52 North Health (formerly NeutroCheck) is a dynamic Cambridge-based start-up, creating affordable, cutting-edge technology to bring healthcare closer to patients. NeutroCheck is an innovative point-of-care (PoC) test that helps assess a patient’s risk of Neutropenic Sepsis (NS). Aimed at cancer patients, the solution is intended to be used at home as a triage tool to inform whether a patient should urgently attend hospital for antibiotic treatment or can safely be managed in the community. NeutroCheck has the potential to significantly reduce the number of patients presenting to A&E/acute oncology units and receiving unnecessary preventative antibiotic treatment, thereby improving patient quality-of-life, and improving hospital resource allocation.
To meet the needs of patients, healthcare professionals and health systems it is imperative that NeutroCheck is accurate, easy-to-use, portable, and cost-effective. 52 North Health approached eg to support the design and development of the NeutroCheck test housing. As it is intended for use by cancer patients at-home, the housing has a complex set of requirements. It must be intuitive, easy for people with dexterity limitations to use, desirable for use in a home environment, able to actuate all the steps required for the assays to run and have a low cost of goods. Prior to starting this project, 52 North Health had conducted user engagement work with patients and healthcare professionals to understand their needs, informing these requirements.
Given the challenging requirements, we utilised the expertise of our multidisciplinary team spanning industrial design and mechanical engineering. Initially, we worked with 52 North Health as their sole design team. As they built their in-house design capability, we became an integrated group to develop the design together.
We provided an agile, flexible and integrated resource, using 52 North’s existing usability studies and offering insight-led concept design solutions. The team worked closely with 52 North Health to understand the detailed assay requirements and uncertainties in order to develop a safe and effective mechanism, which is also cost-effective and simple to manufacture.
As the solution is an in vitro diagnostic, we worked in accordance with ISO 13485, including medical device risk management in accordance with ISO 14971. As with all our projects, we made prototypes of the proposed solutions and engaged users early to reduce risk and incorporate all user and product requirements.
As a start-up, 52 North Health were able to leverage our extensive design and development engineering expertise and experience within the medical sector to forge a developmental road map as their team grew. Our focus on usability within our programmes ensured that the Human Factors studies carried out by the client were fully integrated into development and as such, any use requirements or potential limitations were factored into the product design. We offered a phased approach and were able to use our in-house capabilities to 3D print prototypes of the product for user testing (carried out by the client) and quickly incorporate feedback. This allowed the client to use their financial resources optimally and supported with the funding that they were seeking concurrently.
As part of our risk management programme, we identified potential risks which can be addressed in the iterative development. We continue to work with 52 North Health, as needed, to further develop the solution and bring NeutroCheck to manufacture.