There are over 100,000 digital health applications currently on the market. Each of these applications was designed to give patients better control of their health, from Electronic Health Records (EHRs) that let patients access their medical data from anywhere, to wearables that allow continuous, remote monitoring of patient health.

These rapidly appearing innovative technologies are designed to be of use for players in the healthcare industry, such as hospitals and insurance companies, and indeed, these professionals greatly profit from the new tools. So what’s stopping the mutually beneficial partnerships from popping up by the minute? A complex divide: healthcare providers want to see clinical evidence before investing in a product, and many start-ups either are not aware of this necessity, or don’t have the tools to pursue it.

Challenges of Providing Evidence

In the digital health world, start-ups need to prove scientifically backed evidence to demonstrate how their product or tool actually does provide both better healthcare and business outcomes. Proving these advantages is done through a test trial or pilot, which unfortunately poses a great challenge for many start-ups. The main barriers that digital health start-ups face with providing clinical evidence include:

      1- Understanding the Need

Along with the industry as a whole, most digital health start-ups are just reaching maturity. As a result of the industry’s relative novelty, there is a lack of instructions on how to navigate regulations and expectations. With more start-ups making their way into the healthcare industry, however, it’s becoming apparent that companies must differentiate themselves from the competition.

As the buzz around digital health arose, so did the trend of healthcare professionals seeking clinical evidence, wanting assurance that they are investing in the right tools. However with the industry still being on the rise, so many start-ups are not aware of the significance of conducting a clinical evidence pilot.

      2- Designing the Pilot

Pilots must be designed properly from the very beginning. The primary challenge for providing clinical evidence through a trial is proving both the business case, and the improvement in performance. In order to accomplish this, it is essential that the pilot is managed correctly, with start-ups setting realistic expectations and focusing on their specific needs, for instance, leveraging external expertise, having a large sample size, or working consistently with advisors.

      3- A Difference in Expectations

Clinical trials are expensive, which can be prohibitive for many lean start-ups that don’t have extra overhead to spend. Along with the costs, a pilot requires that the start-up’s partner have a plethora of resources. When the pilots do take place, there may be a difference in expectations between the parties. For instance, some start-ups expect to be paid for the work involved in conducting a lengthy and costly clinical trial, while on the other hand, hospitals expect to be paid for hosting the trial. In actuality, most of the time it is the start-ups that need to pay, which means that they must have secured enough funding to conduct the pilot.

These challenges together contribute to a culture wherein acquiring clinical evidence isn’t generally a priority for start-ups leveraging new technologies. And while clinical evidence isn’t a barrier to entry for most consumers in other industries, it has become increasingly important for risk-averse healthcare providers seeking better efficiency through digital health.

The Burden of Proof

There is no shortage of healthcare applications, but all are competing for limited investor attention and resources. At times, only solutions that are both cost-effective and backed by clinical research make the cut. Fortunately, cash-strapped start-ups are receiving help from like-minded sources. Evidation Health, for instance, is an organization designed to bridge the knowledge gap between tech companies and healthcare providers. Through research and analysis, companies like Evidation are helping prove the efficacy of digital health solutions in the interest of advancing the healthcare system.

In a Competitive Market, You Have to Compete

Combining fast-moving innovative start-ups with a traditional risk-averse system can pose challenges. While the process of proving the clinical and economic viability of a tech solution is both lengthy and costly, start-ups are beginning to realize that in order to compete with other innovative companies, clinical evidence has become a must.

Interested in getting connected with innovative start-ups and healthcare providers? Explore our Finder.

Sharon Shapira manages the Digital Health Sector Strategy and activities at Start-Up Nation Central. An intelligence analyst in an elite IDF intelligence unit, Sharon was responsible for analyzing and processing intelligence in one of the unit's top divisions. She holds a BSc in Biotechnology (cum laude) from Tel-Aviv University.

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