Over the past 10 years, our team has completed over 60 formative and summative usability testing projects with medical devices and Software as a Medical Device (SaMD) products. The FDA, MDR, and other regulatory organizations require that usability engineering, human factors testing, and application of risk management be incorporated into medical device product development and we can help you through the process.
Medical Device Usability Testing
Based on the class of medical device, it’s standard practice for manufacturers to submit human factors data in their pre-market 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
- Surgical devices
- LED light therapy devices
- Pain medication monitors
- Radiology products
- Diabetes medication delivery systems
- Catheter products
- Mobile applications
In addition to patients/consumers, we’ve moderated hundreds of one-on-one in person interviews with surgeons, radiologists, nurses (CNA, NP, CRNA, RN), cardiologists, oncologists, PCPs, ER doctors, hospital lab directors, MRI & CT Scan Technologists, urologists, anesthesiologists, OB-GYNs and other healthcare professionals.
NIH & NSF Grant Partnerships
Through our partnership with a firm backed by 75 years of US and European grant writing, we can help you put together a winning strategy for NIH, NSF, ARPA-H, and DoD grant applications. If you’re an early stage medical device or SaMD startup firm, these grants can help you move forward with product development, research, and follow up fundraising.
Additional Healthcare Research Expertise
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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