Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s pre-sub program and best practices for companies to consider prior to their scheduled appointment with the agency. Specifically, we address a number of questions, including:

• Can you please give a brief overview of what the FDA’s pre-sub program is?
• Is the pre-sub only for certain types of devices or when using certain regulatory pathways or is it available to all device makers?
• Are there questions you shouldn’t ask during the pre-sub?
• What’s the most common mistakes you’ve heard companies made during their pre-sub?
• Will the FDA help a company determine what regulatory pathway to take during a pre-sub?
• Will the FDA give recommendations on things such as testing protocols a certain type of device should go through during a pre-sub?
• Is there any information you shouldn’t share with the FDA during a pre-sub? In other words, can being too transparent hurt you?
• What’s the most important thing for a company to keep in mind with regard to a pre-sub?

There is also mention of the first podcast from 2017 where the pre-sub program was introduced and discussed. Click here to listen to that presentation.

Listen to this episode and see what you think of the eSTAR pilot program. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Scott Whitaker, CEO and president of AdvaMed, the world’s largest medical technology association. He’s participating in the podcast to provide insight into the COVID-19 pandemic and the challenges the medical device industry has been facing as a result. Specifically, we ask him about the following questions.  
  

• We are hearing about the medical device industry mobilizing to support the healthcare professionals treating those with COVID-19. Overall, is the medical device industry keeping up and where are the greatest challenges being encountered?
• What are medtech firms telling you the real pain points are they are facing?
• Can you share your thoughts on the companies who are partnering with medical device manufacturers who aren’t accustomed to manufacturing under the FDA (e.g., Ford and Tesla)? What are the major concerns here?
• How has the response been from the medical device manufacturing supply chain? Have they mobilized in step with the OEMs to enable the manufacture of these critical products?
• Looking ahead, do you think the medical device supply chain will shift geographies and some of it will emerge more prominently within the U.S.? 

 Listen to this episode and see what you think of the concerns brought up regarding the effort against COVID-19. If you’d like to share thoughts, ask questions, or would like to suggest a future participant for Medtech Matters, please reach out to me at [email protected].
 
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.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss recent coverage of a two-minute COVID-19 test that had miscommunicated obtaining emergency use authorization from the FDA. We look at actions the FDA is taking around these types of incidents and also about the potential issues with a relaxing of regulatory rules around certain products during this pandemic. Specifically, we address a number of questions, including:

• We saw a 2-minute COVID-19 test being reported on that incorrectly claimed to have Emergency Use Authorization. The company claimed a misunderstanding. What should companies be doing to ensure they don’t make this mistake as well?
• Is there a concern of future misunderstandings from companies seeking to help, but not accustomed to working with the FDA?
• Does a company who has gained an EUA for a new device still need to seek a traditional regulatory pathway for approval/clearance?
• What does the FDA’s relaxing of regulatory rules mean to medical device manufacturers?
• Reports on the mortality rate for patients put on ventilators differs greatly, but in looking at a fair amount of data, it seems the number is approximately 66 percent. As a result, is the race to make more ventilators the best action or are we really without another choice at this stage since we don’t know who will survive and who won't?
• Is the FDA taking action against any type of misinformation and/or outright lies about a product’s ability to help address COVID-19?

Listen to this episode and see what you think of the concerns brought up regarding the effort against COVID-19. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we can address your ideas/inquiries/suggestions in a future episode.

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.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss questions raised by news of medical technology being rolled out to help battle the COVID-19 virus. Topics such as what Emergency Use Authorization means to how non-manufacturers of medical devices can now produce products for the effort such as ventilators. Specifically, we address a number of questions, including:

• What is coronavirus?
• We’re hearing quite a bit about Emergency Use Authorization, primarily around tests for COVID-19. What does that mean exactly?
• Does EAU lower the regulatory burden compared to other pathways to market?
• To address the need for ventilators, companies like Ford and GM are changing over production to help. How does this happen when the FDA has likely never stepped foot into these facilities?
• With all the rushed approvals/clearances of new medical supplies, is there a concern regarding safety?
• What is the situation for companies with existing devices (already on market) that can be modified to help with the battle against COVID-19?

Listen to this episode and see what you think of the concerns brought up regarding the effort against COVID-19. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we can address your ideas/inquiries/suggestions in a future episode.

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.

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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 concern surrounding the use of EtO for medical device sterilization. Questions have been raised as to the safety of the amount that’s been detected in the air around facilities that provide this type of sterilization process. Specifically, we address a number of questions, including:

• How common is EtO for sterilization?
• How does it compare to other methods?
• Why is it used so frequently?
• What are the problems with EtO?
• Do you expect EtO to go away?
• What is the “root cause” of this problem? Could it have been avoided?
• What type of regulatory pathway requires a notification to the FDA for a change of sterilization process?
• What is the FDA’s EtO sterilization pilot program for changing vendors?
• What are the most important takeaways from this issue for medical device manufacturers?

Several references were mentioned during this podcast and you can locate those items by clicking on each one.

• FDA Website: Ethylene Oxide Sterilization for Medical Devices 
• FDA Innovation Challenge: Ethylene Oxide Sterilization for Medical Devices
  • Challenge 1: Identify New Sterilization Methods and Technologies: The goal of this challenge is to encourage the development of new approaches to device sterilization methods or technologies for medical devices that do not rely on ethylene oxide. 
  • Challenge 2: Reduce Ethylene Oxide Emissions: The goal of this challenge is to develop strategies or technologies to reduce emissions to as close to zero as possible from the ethylene oxide sterilization process. 

