⚡ Quick Summary
This study explores the landscape of digital health business models within the European Union, identifying 11 central dimensions and 6 archetypes that characterize these models. The findings underscore the importance of navigating medical device regulations and developing innovative reimbursement pathways for successful commercialization.
🔍 Key Details
- 📊 Sample Size: 169 European real-world business models analyzed
- 🧩 Methodology: Systematic literature review, expert interviews, and clustering analysis
- ⚙️ Taxonomy Developed: 11 dimensions organized into 4 meta-dimensions
- 🏆 Archetypes Identified: 6 distinct business model archetypes
🔑 Key Takeaways
- 📊 Business Model Taxonomy includes 11 dimensions crucial for DHTs.
- 💡 Six archetypes of digital health business models were identified, each with unique characteristics.
- 🏥 Key drivers for innovation include targeting patients directly and utilizing artificial intelligence.
- 🔄 Surprising patterns were found, such as shifts between regulated and unregulated applications.
- 💰 Revenue models often involve reimbursement from health insurers.
- 🌍 Study enriches understanding of digital health business models for researchers and entrepreneurs.
📚 Background
The healthcare industry is facing numerous challenges, including rising costs and the need for improved care quality. Digital health technologies (DHTs) have emerged as a potential solution, yet their commercialization is complicated by extensive regulations and a diverse array of stakeholders. Understanding the business models that underpin DHTs is essential for navigating this complex landscape.
🗒️ Study
Conducted through a mixed-methods approach, this study aimed to develop a comprehensive taxonomy of business models for DHTs in the European Union. The research involved a systematic literature review, analysis of 169 real-world business models, and qualitative evaluations through expert interviews, culminating in a clustering analysis to identify distinct archetypes.
📈 Results
The study revealed a taxonomy comprising 11 central dimensions organized into 4 meta-dimensions. The analysis identified 6 archetypes of DHT business models: administration and communication supporter, insurer-to-consumer digital therapeutics and care, diagnostic and treatment enabler, professional monitoring platforms, clinical research and solution accelerators, and direct-to-consumer wellness and lifestyle.
🌍 Impact and Implications
The findings of this study have significant implications for the future of digital health. By highlighting the critical elements of business models in the DHT domain, stakeholders can better navigate the regulatory landscape and develop sustainable, innovative solutions. The identification of key drivers for innovation, such as the use of artificial intelligence and the establishment of DHT-specific reimbursement pathways, paves the way for enhanced patient care and improved health outcomes.
🔮 Conclusion
This research provides valuable insights into the evolving landscape of digital health business models. By establishing a structured understanding of the archetypes and dimensions that characterize these models, the study equips researchers and entrepreneurs with the knowledge needed to thrive in a regulated market. The future of digital health looks promising, and continued exploration in this field is essential for unlocking its full potential.
💬 Your comments
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Business Venturing in Regulated Markets-Taxonomy and Archetypes of Digital Health Business Models in the European Union: Mixed Methods Descriptive and Exploratory Study.
Abstract
BACKGROUND: Digital health technology (DHT) has the potential to revolutionize the health care industry by reducing costs and improving the quality of care in a sector that faces significant challenges. However, the health care industry is complex, involving numerous stakeholders, and subject to extensive regulation. Within the European Union, medical device regulations impose stringent requirements on various ventures. Concurrently, new reimbursement pathways are also being developed for DHTs. In this dynamic context, establishing a sustainable and innovative business model around DHTs is fundamental for their successful commercialization. However, there is a notable lack of structured understanding regarding the overarching business models within the digital health sector.
OBJECTIVE: This study aims to address this gap and identify key elements and configurations of business models for DHTs in the European Union, thereby establishing a structured understanding of the archetypal business models in use.
METHODS: The study was conducted in 2 phases. First, a business model taxonomy for DHTs was developed based on a systematic literature review, the analysis of 169 European real-world business models, and qualitative evaluation through 13 expert interviews. Subsequently, a 2-step clustering analysis was conducted on the 169 DHT business models to identify distinct business model archetypes.
RESULTS: The developed taxonomy of DHT business models revealed 11 central dimensions organized into 4 meta-dimensions. Each dimension comprises 2 to 9 characteristics capturing relevant aspects of DHT business models. In addition, 6 archetypes of DHT business models were identified: administration and communication supporter (A1), insurer-to-consumer digital therapeutics and care (A2), diagnostic and treatment enabler (A3), professional monitoring platforms (A4), clinical research and solution accelerators (A5), and direct-to-consumer wellness and lifestyle (A6).
CONCLUSIONS: The findings highlight the critical elements constituting business models in the DHT domain, emphasizing the substantial impact of medical device regulations and revenue models, which often involve reimbursement from stakeholders such as health insurers. Three drivers contributing to DHT business model innovation were identified: direct targeting of patients and private individuals, use of artificial intelligence as an enabler, and development of DHT-specific reimbursement pathways. The study also uncovered surprising business model patterns, including shifts between regulated medical devices and unregulated research applications, as well as wellness and lifestyle solutions. This research enriches the understanding of business models in digital health, offering valuable insights for researchers and digital health entrepreneurs.
Author: [‘Weimar SN’, ‘Martjan RS’, ‘Terzidis O’]
Journal: J Med Internet Res
Citation: Weimar SN, et al. Business Venturing in Regulated Markets-Taxonomy and Archetypes of Digital Health Business Models in the European Union: Mixed Methods Descriptive and Exploratory Study. Business Venturing in Regulated Markets-Taxonomy and Archetypes of Digital Health Business Models in the European Union: Mixed Methods Descriptive and Exploratory Study. 2025; 27:e65725. doi: 10.2196/65725