Designing and developing medical wearables are inherently complex and capital-intensive processes in small and medium enterprises (SMEs), which are accompanied by several challenges. This thesis focuses on the above topic through a case study of designing a novel one-size-fits-all leg cryo-compression wearable to prevent the debilitating side effect of cancer treatment known as Chemotherapy-Induced Peripheral Neuropathy (CIPN). SMEs generally operate with limited resources and infrastructure and lack a structured or formalised procedure for new product development. This often forces them to adopt a more flexible, iterative and multidisciplinary approach to design development. The case study explains the research conducted by the researcher in a collaborative partnership between Paxman Coolers Ltd., the University of Huddersfield, and the National University of Singapore through an Innovate UK-funded Knowledge Transfer Partnership (KTP) project. The collaborative and multidisciplinary efforts of the team provided a robust foundation for navigating the complexities of medical device design, particularly in addressing stringent medical regulatory systems and market requirements. Stakeholder engagement from the very early stages of design development is deemed an essential consideration for optimal wearable design development, with continuous feedback from patients and healthcare providers critical in the refinement of wearable ergonomic fit, usability, and overall functioning within real-world scenarios. The thesis also emphasises the significance of an iterative design process that adapts to usability feedback and external challenges, such as the COVID-19 pandemic and global supply chain disruptions. It also highlights the critical role of academic partnerships in providing SMEs with the necessary tools and expertise to develop medical wearables that are both commercially viable and meet the highest standards of safety and efficacy. Overall, this research highlights that while medical wearable design is challenging in an SME setting, it can be efficiently approached through a multidisciplinary, collaborative approach that integrates human-centred design principles, accesses ergonomic and anthropometric data, and keeps within the medical regulatory framework. These strategies can help SMEs produce safe and efficacious wearable products for regulatory compliance and commercialisation.
| Date of Award | 23 Jul 2025 |
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| Original language | English |
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| Sponsors | Paxman Scalp Cooling & Innovate UK |
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| Supervisor | Andrew Hewitt (Main Supervisor) |
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