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

化疗引起的脱发(CIA)/脱发被广泛认为是化疗最具创伤性的副作用之一。如果不进行治疗，CIA每年影响全球350万名患者和英国超过6.7万名患者。头皮冷却被认为是预防CIA的唯一有效方法。中小型企业Paxman Coolers Ltd.是头皮冷却领域的全球领导者，活跃在63个国家和地区，他们以80%的份额主导着市场。自2017年Paxman头皮冷却系统(PSCS)获得FDA批准以来，对基于机器的头皮冷却的需求呈指数级增长。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的增加，临床实践指南进行了修订，在美国(NCCN 2019/2020)、欧洲(ESMO 2020)和澳大利亚(癌症澳大利亚2020)将头皮冷却纳入癌症护理。在美国，随着最近发布了2 x CPT代码(AMA：2021)，预计在2年内将有更广泛的保险覆盖/付款，这将进一步增加美国的需求，因为治疗在经济上对更多的患者来说是可行的。该项目将在之前成功合作的基础上，将**帕克斯曼冷却器有限公司**与**哈德斯菲尔德大学**S获奖的产品设计团队和技术材料研究的医疗设计专业知识结合在一起。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患者在国际上获得有效头皮降温治疗的机会，并使Paxman朝着他们的长期目标迈出重要的一步，即“向全球所有化疗患者提供头皮降温，Paxman是自然选择”。头皮降温治疗的效果将通过单个患者的帽子最大化，促进优化帽子适配，提高治疗成功率。单患者上限还将促进加强感染控制，这是由于化疗引起的免疫抑制而最重要的因素，冠状病毒疫情特别强调这一点。关键是，这一项目还将解决与这种单患者医疗设备需求增加相关的环境影响。对生态设计的关注将促进循环经济，并将这种产品报废的影响降至最低。

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.