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What the Experts Learned in 2020: SaMD, Digital Health, Cybersecurity
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.
In this second blog in our Q4 series, two experts share their lessons learned about cybersecurity, and four discuss the intersection of Remote Care, Digital Health, and Crisis-Driven Healthcare Transformation.
Cybersecurity For Connected Medical Device
David E Williams, President of Health Business Group
David E. Williams is the President of the Health Business Group, a consulting firm that helps technology-enabled healthcare, medical device, and pharmaceutical companies develop and execute innovative business strategies. Williams holds a podcast called HealthBiz, guests including CEOs, politicians, and entrepreneurs.
What has been your biggest lesson from 2020 in terms of digital health and MedTech?
“Widespread adoption is possible, but so is widespread backsliding. Providers shifted to remote visits in March because the pandemic forced them to do it. Patients like remote care and would like to retain it as an option, but many providers are ready to be done with it.”
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?
“Cyber/physical security. The deployment of IoT will be accompanied by an exponential growth in attacks. Some will be traditional cyber threats, such as viruses and phishing. Others will exploit vulnerabilities in devices to cause physical harm as Stuxnet did.”
Peggy Smedley, President/Editorial Director at Specialty Publishing Co.
Peggy Smedley hosts the podcast The Peggy Smedley Show and is the Editorial Director and President of Specialty Publishing Media. As an award-winning journalist, Smedley has written and collaborated on eight published books, “Mending Manufacturing: How America Can Manufacture its Survival.” She was also awarded the 2019 ASCE Excellence in Journalism Award.
What has been your biggest lesson from 2020 in terms of digital health and MedTech?
“2020 has only further hit home the point that there needs to be a scheme and trust for secure communications with connected devices in every industry and setting, including connected medical devices. I’m personally very enthusiastic about PSA Certified, which is an IoT assurance program offering a strong framework for IoT security assurance. To have a best-in-class IoT device of any kind – such as a connected medical device used by one of my family members – this kind of 3rd party guidance and certification is now absolutely essential.”
Remote Care, Digital Health, and Crisis-Driven Healthcare Transformation
Daniel Bernstein, Founder and Chief Product Officer at metaMe Health 
Daniel Bernstein is the founder of metaMe Health, a company that develops and delivers digital therapeutics to manage and treat IBS symptoms. Prior to metaMe Health, Bernstein founded the medication adherence company Medic8 Manager.
What has been your biggest lesson from 2020 in terms of digital health and MedTech?
“I used to think that it took a carrot/stick approach, ala EMR adoption – for better or worse, for Providers to adopt new technologies and change their routines. What I’ve seen with the onset of the pandemic has been rapid, seemingly-seamless adoption of remote healthcare by both physicians and patients. Our first-hand experience of this was during our pivotal clinical study for our lead asset Regulora where we saw a significant uptick in subject enrollment due to the virtual nature of our study.”
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?
“It wouldn’t be accurate to say that Ed Michael and Chaim Friedman were not on my radar in 2020. Early in 2019, LionBird, the VC firm they manage began their due diligence of metaMe Health which consummated with LionBird as our lead investor closing our seed round in July 2019. Now, 18-months later as we plan our next steps for our digital therapeutic for IBS, coming out of our pivotal study, raising our next round, submitting our application to the FDA, and preparing for entry into the market; I have to say, my admiration for the LionBird team has only increased the more I experience.”
John Nosta, President of NostaLab
John Nosta is the founder of NostaLab, a healthcare “innovation think tank” that focuses on the emergence of technology and the implications to health, wellness, medicine, and the pharmaceutical industry. Ranked as the #1 global influencer in digital health, he is regarded as one of the top global strategic and creative thinkers in his area.
What has been your biggest lesson from 2020 in terms of digital health and MedTech?
“In the simplest of terms, the lessons learned from 2020 is to expect the unexpected and the value of proactivity. Now, let’s add to the complexity of the issue–how can we possibly plan for that unexpected scenario? Today, it’s a pandemic. But tomorrow, there might be a nuclear emergency or issues around drinking water availability. So, do we stockpile iodine or desalination equipment? We just don’t have the resources for establishing contingency plans for many potentialities and that leads to fundamental issues as to where we look and where we place our bet. I wouldn’t put my money on a specific problem, but more so on the resources necessary to solve them–and that’s technology, particularly data analytics and artificial intelligence. The key to managing tomorrow’s conflicts and catastrophes is the ability to think smarter. The collaborative dynamic of technology and human ingenuity will be an essential relationship for solving problems and establishing a robust and dynamic future.”
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?
“That’s a tough question and I’m not sure that the one-year time frame is long enough to pick some clear emerging winners. But I believe that connectivity–mediated by 5G technology–will emerge as a cornerstone of transformation. Data is expanding–variety, volume, and velocity–and the transmission of these data streams will become more and more important, from consumerism to medicine.
A company that has recently appeared is Nanox. They have done something that characterizes the essence of “digital transformation”. Nanox has digitized the x-ray source. This is significant. By digitizing the x-ray source (not the film or process) they are going down a similar path to the innovation and disruption of the digital camera. The results are demonetization (cheap), dematerialization (small), and democratization (global use). This is extraordinarily important from a clinical and social perspective. I would say that Nanox may be the breakout company of 2020, particularly as they have a live demonstration at the Radiological Society of North America (RSNA) meeting in December.
Mark Graban, Management Consultant, Author, and Professional Speaker
Mark Graban is an internationally-recognized consultant, published author, professional speaker, and blogger. Graban is also a Senior Advisor to the software company KaiNexus and consults part-time as a Senior Advisor for healthcare clients with the firm Value Capture.
What has been your biggest lesson from 2020 in terms of digital health and MedTech?
“I’ve heard many organizations this year talk about how they dramatically accelerated plans for Telehealth in response to COVID-19. The common statement is something like “we accelerated years of telemedicine planning into just a few weeks.” The technological capability was always there, but this shows how a strongly motivated organization can do things very quickly (and effectively) when they put their mind to it. Telehealth went from a “nice to have, someday” to a “must-have, right now.”
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?
“One of those organizations is Sutter Medical Foundation. I interviewed their CEO Theresa Frei (to be released soon as a podcast) and she said they accelerated their ‘3-year plan’ into just three weeks.”
Dr. David Levine, Group Senior VP for Advanced Analytics, Informatics & Product Strategy at Vizient
Dr. David Levine is the Senior Vice President of Advanced Analytics and Informatics at Vizient, Inc.
What has been your biggest lesson from 2020 in terms of digital health and MedTech?
“The biggest lesson that I learned was seeing how we went from” implementing digital health was going to take years and a ton of effort” to seeing how quickly it was implemented in the face of the pandemic. Acceptance by patients and providers was higher than expected especially on the older patient population who was thought would be resistant. Of course, the temporary changes in reimbursement was a huge driver in addition to the great need with COVID. What is disappointing is seeing the declining trends now in digital health to almost pre-COVID levels at many providers with the discontinuation or impending discontinuation of reimbursement rules.”
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?
“The acceleration of hospital at home and more robust home monitoring using SaMD was not on my radar in 2020. I see the potential for significant acceleration in this space as this allows much more flexibility for the patient in many cases.”
What’s Next?
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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