With advances in medical technology over the past 20 years, the FDA, EMA, and other regulatory organizations require that usability engineering, human factors testing, and application of risk management be incorporated into medical device product development.
Medical Device Usability Testing
Based on the class of medical device, it is now standard practice for manufacturers to submit human factors data in their premarket submissions to the FDA via their PMA 510k documentation. International standards such as the IEC 62366, ISO 14971, and ANSI/AAMI HE75 outline the details and process we follow. Ultimately the goal is to prove that a new medical device is safe to use, functions as expected, and is easy for consumers and/or healthcare professionals to use.
Our team can help you navigate all the activities along the journey and run medical device usability testing at the right time to move product development and regulatory submissions forward.
We’ve completed exploratory, formative, and summative user experience research on:
- Medical device software
- Catheter products
- LED light therapy devices
- Diabetes medication delivery systems
- Surgical devices
- Mobile applications
Whether you’re exploring the usability of the device itself and/or its instructional directions, we can recruit the target audience that’s needed. In addition to consumers, we’ve moderated hundreds of 1-on-1 interviews with surgeons, radiologists, nurses (CNA, NP, CRNA, RN), cardiologists, oncologists, PCPs, radiology technicians, anesthesiologists, OB-GYNs and other healthcare professionals.
Through our partnerships with complementary industry experts, we can also point you in the right direction for writing and submitting for NIH grants, legal and 510k development, and raising capital for new ventures.
Andrew Koopman – Biotech Business Consultant
Heidi Hattendorf – Healthcare Strategy Consultant
ScienceDocs Inc. – Dr. Stacy Chin – Foundation, Academic and SBIR Grant Writer, PhD in Chemistry
Estimated Timeline: 4-6 Weeks
Frequently Asked Questions
What is the difference between formative and summative usability testing?
Formative UX testing is ideal for early stage product exploration and learning how users interact with prototype devices. Summative usability testing needs to be in person and will involve users interacting with the final version of your product. During summative research First Insights prepares formal test case documents to add to a final 510k or MDR submissions.
How many participants are needed for medical device usability testing?
For formative research, 10-12 participants are ideal. Once summative usability testing is planned, the FDA needs to see that 15 people within a specific job title or consumer profile test a device. So if you have a device that’s used by a nurse and cardiologist, the FDA wants to see that 15 of each job title tests the device.
What’s a typical methodology during a 60 minute medical device user test?
First Insights works to set up a real world environment where the device will be tested such as an operating room, patient room, or home setting. After a brief introduction by our moderator, we let participants act as they normally would if we were not present. Unprompted, participants will read the IFU and directions for the device and then proceed to set it up for use as they might if they were alone in their expected setting. Once the device is set up, a moderator asks follow up questions based on observing expected tasks completed or missed during the setup process.
Does First Insights test SaMD products in addition to Class II devices?
Yes. Our team has expertise running usability tests for medical software used by Radiologists, MRI technologists, Cardiologists, Dermatologists, Nurses, Diabetes patients and many other audience profiles.
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