A Limb Hypothermia Wearable for Chemotherapy-Induced Peripheral Neuropathy: A Mixed-Methods Approach in Medical...

Area of Science:

• Medical Device Design
• Biomedical Engineering
• Oncology Support

Background:

• Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a significant dose-limiting side effect of taxane chemotherapy, causing debilitating pain and sensory loss.
• Current prevention and treatment strategies for CIPN are limited, highlighting an urgent need for effective interventions.
• Limb cryocompression shows promise in mitigating CIPN severity, but dedicated medical devices are lacking.

Purpose of the Study:

• To document the design and development process of a wearable arm wrap for limb cryocompression, a key component of a dedicated CIPN prevention system.
• To outline a collaborative, multidisciplinary approach integrating clinical, academic, design, and commercial expertise for medical device development.
• To detail the application of a novel mixed-methodology (HudPAX) combining evidence-based and user-centered techniques for optimizing the design process.

Main Methods:

• Utilized a collaborative, multidisciplinary approach involving clinical, academic, design, and commercial expertise.
• Employed a novel mixed-methodology (HudPAX) integrating evidence-based and user-centered design principles.
• Incorporated computer-aided design, rapid prototyping, additive manufacturing, and expert focus groups for iterative design and feedback.

Main Results:

• Successfully designed and developed alpha prototypes of the wearable arm wrap from concept to a trial-ready stage.
• Demonstrated the integration of clinical data, ergonomic insights, and user feedback into the design process.
• Established a pathway for progression to beta prototyping for large-scale efficacy trials and manufacturing.

Conclusions:

• The study successfully demonstrates a novel mixed-methods approach for early-stage medical device design and development.
• Cross-sector multidisciplinary collaboration is crucial for addressing the complex challenges in developing innovative medical devices like the CIPN prevention system.
• The developed wearable arm wrap represents a significant step towards a dedicated solution for preventing chemotherapy-induced peripheral neuropathy.