Breast cancer related lymphoedema: an example of patient co-production in creating an innovative solution

Summary

Breast cancer related lymphoedema (BRCL) is an under-recognised health condition that occurs in 20% of women after receiving breast cancer treatment. BRCL can affect a patient's physical and mental health and is costly to the NHS. In this blog, James Moore, a biomedical engineering researcher at Imperial College, talks about how he has involved patients in designing an innovative solution to this issue.  

Content

Breast cancer related lymphoedema (BCRL) is an incurable swelling of the arm that can occur following breast cancer surgery when the lymph nodes are removed. In the UK, one in seven women will get breast cancer and approximately 20% will end up with a swollen arm, depending on the kinds of treatments they receive. Living with lymphoedema can affect a patient's physical and mental health, their day to day living and can be a constant reminder of their cancer.  

At best, BCRL can only be managed with life-long, constant adherence to physiotherapy and use of compression garments. Attempts at treatment, mostly involving additional surgery, has shown mixed success and are largely inaccessible due to additional cost and complexity.

BCRL prevention has been identified as a top priority by lymphatic physiotherapists who are in the best position to understand how difficult it is to manage the disease. A widely accessible BCRL prevention strategy, a well-documented unmet need, would not only see BCRL patients gain an estimated 12 QALYs (quality adjusted life years), but would also save the NHS substantial costs – the 5-year treatment costs per patient for BCRL is £36 K.[1] 

After establishing myself as a leader in cardiovascular biomechanics research and device development, I began research on the lymphatic system in 2004, motivated in part by cancer-related deaths of close ones. Recognising the opportunity to improve lives for cancer survivors, I invented FaciliFlow.

FaciliFlow is a small implantable device manufactured from medical grade silicone. The device would be permanently implanted during lymph node removal surgery to promote regrowth of surgically damaged lymphatic vessels, thus restoring lymphatic function and preventing fluid accumulation. Its dual modes of action include parallel channels to guide fluid flow and vessel regrowth by minimising resistance to interstitial flow, and localised release of VEGF-C (minimising risk of off-target delivery). FaciliFlow can be deployed in minutes by any surgeon.

Following encouraging early animal results, I received a £1.4 million grant in 2020 to develop the device at Imperial College London. I had been covering IP costs himself up to that point. The grant allowed me to hire a highly enthusiastic and committed team that now has the device ready for large animal trials.

We have involved patients, surgeons and industry experts throughout FaciliFlow’s development. In order to design this medical device, we worked with Imperial’s Cancer Research UK Lead Nurse to form a committee of patients who would be able to help us. They told us how BCRL had affected their lives and this enabled us to understand the importance of making the device low-cost and easy-to-use, thus accessible to everyone receiving breast cancer surgery to prevent all cases of BCRL. 

The patient group came about through our interactions with breast cancer surgeons, many of whom are aware of the severity of BCRL and want to help prevent its occurrence. Given the severity of the disease, these patients are strongly motivated to share their input on any type of solution. Their stories include every day struggles, disruptions to their careers and the effects on their families. One patient said that her son gets upset at the sound of the pump she uses to minimise the swelling in her arm because it reminds him that his mum had cancer.

There is a lot of work still to do to make FaciliFlow available for clinical use. First we need to do more preclinical studies, then first-in-human clinical trials in hopes of achieving regulatory approval. In parallel we need to continue our analysis of end-user needs: conduct stakeholder engagement studies, hold patient and public involvement (PPI) meetings and refine our business planning accordingly.

View the short video featuring BCRL patients sharing their stories and hear how we involved them in the development of Facilifow

Reference

1. Humphreys I, Thomas MJ. Evaluation of the economic impact of a national lymphoedema service in Wales. British Journal Nursing 2017: 1093-1100.

About the Author

James Moore is the inventor of Faciliflow and a biomedical engineering researcher at Imperial College. He has developed several medical devices, and find the process of translating technologies to clinical impact to be a fascinating aspect of research.

James has formed a company called Lympha Motus to take FaciliFlow to the market. The company’s CEO, Kate Rowley, has over 25 years of life-science experience, working in both the public and private healthcare sector. She has co-led the formation of several biotech startups. Colleague Arushri Swarup has expertise in bioengineering in the clinical setting through extensive collaboration with Toronto’s Hospital for Sick Children for the design, prototyping, and testing of a novel ear surgical instrument. Alain Vella has experience in the medical device industry through his previous role as R&D engineer at Baxter International. There, he developed 11 medical devices for acute care settings in international markets. The team was awarded joint first prize at the 2022 Siemens Healthineers External Innovation Think Tank for their presentation of FaciliFlow.