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Help Us Build an Authoritative List of SaMD Cleared by the FDA
We didn’t predict it on January 1, 2020, but this has been one heck of a year in healthcare and life sciences, especially in terms of digital health and Software as a Medical Device (SaMD). We’ve been reaching out to a wide range of industry leaders, thinkers, and pioneers in the spaces of digital health, MedTech, and Software as a Medical Device (SaMD) space, asking them to tell us what they learned this year.
Dr. Geraldine McGinty is a radiologist who specializes in the detection and diagnosis of breast cancer. In addition to practicing breast imaging, she is the Chief Strategy and Contracting Officer at Weill Cornell Medical College and has served as both the President and Chair of the Board of Chancellors at the American College of Radiology. Dr. McGinty is an internationally recognized expert in healthcare strategy and imaging economics and an unwavering advocate for patient-centered quality care.
What has been your biggest lesson from 2020 in terms of digital health and MedTech?
“That despite all the risks and concerns we had previously articulated, we could pivot to telehealth and electronic processes successfully when we had no alternative. Sometimes it takes a crisis to drive meaningful change.”
Which organization, trend, or person was not high on your radar at the beginning of 2020 for digital health and MedTech innovation but is now? Why?
“As we have appropriately turned our attention to the impact of structural racism in our healthcare system and the disparate outcomes depending on one’s race and zip code, I’ve become much more focused on the importance of inclusive leadership in addressing those disparities. Any organization that fails to reflect the population it serves is higher on my radar now because we need to press for change. The Amwell Board, for example, is composed entirely of white men. The healthcare workforce is 75% female and overall more diverse than the population in general. I think that presents an opportunity.”
Dr. Lyle Berkowitz is a renowned healthcare and technology innovation expert, award-winning sought-after keynote speaker, and practicing physician. He has a passion for creating real-world solutions that improve the quality and efficiency of the healthcare system for both patients and physicians. Dr. Berkowitz is the Chief Executive Officer of Back9 Healthcare Consulting, where he helps healthcare systems, companies and investors rethink problems and solutions. He was previously the Chief Medical Officer and EVP for Strategy at MDLive.
What has been your biggest lesson from 2020 in terms of digital health and MedTech?
“The biggest lesson learned has been that we could go virtual quickly… the barriers have never been technology, as much as the 3 Rs: Reimbursement, Regulations, and Regularity (a.k.a. culture of virtual health). Watching those 3 Rs will help us understand how much virtual health will stay around after the pandemic is over.”
Which organization, trend or person was not high on your radar at the beginning of 2020 for digital health and MedTech innovation but is now? Why?
“What has moved up on the radar is the importance and reality of autonomous health (diagnosis and care without a provider involved), which should be the front door to even getting to telehealth (which always involves a provider). For example, we saw a huge rise in chatbots to quickly triage and educate on COVID – do you need a test, do you need to see someone, or do you just need to calm down and relax? That example will ideally help us move into a world of digital diagnostics and therapeutics that will finally let us take care of more people for less.”
Gerry Miller is a visionary serial entrepreneur with more than 30 years of experience in technology startups. He is the Founder and CEO of Cloudticity, a company dedicated to improving public health by helping medical providers and companies “wrangle the cloud.”
What has been your biggest lesson from 2020 in terms of digital health and MedTech?
“COVID-19 has driven a tremendous amount of adoption of non-traditional digital health mechanisms (e.g., telehealth), and has highlighted the need for even further innovation in this area. We think telehealth is here to stay but requires consumer technologies to become available for basic vitals and more comprehensive diagnostics. This will drive the adoption of edge computing, even more, leveraging the emerging ubiquity of 5G.”
Which organization, trend, or person was not high on your radar at the beginning of 2020 for digital health and MedTech innovation but is now? Why?
“Telehealth for sure. While COVID-19 has driven adoption (one telemedicine client of ours experienced a 30-fold increase in sessions within a single week), it’s more than just healthcare consumers that will benefit. We see rural populations being better served by the advances made to cope with COVID volumes, as well as smaller hospitals that can use the same technology for consultations with remote experts.”
Dr. Bibb Allen is a Diagnostic Radiology Specialist in Birmingham, AL with over 37 years of experience in the medical field. Allen joined the ACR Board of Chancellors as chair of the ACR Commission on Economics and was later elected chair of the ACR Board of Chancellors and ACR President.
Which organization, trend or person was not high on your radar at the beginning of 2020 for digital health and MedTech innovation but is now? Why?
“Crises often provide opportunities. The pandemic has created a time-sensitive need to share patient data for AI development around SARS COVID-19. Before the pandemic, combing cases from multiple institutions to build diverse training datasets for AI models had serious challenges. Recently, however, organizations including the American College of Radiology (ACR), the Radiological Society of North America (RSNA), and the American Association of Physicists in Medicine (AAPM) have come together with the National Institute for Biomedical Imaging and Bioengineering (NIBIB) at the National Institutes of Health (NIH) to develop a robust centralized database of COVID patients’ imaging examinations including radiographs, computed tomography scans, and other imaging studies. Because of the pandemic of the barriers to data sharing are being expeditiously solved and will hopefully be the model for assembling large datasets of patient imaging for other disease processes for researchers and developers to accelerate the development of AI models for clinical use.”
Dave Saunders, Chief Technology Officer and Co-founder of Galen Robotics is a hands-on product manager with a track record of taking over 40 products from inception to market. At Galen Robotics, he has led strategic planning and consulted with over 100 surgeons and medical leaders in the development of the next generation of surgical robots to address new areas of challenges and opportunities.
What has been your biggest lesson from 2020 in terms of digital health and MedTech?
“From all that we have experienced in 2020, I think the potential for machine learning to benefit us by making devices more adaptive and useful could provide some huge benefits in everything from research, to diagnostics, to interventive care, but work is needed to improve validation of training systems. There’s a big difference between presenting an algorithm that can identify an appendix, and using machine learning to provide a probability model showing how it “almost always knows what an appendix looks like.
The latter might actually be more accurate but right now there’s no clear regulatory path with the FDA getting that through clearance. The fact that you can’t specifically print an algorithm for how a machine learning system knows something, creates a barrier for trusting its results. There is a certain irony to the bias though because relying on a properly trained machine learning system is analogous to relying on a properly trained human being; you can’t print an algorithm for how your brain knows things either.”
Dr. Ayis Pyrros is a neuroradiologist in suburban Chicago at DuPage Medical Group and regularly has his hands in numerous entrepreneurial and intrapreneurial ventures in health informatics.
What has been your biggest lesson from 2020 in terms of digital health and MedTech?
“The biggest lesson I learned from 2020 digital health is how COVID has exposed the US health system as the fragmented dumpster fire it really is. Even after heavy investments in EMR technologies, many patients have missing information from their records, like comorbidities.”
Which organization, trend, or person who was not high on your radar at the beginning of 2020 for digital health and MedTech innovation but is now? Why?
“Healthtensor has automated a large portion of the physician note, mostly geared toward Medicare Advantage. For example, a patient has a low GFR, suggesting renal disease, the note automatically has a section about renal disease, referencing the lab value.”
Over the next few weeks, we will be releasing more blogs sharing the replies from other experts. You can follow this series using #DigitalHealth_SaMD_2020 on Twitter and LinkedIn, or sign up for our newsletter.
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