Sean Fenske, Editor-in-Chief11.10.21
With this final issue of MPO in 2021 (editorial issue, that is), I take time to look back at the past year. At the same time, I wonder what highlights will encapsulate 2022. To gain additional perspective, I reached out to the editorial advisory board to get their thoughts on the subject.
J. Mark King, CEO of SafeCirc and an operating partner with Vance Street Capital, said while navigating the pandemic was a dominate factor of the year, he had a preference for more positive aspects. “I prefer to suggest that in most recent months, the ability to visit plants, visit customers, attend shows and fewer virtual meetings. It is so exciting to see and hear from long time colleagues in the industry we all love.”
I can’t disagree. Attending live events (including our own MPO Summit) has been a welcome step in the right direction. Business travel isn’t always fantastic and it wasn’t long before I realized I didn’t miss the airport experience, but it’s wonderful to see familiar faces that aren’t on my monitor.
For 2022, King emphasizes the importance of valuing people. Of course, he’s right. No one is immune to the labor crisis being experienced across all industries, so ensure the employees you have know how much you appreciate them and the jobs they’ve done over the last 20 months in quite unusual circumstances.
Nikki Willett, chief strategy officer at ComplianceQuest Inc., expressed the importance of embracing the virtual workforce that has come out of the pandemic. Adopting policies and technologies that will help facilitate this movement will be critical for companies.
She also expects more Cloud-based applications to emerge, and with it, “better data quality, integrity, and governance.”
In 2022, Willett will be keeping an eye on the artificial intelligence (AI) and machine learning (ML) landscapes. Further, she mentions the FDA’s challenges in dealing with these innovations. In addition, AI within support systems like a QMS and how it is handled will be an aspect she’ll watch. “These challenges will be interesting as investigators come to a manufacturer to do a quality inspection with an AI-powered QMS system, helping companies show their compliance with good ML practices.”
Brent Noblitt, co-founder and senior partner at Noblitt & Rueland, polled his office and received several comments on items impacting the medical device industry. “Plethora of advances in using AI/ML in medical devices, EU MDR implementation challenges/woes, EU IVDR coming/potential delays [received prior to the announced postponement], UDI implementation FDA/EU, cybersecurity challenges, and SaMD [software as a medical device] and plethora of mobile medical and health apps.”
While I agree all are noteworthy, regulatory challenges are familiar to medtech firms. The real roadblocks in Noblitt’s list, in my opinion, originate with the digital elements. AI/ML, cybersecurity, and mobile apps are still mostly alien to this industry. These aspects will provide the highest learning curve, but may also present the greatest rewards for those who master them.
Geary A. Havran, board chairman and president of NDH Medical Inc., cited issues caused by the pandemic as prominent. “[It] created substantial disruption in supply chains and the availability of labor. These factors tended to complicate the reshoring efforts needed to ensure the availability of medically necessary items for current and future needs. Frequent price increases on manufacturing inputs became the new normal as well as increasing lead times, causing disruptions in production schedules.”
Havran points to those challenges continuing in 2022. He predicts labor shortages will result in growing implementation of automation and supply chain/transportation issues will lead to reshoring efforts and attempts to produce closer to customers.
Dave Sheppard, COO and principal at MedWorld Advisors, echoed the labor and supply chain concerns of Havran. “Most medtech companies [had] to keep employees safe, recruit enough staff for the positions available, and balance the social/cultural issues created by the political environment in this country in 2021.”
While he viewed labor as the primary issue in 2021 and supply chain as second, in 2022, he thinks it plausible these will swap positions. Adding to that could be inflation concerns.
In my opinion, labor has been a long-standing issue, but the pandemic exacerbated it. Some say telehealth was advanced five years in the first five months of the pandemic. Perhaps the same could be said of the labor shortage. The issues emerging would have come about in the next five years, but the pandemic sped up that timetable exponentially. Whether that’s it or not, it’s a problem all medical device makers face and there’s no one answer for anyone.
