The pathway to developing and delivering a mobile phone application into the NHS: The Walk-A-Cise story

Philip Stather is a consultant Vascular Surgeon at NNUH. Alongside treating patients with arterial and venous disease, he undertakes clinical trials and innovation work, developing the Walk-A-Cise mobile phone application to provide remote exercise therapy and clinical devices for venous ulceration. Alongside this he is the NIHR CRN Surgical Specialty Lead, and collaborates on several basic science projects with colleagues across the Norwich research Park. He also runs TeachMeSurgery.

As a consultant vascular surgeon in the NHS and clinical associate professor at the University of East Anglia I am trained to treat a variety of patients with blood vessel problems, and also have a background in research and quality improvement, however none of this had prepared me for developing a new technology for use in the NHS.

Mobile phones are being increasingly used to monitor health, with over 325,000 health apps available for download. These range from patient education, to at home fitness apps with fewer available to monitor health and share data with health care professionals.

The challenge with mobile phone applications is when they become medical devices for use in the NHS. A medical device is any product that performs a medical purpose such as diagnosing, monitoring, or treating a medical condition. Therefore, any mobile phone application that measures (distance, weight, blood pressure, pulse etc), or is used to monitor a condition is classed as a medical device and needs to be registered.

In addition, getting an app in use in the NHS requires assessment against the digital technology assessment criteria (DTAC). This includes clinical safety (DCB0129 and DCB 0160), data protection, technical assurance, interoperability, and usability/accessibility. On top of this, the NHS Digital Toolkit is required to be completed, as is Cyber Essentials.

Medical devices are classified based on risk. The risk depends on the intended purpose, duration of use, and whether it is invasive, implantable, active, or contains a medicinal substance. The categories are:

Class I – generally regarded as low risk

Class IIa – generally regarded as medium risk

Class IIb – generally regarded as medium risk

Class III – generally regarded as high risk

Most mobile phone applications would be Class 1 devices, enabling self-management, remote monitoring, and potentially some treatment. Others such as identifying skin disease from photographs may be classed higher.

Case Study

The Walk-A-Cise mobile phone application is designed to provide virtual supervised exercise therapy for patients with poor blood supply to the legs. A lack of blood causes cramps in the legs when walking and the first treatment should include exercise therapy. Exercise is required to increase walking distance by walking through the pain to improve the smaller blood vessels to help deliver the blood to where it is needed. Several studies have looked at using freely available apps and smartwatches all of which showed the benefits of monitoring this therapy with GPS tracking, however none of these are available on the NHS, and they lack the ability to remotely monitor patients outside of small scale trials.

In order to develop and launch a new mobile phone application into the NHS requires perseverance, patience, and understanding the pathway as below.

Step 1 – Developing the app. Initially a prototype was made to ensure this is something patients would want and use and accuracy of the GPS.

Step 2 – Getting set up within the hospital. This required completion of DTAC and multiple sets of documentation all of which were different for each hospital.

Step 3 – User data. A student project was developed to investigate user uptake, use, and issues.

Step 4 – Funding. Thanks to grants from Medtronic, UEA HSCP and Innovate UK a total of £70,000 was obtained to develop the next version of the app.

Step 5 – User input. Design of the next version of the app was undertaken alongside patients and healthcare professionals to design the app that users want, and get it road tested (Patient and Healthcare Professional Priorities for a Mobile Phone Application for Patients With Peripheral Arterial Disease - PMC (nih.gov).

Step 6 – Building the new version of the app. This required technical expertise, learning design skills, wireframes, and task management.

Step 7 – Regulatory approvals. The app is a Class 1 medical device as it uses GPS tracking to measure distance, therefore required the NHS Digital Toolkit, DTAC, DPIA, Cyber Security, UKCA Mark and registration with MHRA. This required extensive research and documentation regarding the business as well as the app and partnering with another organisation.

Current Status

Following a long process, the Walk-A-Cise mobile phone application is now able to deliver virtual supervised exercise therapy at home. It includes a GPS tracker to monitor walking distance in the community and gives different outputs such as distance to pain, time to pain, total distance before stopping and total walking distance, all designed based on outcomes used in publications, and seen on graphs within the app. In addition patients can undertake a 6 minute walk test which is typically done at the start end completion of supervised exercise classes to monitor progress. There is an inbuilt communication platform, and inbuilt animated work-outs with different levels of difficulty. The app will also connect with your smart watch, and there is a bespoke clinician dashboard to view patients results.

The app is now registered as a Class 1 medical device with the MHRA, obtained a UKCA mark, undertaken Cyber Security certification, completed the NHS digital toolkit.

Next Steps:

They say the next step is always the hardest. Obtaining funding was challenging, designing and making the app was laborious, learning about and completing regulatory approvals was a new experience, however having overcome these we are now in a position to sell into the NHS.

We also aim to test the app in different groups of patients where GPS tracking of walking is beneficial such as those with heart, breathing, and weight issues.