Scalp cooling for the prevention of chemotherapy-induced alopecia: increasing patient access through eco-design and innovative manufacturing.

化疗性脱发被广泛认为是化疗最具创伤性的副作用之一。在没有治疗的情况下，CIA每年影响全球350万患者，在英国超过67,000人。头皮冷却被认为是预防CIA的唯一有效方法。Paxman冷却器有限公司是全球头皮冷却领域的领导者，活跃在全球63个国家，占据80%的市场份额。自2017年Paxman头皮冷却系统（PSCS）获得FDA批准以来，基于机器的头皮冷却需求同比呈指数级增长。最近的国际临床推荐推动了对基于机器的头皮冷却的需求增加，美国（NCCN 2019/2020）、欧洲（ESMO 2020）和澳大利亚（CancerAustralia2020）修订了临床实践指南，将头皮冷却纳入癌症治疗。在美国，随着最近发布的2 x CPT规范（AMA:2021），预计两年内将有更广泛的保险覆盖/支付，随着更多患者的治疗在经济上可行，这将进一步增加美国的需求。在以往成功合作的基础上，该项目将汇集**帕克斯曼冷却器有限公司**和**哈德斯菲尔德大学**屡获殊荣的产品设计团队和技术材料研究的医疗设计专业知识。通过创新、先进的设计和开发，该项目将极大地增加患者和临床获得有效的头皮冷却治疗的机会，并使Paxman朝着“为全球所有化疗患者提供头皮冷却治疗，Paxman是自然选择”的长期目标迈出了里程碑式的一步。头皮冷却治疗的效果将通过单个患者帽最大化，促进优化帽适合和增加治疗成功。单患者帽还将促进加强感染控制，由于化疗引起的免疫抑制，这是一个至关重要的因素，特别是在冠状病毒大流行中。至关重要的是，该项目还将解决与这种单病人医疗设备需求增加相关的环境影响。注重生态设计将促进循环经济，并最大限度地减少产品的报废影响。

Chemotherapy-induced alopecia (CIA)/hair-loss is widely recognised as one of the most traumatic side-effect of chemotherapy treatment. Without treatment CIA affects 3.5 million patients worldwide and over 67,000 in the UK annually. Scalp cooling is recognised as the only effective treatment for CIA prevention.SME, Paxman Coolers Ltd., are the global leaders in scalp cooling, active in \>63 countries they dominate the market with an 80% share.The demand for machine-based scalp cooling has exponentially increased year-on-year since 2017, when the Paxman Scalp Cooling System (PSCS) achieved FDA approval. Recent international clinical recommendation drives increased demand for machine-based scalp cooling, with Clinical Practice Guidelines revised to include scalp cooling for cancer care in the USA (NCCN 2019/2020), Europe (ESMO 2020) and Australia (CancerAustralia2020). In the USA, following recent publication of 2 x CPT codes (AMA:2021) broader insurance coverage/payment is expected within 2-years which will further increase US-demand as treatment becomes financially viable for more patients.Building on previous successful collaborations, this project will bring together, **Paxman Coolers Ltd**, and the medical-design expertise of the **University of Huddersfield**'s award-winning product design team and technical material research.Through innovative, advanced design and development, this project will dramatically increase patient and clinical access to effective scalp cooling treatment internationally and enable Paxman to take a monumental step towards their long-term goal of 'scalp cooling being offered to all chemotherapy patients worldwide, with Paxman as the natural choice'.The efficacy of scalp cooling treatment will be maximised through single-patient caps, promoting optimised cap fit and increasing treatment success. Single-patient caps will also promote enhanced infection-control, a factor of paramount importance due to chemotherapy-induced immune suppression, and particularly emphasised by the Coronavirus pandemic.Crucially, this project will also address the environmental impact associated with increased demand of this single-patient medical device. The focus on eco-design will promote the circular economy and minimise this products end-of-life impact.