Medtech Matters

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, Mike Drues provides his “lessons learned” for each.

 Mike Drues’ 15 Tips for Getting a New Product Through the FDA
1. This is a poker game in every sense—(00:56)
2. Consider regulatory from the beginning—(01:57)
3. Employ a competitive regulatory strategy—(03:22)
4. Use label expansions to your advantage—(05:00)
5. No submission should ever be rejected—(07:05)
6. Communicate early and often with FDA—(08:52)
7. Don't treat FDA as your enemy—(11:10)
8. Don’t be the regulatory police—(13:40)
9. Think globally—(16:40)
10. Don’t reinvent the wheel—(17:33)
11. Don't just copy others—(18:33)
12. Know all your options—(19:32)
13. Don’t be myopic about risk—(19:44)
14. New is not necessarily your friend—(20:30)
15. Design your label like you design your device—(21:50)

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 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 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 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 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 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 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 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 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 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 Least Burdensome Provisions [PDF]
•  What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More

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 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 a new material? Which would you choose?
• Would there be advantages to having a biomaterials approval pathway?
• Would there be disadvantages to having a biomaterials approval pathway?
• What is the likelihood of this happening?

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 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 at the following URL: Requests for Feedback on Medical Device Submissions: The Pre-Submission Program (CDRH, Sept. 2017)

 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 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 documents relevant to the use of human factors with medical device development. You can find those here:

• List of Highest Priority Devices for Human Factors Review [PDF]
• Applying Human Factors and Usability Engineering to Medical Devices [PDF]

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 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 submission process? What should they do?

 
Get more information regarding the MDUFA IV legislation via the following links:

• Overview: Medical Device User Fee Amendments (MDUFA)
•  Specific Fee Schedule: FY 2018 MDUFA User Fees

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.