Background The healthcare industry is undergoing rapid transformation and progress, fueled by technological advances and the growing need for accessible, affordable, and high-quality healthcare services. While there has been significant progress in digitizing healthcare, especially during the COVID-19 pandemic, there is still considerable untapped potential for digital therapeutics (DTx). According to a report by Bloomberg, the digital health market is projected to reach $1.5 trillion by 2030. However, most ventures in the space struggle to gain traction and eventually stop operations. Also, the diverse regulatory guidelines across countries challenge the scalability of DTx. Objective The protocol described here outlines the methodology for a systematic review which's objective is to identify factors that contribute to the successful scaling of digital health companies that have a validated product or service, i.e., growth-stage companies. A further objective is to highlight the key metrics used to quantify success in digital health companies. Method We will search business and scientific databases, including EBSCO, PubMed, ProQuest, and Scopus, summarize the key findings and highlight the specific success factors relevant to the Digital Health Technologies (DHT) industry. The quality of the selected studies will be assessed using the critical appraisal skills program (CASP) checklists. Expected outcome The literature review's primary objective is to identify essential characteristics and recurring patterns that significantly contribute to success among growth-stage digital health companies. It will bridge the existing knowledge gap and provide stakeholders, including investors and entrepreneurs, with a valuable resource that supports informed decision-making and enhances the success of growth-stage digital health companies. OSF Registration: https://doi.org/10.17605/OSF.IO/UYJCA

EP, LB, MN, and TK are affiliated with the Centre for Digital Health Interventions (CDHI), a joint initiative of the Institute for Implementation Science in Health Care, University of Zurich, the Department of Management, Technology, and Economics at ETH Zurich, and the Institute of Technology Management and School of Medicine at the University of St. Gallen. CDHI is funded in part by CSS, a Swiss health insurer, the Swiss growth-stage investor MTIP, and the Austrian health provider Mavie Next. TK is also a co-founder of Pathmate Technologies, a university spin-off company that creates and delivers digital clinical pathways. However, this research did not involve CSS, Mavie Next, or Pathmate Technologies. EP and CK work at MTIP, a Swiss healthtech growth equity firm that helps founders scale up successful and sustainable digital health businesses.

This study did not receive any funding

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