CNYBAC's Usability Test Center assists medical device innovators and manufacturers in conducting usability testing. Often this is needed for CE Mark when selling product outside the US, for validation to promote data to support the safety and effectiveness of your product, but also to conduct early iterative testing to promote quality driven user-centric design. We can assist in the conduct of formative, summative and accompanying document usability testing; coordinate use of simulator environments within Upstate Medical University; recruit and schedule representative user groups for testing; assist with IRB submission and protocol development.
Robert J. Corona, DO, MBA, FCAP, FASCP, Professor and Chair of Pathology, Medical Director of Neuropathology/Muscle Pathology, SUNY Upstate Medical University and Vice President for Innovation and Business Development, CNYBAC. Former Chief Medical Officer and VP, Clinical Affairs for device manufacturer, Welch Allyn.
Kathi Durdon, MA, CCRP, CNYBAC Director of Operations with over 15 years of experience of good clinical practice conduct of human subject research and human factors/usability evaluations. Kathi is a member of the Association for the Advancement of Medical Instrumentation (AAMI) Human Factors Committee and Clinical Investigation Committee, chairs the annual Society of Clinical Research Associates (SoCRA) medical device research and regulations conference, and instructs the SoCRA clinical research certification preparatory course.
Kathleen Pazaras as CNY BAC Building Manager, formerly worked within the SUNY Upstate Medical University Research Administration Office, skilled in database development, worked very closely with basic science and clinical researchers in grant submissions and industry sponsored clinical trial contracting.
For Rates and/or to Coordinate Testing or for more Information, contact:
CNY Biotech Accelerator
841 E. Fayette St., Syracuse, NY 13210
Contact: Kathi Durdon, MA, CCRP