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

Abstract

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.

A randomized controlled trial of hand/foot-cooling by hilotherapy to prevent oxaliplatin-related peripheral neuropathy in patients with malignancies of the digestive system

“…Meanwhile, other devices for delivering continuous hand/foot-cooling during chemotherapy are being developed. 7 …”

“… 2 , 3 , 4 , 5 , 6 Given the lack of evidence on drug or non-drug prophylaxis or treatment, education on avoiding cold touch and oxaliplatin dose modification remain the only strategies for managing OIPN today. 1 , 7 …”

Cryotherapy for Prevention of Taxane-Induced Peripheral Neuropathy: A Meta-Analysis

“…Cryotherapy was shown to prevent TIPN through local vasoconstriction in an animal study, further reducing delivery of the neurotoxic chemotherapy to the peripheral nerves ( 25 ). Moreover, cryotherapy is a safe and easy-to-operate method in clinical settings ( 26 ). Thus, cryotherapy is considered a promising method for TIPN.…”

Human head analysis for mass customisation in medical design: A pilot study

“…This pilot study used the HudPAX approach 11 , a hybrid method that supports the delicate balance between the needs of medical device design, commercial feasibility, and stringent regulatory control. The HudPAX approach integrates the following established design research methods:…”

“…Designers face challenges because they can neither easily nor seamlessly integrate numerical dimensions, spreadsheets, and unprocessed 3-D scans into sketching, model-making, rapid prototyping, animation, digitising, computer-aided design (CAD), tooling, and manufacturing. 11 The reseach team is currently conducting a 5-year project as part of the Paxman Research and Innovation Centre, a £1 million interdisciplinary research centre created by Paxman and Huddersfield University. The Centre is exploring the new Industry 4.0 technologies and mass CASE STUDY customisation infrastructures.…”