Device description
Cimzia® AutoClicks® is an autoinjector that delivers a measured dose of Cimzia (certolizumab pegol) for the treatment of autoimmune and rheumatic conditions including Rheumatoid Arthritis and Psoriatic Arthritis.
The device component includes a button-free delivery system and a wide non-slip grip designed to facilitate potential limitations in patient hand dexterity; and a viewing window to enable patients to see the progress of the injection and two audible clicks to indicate when the injection has started and when it has finished, designed to give patients the confidence that they have received their full injection dose.
Challenge
To provide a comprehensive package of human factors engineering in support of UCB’s development of Cimzia® AutoClicks®
Solution
Emergo by UL (and before that, Medical Device Usability, now part of the Emergo group) first got involved in providing human factors services to UCB in October 2013. Over a period of 5 years, we provided human factors input into the product development program. Our work included:
- Five formative evaluations, involving patients, caregivers and healthcare professionals
- HF validation studies, involving patients, caregivers and healthcare professionals
- Two comparative usability evaluations of Cimzia® AutoClicks® and competitor products
- Writing the HFE / UE report
In total Emergo by UL’s human factors specialists interviewed over 200 patients, caregivers and HCPs, involving simulated use of the product.
Impact
Cimzia® AutoClicks® has been approved for use by the European regulatory authorities.
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