Listen to this episode and see what you think of the challenges currently surrounding EtO sterilization. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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.

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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 FDA’s pilot of an interactive 510(k) template called eSTAR (electronic Submission Template and Resource). This electronic template would be used by companies submitting a 510(k) application so as to try to avoid administrative rejection, one of the most common causes of submission rejection. Specifically, we address a number of questions, including:

• What is the eSTAR program?
• What is the goal of this program?
• What is FDA seeking from companies interested in participating in the trial?
• For what types of devices/510(k) submissions can eSTAR be used and which types can it not be used?
• What does the form ask for?
• Is FDA offering incentives to encourage manufacturers to use eSTAR?
• What challenges do you foresee with this template? Has the FDA neglected to consider anything?
• If this template goes into effect, do you expect it to speed up 510(k) submissions and/or the processing of them?
• Would you encourage a company to participate in the pilot if they meet the criteria?

Listen to this episode and see what you think of the eSTAR pilot program. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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.

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

In the second part of this Medtech Matters podcast series of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s emphasis on human factors (or ergonomics or usability) testing. We mention what medical device manufacturers should be concerned with for less than satisfactory testing protocols, and how the FDA may not even be the worst thing they should be worried about. Specifically, we address a number of questions, including:
 

•  Are there certain areas of human factors the FDA is emphasizing or paying closer attention to?
•  Do you have suggestions or real-world examples on how a company may perform human factors testing?
•  How does human factors testing for a medical device differ based on where the product is intended to be used (for example, in the home versus in a hospital room or used by a physician versus the patient directly)?
•  What type of trouble with the FDA can a company get into for not accomplishing human factors testing in a satisfactory manner?
•  What are the key takeaways device manufacturers should consider with regard to human factors/usability?

 If you’d like to review the FDA’s Human Factors guidance document before listening to this podcast, you can find it by clicking here.

Listen to this episode and see what you think of the FDA’s human factors requirements. 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 [email protected] 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 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 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 FDA’s emphasis on human factors (or ergonomics or usability) testing. Medical device manufacturers need to ensure they are not only satisfying this need, but also fulfilling any potential liability involved. Specifically, we address a number of questions, including:

• What is human factors as it relates to medical device development?
• Were human factors always required by the FDA?
• What is the difference between human factors testing and a clinical trial?
• What types of medical devices are required to go through human factors validation testing?

If you’d like to review the FDA’s Human Factors guidance document before listening to this podcast, you can find it by clicking here.

Listen to this episode and see what you think of the FDA’s human factors requirements. 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 [email protected] 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 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 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 the second part of this two-part Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss change management with regard to how to address it with the FDA. The type of change and the overall implications of it to the functionality and efficacy of the device should dictate which route a company should take—letter-to-file or a Special 510k. Specifically, we address a number of questions, including:

• What is change management and why is it important?
• How does a company or regulatory individual decide when to handle the change internally, such as via a letter-to-file, vs. notifying the FDA with a special 510k or PMA supplement?
• Does it matter what type of change is being made? And I have a list of examples. Perhaps we can take these one at a time?
  • Aesthetic change, such as color or size of a font?
  • Design change, such as the shape or size of the device?
  • Material change, such as the replacement of one material with another or the combination of two materials?
  • Labeling change, such as modifying an existing claim or adding a new one?
  • Change in the manufacturing process, such as for improving efficiency or reducing rejection rate or what about if the product is sent to a contract manufacturer?
  • Software change, such as for a security update or to add functionality?
  • Supply chain change, such as a testing vendor or something many may need to address, sterilization change?
• How does change management for medical devices differ from those for drugs and which is used for combination products (drug/device)?
• Do you have a suggested process to handle change and more importantly, can you defend it?
• What is the relationship between change management and product liability?
• What can happen if a company mishandles their change management procedures?
• What are the most important takeaways for listeners concerned with change management?

Listen to this episode and see what you think of the tips and best practices for handling change management. 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 [email protected] 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 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 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 two-part Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss change management with regard to how to address it with the FDA. The type of change and the overall implications of it to the functionality and efficacy of the device should dictate which route a company should take—letter-to-file or a Special 510k. Specifically, we address a number of questions, including:

• What is change management and why is it important?
• How does a company or regulatory individual decide when to handle the change internally, such as via a letter-to-file, vs. notifying the FDA with a special 510k or PMA supplement?
• Does it matter what type of change is being made? And I have a list of examples. Perhaps we can take these one at a time?
  • Aesthetic change, such as color or size of a font?
  • Design change, such as the shape or size of the device?
  • Material change, such as the replacement of one material with another or the combination of two materials?
  • Labeling change, such as modifying an existing claim or adding a new one?
  • Change in the manufacturing process, such as for improving efficiency or reducing rejection rate or what about if the product is sent to a contract manufacturer?
  • Software change, such as for a security update or to add functionality?
  • Supply chain change, such as a testing vendor or something many may need to address, sterilization change?
• How does change management for medical devices differ from those for drugs and which is used for combination products (drug/device)?
• Do you have a suggested process to handle change and more importantly, can you defend it?
• What is the relationship between change management and product liability?
• What can happen if a company mishandles their change management procedures?
• What are the most important takeaways for listeners concerned with change management?

Listen to this episode and see what you think of the tips and best practices for handling change management. 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 [email protected] 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 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 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.