Success Factors of Growth-Stage Digital Health Companies: Systematic Literature Review

Background: Over the past decade, digital health technologies (DHTs) have grown rapidly, driven by innovations such as electronic health records and accelerated by the COVID-19 pandemic. Increased funding and regulatory support have further pushed the sector's expansion. Despite early success, many DHT companies struggle to scale, with notable examples like Pear Therapeutics and Proteus Digital Health, which both declared bankruptcy after initial breakthroughs. These cases highlight the challenges of sustaining growth in a highly regulated health care environment. While there is research on success factors across industries, a gap remains in understanding the specific challenges faced by growth-stage DHT companies. Objective: This study aims to identify and discuss key factors that make growth-stage DHT companies successful. Specifically, we address three questions: (1) What are the success factors of growth-stage digital companies in general and (2) digital health companies in particular? (3) How do these success factors vary across DHTs? Methods: Following established PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, a systematic literature review was conducted to answer the questions. A comprehensive literature search was conducted using management and medical literature databases: EBSCO, ProQuest, PubMed, Scopus, and Web of Science. The review spanned scientific articles published from 2000 to 2023, using a rigorous screening process and quality assessment using the Critical Appraisal SkillsProgramme(CASP)checklist. Results: From the 2972 studies initially screened, 36 were selected, revealing 52 success factors. We categorized them into internal factor categories (Product and Services, Operations, Business Models, and Team Composition) and external factor categories (Customers, Health Care System, Government and Regulators, Investors and Shareholders, Suppliers and Partners, and Competitors). Of the 52 factors, 19 were specific to DHT companies. The most frequently cited internal success factors included financial viability (n=18) and market demand and relevance of the product and service (n=13). External success factors emphasized the regulatory environment and policy framework (n=15). Key differences were observed between DHTs and broader digital companies in areas such as data security (P=.03), system interoperability (P=.01), and regulatory alignment (P=.02), with DHTs showing a higher frequency of these factors. In addition, success factors varied across different DHT categories. Health System Operational Software companies emphasized affordability and system integration, while Digital Therapeutics prioritized factors related to government regulations and regulatory approval. Conclusions: Essential characteristics contributing to the success of growth-stage digital health companies have been identified. This work, therefore, fills a knowledge gap and provides relevant stakeholders, including investors and entrepreneurs, with valuable resource that can support informed decision-making in investment decisions and, in turn, enhance the success of fast-growing digital health companies.Inaddition, itprovides the researchcommunitywithadirectionforfuturestudies,enhancing the understanding, implementation, and growth of DHTs.