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 such as drug-device, biologic-device, drug-biologic, or drug-device-biologic products
  • Formative testing
  • Validation studies
  • Use-related risk analysis
  • Strategic and ad hoc HFE/UE reports
  • User needs analysis
  • Expert review
  • Design and packaging evaluation, including instructions and warnings, throughout the entire healthcare delivery system
  • 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.