Understanding the viewpoint of clinicians in a healthcare setting is a vital task to comprehend the success of patients undergoing physical rehabilitation. Addressing user experience is an essential activity which designers undertake when formulating product specifications at the early stages of product design. The involvement of clinicians during the product use-phase influences the progress and achievements attained by the patients throughout their rehabilitation journey. Several clinicians (n=16) were asked to participate in a qualitative study to evaluate the performance of different personae in activities of daily living. The experiences of patients who use rehabilitation products as part of their therapy session at the clinic were evaluated. Based on this evaluation, a set of clinician requirements were formulated to reflect the overall experience when using rehabilitation products. Understanding these requirements brought about several implications to be considered during the design cycle. Through these considerations and by adopting a user-centred design approach, designers are in a better position to design innovative products targeted at providing a high-quality user experience which increases customer satisfaction.
Numerous and complex sequence of activities in medical device development often result in time consuming and expensive engineering processes. In this study, patient and designer requirements were identified and integrated within a novel framework which supports medical device design through a consolidated understanding of user-experience whilst directly coalescing the applicable regulatory requirements in terms of product compliance and certification. This assists in the development of safe and reliable products which reflect the need for increased usability considerations during design.
Research funded projects are often concerned with the development of proof-of-concept products. Consequently, activities related to verification and validation testing (VVT) are often not considered in depth, even though various design iterations are carried out to refine an idea. Furthermore, the introduction of additive manufacturing (AM) has facilitated, in particular, the development of bespoke medical products. End bespoke products, which will be used by relevant stakeholders (e.g. patients and clinicians) are fabricated with the same manufacturing technologies used during prototyping. As a result, the detailed design stage of products fabricated by AM is much shorter. Therefore, to improve the market-readiness of bespoke medical devices, testing must be integrated within the development from an early stage, allowing better planning of resources. To address these issues, in this paper, a comprehensive VVT framework is proposed for research projects, which lack a VVT infrastructure. The framework builds up on previous studies and methods utilised in industry to enable project key experts to capture risks as early as the concept design stage.
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