A comprehensive understanding of patients and their needs is a fundamental prerequisite for the development of advanced medical products and therapies. However, in the context of digital health products, focusing solely on the patient is not sufficient. To successfully bring products to market, a wide range of stakeholders must be considered throughout the development process.

Patient centricity—the consistent alignment with patient needs and realities to create the best possible experience for them and their families—has become a core principle in the development of new pharmaceuticals and medical devices. A patient-centered product development approach is regarded as key to achieving better treatment outcomes, higher patient satisfaction, and more effective self-management, particularly for chronic conditions such as diabetes. This is especially relevant for digital health applications designed to support patients in their therapy and seamlessly integrate into their daily lives. Most manufacturers have now recognized the importance of patient centricity and have begun structuring their processes to ensure that patients are involved as early and comprehensively as possible in the development of new products.

Patient Centricity Alone Is Not Enough

However, a sole focus on the patient is insufficient. Medical devices and pharmaceuticals are part of a complex multi-stakeholder ecosystem that includes not only patients but also physicians, insurance providers, administrative bodies, and other key players in the healthcare system. Each of these stakeholders has unique requirements, interests, and contexts that must be taken into account when developing new products and solutions, aligning the value proposition accordingly.

Failure to do so can lead to products failing to integrate into the healthcare system, regardless of their efficacy or potential patient benefits. This could happen, for example, if the administrative burden on physicians is too high or if insurers refuse to cover the costs. The adoption of new solutions in the digital health sector is particularly challenging, as many stakeholders—such as physicians and insurers—have limited experience with digital health products.

Balancing Stakeholder Requirements for an Optimal Overall Value Proposition

Companies developing and launching digital health products face a threefold challenge: First, they must identify the key stakeholder groups that impact market success and understand their specific needs and incentives. Second, they need to balance, prioritize, and align sometimes conflicting requirements to create the greatest possible value for all relevant stakeholders.

A framework for managing these trade-offs is the Quadruple Aim framework, originally developed by the former head of the Centers for Medicare & Medicaid Services (CMS). This framework maps out key dimensions of high-quality healthcare, such as improving patient care experiences, enhancing population health, and reducing overall healthcare costs.

Third, this ecosystem perspective must be applied across different geographic markets. Variations in healthcare systems and cultural differences generate unique requirements that must be incorporated into the regional value proposition.

Co-Creation as the Key to Addressing Stakeholder Interests

Successfully aligning digital health products with the diverse and regionally varying demands of complex multi-stakeholder ecosystems requires a systematic approach. A critical factor in this process is early stakeholder involvement in solution development. The later in the process stakeholders are included, the less flexibility there is to incorporate their needs—and the higher the financial and time costs for making necessary adjustments.

One key decision is whether a solution or parts of it should be classified as SaMD (Software as a Medical Device) or DTx (Digital Therapeutics) or if it should be marketed as a wellness or companion app. This decision significantly impacts product design, development processes, and validation requirements.

Throughout the entire product lifecycle, continuous feedback loops should be established to ensure alignment with stakeholder requirements—from the early conceptual phase to market access. For example, identifying relevant buying centers and addressing them with the right messages through the right channels is crucial.

To analyze stakeholders and their needs effectively, companies should initially leverage industry articles, studies, and market reports to understand the workflows and challenges faced by specific medical specialties and extract initial solution requirements. However, it is equally important to gather real-world data by actively involving representatives from relevant stakeholder groups in the development process—through co-creation workshops, pilot projects, and clinical studies. Companies should not only focus on clinical endpoints for therapy evaluation but also incorporate usability testing to assess softer factors influencing product adoption.

Cultural and Regulatory Challenges

For many established pharmaceutical and medical device manufacturers, whose product development follows highly structured processes, co-creation represents uncharted territory. Additionally, the development of digital health applications—due to their software-driven nature—follows a fundamentally different logic compared to the linear processes of pharmaceutical research. This approach requires navigating a cultural shift away from existing procedural, organizational, and cultural norms. Furthermore, companies must comply with numerous regulations governing direct interactions with patients and healthcare professionals.

Conclusion

Patient centricity remains a fundamental paradigm in healthcare solution development. However, digital health products can only succeed in the market if manufacturers effectively address the needs of other stakeholders, such as physicians, caregivers, and insurance providers, by integrating relevant functionalities and incentive mechanisms. Achieving this requires not only technical and regulatory expertise but also an in-depth understanding of the specific healthcare system. When implemented correctly, a multi-stakeholder approach can significantly reduce the risks associated with developing and launching new digital health products.