Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a common dose-limiting side-effect of taxane-based chemotherapy, causing progressive and often irreversible pain/sensitivity in the hands and feet. Prevention/treatments for CIPN are not well-developed and urgently needed. Limb cryocompression during chemotherapy has demonstrated promising early data of preventing/reducing CIPN severity. Currently there are no medical devices available that are dedicated to the specific requirements of CIPN prevention. As part of our ongoing development of a dedicated CIPN-prevention limb cryocompression system, this study documents the design & development of the wearable arm wrap, a central component of the system, from initial concept to a trial-ready prototype. A collaborative and multidisciplinary approach was adopted to address the complex and high-risk nature of this SME (Small Medium Enterprise)-centered medical device design & development process. The complementary collaboration unites multidisciplinary expertise spanning the scope of the project. Alongside the clinical, academic, and design & development expertise, the integration of commercial expertise is imperative to promote the market viability, and ultimate success, of the development. As the global leading experts in scalp cooling specializing in the prevention of chemotherapy-induced alopecia, UK-based SME Paxman Coolers Ltd is optimally positioned to support the commercial and regulatory dimensions. Development and adoption of a novel mixed-methodology (HudPAX) facilitated the integration of evidence-based and user-centered techniques to optimize the design & development approach and ensure integration of all critical design inputs. Alpha prototypes were designed through evidence-based approaches, with data from existing clinical trials utilized to determine the preliminary design inputs, alongside 3D ergonomic data. Investigations utilized computer-aided design, rapid prototyping, additive manufacturing, sketch modeling, and fast ideation. User-based approaches facilitated stakeholder-feedback through expert focus groups, informing further design & development and projecting the design into the next stage, Beta prototyping, for use in large-scale efficacy trials and upscaling manufacturing. This paper demonstrates a novel mixed-methods approach, which promotes cross-sector multidisciplinary collaboration, to address the complex multi-layered challenges posed by an early-stage medical device design & development process.

This paper examines a long-term study on patient experience to identify value generated through collaborative medical design research, in developing a scalp cooling device to prevent chemotherapy-induced alopecia (CIA)/ hair-loss. Developing a new medical device is long and complex, requiring a cross-platform multi-disciplinary team. User feedback is essential to ensure continuous development to improve efficacy. Qualitative and quantitative data was gathered from chemotherapy patients using scalp cooling in 9 different countries.Analysis of patient experience captures the impact design research has had for scalp cooling patients globally and guides continuous development, placing the patient at the centre of the design method, driven primarily by the aim of maximising treatment efficacy for all patients and promoting positive patient experiences. Overall, patient experience of scalp cooling using this device is highly positive and impacts significantly on five key areas of wellbeing. The outcomes will help develop an improved cap for global use.

Scalp cooling is a clinically proven treatment for addressing chemotherapy-induced alopecia (CIA). Previous studies show that the efficacy of this treatment relies on accurate cranial data so that designers can produce close-fitting scalp cooling caps. The cephalic index is often used, but are that data still accurate? In this literature review, we identified and explored previous studies concerning head size and shape with the goal of identifying shortcomings for design purposes. The literature review indicates that a more suitable method is needed to collect data to enable mass customisation of scalp cooling caps. Head data are more complex for design.

The volume and complexity of Biomedical Imaging (BMI) data can be handled by well-known Product Lifecycle Management (PLM) solutions if a research study in this field is modeled as a cyclic process of four phases: study specifications; raw data acquisition; data processing and results publication. However, current PLM systems do not provide easy, flexible and user-adapted data access, especially in the context of heterogeneity expertise environments such as BMI. This paper presents VAQUERO (VisuAlization and QUERy based Ontology), a visual ontology-based data query approach, that aims at providing different kinds of users in the BMI field (common/ external, domain expert and technical users) with easy self-access to their data stored in a PLM Teamcenter system.

Scalp cooling is a clinically proven treatment for addressing chemotherapy-induced alopecia (CIA). Previous studies show that the efficacy of this treatment relies on accurate cranial data so that designers can produce close-fitting scalp cooling caps. The cephalic index is often used, but are that data still accurate? We conducted a pilot study to explore mass customisation of scalp cooling caps.