An integrated model incorporating critical success factors and risk management for the development of in vitro diagnostic technologies

Abstract

Health innovation is essential for improving the quality of life, enabling solutions that expand access to and efficiency of healthcare services. Medical devices, particularly in vitro diagnostic tests (IVDs), which are conducted on biological samples outside the human body, play a critical role in diagnosis and treatment management, facilitating decentralized care and bringing healthcare closer to patients. However, developing such technologies is complex, as it involves technical, regulatory, market, and managerial challenges. In this context, the New Product Development (NPD) process helps address these barriers by guiding the use of management practices and tools that support development. Among these, NPD models structure processes, assist decision-making, support risk monitoring, and facilitate cross-functional integration. Although numerous models exist in the literature, a gap was observed regarding models specifically focused on IVD development, which is relevant because more general models may limit applicability in this context. Therefore, this study aimed to propose a model incorporating critical success factors and risk management practices to support the development of new in vitro diagnostic technologies. To achieve this, the Design Science Research (DSR) method was adopted. The DSR method guides the construction of artifacts (the NPD model) capable of solving real-world problems, in this case, providing a structured representation of the NPD process. Initially, a Systematic Literature Review was conducted to map gaps and identify models applicable to medical device development. Based on these findings, the development stages, six critical areas, and a risk management approach were defined, which underpinned the first version of the model (v.1). Subsequently, interviews and questionnaires with seven professionals allowed the identification of challenges, critical factors, and stakeholders, leading to the first optimization (v.2) by integrating empirical data with literature findings. Evaluation with six specialists and a focus group led to a second optimization (v.3), incorporating practical context insights and confirming the model’s potential for IVD applications. Finally, the last stage consolidated the lessons learned, resulting in the final version of the model (v.4), named IRIS (Integrated Risk and Innovation Strategic), accompanied by supporting materials to facilitate its application in real-world scenarios. This study presents an innovative proposal by developing an NPD model tailored to IVDs, even though it integrates existing elements. The tool, which has a national focus, contributes to expanding knowledge and consolidating good practices related to critical success factors and risk management. Among the limitations, the following stand out: the small number of respondents and the fact that the model may not yet address all IVD-specific requirements, necessitating continuous refinement. These limitations, however, open opportunities for future research, such as applying the model in real projects and enhancing it with new tools and metrics. In summary, the developed model not only expands academic knowledge but also serves as a practical resource to support the development of diagnostic technologies that positively impact health and quality of life.