What makes medical device UX different from other healthcare UX work?
Medical device interfaces are subject to FDA human factors engineering requirements under IEC 62366-1, which mandates structured usability testing and documentation showing that use-related risks have been identified and mitigated — a regulatory bar that patient portals and general healthcare apps don’t carry.
What’s the difference between a physical medical device and Software as a Medical Device (SaMD)?
A physical device has hardware — sensors, screens, mechanical components — that a studio like Delve can design end-to-end. SaMD is software that performs a medical function on its own, like a diagnostic algorithm or a digital therapeutic, and follows its own FDA submission path even without physical hardware.
Do we need a studio with FDA submission experience even at the prototype stage?
Yes, ideally. Human factors requirements shape early design decisions — how you structure your usability testing plan, how you document use-related risks — and it’s far more expensive to retrofit that thinking after a design is largely finished.
How does designing for a clinician differ from designing for a patient using the same device?
A clinician brings trained expertise and needs efficiency under time pressure; a patient using an at-home device needs the interface to teach itself, often with zero clinical background. Some devices, like Vasolabs, have to serve both audiences on the same screen — a genuinely harder design problem than either alone.
What does medical device UX design typically cost?
It varies enormously by device complexity and whether physical hardware is involved. Software-only SaMD design engagements can be scoped in the tens of thousands; full physical device development spanning industrial design, engineering, and FDA submission support, like Delve’s work, runs substantially higher given the disciplines involved.
How long does medical device UX design typically take, including regulatory review?
It varies widely, but human factors validation and FDA review add real time beyond the design work itself — often many months to over a year, depending on device classification and how much simulated-use testing the FDA review requires.
Should the same studio handle both the physical device and its software interface?
Not necessarily, but it can reduce risk. A studio like Delve that handles industrial design, engineering, and interface design together avoids the handoff gaps that can occur when the physical device and its software are designed by separate vendors.
What usability testing methods matter most for FDA human factors submissions?
Simulated-use studies with representative users performing realistic tasks under conditions that mirror real-world use are central to FDA human factors validation — a studio should be able to describe specifically how they’ve structured this kind of testing before, not just general usability testing experience.
