Are we ready for the second Digital Health Revolution?
At the start of this decade entrepreneurs promised a digital health revolution. This was expected to completely disrupt the status quo of healthcare delivery. Mostly spurred by mobile health and digital IT automation, the solutions we’ve seen so far include some well-timed nudges toward compliance and diagnosis, particularly among employers and payers. However, nothing on the market today matches the leap to disease prevention that would reduce costs across the system that was promised in those early days.
Today we know more about the complexities in the healthcare system that have created barriers to all-encompassing digital health. A lack of interoperability from hospital to home, and even from wellness products to medical products has stymied progress. In addition, a lack of standardization in patient health records and failed connected devices from early adopters have plagued the industry.
Adoption hurdles have made this revolution feel more like an incremental evolution; but several indicators suggest a quickening of the innovation pace in digital health.
Citing these challenges, HIMSS recently launched a call to action on interoperability. Healthcare venture capital has shifted focus from emerging companies that circumvent regulations toward companies that comply with them. Perhaps most importantly, a regulatory ally in FDA has bolstered efforts from medical device designers and developers.
Consumer electronics are playing nice
As large consumer electronics companies have moved into the healthcare space, they have not become the threatening presence the industry had feared. Early in the decade, device companies were warned to be wary of the big players, like Google and Apple, coming into the MedTech space. Instead, these firms have proven to be willing partners with device companies. And although they are also forging their own companies and products, they are doing so with a careful and collaborative approach.
Take Google’s company Verily Life Sciences, a company that develops tools and platforms to enable continuous health data collection. The company has set ambitious goals to disrupt traditional monitoring methods, but they don’t threaten developers of everyday medical devices, even connected ones.
Instead, for example, the company has partnered with Dexcom to develop miniaturized continuous glucose monitors (CGM) to help people with Type 2 diabetes manage the condition. Verily and Dexcom are focused on minimizing the cost and size of CGM body-worn components, and providing connectivity to enable more people to control their diabetes with timely, actionable information.
A slender path from wellness to medical
Another prediction that hasn’t quite surfaced is that wellness companies would move into the MedTech space. But many of the small players have opted away from designating themselves as medical. They don’t want the risk, costs, or regulatory oversight associated with becoming a true medical product. This is particularly true for emerging or midrange companies—and it makes sense. Developing software or an IoT device for a medical market requires levels of design controls that digital companies might not expect. Companies that don’t know how to design to FDA 21 CFR 820.30 will find they are at a huge disadvantage if they try to diversify into medical.
For example, Ada is a globally available personal health companion app. An AI-powered platform, the app learns consumer’s symptoms and health conditions to offer telemedicine, or “doctor”, services in return. While the goal is to help doctors better manage overall health, the company has adamantly avoided being classified as a medical device. Rather, they tote themselves as an “AI assistant” that provides curation and access to doctor expertise and relevant medical information that is validated against medical sources and real-world cases.
At least one large wellness company, FitBit, is experimenting with how to bridge the gap from wellness to medical health. The company has dramatically increased its R&D budget over the last four years to prepare to shift into medical-grade technology. However, CEO James Park has told Bloomberg that it’s efforts will require several more years of development.
There are some additional exceptions to moving from wellness to medical. Behavior change company 2Morrow, started as an app designed to help people quit smoking has expanded to a clinically tested behavior change platform that aims to treat chronic pain, smoking addiction, weight management, and stress management. However, it is worth noting that from the outset, 2Morrow based its app development on sound scientific research in behavior change.
Medtech is gaining experience in digital health
Without the expected outside competition, medical technology companies have driven the development of SaMD and IoT medical devices. And these products are becoming more sophisticated and valuable to users and other stakeholders. In addition, the digital health portion of almost any device development has taken on greater importance.
Device makers have gained insights into how both caregivers and patients might use devices effectively. They have also have learned much about the accuracy of data, and the need for interoperability, as well as holistic approaches to increase the value of their digital efforts. Although the industry still has not implemented all these lessons, some companies have made significant strides.
Bigfoot Biomedical is “drawing a circle around everything that it takes to manage insulin-requiring diabetes.” It looks at every aspect of the disease and its complexity and is working on ways to design simpler solutions for people with diabetes, their caregivers, and for the insurance payer. Its comprehensive approach includes devices, software and service for safer and more cost-effective insulin administration.
The automatic nature of digital health is the key to its success. In many cases, removing the barriers holds advantages beyond devices. For example, Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults.
The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.
Medical products are still facing challenges, however. One big challenge centers on the topic of cybersecurity, currently an issue of heightened concern. The increase in digital access points coupled with a lack of security training for end users, has increased the vulnerability of those records. Hospitals have been victims of cyber-attacks that hold entire care systems hostage, with patient lives in the balance. To battle these threats, the entire healthcare system has revised strategies to frame cybersecurity in a risk-based approach. The risk assessment starts, not at the IT security level, but permeates the entire development and deployment process of medical devices.
But even as the industry faces challenges, it has found more support than expected. As mentioned earlier, large electronics firms bring their advanced digital expertise and rely on the medical device industry to manage the complexities of regulatory oversight, quality control, and risk management.
Perhaps the most unexpected shift for industry was that FDA has become an unexpected ally. In the early days, many thought the digital field would be a way to bypass a sluggish regulatory system. However, FDA has transformed into a nurturing partner, willing to allow experimentation and development leeway.
In particular, FDA has begun to develop policies to align its regulatory approach with the evolving nature of digital devices. In 2017 the agency announced a digital health innovation action plan, which stated that it would hire a digital health staff, launch a digital health software pre-certification pilot program, and release new guidance documents for SaMD.
The pre-certification program establishes a new approach for a risk-based and accelerated review of digital health products by "looking first at the software developer or digital health technology developer, not the product." Nine companies have been selected for the inaugural program representing a diverse range of SaMD developers.
The SaMD documents set key definitions for Software as a Medical Device, framework for risk categorization for Software as a Medical Device, the Quality Management System for Software as a Medical Device, and the clinical evaluation of Software as a Medical Device.
Together, they state that low-risk products do not need to undergo premarket review, as well as establish evaluation protocols for SaMD applications.
The digital health evolution
As we move into the next decade, many expect to see the watershed moment at any time, the point at which medical practice, is fully digital. Perhaps we are already there, with a few minor tweaks to come. As in any technology shift, we should expect more surprises in how digital health evolves. There are certainly deeper levels of opportunity that have yet to be explored.