PA Consulting
281 Case Studies
A PA Consulting Case Study
Ethicon Endo-Surgery, Inc. partnered with PA Consulting to develop a novel colonoscope to address the challenge of creating a smaller, lighter, more flexible device that could navigate the colon more effectively than existing scopes. The project needed to move quickly from concept into clinical trial-ready units while managing development risk and maintaining compliance.
PA Consulting designed and built the colonoscope from initial concept through clinical trial units in just 12 months, using early prototype testing, regular design reviews, and parallel development of verification tests, packaging, and manufacturing capability. PA Consulting also commissioned a custom manufacturing facility, validated production equipment and assembly procedures, and delivered a full design history file and device master record, with phase one study results showing the device was successful in over 90% of patients with previous failure of complete colonoscopy.