Software as a Medical Device (SaMD) is a hot market in digital health, and it is forecast to explode into a $56 billion global market by 2025. BrightInsight has been on the leading edge, helping our customers like Roche and Sanofi bring compliant SaMD solutions to market faster, around the world.
In an effort to help our customers understand this developing market and execute the best SaMD solutions possible, we conducted market research with HealthXL, a digital health community and advisory company. That included surveying the biopharma industry, analyzing nearly three years' worth of data about the top 30 pharma companies, and interviewing digital health leaders with significant experience developing and launching SaMD solutions. Here are five key SaMD takeaways from these digital health leaders.
Leveraging a platform is where the big opportunities lie. The key opinion leaders expressed excitement about the potential for SaMD solutions to support the many steps in the patient journey, which could all be accessed on the same platform. This would be life changing for patients and care teams alike.
Pharma companies also find that utilizing a platform saves them time and money and optimizes regulatory processes, helping them get to market more efficiently.
“The big opportunity is the platform play—to build digital modules for the entire patient journey. Expand beyond ‘digital therapeutic’ to diagnosis, management and everything in between. We could be doing screening, diagnosis, prescription, treatment and assessment all remotely on software. This is where it’s going: ‘End to end.’”
Many pharma companies are choosing to partner up in order to launch SaMD solutions. This is due, in large part, to the sticker shock companies often experience when launching SaMD on their own. Our survey found that bringing SaMD to market takes three times as long and costs five times more than expected on average.
Building on a compliant platform makes a world of difference. However, the digital health leaders we spoke to preferred solutions that are customizable. Finding a partner with a pre-built platform that can be customized and configured to fit your unique needs and use cases can speed time to market and reduce overall costs. Just make sure to choose a partner that meets the same quality standards as your company.
"Selecting the right partner is not only a technology fit; the culture fit is also important. Identifying a model, how you commercialize it and in what market, becomes a critical conversation. Also you want to test these claims; there needs to be due diligence, proof of concept and so on. It is a fairly comprehensive approach, and the initial set-up phase can be quite complex, but all of that adds flexibility."
The digital health leaders we spoke to noted that regulatory compliance is one of the top challenges in the space, especially in foreign markets. Regulations are constantly evolving, and there are significant differences in regulatory approaches from one region to another. Look for a partner that brings new perspectives and expertise that can optimize your process—this expertise can save you headaches down the line.
“I think the challenge is that the regulatory framework is not harmonized across the globe. It needs to be adaptive; it is rather easy to leave it with the legal manufacturer who deals with that complexity. This is where the partner model has a lot of benefits. Leaving that to the partner is a risk mitigation in terms of liability issues.”
When we surveyed industry leaders, over 60% of respondents found disease management to be the most promising use case. Close behind were patient adherence and patient diagnosis. Ultimately, SaMD has exciting potential for matching patients to the right treatment and dose faster, which in turn can improve quality of life and outcomes.
"Throughout the patient journey, there is opportunity. Diagnosis and clinical decision support systems are enabled by data-based algorithms, and advanced analytics provide clear risk stratification to aid diagnosis and early detection, or to triage treatment options. Detection and even screening are the next layer of SaMD. In disease management and continuous care management there are complementary therapeutics that have feedback loops to the care team or the patient, such as cognitive behavioral therapy or nutrition support."
Experts see potential for SaMD to accelerate care in many therapeutic areas. Metabolic disease is currently the most active area, but 75% of pharma execs suggested that neurology has significant potential for SaMD solutions. Other promising therapeutic areas include oncology, cardiovascular and autoimmune.
"There are potential opportunities across all therapeutic areas, but chronic diseases— where patient behavior is a key element of good outcomes—hold a lot of promise. Neuroscience and oncology are also very interesting. In neuroscience, SaMD has the opportunity to have disease-modifying impact, while in oncology SaMD can help to provide better insights on patients in between their care visits.
The BrightInsight Platform helps biopharma and medtech companies build, scale and maintain digital solutions while supporting ever-changing global security, privacy and regulatory requirements. We help bring digital health solutions to market faster with the goal of improving patient outcomes.
To learn more about launching SaMD solutions, check out our recent White Paper, Expectation vs. Reality: Cost and Time to Bring SaMD to Market or reach out to us
directly with any questions.