While a great idea and good business acumen have scaled strong Digital Health companies over the past decade, there is a shift in focus to proof points, with Clinical Strength being a priority data point. Galen Growth first published its industry-leading research report in 2022 looking at the Clinical Strength of a Digital Health venture by evaluating a venture’s clinical trials, regulatory filings, and peer-reviewed publications.

This report dives deep into the Global Digital Health ecosystem to demonstrate the importance of proof points for ventures to attract funding, types of products that have proven Clinical Strength, as well as the growth of proof points and its impact on venture success.

Key Insights

• There is a shift in focus underway in Digital Health to proof points, with Clinical Strength being a priority data point. Across the globe, 18% of all private Digital Health ventures have proven Clinical Strength through Clinical Trials, Regulatory Filings, or Peer-Reviewed Publications.
• The regulatory landscape for Digital Health is becoming more favorable across the globe, with the FDA releasing the Digital Health Policy Navigator in January 2022 and the German DiGA program growing to over 50 successful applications. With 22% share of ventures boasting proven Clinical Strength, Europe takes the top spot
• Digital Health ventures can benefit from partnerships that provide them with access to patients, funding, and medical knowledge. In the top 5 Digital Health Clusters (by % of ventures with Clinical Strength), ventures with proven Clinical Strength have at least a 1.3x higher share of partnerships than ventures without proven Clinical Strength.
• Navigating health-related apps, software and devices remains a challenge, with healthcare providers and payers requiring proof points of the product’s benefit to the intended user. HealthTech Alpha has catalogued over 16,000 products (mobile apps, software, and devices) that have been developed by private ventures focused primarily on Digital Health. 22% of the Digital Health apps were developed by ventures that have proven Clinical Strength.
• Investors are focusing their funds more on ventures that can provide evidence of their solution’s effectiveness. Within the Remote Devices Cluster, 64% of Growth- and Late-Stage ventures have proven Clinical Strength. 81% of the cumulative funding value from 2022 – H1 2023 deployed to ventures in this cluster went to ventures with proven Clinical Strength.

The “Global Digital Health Innovation Thematic Report on Clinical Strength in Digital Health” report includes data on the following companies: CyMedica, Neurophet, AstraZeneca, Roche, Novartis, NHS, Mayo Clinic, Tempus, Lunit, 23andME, SOPHiA Genetics, Helix, HeartFlow, Idoven, Health.io, Saluda Medical, Synaptive Medical, Augmedics, Spect, Owlstone Medical, Mojo Vision, Eargo, Finni Health, Densitas, Hygieia, Selfapy, Perspectum, Castor, Eyetelligence, SigTuple Technologies, The Intellect Company, Droobi Health, Neteera Technologies, Distalmotion, Aledade, Cognito Therapeutics, EOFlow, Lucira, Winterlight Labs, Limbix, XRHealth, Medtronic, Pfizer, Cambridge Cognition, Big Health, Geisinger, Chugai Pharmaceutical, MD Anderson Cancer Center, Novo Nordisk, Point32Health, Freenome, Biofourmis, Generate Biomedicines, Diabeloop, Valera Health