Interview with Alison Bray, Lead Healthcare Scientist - Medical Device Development, The Newcastle upon Tyne Hospitals NHS Foundation Trust
What is your background and what led you to working in your field?
I made a last-minute switch from arts to sciences A-levels, and I’m so glad I did. I studied maths and physics at university, where a final-year module on medical physics piqued my interest. I did two months work experience in Newcastle Hospitals' Medical Physics department after my degree and thereafter took the first opportunity I could to join the team as a bona fide employee. I spent several years working in urological-based research, followed by a few years in a patient-facing clinical measurement role, before moving to my current post as the lead for medical device development within our clinical engineering group.
Is there anything you wish you learned sooner?
Ask, ask, ask. If you’re finding something challenging, and even if you aren’t, ask for advice and insight from others. Someone from your team, organisation, or the wider community will have faced the same challenges and will be happy to share their experience. Outside influence helps to keep your knowledge and practices up to date and non-stagnant.
What does your job entail and what have you found the most surprising aspect?
I spend a lot of my current role developing our quality system with the aim of becoming accredited to ISO 13485, which is a quality standard for medical device matters. I’m part of the project team for several device development and evaluation projects, some in the early stages of development, and others in which our devices are being used in large-scale patient studies. I’m surprised how much I enjoy the regulatory aspects of medical devices, having been terrified of them a few years ago. I really enjoy supporting our clinical and academic colleagues in these aspects so that they can focus on their areas of expertise.
What are the challenges and how do you deal with that?
The main challenge is having a small team and dealing with many competing demands. People in the NHS are inventive and innovative so there is a high demand for our services. Our quality system is helping us become more efficient to better cope with this. Another challenge is the hugely complex regulatory landscape, made more complicated by Brexit because our legislation has now deviated from our EU neighbours. Finally, it’s identifying which devices are likely to success and which are likely to fail, before investing a huge amount in their development. We’re working with our commercially-minded colleagues to embed those due diligence processes early on in the development pathway.
What do you enjoy most about your role?
No two months, weeks or even days are the same. Continuous opportunities to learn, whilst contributing to improvements in healthcare, keeps the work interesting, challenging and rewarding. And the people are lovely. The NHS attracts a special kind of person.
What could collaborators expect of your service?
Friendly demystification of the rules and regulations surrounding medical devices, and inventive solutions to technical problems from people with curious minds.
How is patient benefit built in?
Our projects generally begin with an approach from a clinician who sees an unmet clinical need that could be addressed by a novel medical device. This all ultimately comes down to patient benefit, by making a diagnosis or therapy faster, more accurate or effective, or less unpleasant for them. When deciding whether to embark on a new development project, input from patient panels feeds into this decision. We involve patients throughout development to ensure that the solution is acceptable to them and that the benefits outweigh the risks. And eventually our devices are evaluated in order to determine whether they improve patients’ health outcomes.
Can you give an insight into the wider team and what they might be up to on any given day?
Most of us have physics and engineering backgrounds, but we also benefit from having people with qualifications in areas such as biology, physiology and psychology. Some have spent their careers in the NHS, whilst others have joined from industry.
We get up to all sorts: device development and testing on the bench, technical and regulatory documentation, shadowing clinical colleagues to gain insight for a new project, patient and public engagement, teaching, research study design, data analysis, patient and clinicians interviews and surveys, commercial discussions with industry, reviewing literature, publications and presentations. And much more besides.
What studies / projects have you been working on recently?
We’re working with Newcastle University to develop a novel electromyography (EMG) system, which means measurement of electrical muscle activity. The system makes 32 measurements along the length of the EMG needle, instead of just one measurement at the tip. The aim is to obtain much more detailed information about the muscle, allowing faster and more accurate diagnosis of neurological conditions such as motor neurone disease.
We were recently involved in developing a prototype organ oxygen persufflation system, also with Newcastle University. This device aims to keep organs that may be suitable for transplantation healthy for longer, increasing the chance that they will be usable, and of transplant success. It does this by pumping oxygenated gas through the vessels of the organ at controlled flow rates and pressures.
We are also involved in evaluation studies for devices we have developed, which are at a later stage. These include the Newcastle Infant Dialysis and Ultrafiltration System, which removes waste products and excess fluid from the blood of very small babies, and the Flowtaker home urine flowmeter for men with urinary problems.
Plans away from work?
Drumming! My beloved band recently parted ways after four years, but new ventures are underway. Cycling, badminton and bouldering to keep fit. Hanging out at home with my two lovely gentlemen (one human, one feline). And visiting far-flung places (global pandemic-permitting).
What advice would you give to your younger self?
Your older self will thank you if you choose that Metallica gig with your sister over that Boyzone concert with your school friends as your first ever musical event.