Early clinical evidence generation is key to ensuring that healthtech innovations solve the problems that matter the most to patients, says ARC Hub Clinical Lead, Prof. Aoife Lowery.

Harnessing early evidence generation to deliver patient-first healthtech

Prof. Aoife Lowery
Home > Harnessing early evidence generation to deliver patient-first healthtech

At the core of the ARC Hub’s philosophy is the belief that bringing the different strands of a solution together early, is key to developing effective and scalable healthtech innovations. By far the most important strands to connect at the beginning of development are the innovators developing solutions, and patients with specific, unmet needs.

The ARC Hub team sat down with Professor Aoife Lowery, our Clinical Lead, who has a particular passion for early clinical evidence generation. Aoife holds a dual role as a Consultant Surgeon at Galway University Hospital and Associate Professor in the Discipline of Surgery, University of Galway. As Aoife explains, ‘clinical evidence’ goes beyond proving that a healthtech solution works. It must also demonstrate that the solution addresses a real and meaningful problem.

Professor Lowery, your expertise lies in many aspects of medicine – including surgery, oncology and clinical evidence generation. What is the focus of your role at the ARC Hub?

Professor Lowery: My role is to ensure that clinical insight is embedded in the ARC Hub’s projects from the outset. I support research teams to understand real, unmet clinical needs, what existing patient pathways look like, and which constraints may exist within healthcare systems that could impact the design of their technology. Supporting healthtech researchers to learn from clinicians and patients early in the development process is essential. It provides them with potentially unique insights that ultimately help accelerate the pathway towards clinical adoption.

What was it that attracted you to join the ARC Hub’s founding team?

Professor Lowery: The ARC Hub interested me because it’s not just focused on what technology can do in healthcare. It’s focused on what patients and the healthcare system actually need. The Hub puts clinical validation right at the heart of the innovation process and helps researchers to develop healthtech solutions that address specific, unmet needs that are relevant to our patient population – rather than shoehorning patient needs into technological capabilities. This mindset resonated with me and I felt I could really contribute to it.

Why do you see that patient-first mentality as being so important?

Professor Lowery: Every patient deserves the best care that is available. As a clinician I think we have a responsibility to keep improving the delivery of care. An important part of this is treating patients as individuals. Optimising care is not simply about following existing practice, it’s about listening and understanding what matters to each patient. Understanding how patients actually feel about their condition, and what their own priorities are in terms of outcome, is often how you come up with ideas for innovation in patient care.

The quality of patient care also depends on the environment and system they are treated in. Researchers who work in a clinical environment can meet patients, nursing staff, dietitians, and practicing clinicians. It gives them a much better picture of how a particular problem affects the patient, the clinical workflow or system – and, from a patient’s perspective, what an ideal solution could look like.

What do you see as the special value of early evidence generation in the process of healthtech innovation?

Professor Lowery: Early evidence generation speeds up genuine processes in healthcare innovation. When healthtech researchers speak directly to patients or clinicians they often uncover a unique insight – which may refine their approach or even drive them towards a different solution. Putting an early prototype into the hands of users is really important, because you often find that little things make a big difference to the patient. For example, a device may be too heavy or cumbersome or just not feel right. Before deciding on a technology, researchers should examine what characteristics the perfect solution could have – and then go back and build for that outcome.

The unique thing about the ARC Hub is that both the clinical aspect and commercial aspect of a new healthcare technology come together at the very beginning of the development phase. This is a really important shift, because clinical evidence is the main factor that determines whether or not an innovation can be realised. Delaying the generation of clinical evidence can create significant challenges, as major design decisions are often made early in the development process and therefore are already locked in. Changing course may mean unwinding years of development.

Before developing a solution, it’s important to ask: What would a patient see as a win, in terms of improving symptoms? Our team are currently working on a solution for Oral Mucositis, which is a common and debilitating side effect of some cancer treatments. It is important for the research team to understand the priorities of the patient and healthcare professionals when developing a solution. Would the patient prioritise a reduction in pain? Or an improvement in their ability to eat? Would healthcare professionals prioritise a reduction in infection or hospital stay? We try to identify the key elements that would address these priorities.

Without early clinical interaction, a team might focus on relieving one particular symptom, only to discover later that it’s not the one that matters the most to patients. Or a team could develop a successful treatment, only to find that it does not fit within the existing treatment pathway or is too burdensome to implement in practice. The result is an effective treatment that clinicians may struggle to adopt.

Your role is clearly very hands-on and patient-focused. How does serving patients in Galway help drive innovation at the ARC Hub?

Professor Lowery: Above all, our responsibility is to serve patients and ensure they have access to the most effective healthcare solutions. The ARC Hub is driving innovation based on what patients in our region actually need. For example, we have a regionally dispersed population where some patients are affected by inequity of access to healthcare because of basic geographic challenges. We also have an ageing population.

These challenges have led us to, for example, look at innovations in the fields of telehealth, remote monitoring, and clinical decision supports to deliver healthcare outside of traditional clinical settings. We also have a focus on chronic disease and innovations such as smart implants, wearables and decision support tools that can help manage patients with chronic disease more precisely, even at a distance. However, our focus on regional needs doesn’t limit the applicability of our ideas. The solutions we are working on will improve the lives of patients in our region – and also patients in regions globally that have similar challenges.

An important component of the ARC Hub’s vision is that clinical trials of the novel technologies developed will be undertaken in the region. This will have the benefit of early access for our patient population and early adoption by our healthcare professionals, as well as rooting further development and innovation in the region.

For me, the main thing is making sure that every patient gets the best possible care. Being able to participate not only in the delivery of that care, but also the innovation and the research that drives improvement in it, is what motivates me.