If you have an opinion on this, feel free to reach out to me with it. Otherwise, have a fantastic holiday season and new year.
Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com
J. Mark King, CEO of SafeCirc and an operating partner with Vance Street Capital, said while navigating the pandemic was a dominate factor of the year, he had a preference for more positive aspects. “I prefer to suggest that in most recent months, the ability to visit plants, visit customers, attend shows and fewer virtual meetings. It is so exciting to see and hear from long time colleagues in the industry we all love.”
I can’t disagree. Attending live events (including our own MPO Summit) has been a welcome step in the right direction. Business travel isn’t always fantastic and it wasn’t long before I realized I didn’t miss the airport experience, but it’s wonderful to see familiar faces that aren’t on my monitor.
For 2022, King emphasizes the importance of valuing people. Of course, he’s right. No one is immune to the labor crisis being experienced across all industries, so ensure the employees you have know how much you appreciate them and the jobs they’ve done over the last 20 months in quite unusual circumstances.
Nikki Willett, chief strategy officer at ComplianceQuest Inc., expressed the importance of embracing the virtual workforce that has come out of the pandemic. Adopting policies and technologies that will help facilitate this movement will be critical for companies.
She also expects more Cloud-based applications to emerge, and with it, “better data quality, integrity, and governance.”
In 2022, Willett will be keeping an eye on the artificial intelligence (AI) and machine learning (ML) landscapes. Further, she mentions the FDA’s challenges in dealing with these innovations. In addition, AI within support systems like a QMS and how it is handled will be an aspect she’ll watch. “These challenges will be interesting as investigators come to a manufacturer to do a quality inspection with an AI-powered QMS system, helping companies show their compliance with good ML practices.”
Brent Noblitt, co-founder and senior partner at Noblitt & Rueland, polled his office and received several comments on items impacting the medical device industry. “Plethora of advances in using AI/ML in medical devices, EU MDR implementation challenges/woes, EU IVDR coming/potential delays [received prior to the announced postponement], UDI implementation FDA/EU, cybersecurity challenges, and SaMD [software as a medical device] and plethora of mobile medical and health apps.”
While I agree all are noteworthy, regulatory challenges are familiar to medtech firms. The real roadblocks in Noblitt’s list, in my opinion, originate with the digital elements. AI/ML, cybersecurity, and mobile apps are still mostly alien to this industry. These aspects will provide the highest learning curve, but may also present the greatest rewards for those who master them.
Geary A. Havran, board chairman and president of NDH Medical Inc., cited issues caused by the pandemic as prominent. “[It] created substantial disruption in supply chains and the availability of labor. These factors tended to complicate the reshoring efforts needed to ensure the availability of medically necessary items for current and future needs. Frequent price increases on manufacturing inputs became the new normal as well as increasing lead times, causing disruptions in production schedules.”
Havran points to those challenges continuing in 2022. He predicts labor shortages will result in growing implementation of automation and supply chain/transportation issues will lead to reshoring efforts and attempts to produce closer to customers.
Dave Sheppard, COO and principal at MedWorld Advisors, echoed the labor and supply chain concerns of Havran. “Most medtech companies [had] to keep employees safe, recruit enough staff for the positions available, and balance the social/cultural issues created by the political environment in this country in 2021.”
While he viewed labor as the primary issue in 2021 and supply chain as second, in 2022, he thinks it plausible these will swap positions. Adding to that could be inflation concerns.
In my opinion, labor has been a long-standing issue, but the pandemic exacerbated it. Some say telehealth was advanced five years in the first five months of the pandemic. Perhaps the same could be said of the labor shortage. The issues emerging would have come about in the next five years, but the pandemic sped up that timetable exponentially. Whether that’s it or not, it’s a problem all medical device makers face and there’s no one answer for anyone.
If you have an opinion on this, feel free to reach out to me with it. Otherwise, have a fantastic holiday season and new year.
Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com
