The FDA finds human factors' design & testing to be critical for ensuring the safety and effectiveness of medical devices.
A design that addresses your users needs and challenges will result in an effective, more usable and life-saving medical solution.
"If you think good design is expensive, you should look at the cost of bad design." - Dr. Ralf Speth
Most early stage startups have limited funds, small development teams and not enough time. In such conditions, every desicion might have a significant cost.
Studies show that about 50% of developers time is spent on unnecessary rework.
Prioritizing UX research, conducting user testing by using interactive mockups, defining stakeholders needs & goals, can prevent costly redesign later, minimize development rework and ensure efficient use of resources.
The U.S. Food and Drug Administration (FDA) has established a set of guidelines for the user interface (UI) and user experience (UX) design of medical devices. These guidelines are aimed at ensuring the safety, usability, and effectiveness of medical devices for both healthcare professionals and patients.
Table A-1, Section 8 of the FDA guidelines provides detailed instructions for the guidelines' validation through rigorous user testing. Meeting the expectations outlined in this section is a key regulatory requirement.
Having the right idea is not enough anymore.
In a crowded market, superior UX sets startups apart: Intuitive interfaces, delightful interactions and efficient workflows along with itirative design based on users feedback and analytics, attract and retain users, giving startups a competitive edge.
“For medical devices, User experience is not just about usability, it’s in the heartbeat of innovation, ensuring every interaction is a step towards better health.”
