Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s Special 510(k) program, which offers a pathway for medical device manufacturers making modifications to its own legally marketed device. It is a method for device makers to avoid the need to completely resubmit their device as a new device to the agency. Specifically, we address a number of questions, including:What is the Special 510(k) program and how does it differ from the standard 510(k) program?When is it appropriate for a device manufacturer to use this program?In January 2018, we discussed  the then new alternative 510(k) (click here to listen to that podcast). How is this different from that?Is this yet another specialized version of the 510(k) to better address the industry needs? Are we creating too many “special case” 510(k) variations or is this ultimately a good thing?What are the most important takeaways of this guidance listeners should keep in mind?If you’d like to

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 topic to cover as part of this “Beyond 510(k)/PMA” series. Specifically, we address a number of questions, including:What is the safer technologies program?How does this program differ from the Breakthrough Designation Program?So like BDP, STeP is not a regulatory pathway on its own, correct?What are the criteria for eligibility into STeP?What are the mechanics of STeP?Is STeP an already active program?Are the BDP and now STeP part of an effort by the FDA to encourage true innovative technologies and perhaps disrupt the history of incremental innovation within the industry?I know the FDA is hosting a pair of webinars to he

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 Exemptions (August, 2019) (Click here to read the guidance.)Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (August, 2019) (Click here to read the guidance.)Specifically, we address a number of questions, including:Can you please provide a brief overview of what's in these guidances and what their purpose is? Why is PMA, HDE and de novo included but 510k is NOT included in this guidance?When is higher risk acceptable and what is the tie-in to the term uncertainty?What else is important in these guidances and what are the most important takeaw

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 part of this “Beyond 510(k)/PMA” series. Specifically, we address a number of questions, including:What is the purpose of the Breakthrough Devices Program and why does it exist?Is the BDP a “pathway” to market like the 510k or PMA?How early in the product development lifecycle should we consider a BDP?What are the requirements of the Breakthrough Devices Program?What are the mechanics of the process?What goes into the BDP Pre-Sub Package?What is the benefit of BDP status?What if you don’t like FDA’s decision, can I appeal?Is there a database of BDP devices?Should we issue a press release announcing our BDP designation?Wh

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 shed light on when this option could be most beneficial or be the best option for a regulatory submission, we attempt to provide an overview of it—a De Novo 101, if you will. Specifically, we address a number of questions, including:What is the De Novo regulatory pathway?How does the De Novo differ from the PMA and 510(k) regulatory pathways?For what situation or type of device is the best case to use the De Novo pathway?When shouldn’t the De Novo be used?Do you have any suggestions or best practices for using a pre-sub meeting when planning to use the De Novo pathway?Listen to this episode and see what you think of

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 statement). Of course, those fixes are rather general in how they are presented, but we dig into each of the three and share our own thoughts on the proposed solutions. Specifically, we address a number of questions, including:Should products that are intended to reside in the body for an extended period of time require a PMA pathway? How would that compare to the current protocol?Would an "implantable 510(k)" be a middle ground to address the issue—does not require a full PMA, but updates to implantable products can’t go through the standard 510(k) pathway either?Might making sub-pathways or application speci

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 reporting program?Was the reporting of the “discovery” of this program fair or was it media hype?Why did the FDA recently cancel the program?What will medical device manufacturers be required to do now?What is the ultimate result of this ban/change?What are the takeaways and/or lessons to be learned?Listen to this episode and see what you think regarding the FDA’s decision to cancel the alternative summary reporting program. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upc

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 agency, types of 483s involved, definition of non-binding, what happens if a manufacturer ignores the FDA recommendation, and the most important takeaways from the guidance. Listen to this episode and see what you think regarding the FDA’s new guidance for this type of communication with the agency. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode. Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferr

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 it’s actually something we need. Specifically, we address a number of questions, including:What’s lead to this new guidance? Do we really need it?Why is FDA doing more inspections?What is the goal of this guidance/program?What is the difference between Form 483 and Warning Letter?What is the process described in this guidance?What does FDA respond with?Listen to this episode and see what you think regarding the FDA’s new guidance for this type of communication with the agency. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com

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 a number of questions, including:  What were the main contents of this announcement with regard to the evaluation of materials by the FDA? Are there certain materials they are expected to target early in this review process? What are technology-specific guidances and how do they relate to this effort? Will the FDA ban specific materials if they do not meet a certain criteria or have too high an incidence of reactions among patients? Will this effort ultimately lead to a regulatory pathway to approve materials for medical device manufacture? Does having a review process for materials that would be approved for use in

