Using Patient Feedback to Optimize the Design of a Certolizumab Pegol Electromechanical Self-Injection Device: Insights from Human Factors Studies.

Barbara Domańska,Clovis Pichon,Irina Mountian,Oliver Stumpp,Serkan Oray,Steven Poon

doi:10.1007/s12325-017-0645-1

Barbara Domańska, Clovis Pichon + Show 4 more

Open Access

https://doi.org/10.1007/s12325-017-0645-1

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Abstract

IntroductionWe incorporated patient feedback from human factors studies (HFS) in the patient-centric design and validation of ava®, an electromechanical device (e-Device) for self-injecting the anti-tumor necrosis factor certolizumab pegol (CZP).MethodsHealthcare professionals, caregivers, healthy volunteers, and patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or Crohn’s disease participated in 11 formative HFS to optimize the e-Device design through intended user feedback; nine studies involved simulated injections. Formative participant questionnaire feedback was collected following e-Device prototype handling. Validation HFS (one EU study and one US study) assessed the safe and effective setup and use of the e-Device using 22 predefined critical tasks. Task outcomes were categorized as “failures” if participants did not succeed within three attempts.ResultsTwo hundred eighty-three participants entered formative (163) and validation (120) HFS; 260 participants performed one or more simulated e-Device self-injections. Design changes following formative HFS included alterations to buttons and the graphical user interface screen. All validation HFS participants completed critical tasks necessary for CZP dose delivery, with minimal critical task failures (12 of 572 critical tasks, 2.1%, in the EU study, and 2 of 5310 critical tasks, less than 0.1%, in the US study).ConclusionCZP e-Device development was guided by intended user feedback through HFS, ensuring the final design addressed patients’ needs. In both validation studies, participants successfully performed all critical tasks, demonstrating safe and effective e-Device self-injections.FundingUCB Pharma.Plain Language SummaryPlain language summary available on the journal website.Electronic supplementary materialThe online version of this article (10.1007/s12325-017-0645-1) contains supplementary material, which is available to authorized users.

Highlights

We incorporated patient feedback from human factors studies (HFS) in the patient-centric design and validation of avaÒ, an electromechanical device (e-Device) for selfinjecting the anti-tumor necrosis factor certolizumab pegol (CZP)
We report the results from formative and validation HFS conducted across the UK and USA to support the development of avaÒ, an electromechanical injection device (e-Device) designed for self-injection of CZP
A skin sensor on the device was included so injection could be initiated only when the e-Device was placed in full contact with the skin, and to ensure that the needle would be fully retracted and hidden from the user when not in use

Summary

Introduction

We incorporated patient feedback from human factors studies (HFS) in the patient-centric design and validation of avaÒ, an electromechanical device (e-Device) for selfinjecting the anti-tumor necrosis factor certolizumab pegol (CZP). Methods: Healthcare professionals, caregivers, healthy volunteers, and patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or Crohn’s disease participated in Enhanced content To view enhanced content for this article go to http://www.medengine.com/Redeem/ 5ECCF0600829E6C8. Anti-tumor necrosis factors (anti-TNFs) can be an effective treatment option for a number of chronic inflammatory diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), and Crohn’s disease (CD). As a number of factors affecting treatment adherence are associated with treatment delivery [3], optimizing device design can provide an opportunity to improve adherence, enhance the patient experience, and aid disease management. Self-injection devices can be designed to meet patients’ unmet needs and provide flexibility and control for treatment administration, with additional features such as injection reminders to aid scheduling, promoting ease of use [2, 3]

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