The Missing Step Between an Unmet Need and a Medical Device

Identifying the Real Problem Behind a Medical Device Request

A healthcare professional says they need a new medical device. The problem sounds clear, and an innovator can already picture a solution. 

That is often the moment to pause. 

The request may be entirely reasonable, but it is usually the start of understanding a need, not the end of it. Before deciding what to build, we need to know who experiences the problem, when it occurs and what happens today when people try to work around it. 

Having spent around 15 years in medical device development and now working with healthcare innovators on a daily basis, I’ve come to value that early investigation as much as the technical work that follows. A well-made device can still struggle to be adopted if it solves only part of the problem. 

Understanding User Needs in Medical Device Development

If someone asks for a smaller, lighter or easier-to-clean device, those are valuable clues. However, they are also prompts for further questions, such as:

• Who finds the current device difficult to use?  
• What are they trying to do at that point in care?  
• Is the difficulty caused by the device itself, the space around it, the time available, or the way it fits into a wider task? 

The answers can change the design brief. They may also show that a new device is unnecessary. An existing product, a change in how it is used, or a different service approach might address the need more effectively. For an innovator, discovering that early is useful progress. It means time and money can be directed towards a problem that genuinely needs a new solution. 

Involving Patients, Carers and Healthcare Professionals in Design

The person who identifies a need may not be the person who uses a device most often. Depending on the product, patients, families, carers, clinicians, cleaning staff and others may each see a different part of the problem and have their own solutions. 

Their perspectives can reveal requirements that are easy to miss in a meeting room. Whether instructions make sense, how a product is cleaned between uses, where it is stored, or whether it can be used comfortably in the intended setting. 

These details are not finishing touches. They influence whether a device can be used safely and consistently. Bringing users into the conversation early gives designers and developers a better brief and makes later decisions easier to explain. 

Designing Medical Devices for Real-World Healthcare Settings

A device does not enter healthcare on its own. It enters an existing pathway, with established roles, pressures and constraints.

A design that works well in a controlled demonstration may encounter different conditions in a busy ward, a community clinic or someone’s home. Innovators need to understand where their device would fit, what it might replace, who would use it and what support those users would need. 

This is also where development and adoption meet. Technical performance matters, but healthcare teams must be able to incorporate a solution into the way they deliver care. Thinking about that only after development can leave innovators facing questions they could have explored much earlier. 

Turning User Research into Medical Device Design Requirements

Early conversations are most valuable when they lead to clear design choices:

• Which needs are essential? 
• Which assumptions still need checking? 
• What would show that the solution works for its intended users? 

That thinking should connect with the device’s intended purpose, risks, usability and evidence plan. It gives the team a way to test whether the product they are developing still address the problem they set out to solve. 

It also helps when people disagree. A clear account of the need makes it easier to weigh different requests against the same goal, rather than adding features simply because each one sounds useful or be a ‘nice to have’.

From User Needs to Successful Medical Device Development

When an unmet need is presented as an idea for a device, the most useful first response may be…  “Can you show me what happens next?” 

Watch the task where possible. Speak with the people involved, whether that is the patient, parent, carer and, or healthcare professional. Understand the workarounds and their consequences. Then decide whether the answer is to adopt something, adapt something or develop something new. 

Medical device development requires considerable care, evidence, resources and money.  

In one project, our commercial team requested a new standing frame with features to support positioning and help children take part in activities with their peers. Several existing frames already offered those functions, so we visited homes and special schools and spoke with clinicians, carers and parents to understand why they were asking for them. 

Those conversations and observations revealed a different problem. The devices were complex to use, instructions were unclear, and parents and carers lacked confidence to change settings, even when they felt a child looked uncomfortable. We also identified design issues, including leg height adjustments that could slip rather than remain securely in position. 

This changed the direction of the project. We focused on addressing the existing frame’s design and usability issues, rather than developing a new product. We also updated our post-market surveillance processes to ensure feedback was captured and could inform further improvements. By understanding the difficulties behind the original request, we were able to bring an improved product to market sooner and at lower cost than developing a new frame. 

Taking time to define the need properly helps make that investment count. More importantly, it gives the eventual solution a better chance of working and being sustainable for the people and settings it was designed for. 

The understanding gained through this work should also help shape the decision to invest. Before committing to development, bring R&D, commercial, marketing, clinical and regulatory colleagues together to agree a business plan grounded in the need for people using the device, the people affected and the setting in which a solution would be used. Connecting those findings to the market opportunity, route to adoption, evidence requirements, costs, resources and timescales. This gives stakeholders a shared basis for deciding whether to proceed, what still needs investigating and what success would look like.  

The plan follows from understanding the user need and keeps that need at the centre of development. 

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.