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 FDA announced their efforts to modernize the 510(k) clearance pathway. Predicate devices seems to be a focal point. Is there a reason for the agency to seek to cut off the predicate device at 10 years or is that really just an arbitrary number they selected?If we were to cut off predicate devices at a certain time from being used, are we doing a disservice to all stakeholders involved? Do older predicate devices still offer advantages to the regulatory approval process?Is this a reactionary move to the bad press the FDA (and industry as a whole) suffered last year, such as the release of the findings from the Internation

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 the FDA handled their approval process?What are the challenges to pursuing personalized medicine given the current regulatory environment as it relates to finished devices?What are the most significant changes that would need to occur within the regulatory environment to enable the review and approval of personalized medicine technologies?What is the impact on the manufacturing side with regard to regulating protocols involved with the development of personalized medicine technologies (for example, additive manufacturing and 3D printing)?There was also reference made to a previous podcast on the topic of regulating the p

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 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 the industry, pain management technologies market success, reform or improvment in reimbursement and CMS, and a couple other items. In part 2 of this two-part podcast series, we continue the "wish list" discussion with a focus on pain management technologies and their opportunity to grow in popularity given the anti-opioid environment. We also discuss the reimbursement process and the opportunity for improvement there.Listen to the podcast streaming via the player or get

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 the industry, pain management technologies market success, reform or improvment in reimbursement and CMS, and a couple other items. In part 1 of this two-part podcast series, we address the first item, an improved image, and discuss the recent "black eyes" suffered by the medtech industry, such as The Bleeding Edge documentary and an investative report that cited dangerous medical devices. We also discuss announced changes the FDA intends to introduce such as the 510k Modernization effort.Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendo

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 of medicine to some degree. This is primarily based upon a comment from a reader who offered feedback based on my Editor’s Letter in MPO’s sister publication, ODT. That comment is shared and Mike and Sean discuss it, along with several other points brought up in the October MPO Letter.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 listener

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 points brought up in the documentary and analyze whether each is a fair criticism or not. Discussion topics in this third and final part include:  The dismissal of nine reviewers from the FDA who brought up concerns regarding certain processes and products.The lobbying power of the medtech and pharma sectors.The call for less innovation by several people in the documentary.A J&J executive admitting on film during a deposition that they were aware of issues with their mesh product.The observation that doctors seemed to require more evidence to abandon a product they were using then it took to initially have it approv

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 highlight a good number of points brought up in the documentary and analyze whether each is a fair criticism or not. Discussion topics in this part include:Alleged recommendation by FDA for the da Vinci Surgical System to be submitted as a 510(k) rather than as a PMA as originally submitted by Intuitive Surgical.Clinical trials for drugs compared to those for medical devicesFootage of the Essure review meeting and comments made during the meetingThe MAUDE event reporting systemBefore listening to the podcast, it would be best to view the documentary via Netflix. Listen to the podcast streaming via the player or get the p

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 highlight a good number of points brought up in the documentary and analyze whether each is a fair criticism or not. Discussion topics in this first part include:  Overall impressions of the documentaryThe statement that a recalled device can be used as a predicate device for 510(k) clearance.The impact and concerns involved with a “daisy chain” of device reviews or “predicate creep” within the regulatory 510(k) review process.Should implantable devices be required to have a removal protocol included in its regulatory submission in order to gain approval/clearance?Before listening to the podcast, it would be best to view th

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 variety of factors that would impact a company’s decision as to whether the program is right for their product. Specifically, the following questions are addressed:What is the breakthrough designation program?How does a manufacturer apply for breakthrough designation?Why are nearly half of breakthrough designation applications rejected and what should be done to avoid that?What are the options for a company if its breakthrough designation application is rejected?Are there non-regulatory advantages of obtaining breakthrough designation, such as public relations, fund-raising, etc.?As mentioned during the podcast, further inf

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 were relevant then that still resonate today within the magazine and industry. Given that theme, in this podcast, we discuss lessons learned from the last 15 years of getting products through the FDA and into the market. The 15 “best practices” (or at least factors to keep in mind during the development of a new product) are provided to help ensure a smoother ride through the regulatory approval or clearance process. Following is a quick list of these 15 tips along with the timestamps in case you are interested in hearing only a few (but hopefully, you stick around to gain insights on all 15). Expanding on each of these,