MCA is?What is the connection between BIO El Paso and MCA?What’s the impact you are making on the medical device industry?The Devise Product Realization Hub offers a variety of services free of charge to companies. Can you discuss these?Do you have any success stories you could share?What are the next steps for this program and your organizations as they remain relevant to the medical device indu

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Tom O’Brien, worldwide president of Endomechanical at Ethicon. He shares insights on the company’s approach to the development of surgical instrumentation and reducing surgical complications. O’Brien also offers data from a recent study on the new Echelon Circular Powered Stapler and the improvements it offers for clinicians. Specifically, the following questions are addressed.Can you start by explaining what is encompassed within the Endomechanical unit at Ethicon?When it comes to the design and development of a surgical device, what are the key priorities for Ethicon and why?When companies talk about reducing surgical complications, what do they really mean and how is Ethicon trying to do this?Speaking of complications, Ethicon recently had data on a new stapler, the Echelon Circular Powered Stapler. Can you speak to the study about this device and what benefits it p

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the final rule recently announced for the FDA’s de novo regulatory pathway. As part of the discussion, the de novo is explained, when it should be used, why it exists, and what points of interest were included in the final rule. Specifically, the following questions are addressed:Can you please briefly explain what the de novo regulatory pathway is?How does this option differ from the 510(k) and PMA?When is the de novo used?Were there any surprises or changes made in the final rule as issued?Apparently there was some dissatisfaction with the agency not removing inspection requirements in the final rule. Can you explain why this was an issue?What should device makers keep in mind if they are exploring the de novo regulatory pathway for a product?Listen to this episode and see what you think of the de novo regulatory pathway. If you’d like to share thoughts, ask questions, or have a suggestion

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the options available to a medical device firm who thinks the FDA is requiring them to take unfair measures or is being overly burdensome. We discuss the formal and informal options as well as the potential consequences. Specifically, the following questions are addressed:If after a 510k submission or pre-sub meeting, is there something you can do if you feel the FDA is being overly burdensome? Can you do something if you think the agency is asking more of you than of your competitors?What informal actions can you take?If you’ve had no success with the informal options, are there formal actions you can take?What about least burdensome? Can you cite that with any success?Are there consequences to embarking on any of these actions? Might a company face pushback for questioning the agency?What are the most important items medical device manufacturers need to keep in mind if they choose to questi

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Fazila Seker, president and CEO of MOLLI Surgical. She explains the benefits of the MOLLI Surgical system as compared to the way breast tumors are traditionally located and marked for surgical removal. Further, the magnetic innovation behind the system is discussed. Specifically, the following questions are addressed.What is MOLLI Surgical? What is your primary clinical focus areas?How does your technology differ from the typical treatment device used for breast surgery?Is this the first time a magnetic solution has been used for this type of application in breast surgery?What has been the response from surgeons and medical professionals who have used your system?What are the next steps for MOLLI Surgical? What can we expect down the road?Listen to this episode and see what you think of the MOLLI Surgical system. If you’d like to share thoughts, ask questions, or s

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the three systems of risk as they relate to the U.S. regulatory system. While many are familiar with the device classification system, they may not be as familiar with the other two systems or their purpose. Whether or not all three systems are actually needed is also explored. Specifically, the following questions are addressed:First, can you explain how we handle risk in medtech manufacturing in the U.S.?What is the medical device classification system and why do we have it?What is the Significant Risks vs. Non-Significant Risk system?What about software? What is the Software classification system?How are the three systems of risk related?Do we need three separate systems to handle risk?What are the most important items medical device manufacturers need to keep in mind with regard to risk?Listen to this episode and see what you think of the three systems of risk. If you’d like to share thou

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