Investigation of Additive Manufacturing in New Medical Product Development for Chemotherapy-Induced Alopecia

Chemotherapy-Induced Alopecia is a side effect of chemotherapy drugs that target rapidly dividing cells; hair follicles are the second most rapidly dividing cells in the body resulting in hair-loss. The Paxman Scalp cooling process works by cooling the hair follicles, slowing these cells down to prevent the chemotherapy drugs from targeting them. Different demographics have varying ergonomic and anthropometric requirements; the Paxman devices are used currently in over 50 Countries. One main factor to successfully reducing hair-loss is the tight mimicking fit of the cooling cap to the patients scalp. The Asian demographic have a notably different head shape and sizes comparative to Caucasian heads. The aims are to design and develop scalp-cooling caps for Asian demographics, so they experience a similar level of clinical efficacy as the current generation of cooling cap whilst analysing low-cost Additive Manufacturing for Rapid Tooling and Rapid Prototyping. This study explores how the current generation of cooling cap utilises industrial Selective Laser Sintering technologies in Rapid Tooling for the first time in sheet silicone thermoforming. For an SME obligated to comply with Medical regulations, there are limitations that can be reduced using Fused Deposition Modelling for one-off tool production. These are achieved through a mixed methods approach, combining the reflective practice, the double diamond process, Design Science and Design Thinking. Additive Manufacturing was utilised as a tool for design validation; enabling continuous improvement to address critical design inputs. The research evidenced how a SME can generate Rapid Prototyping capabilities in-house for assessing feasibility and function in a medical setting at a much lower cost; thus creating a faster penetration into the market whilst enabling the company to explore, innovate and test more efficiently. These studies development of new Cooling Caps for Asian demographics using clinical trials and regulatory proceedings in attaining Japanese regulatory Ninsho and Shonin and Medical Device Single Audit Program approval. The Cooling Caps, designed and manufacture from this research, part funded by Innovate UK are now sold internationally in over 50 countries.