Case study: Collaborating for innovation
A better way to diagnose constipation in young people
Paediatric constipation is a serious condition, with 27,500 children per year treated in hospital in England alone. One of the diagnostic tests that’s used is an X-ray measure of gut transit time - patients swallow some X-ray visible pellets for three days in a row and then have an X-ray of the abdomen to see how far the pellets have moved. But X-rays don’t give a good image of colon anatomy and provide a harmful radiation dose, so we saw the need for something better.
We set out to develop the Magnetic Resonance Imaging (MRI) equivalent of the X-ray test. MRI does not use harmful radiation and the images of the body are much better quality than for X-rays.
We had created an adult prototype - a multi-vitamin-sized adult ‘torpedo’ pill. The challenge was to make a version of MRI-visible markers that are easy to swallow for younger patients. But we had no funding to design and make the paediatric product, or to investigate if the test was feasible in young patients.
We called our project MAGIC (short for MAGnetic resonance Imaging in paediatric Constipation). Armed with only the adult prototype and concept, and the idea for a paediatric product, our plan was not well suited for many funding schemes, which tend to support research further along the innovation pathway.
We partnered with Nottingham University Hospitals NHS Trust, its Research and Innovation team and our Sir Peter Mansfield Imaging Centre and applied for funding from the NIHR Invention for Innovation (i4i) programme.
Developing the test
We relied on NIHR infrastructure to initially develop, and later support, our i4i bid.
The NIHR Research and Design Service East Midlands helped us with bid development, methodology and study design, health economics and statistical support. The NIHR Biomedical Research Unit (BRU) in Gastrointestinal and Liver Disease (now the NIHR Nottingham Biomedical Research Centre) provided expertise in patient and public involvement and for the Ethics application. The NIHR Enteric Health Technology Cooperative (HTC) provided us with ad-hoc technology consultancies and business introductions in our quest for small and medium sized enterprises to work with on our project
We were successful in our funding application and were awarded £603,000 by i4i. The i4i team at the NIHR worked with us at every step to help achieve our goals. We had useful business introductions, we accessed advice on intellectual property, and scoped together the best way forward for the project. It’s difficult to put a price on all this expert consultancy by the i4i Programme team.
The i4i award also allowed us to work with four UK-based specialist companies. We worked on the initial design of the capsules with Renfrew Group International. Medical device manufacturer JEB Technologies then took over and further improved the mini-capsules design and manufacturing process. We also worked with medical image analysis company Motilent to design an initial software module for analysis of the mini-capsules’ images. Medical supplies distributor Pentland Medical helped us to understand the market for our devices.
Our medical device is remarkably simple: small capsules, made of a medical-grade plastic shell. They do not dissolve in the gut, and they are filled with a MRI-visible liquid that stands out in the MRI images of the gut. The patient swallows a batch of capsules each day for three days and then has the MRI scan.
To test the imaging of the mini-capsules, we had initially used a crude model made with lots of sausages stuffed in a large chicken from a local supermarket (this was outside NIHR funding). We went on to obtain ethics approval to assess safety and acceptability of the method in a group of 25 children presenting with difficult to treat constipation and 25 healthy young controls.
Involving parents and young patients
From the very start of our research project, we included a number of parents and young people who had been affected by paediatric constipation. They have been an active part of the design and development of the mini-capsules - they told us what kind of capsule they wanted and what kind of packaging. They also helped us design patient information sheets for different age ranges and the materials required for ethics approval.
One of the members of the Nottingham University Hospitals’ Young Person’s Advisory Group (YPAG), Anmol, gathered the group’s thoughts on the project:
“Our YPAG has inputted our feedback every step of the way and in doing so, we know that the project, innovation and study is well-suited for young people. An ongoing goal that we and Dr Luca are adamant about is putting the patient first. From the outset, Dr Luca took his time to allow us to fully understand his project by making model gut transits using a marble run made with drainpipes and squirty cream for blockages. Through fun child friendly activities everyone was given the opportunity to express their opinions. We love the work that Dr Luca is doing and wish that more projects would get involved with the age group they’re targeting.”
It turned out that i4i was the ideal home for MAGIC. MAGIC is now approaching its end, and we’re working to set up its natural continuation, MAGIC2, which will address innovation for large-scale manufacturing of the mini-capsules, clinical effectiveness, add-on software for image analysis, commercialisation, adoption and distribution.
We also launched the study website www.gastrointestinalmri.org.uk so you can follow our exciting journey as it happens!