April 11, 2024
Dr. Henry Mahncke

CEO of Posit Science, developers of the BrainHQ brain training program. Focused on digital health and bringing science to the people.

Digital health startups have a unique challenge compared to other software startups. They have to show that their service actually works—not just that it “works” like any software works (the app opens, the data is saved, there aren’t any show-stopping bugs), but that it actually works.

For example, a weight loss app should have data showing users lose weight, or a mental health app should have data showing that it helps with a user’s mental health. At our company, BrainHQ, we make a brain training app, and it’s essential to have gold-standard scientific evidence that it improves brain health and performance.

The difference between a digital health app with evidence and without evidence is enormous. Scientific evidence lets an app make strong evidence-based marketing claims that matter to users and drive growth—”54% reduction in time to fall asleep” (from sleep-training app Sleep.io) or “think faster, focus better, and remember more” (from BrainHQ). An app without scientific evidence must fall back on generalized, often weak claims.

Evidence-based claims can make the difference between being a flash in the pan and driving sustained commercial success across consumers, healthcare provider networks and insurance payors.

Steps To Build A Flywheel Of Scientific Validation
How can a new digital health startup get this kind of scientific evidence? As randomized controlled trials take money and time, building a flywheel of scientific validation—an engine that started slowly, then spun up to the point where dozens of papers are published annually—can be a successful strategy. Here’s how this can be accomplished.

1. Start the flywheel by making friends.
The first step is to form a scientific advisory board (SAB) composed of academic scientists who are thought leaders in your field of digital health and who are excited about bridging the industry/academic divide. Perhaps you know a few already through the work you’ve done developing your digital health program, or perhaps you can get a friendly introduction to a few.

If it comes down to it, you can cold-email researchers with a brief note (remember, these are busy people) describing your science and asking if they would be interested in learning more and considering joining your SAB.

2. Push the flywheel by making your research program their research program.
Scientific studies (especially for innovative commercial programs) need academic partners, often for access to patients and always for credibility.

One approach I recommend avoiding is approaching academic scientists with your digital health app and asking them to run a study for you. Regardless of how cool or “guaranteed to work” the app is, academic scientists have their own research priorities. Their time is typically already 100% spoken for by existing research programs.

To become a part of that 100%, consider collaborating on a grant. The National Institutes of Health (and virtually every other large federal agency) is mandated by Congress to offer Small Business Innovation Research (SBIR) grants. These grants can only go to qualified small businesses, which means that, while they aren’t easy to get, they also are not as brutally competitive as the research grants that academic scientists are fighting for.

SBIRs (and their cousins, Small Business Technology Transfer grants) allow you to fund research activities by your academic partner at their university using your digital health program. This is a win for your company and a win for your academic partner.

3. Accelerate the flywheel by making their research program your research program.
After you have a few high-quality scientific publications, you may find that researchers begin to reach out to you to ask if they can use your digital health program in their grant-funded studies. This is an incredible opportunity to advance the science of your field while making friends and advocates.

At BrainHQ, for example, we responded to a growing interest by developing an investigator-initiated research program. In a case such as this, a key goal for success is to provide great scientific support to academic partners and provide your app to virtually any qualified investigator.

It’s important to distinguish between company-sponsored research (where you should maintain very tight control over the protocol to answer specific research questions important to advancing your business) and investigator-initiated research (where you won’t get to influence the protocol in any way beyond ensuring that good science is being done).

4. Keep the flywheel spinning by becoming the partner of choice.
As your scientific credibility and published research grow, you may find that academic scientists, who have invented something new in your field, approach you to become their commercialization partner. As you know better than anyone, it’s not easy to start a company. You should view academic innovations not as competitors but as part of your product roadmap.

Academic scientists want their innovations to make a difference in the world and to be brought to market by people who understand the importance of good science. Being that partner can accelerate your own pace of innovation.

Summing It All Up
Science matters in digital health. It’s a new field, and its development must go forward on solid, evidence-based ground. Building out your science in the right way can help ensure that your innovations can take their rightful place in healthcare alongside pharmaceuticals and medical devices.