Medtech Matters

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 medical devices run counter to allowing for a broad selection of materials for a given device and ultimately limit options for innovation?

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 [email protected] and we’ll try to respond in an upcoming Mike on Medtech podcast.
 

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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 International Consortium of Investigative Journalists and The Bleeding Edge documentary or was this already in the works?
• Is the current version of the 510(k) pathway worth saving or is it long since outdated from when it was first launched?
• In my Editor’s Letter, I reference an article that’s also running in the same issue, which focuses on value-based healthcare. In that article, the author, Vicki Anastasi of ICON, explains that a PMA pathway for device approval could be a better option for a company from a financial or reimbursement standpoint. Do you agree?

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 [email protected] and we’ll try to respond in an upcoming Mike on Medtech podcast.
 

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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 practice of medicine. This relates to the use of additive manufacturing technologies within the healthcare space, such as fabricating an implant right in the OR. Click here to listen to that podcast.

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 [email protected] and we’ll try to respond in an upcoming Mike on Medtech podcast.

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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 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 [email protected] and we’ll try to respond in an upcoming Mike on Medtech podcast.
 

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For more medtech news and information, visit https://www.mpomag.com. 

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 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 [email protected] and we’ll try to respond in an upcoming Mike on Medtech podcast.

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For more medtech news and information, visit https://www.mpomag.com. 

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 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 [email protected] and we’ll try to respond in an upcoming Mike on Medtech podcast.

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For more medtech news and information, visit https://www.mpomag.com. 

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 approved.
• The money paid to doctors by the medtech industry.

Before 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 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 [email protected] and we’ll try to respond in an upcoming Mike on Medtech podcast.

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For more medtech news and information, visit https://www.mpomag.com. 

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 devices
• Footage of the Essure review meeting and comments made during the meeting
• The MAUDE event reporting system

Before 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 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 [email protected] and we’ll try to respond in an upcoming Mike on Medtech podcast.

Send us Fan Mail

For more medtech news and information, visit https://www.mpomag.com. 

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 documentary
• The 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 the documentary via Netflix.
 
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 [email protected] and we’ll try to respond in an upcoming Mike on Medtech podcast.

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For more medtech news and information, visit https://www.mpomag.com. 

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 information about the Breakthrough Designation Program can be found at the FDA’s website in its draft guidance, which can be viewed here: Breakthrough Devices Program Draft Guidance [PDF file].

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 [email protected] and we’ll try to respond in an upcoming Mike on Medtech podcast.

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For more medtech news and information, visit https://www.mpomag.com.