Bridging Gaps in Healthcare Innovation: A Systematic Review of Design Methodologies for Problem Discovery in Technological Health Products

Digital health and medical technology products are often developed with strong technical expertise but shallow early problem framing. This can lead to misaligned solutions, rework, and low adoption in real-world care. This systematic review synthesizes how design methodologies are used to deepen problem understanding during the creation of technological healthcare products. We followed PRISMA 2020 guidance and structured the protocol using PICOC. We searched PubMed, Scopus, ScienceDirect, and BVSalud for peer-reviewed articles in English published from 2016 onward that described frameworks or methodological processes for developing technological health products. A nine-item quality checklist assessed how clearly studies reported procedures, objectives, structures, challenges, limitations, and multidisciplinary collaboration. The search identified 513 records; 33 full texts were screened, and 11 studies met the inclusion criteria. Most used a human-centered, user-centered, or participatory design to support the development of medical devices, monitoring systems, digital mental health services, reproductive health platforms, and tools for older adults and children. Design methods were widely applied to improve usability, acceptability, and experience, and to address the needs of specific populations. However, most frameworks focused on solution refinement and usability testing rather than deep, systematic early-stage problem discovery, and regulatory, data, and interoperability constraints were rarely integrated in the initial design phases. The review indicates that design methodologies play an important role in the included health innovation literature but also reveals a gap: there is no consolidated, early-stage instrument that links problem discovery, evidence synthesis, and explicit go/hold/no-go decisions for technological health products.