Sean Fenske, Editor-in-Chief05.01.20
The medical device industry has heard the “call to arms” to help against the COVID-19 virus, and has proved itself up to the task. While there have certainly been challenges in the supply chain and the availability of necessary components, the community has set aside competitive feelings and joined together to try to address the needs of front-line healthcare workers. Whether developing and/or manufacturing ventilators, personal protective equipment (PPE), diagnostic tests, patient beds, or any other necessary equipment to help with the cause, the response has been inspired.
I’ve personally seen news from companies every single day since this pandemic really took hold in the U.S. of how they are doing a part toward the effort. I think I can safely say on behalf of everyone at MPO, we appreciate it.
With that in mind, I took an opportunity to speak with Scott Whitaker, president and CEO of AdvaMed, about the industry’s response via the MPO podcast, Medtech Matters. While the channel has primarily focused on regulatory issues via the show Mike on Medtech, which has been a mainstay of the podcast since the start, I’ve wanted to branch out to speak with other industry voices to expand the focus and coverage. Having a chance to interview Whitaker seemed like the perfect time to start.
“We are on the front line of diagnosing the disease, treating patients in hospital settings who have the disease, and then protecting our healthcare workers who are fighting the disease…in a personal way,” explained Whitaker when asked about how the industry is responding to the pandemic. “Are we stepping up to the challenge? The answer is absolutely yes. What are the biggest challenges ahead of us? I think it’s probably on the diagnostic side. And there are two parts of the diagnostic piece that are important here. There’s PCR tests, which are right up front to determine if there’s a live virus…and then there’s the serology test to determine levels of immunity. Our companies are doing both of those and both of those are essential in order to help America get back to work again, and other countries as well. That’s probably the biggest challenge we’re facing right now.”
I also asked Whitaker about the pain points the medical device OEMs are facing and what he’s hearing from them. “I think it’s a combination of time and, to some degree, manpower,” he replied. “I’ll tell you what has worked remarkably well for virtually everyone in the industry. As you’re trying to scale up manufacturing, whether its PPEs or ventilator hospital equipment or its on the diagnostics side where you’re creating new tests…having a public/private partnership with the government, particularly in this case the FDA, to make sure we’re able to speed these products to hospitals and test centers that need them, is critically important. FDA has been just remarkable in the work that they’ve done, connecting us with their front-line workers, clearing these products quickly, getting them into the Emergency Use Authorization program, helping us understand how to scale up manufacturing to go from an eight-hour shift to a 24/7 shift and still be compliant. All of that work is being done hand and glove with the FDA and it’s been great.”
When asked specifically about some of the scale-up efforts happening where medical device manufacturers were working with other industries, such as automotive firms, to increase capacity, Whitaker said, “We welcome the help, because scaling up to mass production levels for a crisis is important. But we also want to make sure that what they’re doing on one side of it—the GMs, the Fords—is consistent with the process that we’re going through so that when a machine is delivered, it’s delivered in a way that’s consistent with the manufacturing practices of our industry and delivers the results that healthcare workers expect.”
When asked about the value suppliers have brought to the cause, Whitaker explained, “Think about the PPE space—the masks, gloves, gowns, things of that nature that are critically important and challenging to manufacture at a high scale, but don’t have the complexity of a ventilator…It’s that area where the suppliers have been most helpful to us.”
He added, “When you think about the supplies that go into the more complex machines, we’ve had challenges bringing in some of those parts from other parts of the globe where we do manufacturing of component parts now…but we have been able to overcome most of those challenges with the help of the U.S. government and foreign governments as well in prioritizing those shipments and getting them into the country.”
Should you be interested in hearing the entire interview with Advamed’s Scott Whitaker, you can access the show, Medtech Matters, via your choice of podcast vendors, such as iTunes/Apple Podcasts or Spotify, or listen via the player at MPO’s website (bit.ly/medtechmatters).
Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com
I’ve personally seen news from companies every single day since this pandemic really took hold in the U.S. of how they are doing a part toward the effort. I think I can safely say on behalf of everyone at MPO, we appreciate it.
With that in mind, I took an opportunity to speak with Scott Whitaker, president and CEO of AdvaMed, about the industry’s response via the MPO podcast, Medtech Matters. While the channel has primarily focused on regulatory issues via the show Mike on Medtech, which has been a mainstay of the podcast since the start, I’ve wanted to branch out to speak with other industry voices to expand the focus and coverage. Having a chance to interview Whitaker seemed like the perfect time to start.
“We are on the front line of diagnosing the disease, treating patients in hospital settings who have the disease, and then protecting our healthcare workers who are fighting the disease…in a personal way,” explained Whitaker when asked about how the industry is responding to the pandemic. “Are we stepping up to the challenge? The answer is absolutely yes. What are the biggest challenges ahead of us? I think it’s probably on the diagnostic side. And there are two parts of the diagnostic piece that are important here. There’s PCR tests, which are right up front to determine if there’s a live virus…and then there’s the serology test to determine levels of immunity. Our companies are doing both of those and both of those are essential in order to help America get back to work again, and other countries as well. That’s probably the biggest challenge we’re facing right now.”
I also asked Whitaker about the pain points the medical device OEMs are facing and what he’s hearing from them. “I think it’s a combination of time and, to some degree, manpower,” he replied. “I’ll tell you what has worked remarkably well for virtually everyone in the industry. As you’re trying to scale up manufacturing, whether its PPEs or ventilator hospital equipment or its on the diagnostics side where you’re creating new tests…having a public/private partnership with the government, particularly in this case the FDA, to make sure we’re able to speed these products to hospitals and test centers that need them, is critically important. FDA has been just remarkable in the work that they’ve done, connecting us with their front-line workers, clearing these products quickly, getting them into the Emergency Use Authorization program, helping us understand how to scale up manufacturing to go from an eight-hour shift to a 24/7 shift and still be compliant. All of that work is being done hand and glove with the FDA and it’s been great.”
When asked specifically about some of the scale-up efforts happening where medical device manufacturers were working with other industries, such as automotive firms, to increase capacity, Whitaker said, “We welcome the help, because scaling up to mass production levels for a crisis is important. But we also want to make sure that what they’re doing on one side of it—the GMs, the Fords—is consistent with the process that we’re going through so that when a machine is delivered, it’s delivered in a way that’s consistent with the manufacturing practices of our industry and delivers the results that healthcare workers expect.”
When asked about the value suppliers have brought to the cause, Whitaker explained, “Think about the PPE space—the masks, gloves, gowns, things of that nature that are critically important and challenging to manufacture at a high scale, but don’t have the complexity of a ventilator…It’s that area where the suppliers have been most helpful to us.”
He added, “When you think about the supplies that go into the more complex machines, we’ve had challenges bringing in some of those parts from other parts of the globe where we do manufacturing of component parts now…but we have been able to overcome most of those challenges with the help of the U.S. government and foreign governments as well in prioritizing those shipments and getting them into the country.”
Should you be interested in hearing the entire interview with Advamed’s Scott Whitaker, you can access the show, Medtech Matters, via your choice of podcast vendors, such as iTunes/Apple Podcasts or Spotify, or listen via the player at MPO’s website (bit.ly/medtechmatters).
Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com
