IBV drives “agile and participatory” design and development of medical devices
The traditional waterfall project management model, widely used across industry, has proven to be rigid and poorly suited to environments where rapid response and user interaction are essential, such as the medical devices and healthcare technologies sector. The shift towards a more human-centred healthcare model, driven by telemedicine and patient empowerment, calls for innovative solutions that improve quality of life. To meet this need, it is crucial to accelerate the design of medical devices while complying with the stringent regulatory requirements applicable to the sector (Medical Device Regulation – MDR) and ensuring a high level of acceptance among patients and healthcare professionals.
In this context, the Instituto de Biomecánica (IBV) has developed an initiative aimed at transforming the way products are conceived, developed and validated within the medical devices sector, which is of high strategic value to the Valencian Region. The project, entitled AGILE-CV, has enabled progress in the transfer and adaptation of agile and participatory methodologies—so far scarcely implemented in the sector—providing companies with more efficient, dynamic strategies and tools aligned with current market demands. In this way, the aim is to optimise the development of new products, reduce time to market and facilitate decision-making in today’s competitive and rapidly changing environment.
The new methodology developed by IBV has involved adapting participatory methodological tools such as design thinking, lean and design sprint, among others, for application within an agile medical device development process, promoting collaboration between patients and healthcare professionals and design and development teams from companies in the sector. In addition, key aspects to be considered have been defined according to product typology and the characteristics of the healthcare market. Finally, the methodology has been validated through use cases with companies in the sector collaborating on the project.
Applied innovation and knowledge transfer to the sector
By using immersive prototyping tools and a platform developed as a participation channel, it has been possible to develop a specific methodology for validating a prototype birthing pool developed by the company Hidromasaje ECA, within the framework of medical device certification traceability. The validation focused on key aspects such as ensuring patient and professional safety, ergonomic efficiency and ease of use.
In addition, the methodology was applied with the company BibePumb to identify and define the requirements and functionalities of a baby monitoring system based on respiratory rate, as well as a minimum viable product for the associated app. This process involved the participation of end users (parents of babies) and the professional perspective of a paediatrician.
Finally, it is worth noting that the AGILE-CV project, developed by IBV (for the medical devices sector) and by AJIU (for the toy sector), is supported by the Regional Ministry of Industry, Tourism, Innovation and Trade of the Generalitat Valenciana, through IVACE+i, with funding from the European Union, via the ERDF Programme Comunitat Valenciana 2021–2027 (IMDEEA/2025/68 and IMDEEA/2025/71).
