Needs finding
The Biodesign method. Observe clinical work, catch the moments that are slow, awkward, or unsafe, write the need without a solution in it, and only then think about technology. The hardest part of device design is not the device.
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Most student device projects start with a technology and go looking for a use. Most failed device companies did the same. The Stanford BiodesignBiodesign Stanford's process for medical technology innovation that starts from an observed clinical need rather than a technology looking for a use. Related: Needs findingNeeds finding Observing clinical work to catch the moments that are slow, awkward, or unsafe, before proposing any solution., Need statementNeed statement One sentence, "a way to [do X] for [whom] that [outcome]," with no solution in it.. Glossary entry process inverts it: go where care happens, watch, write down every moment that is slow, awkward, or unsafe, turn the best of them into a one-sentence need with no solution in it, and only then ask what technology might fit. The method is teachable, and the needs-findingNeeds finding Observing clinical work to catch the moments that are slow, awkward, or unsafe, before proposing any solution. Related: BiodesignBiodesign Stanford's process for medical technology innovation that starts from an observed clinical need rather than a technology looking for a use.. Glossary entry habit is what separates engineers who build useful things from engineers who build impressive ones.
Observe
Get into a clinic, a rehabilitation gym, a home, or a lab. Shadow, volunteer, or simply be present with permission. Watch without proposing. Keep a needs journal: time, place, what happened, why it seemed slow or awkward or unsafe, who was affected. Twenty observations a day is normal; most will be useless; the good ones are worth a company each.
Some prompts. Where did someone wait? Where did someone improvise, tape something, or work around a device? Where did two people have to do what one should? Where did a device get abandoned in a drawer? Where did someone wince?
Write the need statement
One sentence: a way to [accomplish something] for [a specific population] that [produces a measurable outcome]. “A way to let a person with late-stage ALSAmyotrophic lateral sclerosis (ALS) A progressive disease of motor neurons that removes movement and eventually speech while leaving thought intact; the population many BCIs are built for. Related: Locked-in syndromeLocked-in syndrome Full awareness with almost no voluntary movement, sometimes only the eyes; communication depends entirely on assistive technology. , Augmentative and alternative communication (AAC)Augmentative and alternative communication (AAC) Any tool that helps someone who cannot speak communicate, from picture boards to eye-gaze spellers to BCIs. . Glossary entry send an urgent message in under ten seconds, in the dark, without a caregiver’s help.” No solution words: not “an EEG-based,” not “a wearable.” The moment a solution enters the sentence, you have stopped describing the problem.
Write ten. Then rank them by how many people have the need, how badly, how well it is met now, and whether you could plausibly address it. Pick one or two.
Which of these is a need statement? (a) 'A low-cost EEG headband for detecting seizures at home.' (b) 'A way for a parent of a child with epilepsy to be alerted to a night-time seizure reliably enough to sleep.'
(b). It names the population, the outcome (alerted reliably enough to sleep), and contains no solution. (a) is a product idea; it has already decided the answer is EEGElectroencephalography (EEG) Recording the brain's electrical activity from electrodes on the scalp, a few tens of microvolts of blurred, summed cortical activity. Related: Electrocorticography (ECoG)Electrocorticography (ECoG) Recording from electrodes placed on the surface of the brain under the skull, usually during epilepsy surgery evaluation; cleaner and sharper than EEG. , Magnetoencephalography (MEG)Magnetoencephalography (MEG) Recording the tiny magnetic fields produced by cortical currents with superconducting sensors in a shielded room; less blurred by the skull than EEG, and far more expensive. , Volume conductionVolume conduction The spreading of currents from a source through the conductive tissues of the head, which is why one source shows up on many electrodes and why scalp EEG is blurry. , Microvolt (µV)Microvolt (µV) One millionth of a volt. Scalp EEG is tens of microvolts; a AA battery is 1.5 million of them. . Glossary entry and a headband. The parent might be better served by a bed-motion sensor, a heart-rate monitor, or a camera. Deciding that too early is how the wrong device gets built well.
Validate the need
Talk to ten people who have it. Do they describe it the way you did? How do they cope now, and what does that cost them? Would they change anything? What has been tried and abandoned, and why? The speech-language pathologist, the occupational therapist, and the nurse have seen a hundred cases; interview them too. Adjust the statement. Half the time the need you wrote is not the one they have.
Then, and only then, solutions
Brainstorm broadly. List every way the need could be met, including ones with no technology at all. Screen against the need statementNeed statement One sentence, "a way to [do X] for [whom] that [outcome]," with no solution in it. Related: Needs findingNeeds finding Observing clinical work to catch the moments that are slow, awkward, or unsafe, before proposing any solution. . Glossary entry’s outcome and against the constraints you learned (cost, setting, who maintains it). Prototype the crudest version that tests the riskiest assumption. Bring it back to the people with the need.
Why this is a spine
Companies pay for this. The “clinical and regulatory” spine begins here, because a person who can find a real need, validate it, and write it precisely is rarer than a person who can build a device, and the device companies know it. The BiodesignBiodesign Stanford's process for medical technology innovation that starts from an observed clinical need rather than a technology looking for a use. Related: Needs findingNeeds finding Observing clinical work to catch the moments that are slow, awkward, or unsafe, before proposing any solution. , Need statementNeed statement One sentence, "a way to [do X] for [whom] that [outcome]," with no solution in it. . Glossary entry fellows who run this process full time go on to found companies and run product teams. A student who has run one cycle with a real person has done what most engineers never do.
Deep dive Stakeholders are not the same as users 3 min
The person who uses a device, the person who buys it, the person who sets it up, the person who pays, and the person who is liable are often five different people. A communication device is used by a patient, set up by a caregiver, prescribed by a speech-language pathologist, paid for by an insurer, and regulated by the FDA. A need that ignores any of them produces a device nobody adopts. Map all five for your need; the caregiver’s need (“set it up in two minutes at 3 a.m.”) is often the one that decides adoption.
Deep dive Needs that are not device needs 2 min
Some needs are met by a process change, a checklist, a training, or a phone call. BiodesignBiodesign Stanford's process for medical technology innovation that starts from an observed clinical need rather than a technology looking for a use. Related: Needs findingNeeds finding Observing clinical work to catch the moments that are slow, awkward, or unsafe, before proposing any solution. , Need statementNeed statement One sentence, "a way to [do X] for [whom] that [outcome]," with no solution in it. . Glossary entry screens explicitly for whether a need requires technology at all. Recognizing that the best solution is not a device, and saying so, is a mark of an engineer who understands the problem.
Explain what this page was about to your roommate in three sentences. No jargon they would not know.
We watch care where it happens and log about 20 slow or awkward moments per day, looking for waits, workarounds, and devices left unused in drawers. We write the need as a way to reach a measured result for a named group, such as sending an urgent message in under 10 seconds in the dark without helper aid, with no device named inside. We then test the wording with 10 people who live with the need, including the nurse and therapist, and we revise the sentence until it matches how they cope and what they would change.
Yours does not have to match. Check that the three ideas are there.