SULSA consultation aims to improve medical innovation
That eureka moment when a researcher conceives an idea that if proved correct could revolutionise their field of expertise is undoubtedly a highlight in the life of any university and R&D industry.
But even when it goes from there to development and testing it still has to pass a complex system of regulations, which is at risk of becoming more complicated in a post-Brexit world. And even then, a medical device has to be adopted by an NHS which operates with different hospitals, boards and trusts, all with various processes.
It seems the answer to this logjam of bureaucracy is for academia, SMEs, the NHS and governments is to work more closely. But is it really that simple?
Professor Marc Desmulliez, is manager of the Medical Device Manufacturing Centre at Heriot-Watt University, part of the Scottish Universities Life Sciences Alliance (SULSA). He works to help SMEs produce a small batch of medical devices through development and guide through regulations and adoption by the NHS.
Meaningful consultation
Professor Desmulliez says the Medicines and Healthcare products Regulatory Agency (MHRA) public consultation, which has just launched, requesting views on changes to how medical devices will be regulated across the UK, is a great way for academics, SMEs, the NHS and patients to have their voices heard.
He says SMEs are looking for the UK Government to follow broadly the same regulations currently in place with the European Union. This will “reduce cost by avoiding a multiplicity of regulatory frameworks – at the end of the day it is the pennies that count because without pennies you cannot work.”
Once regulation is complied with, the challenge for SMEs and the NHS is to learn how to understand each other, Professor Desmulliez says. “There has to be a platform where clinical engineers from the NHS can understand the new technologies and for the SMEs to understand the unmet clinical needs and the way the NHS adopt new technologies.”
Better guidelines
Dr Michelle Williams, Senior Clinical Lecturer at the University of Edinburgh, is developing machine learning to help detect the risk of heart attack, stroke or cardiovascular death in patients. This is being done by analysing routine CT scans of the chest, taken for non-heart reasons, and linking the results with the patient’s medical record.
She says clearer guidelines for regulation are needed, to allow researchers to work more efficiently, the NHS to take on board medical devices and for patients to be safe.
Better guidelines would smooth the path from “bench to bedside”, according to Dr Williams. “There are a lot of different guidelines at the moment and we need nice, clear guidelines.”
She adds: “The NHS can be quite slow to adopt new ideas – a lot of paperwork and a lot of hoops to jump through. It is not always clear what the route is.”
Adoption by NHS is key for Dr Michele Zagnoni, from the Department of Electronic and Electrical Engineering at the University of Strathclyde and CEO of ScreenIn3D Limited, who is developing a medical device to test the efficacy of multiple anticancer therapies directly on patient tumour biopsies, thus enabling a recommendation for the most appropriate treatment going forward.
He says they are now looking to understand the regulatory hurdles at a US, EU and, post-Brexit, UK level. But at this stage he would already like the ability to work with the NHS as ultimately that is where the medical device will have to work. He says: “Interaction with NHS is a very important connection to develop but at the moment I perceive that as a barrier.”
Part of the problem is caused with different processes in places across different hospitals and health boards but there is also a lack of testing actually taking place in hospitals.
Dr Zagnoni says he appreciates it is not a case of simply opening the door to a ward and starting work, and many checks and balances would have to be taken into account but he adds: “What would be very beneficial at early stages of technology development would be to test medical devices in the NHS – testing in the real world conditions.”
Pilot scheme
Dr Zagnoni says that the hospital environment is different from a laboratory, for example the length of time it takes to deliver a biopsy for testing. He adds: “If there were ways of creating schemes to pilot technology in the hospital without disrupting the hospital that would be ideal.”
To find out more about the MHRA consultation, and to contribute to it, go to: