Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the brand new (in fact, yet-to-be-launched) Safer Technologies Program (click to review the guidance) . Since it was only recently introduced, there are still a number of questions device manufacturers have about the program. With this in mind, we thought it would be a great topi...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss two recently issued FDA guidance documents. As they can be coupled together, we discussed both in one podcast. They are: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exem...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the still relatively new Breakthrough Devices Program (click to review the guidance) . Since it was only introduced last year, there are still a number of questions device manufacturers have about the program. With this in mind, we thought it would be a great topic to cover as pa...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the third most commonly used (although still substantially less than the 510(k) and PMA) regulatory pathway available to medical device manufacturers. Since it is not nearly as common as the two primarily used pathways, the De Novo is not nearly as understood as them. In order to...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the subject of my latest Editor’s Letter, which appeared in the June issue of MPO ( click here to read that Letter ). It features yet another PR hit on the industry along with recommendations on what can be done to fix the problem ( click here to read the NY Times Editorial Board...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the recently announced cancellation of the FDA’s alternative summary reporting program, the reasons it existed, why it was cancelled, and what manufacturers will need to do going forward. Specifically, we address a number of questions, including: What is the alternative summary r...

In the second part of this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we continue our discussion of a recently released guidance from the FDA, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments,” or more simply, a sort of pre-sub for 483s. The discussion revolves around the timeline for the communication with the ag...

In the first part of this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the recently released guidance from the FDA, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments,” or more simply, a sort of pre-sub for 483s. The discussion revolves around what this guidance is, what’s new about it, and whether or not i...

In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the FDA’s letter from March 15, which provided a statement from FDA Commissioner Scott Gottlieb, M.D., and Jeffrey Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions. Specifically, we address...

In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the FDA’s announcement of their effort to modernize the 510(k) regulatory pathway. This podcast is an extension of the MPO January/February Editor’s Letter on the same topic. ( Click here to read that Editor's Letter. ) Specifically, we address a number of questions, including: Late last year, the...

In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the impact of personalized medicine on the medical device sector. Specifically, we address a number of questions, including: As far as we’re concerned with regard to the medical device industry, what is personalized medicine? For the few devices that have been “personalized” for an individual, how has t...

This is part 2 of a two-part podcast series. If you haven't listened to the first portion yet, click here to first listen to that part. In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss my lastest Editor’s Letter that appeared in the November/December issue of MPO , My Holiday Wish List (for Industry) (click here to read that Letter). In this Lett...

In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss my lastest Editor’s Letter that appeared in the November/December issue of MPO , My Holiday Wish List (for Industry) (click here to read that Letter). In this Letter, I outlined a few things that I would like to see for the benefit of the medical device industry. The items included an improved image for...

In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss my lastest Editor’s Letter that appeared in the October issue of MPO , Regulating the Practice of Medicine (click to read that Letter). In it, I pose several scenarios regarding the industry’s direction and whether the FDA’s mission needs to be altered such that it would ultimately regulate the practice...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we conclude our conversation on the Netflix documentary, The Bleeding Edge. The documentary presents harsh criticism of the industry in terms of how devices are approved and what is done when problems arise. Throughout all three parts of this podcast series, we highlight a good number of po...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we continue a discussion that will span several parts. The conversation is centered around the recently released Netflix documentary, The Bleeding Edge. The documentary presents harsh criticism of the industry in terms of how devices are approved and what is done when problems arise. We hig...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we begin a discussion that will span several parts. The conversation is centered around the recently released Netflix documentary, The Bleeding Edge. The documentary presents harsh criticism of the industry in terms of how devices are approved and what is done when problems arise. We highli...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss a relatively new FDA regulatory review option—the Breakthrough Designation Program. Do you have questions about this program, how it impacts the device review process, what types of products are accepted, or other inquires? If so, this podcast is perfect as Mike explains a variet...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we continue the 15 year anniversary theme that ran throughout the June 2018 issue of MPO and within my lastest Editor’s Letter that appeared in that issue, The More Things Change... (click to read that Letter) . In it, I take a look back at the very beginnings of MPO and see what topics wer...

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 al...

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 Eu...

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 prin...

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 q...

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 episo...

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 su...