Sean Fenske, Editor-in-Chief11.04.20
This year has certainly been one many would like to forget. It’s been filled with more bad news than any in recent memory and you would have to go back quite a bit to find a similarly depressing year. Regardless, if you don’t learn from history, you’re doomed to repeat it. And while there’s not much we can do to avoid a pandemic, we can certainly be better prepared for the next one.
There’s also something to be said for taking positives out of this otherwise dreadful situation and those items are what make up my 2020 holiday wish list. While there’s much to forget about in 2020, including masks, social distancing (although admittedly, there are some aspects of social distancing I wouldn’t mind keeping in place), a lack of industry events, significantly less going out, no travel, etc., there are potential “lessons learned” during this time that we can use going forward.
New perspective on device design: During the pandemic, we saw innovation coming from a variety of sources. There were design competitions to create devices to help address the pandemic and provide healthcare in the environment it created. The industry was supplemented in manufacturing critical supplies by companies that don’t operate within medtech. In addition, suppliers who don’t typically serve medtech offered what assistance they could, whether to medical device manufacturers or directly to healthcare providers. The collaborative effort was truly something to marvel, even if it was the result of a horrible situation.
I’d love to see a way to perpetuate this degree of collaboration. Because with this effort came stories of new ways to create necessary supplies. Dyson designed a ventilator in only 10 days. Additive manufacturing firms provided components to convert CPAP and other similar devices into makeshift ventilators. Personal protection equipment was being provided by clothing design firms. Innovation happened exactly when expected, according to the well-known adage—“necessity is the mother of invention.” Outsiders offered a fresh perspective on the design and development of medical technologies.
Some of these may not have made it to market without the emergency situation of the pandemic. I don’t know what would have made it past an FDA review process and what wouldn’t. But that’s not really the point. The takeaway is to figure out a way to reexamine the way devices are developed and get a fresh perspective to determine if there’s a better way. Certainly not an easy task, but then again, this is a “wish” list.
Regulatory review: Another outcome of the pandemic was how quickly necessary products have gotten to market. New technologies were granted emergency use authorization (EUA) from the FDA, a temporary permission from the agency that ends once the pandemic is over. Those products will still need to gain FDA approval or clearance to remain on the market, but could the real-world evidence from their use during the pandemic be used in the regulatory decision? Further, what criteria enabled the agency to authorize the use of these devices to avoid the lengthy review process? Is there a middle ground to be found between the traditional process and the EUA protocol that would enable certain devices to reach the market faster? Perhaps use this for breakthrough devices, since those devices are supposed to go to the “front of the line” when granted that designation. Is that happening as effectively as it should?
Reimbursement: With faster agency review, we also need to reevaluate the reimbursement decision making process. Fortunately, there’s already work being done here as CMS has proposed new rules regarding the way breakthrough devices are paid for. But what about the overwhelming number of devices that aren’t deemed breakthrough technologies? Sure, priority absolutely must be given to innovative medical devices to incentivize the development of these types of solutions. But there are many necessary new products that should come to market in an efficient timeframe. A lack of reimbursement stands squarely in the way of that happening. The proposals from CMS are a fantastic start, but I would like to see more changes to the process. Add reimbursement reform to the wish list.
There are many other lessons to be learned from the pandemic and there will be just as many changes occurring as a result. Whether or not they last remains to be seen, but it seems assured we will not “return to normal” perhaps ever again. The pandemic has accelerated telehealth adoption, revealed weaknesses in the supply chain, and put the spotlight on domestic manufacturing. For more insights and revelations born out of the pandemic, be sure to read this issue’s cover story, which focuses on a number of these dynamics from this past year.
To all, have an enjoyable holiday season, and above all, be safe as you spend time with friends and family.
Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com
There’s also something to be said for taking positives out of this otherwise dreadful situation and those items are what make up my 2020 holiday wish list. While there’s much to forget about in 2020, including masks, social distancing (although admittedly, there are some aspects of social distancing I wouldn’t mind keeping in place), a lack of industry events, significantly less going out, no travel, etc., there are potential “lessons learned” during this time that we can use going forward.
New perspective on device design: During the pandemic, we saw innovation coming from a variety of sources. There were design competitions to create devices to help address the pandemic and provide healthcare in the environment it created. The industry was supplemented in manufacturing critical supplies by companies that don’t operate within medtech. In addition, suppliers who don’t typically serve medtech offered what assistance they could, whether to medical device manufacturers or directly to healthcare providers. The collaborative effort was truly something to marvel, even if it was the result of a horrible situation.
I’d love to see a way to perpetuate this degree of collaboration. Because with this effort came stories of new ways to create necessary supplies. Dyson designed a ventilator in only 10 days. Additive manufacturing firms provided components to convert CPAP and other similar devices into makeshift ventilators. Personal protection equipment was being provided by clothing design firms. Innovation happened exactly when expected, according to the well-known adage—“necessity is the mother of invention.” Outsiders offered a fresh perspective on the design and development of medical technologies.
Some of these may not have made it to market without the emergency situation of the pandemic. I don’t know what would have made it past an FDA review process and what wouldn’t. But that’s not really the point. The takeaway is to figure out a way to reexamine the way devices are developed and get a fresh perspective to determine if there’s a better way. Certainly not an easy task, but then again, this is a “wish” list.
Regulatory review: Another outcome of the pandemic was how quickly necessary products have gotten to market. New technologies were granted emergency use authorization (EUA) from the FDA, a temporary permission from the agency that ends once the pandemic is over. Those products will still need to gain FDA approval or clearance to remain on the market, but could the real-world evidence from their use during the pandemic be used in the regulatory decision? Further, what criteria enabled the agency to authorize the use of these devices to avoid the lengthy review process? Is there a middle ground to be found between the traditional process and the EUA protocol that would enable certain devices to reach the market faster? Perhaps use this for breakthrough devices, since those devices are supposed to go to the “front of the line” when granted that designation. Is that happening as effectively as it should?
Reimbursement: With faster agency review, we also need to reevaluate the reimbursement decision making process. Fortunately, there’s already work being done here as CMS has proposed new rules regarding the way breakthrough devices are paid for. But what about the overwhelming number of devices that aren’t deemed breakthrough technologies? Sure, priority absolutely must be given to innovative medical devices to incentivize the development of these types of solutions. But there are many necessary new products that should come to market in an efficient timeframe. A lack of reimbursement stands squarely in the way of that happening. The proposals from CMS are a fantastic start, but I would like to see more changes to the process. Add reimbursement reform to the wish list.
There are many other lessons to be learned from the pandemic and there will be just as many changes occurring as a result. Whether or not they last remains to be seen, but it seems assured we will not “return to normal” perhaps ever again. The pandemic has accelerated telehealth adoption, revealed weaknesses in the supply chain, and put the spotlight on domestic manufacturing. For more insights and revelations born out of the pandemic, be sure to read this issue’s cover story, which focuses on a number of these dynamics from this past year.
To all, have an enjoyable holiday season, and above all, be safe as you spend time with friends and family.
Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com
