Survey: Many digital health startups do not have clinical trials, regulatory documents

Many risk-supported digital healthcare start-ups are not clinically stable, as measured by the number of regulatory documents and clinical trials, according to study published in JMIR.

The analysis examines digital health companies using the Rock Health Digital Health Financing Database, FDA 510 (k) data, De Novo and pre-market approval documents, and the number and type of clinical trials listed on ClinicalTrials. gov. The researchers then assigned a “clinical stability” score to each company, the sum of the number of regulatory requests and the clinical trials weighed equally.

Of the 224 startups included in the study, 98 had a clinical stability score of 0, while 45 received a score of five or higher. The mean score is 2.5, with 1.8 clinical trials and 0.8 regulatory requests, and the mean score is one.

The companies that aimed to diagnose conditions had the highest average score of 2.8, followed by treatment-oriented companies with 2.2, and finally start-ups for prevention with a score of 1.9.

Startups that sold their products to employers received an average clinical stability score of 3.1 compared to 2.7 for suppliers, 2.2 for consumers and 2.0 for payers.

Researchers also looked at public statements made by companies or qualitative statements about clinical, economic and commitment outcomes. The average number of claims filed by companies is 1.3, with 43% of companies filing zero claims. The study also notes that start-ups that sell to employers make more clinical, economic and engaging claims than companies that sell to other types of customers, such as consumers, suppliers and payers.

Overall, the study did not find any relationship between clinical stability and the number of claims, stability and overall funding, or clinical stability and age of onset.

“Despite hundreds of digital health companies addressing the myriad needs across the care continuum, clinical stability and public communication of claims remain low in much of the sector,” the study authors wrote. “These results highlight a significant opportunity for companies to differentiate and for customers to demand greater validation of the products and services they buy.


The study’s authors, some of whom are members of Rock Rock’s research team, noted several limitations of the analysis, such as the possibility of skipping documents or clinical trials and the decision to include only backed by risky companies that have raised more than $ 2 million.

They suggest that future studies may use condition-specific performance indicators that can be standardized in clinical areas to provide a clearer picture of the impact.

Although the analysis found that many startups lacked clinical stability, it found that 20% of startups received a score of five or higher, suggesting a core of highly tested products. However, a number of low-performing companies have shown that many start-ups backed by risks have no clinical evidence.

“Although this subpopulation may portend progress, the lack of meaningful clinical validation for almost half of digital health companies (44% had a clinical stability score of 0) highlighted a major gap in health technology today,” the researchers wrote.

“The lack of an overall correlation between the company’s overall risk financing and its clinical stability score similarly underscores a significant asymmetry in the way companies are potentially valued in today’s market (ie there is no link between clinical impact and funding). However, it is possible that the funding amounts reflect future expected value rather than current value. “

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