The challenges of implementing design research within SME based medical product development: Paxman scalp cooling case study

Abstract

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.

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

“…We collected anthropometric data from cephalic, circumference, and shape profiles to establish how accurate and viable each method was for gathering data against what we currently know from prior Paxman studies. 1,4,5,12 Fifty-five per cent of the pilot study participants reported poor fit in the crown area. This finding was unexpected given that 55 per cent of the participants are of Caucasian background, and they used a Caucasian style cap.…”

“…Scalp cooling relies heavily on close fit to the patient's scalp for optimal efficacy. 5 In addition to safety and efficacy, other crucial parameters for the design process are properties attributed to the cap materials-namely, flexibility, tear resistance, ability to hold liquids at pressure, comfort, heat exchange capabilities, and regulatory requirements such as biocompatibility.…”

Are traditional head size and shape measurements useful in modern medical design? A literature review

“…From the 175 studies a collection of relevant papers 1,2,3,4,5,6 focused on the human head size data, which had the most impactfil influence on this study, including studies such as SizeChina, Caesar, Gayre's race studies, and some of the research team's published literature.…”

“…The researchers retrieved more than 175 papers, including journal articles, clinical studies, conference studies, and content from master's and PhD theses. From the 175 studies a collection of relevant papers 1,2,3,4,5,6 focused on the human head size data, which had the most impactfil influence on this study, including studies such as SizeChina, Caesar, Gayre's race studies, and some of the research team's published literature.…”