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

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:

Radiology related 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 – https://www.linkedin.com/in/andrewkoopman/ 

ScienceDocs Inc. – Dr. Stacy Chin – Foundation, Academic and SBIR Grant Writer, PhD in Chemistry – https://www.sciencedocs.com/chemistry-sbir-grant-writer-chin/ 

Richard Hamer – FDA & Regulatory Consultant – https://www.linkedin.com/in/richard-hamer-bb1382/ 

Helpful Documents 

US Dept. of Health and Human Services – Applying Human Factors and Usability Engineering to Medical Devices https://www.fda.gov/media/80481/download

FDA Perspectives on Human Factors in Device Development  https://www.fda.gov/media/84709/download


Estimated Timeline: 4 – 6 weeks