Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the May issue of MPO, The Power of My Voice (click to read that Letter). In it, I provide my own opinions on the technology, how it’s being used in medical devices, and how it could potentially be used for healthcare in the future. I also offer an example of a partnership between the Mayo Clinic and an Israeli company, Beyond Verbal, where voice-enabled technology is being tested as a diagnostic tool for coronary artery disease. I don’t, however, get into the regulatory concerns and potential pitfalls of voice-enabled technology so we discussed it on this episode of Mike on Medtech. Sharing his own thoughts on this topic, Mike Drues delves into the FDA’s oversight of voice-enabled medical devices and how they are treated. Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of po

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the April issue of MPO. Click here to read that Letter. In it, I reach out to a number of industry experts on regulatory strategies and compliance to ask about a number of changes happening worldwide. One of the primary topics is the European MDR and how its transformation will affect companies’ strategies for the launch of their product. Specifically, the potential of the U.S. to become a “first to market” target going forward versus what has been an EU/CE mark first strategy for quite some time. Having his own comments on this topic, I posed similar questions to Mike during this episode to get his insights and what shifts he saw as potential outcomes of the MDR changes. During the discussion, there is mention of a previous podcast topic—the Alternative 510(k). Click here to listen to that podcast. Listen to the podcast streaming via the player

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the March issue of MPO. Click here to read that Letter. In it, I bring up a potential future view of healthcare and more specifically, how technology is delivered. I ponder if hospitals or doctor’s offices will employ the use of 3D printing to develop devices, implants, and instruments. One aspect of this topic, however, I was unable to address within the Letter was the regulatory and liability issues that go along with such a plan. As such, that’s the topic of discussion for this episode of Mike on Medtech. Listen to this episode and then see if you think this practice will become accepted in the near or far-off future, or will it never materialize at all. 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. Once you’ve h

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss two terms that are sometimes used interchangeably, but are, in fact, unique in purpose and definition—quality and regulatory. Should they be best treated as separate entities or addressed as a unit? Listen to this episode and then see what you think. Specifically, the following questions and topics are addressed in this discussion:What’s the difference between quality and regulatory?Should we separate quality and regulatory?Would we have fewer problems if we did not separate them?What are the challenges for the future?Real world and medical device industry examples provided.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. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Me

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recently announced alternative 510(k) pathway that attempts to trim the time to clearance for medical device manufacturers. Is it, however, an option that already exists packaged in a new wrapper or is it a truly new option put forth by Gottlieb's FDA? Listen to this episode and then see what you think. Specifically, the following questions and topics are addressed in this discussion: What is the “new” alternative 510(k)?What are the types of 510ks and how do they differ?What does “least burdensome” mean?Does abbreviated 510k mean less time or less work for the company?How does this compare to what’s available in the EU?Which is a better system between the new MDR and this 510k?What are the lessons to be learned/advice moving forward?For Further Reference Check out the following links for more information about this topic.New Steps to Facilitate Beneficial Medical Device Innovation The

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss what the implementation of a regulatory approval pathway for biomaterials would mean for medical device manufacturers, patients, and the healthcare industry. While such a pathway doesn’t currently exist, the potential advantages are explored. Further, the competitive advantage such a pathway could offer to materials manufacturers and suppliers is presented. Specifically, the following questions and topics are addressed in this discussion: Currently, can biomaterials be approved by FDA?Drugs are approved, and a drug is sort of a “biomaterial” so shouldn’t biomaterials be approved?If we haven't had a biomaterial approval pathway thus far, why do we need one now?How many companies developing new medical devices vs. how many companies developing new biomaterials?What are device manufacturers more likely to do: develop a new device using an existing material vs. developing a new device using

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use of an FDA pre-sub (or pre-submission) prior to making a formal submission of a 510(k) or PMA to the agency. While a number of companies are taking advantage of this, as of right now, still free opportunity, many others are not. When submissions are being rejected at such high percentages (Mike offers the numbers in this podcast), it only makes sense for more companies to utilize this opportunity. Specifically, the following questions are addressed in this discussion:  What is a “pre-sub” and why should engineers need to care about it?How early in the product development lifecycle should companies involve FDA?What is a pre-sub lite?What part in a pre-sub do engineers play, say with regard to testing matrix?In September, we received guidance revisions with regard to the pre-sub. What was of significance in these revisions? You can review the pre-sub guidance discussed during the podcast

