Exponent UX
for Medical Devices

Medical device development is expensive and littered with regulatory landmines. Mitigating the risk of injury to patients and the risk of legal exposure to both manufacturers and healthcare providers is essential.

We can streamline the regulatory review and approval process by helping you identify, test, and address the issues most likely to be of concern. We can help you navigate tricky waters if you’re designing a “niche” device that could cross multiple regulatory agency boundaries or when you’re new to a particular agency’s review.

Whether you’re designing a new medical device, have regulatory compliance or usage issues, challenges with your facilities, or concerns related to healthcare professionals, caregivers, or patients, Exponent UX can help.

Our services include:

  • Proof-of-concept and product viability support for all types of medical devices, including implantables and combination products
  • User needs analysis
  • Time and motion studies and workflow analyses
  • Use-related characterization analysis of users and use environments
  • Use-related risk analysis support
  • Expert review
  • Evaluation of design, labeling, training, and packaging, including instructions for use and use-related safety communications, throughout the entire healthcare delivery system
  • Formative human factors testing design and conduct
  • Human factors validation study design and conduct
  • HFE/UE report support

 

Selected additional Exponent services

  • U.S. and international regulatory compliance support
  • Product warranty and recall support
  • Litigation support

Get in touch

To learn more about how Exponent UX can help better inform your product or process design decisions and drive exponential advantage to your company, send us a message here.