A human-centred design framework for developing smart healthcare products in an IPD context

Abstract

The development of smart healthcare products is rapidly transforming patient care, enabled by advances in technology, Internet of Medical Things (IoMT), and artificial intelligence (AI). However, these innovations exist within a highly regulated and multidisciplinary context that demands not only functional and manufacturable products, but also solutions which are safe, usable, and desirable. Although Integrated Product Development (IPD) offers a structured approach focused on cross-functional collaboration ensuring product quality, accelerated time-to-market, and reduced development costs, it often lacks deep engagement with other factors such as user experience (UX). On the other hand, Human-Centred Design (HCD) prioritises function, usability, and empathy for users but does not sufficiently address the crossfunctional dependencies presented in IPD. This dissertation proposes a new theoretical framework that vertically integrates the principles of HCD within the IPD context for the development of smart healthcare products. The framework builds upon the traditional IPD pillars of design, manufacturing, and business by incorporating additional pillars, identified as human factors (HF) and regulatory which are pivotal to the healthcare industry. Using other established design research methodologies, a theoretical framework was iteratively developed and refined through a data gathering survey and two validation surveys. The key findings from the final validation survey indicated strong support for the usability and relevance of the new framework, with the majority of participants agreeing that the model effectively addressed both cross-functional integration and the vertical integration of HCD and IPD as well as addressing the software aspects cybersecurity and data privacy. The developed framework enables a structured, phase-based approach that integrates both the user needs and the technical considerations from the earliest stages of development. While this framework provides a more holistic approach to the development of smart healthcare products, limitations in the study’s survey sample sizes and scope are acknowledge. Future work is recommended to use the developed framework to develop a real-world case study and to expand the framework’s consideration of human interaction at other levels of product development such as at the manufacturing level.