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use of human factors (or ergonomics or useability) in medical device design, the FDA’s increased interest in its use, and how different users impact the device development (such as patient/home use versus physican/hospital use). Specifically, the following questions are addressed in this discussion: What exactly are human factors with regard to the development of medical devices?Last year, the FDA put out human factors guidance for medical device manufacturers. Have human factors always been a part of the FDA’s processes in some way or is it a relatively new element?How do manufacturers or how should manufacturers conduct human factors testing?As more devices are being sent home and used outside a healthcare environment, can you share the considerations for human factors development with devices used directly by patients? Also, during this discussion, reference is made to two FDA guidance

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the passage of MDUFA IV and the changes that are associated with it. Further, we discuss the potential impact this law will have on medical device innovation. In an era of politicians calling for greater healthcare technology and a reduction of healthcare costs, stagnating innovation in medtech seems to be counterintuitive to this demand; unfortunately, that’s exactly what MDUFA IV could do. This law could adversely impact the design and development of medical devices based on companies seeking to avoid the increased fees. Examples of companies changing their product submission strategy are also shared. Specifically, the following questions are addressed:This is the fourth version of MDUFA, which has been around for quite some time now. Why is this latest version significant?What are the significant changes in this version of MDUFA ?What about those companies who are currently in the submissi

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss many of the concerns and issues involved with the off-label use of a medical device. Further, we talk about the advertising and promotion of such use, what’s permitted, and what will get a company in trouble. Specifically, the following questions are addressed:What is off-label use as it relates to a medical device?What are the limitations of off-label use? Where is the real line between what’s allowed and what’s not?How are off-label use and real-world evidence connected?Can a device manufacturer advertise off-label use without going to jail? How might FDA’s view of advertising off-label use change in the future?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. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us t

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the differences between materials and biomaterials, biocompatibility, biofriendly, biostable, and bioabsorbable. Specifically, the following questions are addressed: What’s the difference between a material and a biomaterial?What’s the difference between a biocompatible material versus a biofriendly material?How is a biostable material different from a bioabsorable/biodegradable materials?Do bioabsorables pose additional challenges?Do the regulatory rules for biomaterials differ from the ones that are currently followed for more traditional materials?What’s your response to companies who would rather not attempt to introduce a new material (or biomaterial) to the regulatory approval process?Check out the guidance mentioned in this podcast—ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Listen to the podcast

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the impact 3D printing has made on the current medical device industry, the challenges that are restricting greater use, and a couple of examples of bleeding edge applications that will likely play a substantial role in medtech and healthcare very soon. Always an interesting topic, this podcast likely represents only the first of a series of discussions that center around 3D printing in healthcare. Check out the video mentioned in this podcast where we discuss the FDA’s additive manufacturing guidance. 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. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, o

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the significance of reimbursement as it relates to product development. Not all medical device designers and engineers make the necessary connections between these two seemingly unrelated topics. In reality, however, the two need to be considered carefully alongside regulatory issues to ensure a delicate balance among all three is discovered. At that point, product development should begin in earnest. 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. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’l

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recent Editor's Letter that appeared in the March 2017 issue of MPO. In it, I wrote about a blog Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, authored regarding findings of recent hospital inspections as related to medical device reporting. Suffice to say, changes are needed with regard to the reporting of incidents by those involved in healthcare. How might we resolve the issue? Listen to this episode to hear what suggestions are made. 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. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion fo

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use of real world evidence in the medical device approval process, which has gained much attention lately due to several reasons. It was specifically mentioned in the 21st Century Cures Act and it was also the topic of a recently released FDA Guidance document (PDF). Further, we seek to gain some additional insights on what real world evidence actually is, why it matters to medical device manufacturers, and how they might be able to make efficient use of it. 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. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic f