Tag Archives: NICE

Involving patients and the public in medical device development

There’s an often overlooked aspect of getting a medical device into the healthcare system (e.g. the NHS in the UK).

An aspect that was revealed to those attending a recent Medilink East Midlands conference in Nottingham. An aspect known as “Patient Public Involvement” (PPI). There’s lots of activity within the NHS to increase PPI throughout all aspects of health and social care in the UK.

Recognition of the importance of involving patients and public in healthcare has implications for the development of medical devices and combination products. Should you be looking for sources of grant funding for planned research, the UK National Institute for Health Research (NIHR) asks applicants to “… describe how they have involved the public in the design and planning of their study as well as their plans for further involvement throughout the research and if not, to explain why.”

NICE is crystal clear about the importance of PPI, expecting the steps taken by a manufacturer to be included in the information they provide for the decision making process, with the “patient voice” increasingly expected to be heard by review panels.

So, what is Patient Public Involvement in medical device development?

Perhaps unsurprisingly, there are many layers to PPI within the NHS. Lots of the layers revolve around Governance and service provision, with layers relating to delivery of treatment buried deep.

There exists a massive opportunity for the developer of a medical device from interaction with patients and service users. By listening to people, we can understand diverse health needs better, “to improve patient safety, patient experience and health outcomes; supporting people to live healthier lives” (NHS PPI Policy). It is revealing that patients are referred to, within the PPI Policy, as “experts by experience”.

Why should that matter to you as a manufacturer/developer?

Simply put, three reasons:

Firstly, it helps you get access to research funding from NIHR and other bodies; as you can clearly demonstrate involvement of the public at an early stage in development.

Secondly, it supports the case for your medical device to be adopted by NICE and subsequently, Commissioning Groups, as the “patient voice” is clearly listened to.

Thirdly, and by no means least, proper patient involvement massively informs the development of your product.

“No matter how complicated the research, or how brilliant the researcher, patients and the public always offer unique, invaluable insights. Their advice when designing, implementing and evaluating research invariably makes studies more effective, more credible and often more cost efficient as well.”

InvolvProfessor Dame Sally Davies, Chief Medical Officer (Foreword in Staley, 2009)

There are other, ancillary benefits too, such as:

  • Patient stories, testimonials are a useful resource to show the value of a medical device for their quality of life,
  • As a marketing tool, articulating your participation with patients and public, throughout development of products that they and the NHS want and need.

How can I involve patients in development activities?

You may already have sensed some similarities or cross-over between patient involvement and the discipline of Human Factors Engineering / Usability.

There’s a good reason for that.

Usability is a great way of ensuring patient involvement in development of medical devices destined for the NHS; in a planned, documented and well thought out manner. There is a clear link between the drive to demonstrate patient involvement and Usability studies, particularly in the earlier stages of development. Formative Usability studies, involving patients and users, inform the requirements for a medical device, test out concepts and gain valuable feedback that hugely influences the final design. Evidence of all this is looked for by grant funders and regulatory decision makers.

And let’s not forget, that early discovery of what users and patients really need a medical device to do for them, can provide you with a competitive advantage for product development. When you really understand what drives the users / patients, what they are “putting up with”, the work-arounds they (subconsciously) use to improve their quality of life with a device, your product will “just work”.

What next

When you’re writing applications for research funding, or drafting your NICE submission (or ideally much earlier in development), consider how you could weave in some Usability activities and data to make the case for patient and user involvement. If you’ve already undertaken (or plan to) as programme of Usability studies, examine how the results can support your application.

If you’re unsure how to get started, call our team now. We will be happy to explore how we can help you get there sooner.