Sean Fenske, Editor-in-Chief02.03.23
With another year past, we are further from the nightmare of the pandemic. Unfortunately, we’re still feeling its effects, whether direct or indirect. Labor shortages and hiring challenges, already a concern prior to COVID-19, were exacerbated rapidly with its arrival. Supply chains are still in a recovery mode, although now we have companies faced with shortages of critical components while others are dealing with a surplus from hoarding. It will take some time before we are “back to normal” and still, no one knows what that will look like completely.
When I revisit similar Editor’s Letters from both 2020 and 2021 (which were produced at the end of those years), it’s interesting to see what concerns were top of mind. My wish list in 2020 included an interest to see the broadening of the new approach to device design (i.e., the collaboration that occurred during the early stages of the pandemic); a review of the regulatory process that took advantage of lessons learned from granting emergency-use authorization; and revisiting the reimbursement process so this aspect of medical device development could be sped up—lofty aspirations that are no closer to taking place.
In 2021, I leveraged my editorial advisory board members (similar to what’s presented on page 42 of this issue) to gain insights about what they were keeping an eye on. Return of live events, focus on people, virtual workforce, artificial intelligence, MDR and IVDR, UDI, and more topics were all mentioned. Many of the topics certainly were top of mind in 2022, and will undoubtedly continue through this year as well. MDR will likely make headlines for many years to come as a proposed implementation delay seems almost certain and there are also reports of companies withdrawing from the EU market due to the more stringent (and expensive) guidelines. It’s a topic we’ll be keeping an eye on.
In 2023, however, I’ve identified three focal points that should be a part of every medtech firm’s list of “new year resolutions.” My proposed areas of focus are cybersecurity, sterilization, and the supply chain.
When it comes to cybersecurity, the industry seems to have made progress and has started to take this issue more seriously, but it seems to still be lagging far behind where it needs to be. Cyber threats aren’t going away, they aren’t going to be resolved universally, and it is just as much a medical device manufacturer’s concern as a hospital concern. It must be a collaborative effort to address the problem. With this in mind, make 2023 the year you become familiar with the Healthcare and Public Health Sector Coordinating Council and its Cybersecurity Working Group (www.healthsectorcouncil.org). Additionally, visit the MITRE Health Cyber site (healthcyber.mitre.org). Both sites have a wealth of information and resources for device makers who are unsure how to address cybersecurity challenges.
In terms of sterilization, there is growing concern regarding the use of ethylene oxide (EtO) as a method for medical devices. While approximately 50% of all devices are currently sterilized with this process, that figure could begin to decrease. Of course, before we see a dramatic decrease in the use of EtO, capacity issues will need to be addressed using other options available to the market. The FDA is actively engaged in innovation challenges to encourage the development of alternative sterilization methods. Further, the agency encourages developers to seek alternative options for new medical devices requiring sterilization. For anyone starting a new project in 2023, it may be in your best interest to thoroughly explore your device’s sterilization options to see if any other method could be used.
Finally, we arrive at supply chain. I wish I had a universal answer to address the array of challenges the industry faces here, but unfortunately, there isn’t one. One size most certainly does not fit all. However, that very sentiment should be taken to heart when manufacturers address their supply chain concerns. What your neighbor, customer, supplier, or competitor is doing is not necessarily the answer for you. Best practices are great to hear and recommendations are fantastic, but ultimately, only you and your team know what the answer will be—or, at least, the best path to take—to resolve issues. Do not take the approach of “me too” to fix supply chain problems. Communicate with your supply chain organizations and get a clear view of the big picture. You know your tier one suppliers, but how familiar are you with tier two, three, or even four? Where are the biggest risks? What do your international suppliers look like and would you be better served with someone closer to you? Make 2023 the year you truly evaluate your supply chain.
What other items are on your new year resolutions list? I’d love to hear about them.
Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com
When I revisit similar Editor’s Letters from both 2020 and 2021 (which were produced at the end of those years), it’s interesting to see what concerns were top of mind. My wish list in 2020 included an interest to see the broadening of the new approach to device design (i.e., the collaboration that occurred during the early stages of the pandemic); a review of the regulatory process that took advantage of lessons learned from granting emergency-use authorization; and revisiting the reimbursement process so this aspect of medical device development could be sped up—lofty aspirations that are no closer to taking place.
In 2021, I leveraged my editorial advisory board members (similar to what’s presented on page 42 of this issue) to gain insights about what they were keeping an eye on. Return of live events, focus on people, virtual workforce, artificial intelligence, MDR and IVDR, UDI, and more topics were all mentioned. Many of the topics certainly were top of mind in 2022, and will undoubtedly continue through this year as well. MDR will likely make headlines for many years to come as a proposed implementation delay seems almost certain and there are also reports of companies withdrawing from the EU market due to the more stringent (and expensive) guidelines. It’s a topic we’ll be keeping an eye on.
In 2023, however, I’ve identified three focal points that should be a part of every medtech firm’s list of “new year resolutions.” My proposed areas of focus are cybersecurity, sterilization, and the supply chain.
When it comes to cybersecurity, the industry seems to have made progress and has started to take this issue more seriously, but it seems to still be lagging far behind where it needs to be. Cyber threats aren’t going away, they aren’t going to be resolved universally, and it is just as much a medical device manufacturer’s concern as a hospital concern. It must be a collaborative effort to address the problem. With this in mind, make 2023 the year you become familiar with the Healthcare and Public Health Sector Coordinating Council and its Cybersecurity Working Group (www.healthsectorcouncil.org). Additionally, visit the MITRE Health Cyber site (healthcyber.mitre.org). Both sites have a wealth of information and resources for device makers who are unsure how to address cybersecurity challenges.
In terms of sterilization, there is growing concern regarding the use of ethylene oxide (EtO) as a method for medical devices. While approximately 50% of all devices are currently sterilized with this process, that figure could begin to decrease. Of course, before we see a dramatic decrease in the use of EtO, capacity issues will need to be addressed using other options available to the market. The FDA is actively engaged in innovation challenges to encourage the development of alternative sterilization methods. Further, the agency encourages developers to seek alternative options for new medical devices requiring sterilization. For anyone starting a new project in 2023, it may be in your best interest to thoroughly explore your device’s sterilization options to see if any other method could be used.
Finally, we arrive at supply chain. I wish I had a universal answer to address the array of challenges the industry faces here, but unfortunately, there isn’t one. One size most certainly does not fit all. However, that very sentiment should be taken to heart when manufacturers address their supply chain concerns. What your neighbor, customer, supplier, or competitor is doing is not necessarily the answer for you. Best practices are great to hear and recommendations are fantastic, but ultimately, only you and your team know what the answer will be—or, at least, the best path to take—to resolve issues. Do not take the approach of “me too” to fix supply chain problems. Communicate with your supply chain organizations and get a clear view of the big picture. You know your tier one suppliers, but how familiar are you with tier two, three, or even four? Where are the biggest risks? What do your international suppliers look like and would you be better served with someone closer to you? Make 2023 the year you truly evaluate your supply chain.
What other items are on your new year resolutions list? I’d love to hear about them.
Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com
