Software as a Medical Device (SaMD) has become an increasingly important tool in the healthcare arsenal in recent years, and its growth is likely to accelerate in 2022. And with good reason, as SaMD and other digital solutions reshape patient-provider interactions and reveal the power of data sharing, collection and tracking.
If you aren’t familiar with SaMD, it’s software developed specifically to prevent, diagnose, treat, or manage medical conditions, without hardware. Read our blog, Everything You Need to Know About Software as a Medical Device, for more info.
Here are some key trends and updates to keep an eye on throughout the coming year:
With its recently released draft guidance update—the first since 2005—the agency is looking to clarify and streamline the process, according to Sonia Nath, Partner at Cooley LLP. Rather than the three-tier "Levels of Concern" framework instituted in 2005, under the new guidelines, each SaMD product will be classified as "basic" or "enhanced risk."
Nath says the rationale for the guidance is to be more explicit about what regulators need to speed up the approval process and cut down on the back-and-forth with applicants.
"I don't see it as increasing the burden so much as the agency making sure that companies are thinking about the full product lifecycle and development at the time of submission, and that they have these elements that will be the backbone of their Quality Management System," she says.
The draft guidance update is also an indication of increased SaMD development, as the FDA tries to keep pace with an influx of cutting-edge submissions.
Another factor leading to more SaMD development is the increasing prevalence of Virtual First Care, or V1C. The COVID-19 crisis pushed V1C to the forefront, allowing healthcare providers to deliver care without risking physical contact. That makes remote disease management tools like SaMD even more urgent.
With the expansion of CMS reimbursement for virtual care, V1C is beginning to be regarded as a default starting point for healthcare delivery going forward. And with virtual health visits expected to rise further, so too will the demand for regulated connected devices and SaMD to monitor patient health between appointments.
So, what can you expect for 2022? To help answer that question, we partnered with HealthXL to interview digital health executives at top-tier global companies, survey SaMD activity at the leading 30 firms and analyze publicly available data from an almost three-year period. Here are some of the key takeaways:
"Disease management holds the most promise given the holistic opportunity it provides: Allowing patients to see how they are doing with their disease. But diagnostics and monitoring are also big opportunities in this space."
"Oncology and hematology have big applications, as do autoimmune metabolic diseases. There is also potential in rare diseases."
"It’s important to account for post-launch costs in a 3- to 5-year budget. The ongoing maintenance, feature upgrades, security testing, hosting and technical support are just a few areas to consider."
"External partners—like BrightInsight—can save about two thirds of the cost per SaMD solution."