Software as a Medical Device (SaMD) is one of the hottest segments in digital health. And it’s easy to see why: it’s changing how patients and providers interact and streamlining the way data is shared, tracked and analyzed.
In partnership with HealthXL, a digital health community and advisory company, we surveyed the pharma industry about SaMD, interviewed top digital health leaders and analyzed publicly available data for the top 30 firms over a nearly three-year period.
The insights from this survey reveal the huge potential for SaMD for biopharma, as well as the potential pitfalls.
61% of survey respondents said that disease management is the most promising use case in SaMD. Other strong contenders include patient adherence and patient diagnosis.
Our market analysis found that the most active therapeutic area across SaMD is metabolic diseases, which accounts for 30% of engagements.
Drilling down further, the most common indications within SaMD are diabetes, asthma, cancers and heart failure.
We found that the expectation of what it would take to successfully launch a SaMD product was different from reality in two important ways: cost and time.
In fact, 55% of the key opinion leaders we interviewed expected development of a SaMD project to take just one to two years, when in reality 66% of them said their projects took three years or more to launch.
Meanwhile, our survey found that 71.4% of firms that had brought a SaMD to market misestimated the cost.
Estimates of the cost required to bring SaMD to market varied considerably between firms that had already launched a SaMD product and those that had not. Nearly 70% of firms that had not launched a SaMD expected it to cost less than $5 million, while nearly 60% of those that had launched a SaMD reported spending $5 million or more.
One executive insight from our interviews with digital health leaders:,
"External partners—like BrightInsight—can save about two thirds of the cost per SaMD solution."
