Title: Development and evaluation of a medical device to monitor arthritis patients at home
Funder: Versus Arthritis

Abstract: The purpose of this proposal is to develop and evaluate a prototype device, which can monitor the condition of someone with arthritis at home. The proposal scope involves gathering feedback from key stakeholders as they test device and software versions over a finite development period. Toward the project end, a final version of the prototype will be assessed for conformity with medical device regulations and a plan to commercialise drafted. The key aims and objectives of the proposal are: Aim 1. User experience and lab testing. Device and software design ideas will be gathered from people living with arthritis, laboratory, clinical and industry partners. This ensures the requirements of each user group are incorporated and tested over the course of the project. The stability of key analytes in the sample after transit and its ability to integrate into routine clinical lab sample processing will be assessed. Aim 2. Hardware and software development. Minimal electronic hardware will be designed in place of the existing printed circuit board design, which sends sample date and time data using Internet of Things technology. The firmware (software used to run the device electronics) will be updated and a mobile phone app created to guide users through the sampling procedure. Aim 3. Device regulatory certification. The final iteration of the device hardware and software will be evaluated to achieve CE certification. This will allow unrestricted commercialisation and clinical trials of the device in UK and Europe. Aim 4. Marketing and commercialisation roadmap. A marketing strategy to generate customer leads and drive sales and a commercialisation roadmap will be drafted to ensure a successful business startup. This is the first known project in Europe to develop and evaluate a home blood sampling device for people with arthritis. The proposal is important because it develops a technology which delivers patient-centric home monitoring services that could be used to manage other chronic conditions. The project started 3 years ago, with a study that confirmed C-reactive protein could be reliably measured in dried blood spot samples, when compared to conventional venous blood samples. Importantly this study also established that it was feasible for people with arthritis to take and send samples from home. The internal workings of the current device prototype have been developed over the last two years. The proposal fits Versus Arthritis scope to develop a commercially viable product to help improve the lives of those living with musculoskeletal conditions. The proposal supports Versus Arthritis research to improve disease management and health care services. These topics were identified by Versus Arthritis as being historically underfunded in a recent review of UK health research data. Key outcomes include a robust user-friendly device and software package which meets customer needs. Importantly the project will also test the device conformity with UK and EU safety standards and will plan a clear path to market. This proposal will ultimately bring the device closer to a consumer ready product and enable clinical utility testing.


Research activity codes: 5.3 MEDICAL DEVICES
Health categories: MUSCULOSKELETAL