By Christopher White, Chief Operating Officer, General Counsel and Secretary at AdvaMed
Note: This article was originally published on LinkedIn on August 14. View the original post here.
Back in the pre-pandemic “old days” I regularly posted blogs here on LinkedIn and kept current with friends, classmates and fellow medtech & legal colleagues on Twitter. That changed in March, and the sad truth is that I’ve been completely off social media for 5 months. At a time when we are all remote, connecting on social media would seem more natural and necessary. But, like many others, there’s been a lot to balance in the past months–family, new professional experiences, remote learning, etc.–and it was difficult to find the time! But, as we move into August and as the uncertainty and change somehow feels more routine, I look forward to catching up on this platform, reconnecting and getting back to my social media normal!
In March, I took on an additional role as AdvaMed’s COVID-19 Action Team Leader to help coordinate the medtech industry’s response to the pandemic. And in this role, I’ve been privileged to work with my colleagues in new ways and see first-hand the many extraordinary contributions of my colleagues and our members across the global medical technology industry to prevent, diagnose, treat and eradicate this illness.
- Diagnostics. One of the most central ways medtech is taking on the pandemic is by accelerating production of diagnostic tests. In July, AdvaMed launched a national testing supply registry – in partnership with 13 commercial diagnostics manufacturers – to help state and federal governments in their pandemic response. The data show critical recent milestones, including over 100 million molecular COVID-19 tests shipped nationwide since March, and daily shipments now crossing the 1 million mark.
- Rapid & Increased Device Production. This industry works around the clock to meet the demand for tests, as well as other essential products including ventilators and personal protective equipment, and to ensure effective deployment. This includes AdvaMed’s work with industry allies and partners to establish our VentConnect platform in May to connect ventilator makers with component suppliers to quickly scale production and distribution of these critical devices. We recently expanded that platform – now the MedDeviceNetwork – to help scale production of other complex medical technologies needed in the fight against COVID-19 and future health care emergencies.
- Safe Return to Procedures; Ethics. Our work led to global “return to procedures” guidance for health care facilities – released in May in conjunction with partner health care associations – to facilitate the safe resumption of procedures delayed or postponed due to COVID-19. We further developed COVID-19 compliance guidance to support rapid decision-making and mitigate compliance/corruption risks during the pandemic.
- Resources. Drawing from collective industry experience and best practices, we established a COVID-19 MedTech Resource Center to provide essential information, tools and other resources to support our collective work for patients worldwide. We’ve also launched dedicated website landing pages for the latest industry news on the response to the outbreak, FDA emergency use authorizations for new diagnostics, and other actions.
All these efforts and more come as we continue to pursue our broader policy advocacy for patient access to innovative technologies, like working to advance new regulatory safe harbors to the Federal Anti-Kickback Statute (AKS) supporting value-based arrangements. Unprecedented times require innovation and creativity, and medtech can bring more and better solutions if not restrained by outdated AKS laws.
At this time when patients, medical systems and economies worldwide are facing tremendous challenges, a nimble and robust medtech industry is more valuable than ever. Ensuring this readiness doesn’t just happen. Preparing medtech to respond to moments such as this underpins all of our industry’s work across legal and regulatory policies.
We constantly strive for a legal environment and a public policy framework that support medical innovation, encourage education for technology users, and promote patient access to the best medical technology. This moment illustrates the value of this work.
This is a stressful time, as we face a barrage of information about healthy preventive practices, track the growing numbers of infected individuals, and weather ongoing disruptions in day-to-day life as a result of COVID-19. At times such as this, it is good to know medtech is there. I am confident that the incredible innovators in the medtech industry will continue to play an outsized role in the solutions to the pandemic!