The device was smaller, lighter and more flexible than existing 'scopes' and used a guidewire to facilitate navigation through the colon. Risk to the programme was minimised through early prototype testing and regular design reviews.
The design of the verification tests and packaging were completed in parallel with the device development and the commissioning of a custom manufacturing facility at PA’s Cambridge Technology Centre.
Whilst production equipment and assembly procedures were developed and validated, training and testing continued so that trials could begin immediately.
Disciplined, compliant control of the project delivered a full Design History File, Device Master Record, and devices ready for clinical trials within one year.
An extract from the published conclusions of the phase one study said: "…successful in over 90% of patients with previous failure of complete colonoscopy."
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