How to develop an effective needs statement

At the heart of the Biodesign process is a deceptively simple but critically important shift: moving from a problem to a needs statement.

A problem describes what is wrong. A needs statement defines what a solution must achieve, for whom, in what context and to what end. This distinction matters because jumping straight from an observed problem to a proposed solution is one of the most common failure points in health technology innovation.

The Biodesign process interrupts that impulse deliberately, insisting that innovators first invest deeply in understanding the unmet need before entertaining any solution. It is this discipline, resisting the pull toward premature solutioning, that separates innovations that reach patients from those that stall in development.

A well-constructed unmet needs statement doesn't constrain creativity; it focuses it. It becomes the lens through which every subsequent design decision is evaluated, and the benchmark against which every proposed solution is tested.

Once you've identified what looks like an unmet need, a few questions naturally follow:

  • Which unmet need is worth pursuing?
  • Why does this need remain unmet, despite existing solutions?
  • How do I align my research project to solve the right one?

These are the right questions to ask. But before diving into them, there's something important to acknowledge: each question carries hidden assumptions that can quietly narrow your thinking before you've even started. Recognising those assumptions and challenging them, is the foundation of a strong needs statement.

Step 1: Check whether you have an unmet need or just a problem area

The first question: which unmet need is worth pursuing? assumes you've already arrived at a genuine unmet need. Often, you haven't, and that's perfectly fine.

What you likely have at this stage is a broad problem area. Rather than rushing to judge its merit, spend time scoping it. Get curious about it. Who experiences this problem? How often? What does it cost them, in time, money, health or quality of life? What have they already tried?

This scoping phase is not wasted time.

It's the work that separates a well-defined unmet need from a vague hunch.

Ask yourself:

  • Can I describe this problem in terms of a specific person experiencing it in a specific situation?
  • Is the problem recurring, or a one-off?
  • How significantly does it affect the people experiencing it?

Only once you can answer these concretely should you move to evaluating whether the need is truly unmet.

Step 2: Rigorously test whether the need is actually unmet

It's easy to assume a need is unmet because no high-tech solution exists. But "unmet" doesn't mean "unsolved by technology", it means no existing solution adequately addresses the problem for the people experiencing it.

Test this with genuine rigour:

  • Look beyond your field. Are there low-tech, behavioural, or workaround solutions already in use? A person with a blocked airway doesn't necessarily need an app, a steam inhalation under a towel might do the job just as well. If a simple solution already works, your need may already be met.
  • Talk to the people with the problem. Secondary research and expert opinion are valuable, but nothing replaces direct conversation with the people who live with this problem daily. What do they use? What still frustrates them?
  • Repeat the identification process. Go back to the beginning and re-identify the need using different methods – interviews, observation, literature review, market analysis. If the same unmet need surfaces repeatedly across different approaches, you can be more confident it's real.

If, after this process, a genuine gap still exists, you have a defensible unmet need.

Step 3: Align your research to the right unmet need

This is the step most researchers find daunting, but if Steps 1 and 2 have been done well, it becomes considerably clearer.

Alignment is about the intersection of three things:

  1. The significance of the need – How many people are affected, and how severely?
  2. The feasibility of a solution – Given your skills, resources and research domain, can you meaningfully contribute to solving it?
  3. The originality of your approach – Is there genuine space for your contribution, or is the field already saturated?

A strong needs statement sits at the centre of all three. It doesn't have to be the biggest problem in the world, but it should be a real one – and one where your research can make a genuine difference.

Writing the needs statement

Once you've done the groundwork, your needs statement should be able to answer four things clearly:

  1. Who is affected?
  2. What is the specific problem they face?
  3. Why do current solutions fall short?
  4. What is the consequence of leaving this need unaddressed?

A well-scoped problem description might look like this:

Elderly patients managing multiple chronic conditions often miss or incorrectly time their medications, not due to lack of motivation, but because existing reminder tools don't account for variable daily routines. Current solutions rely on fixed schedules, which don't reflect the reality of how these patients live. This leads to preventable hospital admissions and poorer health outcomes.

A needs statement might look like this:
A way of managing multiple chronic conditions in elderly patients, for medication compliance at home.

This frames the problem in terms of a problem, a population and an outcome.

And note that this may not be a perfect need statement yet – getting to a good needs statement requires a lot of refinement, reiterating and scoping. Each word must be used with care and should not embed its own bias into the need statement.

A final word on assumptions

Every researcher brings assumptions to their work.

That's not a flaw, it's human. The goal isn't to eliminate your perspective, but to hold it lightly enough that you can genuinely consider alternatives.

The most effective needs statements come from researchers who were willing to be wrong about their initial instincts and kept digging until the evidence pointed clearly in one direction.

That kind of rigour is what transforms a research idea into a research contribution.

This article was written by Shama Kazmi, MIME Project Manager. With a background in medtech IP commercialisation and Biodesign, Shama is passionate about supporting medtech research innovation teams to succeed in their translational journeys.