Expectation vs. Reality: Industry Insights on the Cost and Time to Bring SaMD to Market

Software as a Medical Device (SaMD) is more relevant than ever in today's digital-focused healthcare market. SaMD solutions allow patients and providers to interact in new ways, and streamline the sharing, tracking and analysis of data.

SaMD solutions hold tremendous potential for biopharma companies looking for ways to engage patients and providers. With so much unlocked potential in this relatively new technology, we wanted to understand how the biopharma industry is thinking about SaMD development. So we partnered with HealthXL, a digital health community and advisory company, to survey the biopharma industry about SaMD; interview digital health leaders at industry-leading global companies; and collect and analyze publicly available data for the top 30 firms for over three years. You can take a deeper look at our findings by reading our recent white paper.

“Disease management holds the most promise given the holistic opportunity it provides: Allowing patients to see how they are doing with their disease," one executive explained.

Exploring top SaMD use cases

SaMD solutions yield a significant value in a variety of use cases. According to our survey respondents, the most promising SaMD use cases are as follows:

“Oncology and hematology have big applications, as do autoimmune conditions, such as arthritis, and metabolic diseases like diabetes,” another executive told us.

Related: Software as a Medical Device (SaMD) Solutions

Evaluating important therapeutic areas

When it comes to the most active therapeutic areas, survey respondents ranked the top three categories as:

“It’s important to account for post-launch costs in a 3- to 5-year budget," a survey respondent said. "The ongoing maintenance, feature upgrades, security testing, hosting and technical support are just a few areas to consider.”

Surveying expectations and reality

We asked leaders from across top-tier global biopharma companies that had not yet brought a SaMD solution to market how much they expected the process would cost. We found 69% assumed it would cost less than $5 million. Even more surprising, 47.4% of executives thought it would cost less than $1 million.

When we asked executives who had already brought a SaMD solution to market, 57% estimated a cost of more than $5 million, and 93% thought it would cost more than $1 million.

The upshot? Senior digital health leaders reported the cost to market was about five times higher than expected. And when it came to the time it would take to bring a solution to market? Time to market was roughly three times higher than expected.

Solving cost- and time-to-market challenges

Since executives seemed surprised by the cost and time required to bring a SaMD solution to market, we came up with five tips to help solve these challenges.

To access those tips and learn more, download our white paper, Expectations vs. Reality: Cost and Time to Bring SaMD to Market.

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