User-Centric Approach to Specifying Technical Attributes of Drug Delivery Devices: Empirical Study of Autoinjector-Cap Removal Forces

References

• Schneider A, Kolrep H, Jordi C, et al. How to prevent medication errors: a multidimensional scaling study to investigate the distinguishability between self-injection platform device variants. Expert Opin Drug Deliv. 2019;16(8):883–894. doi:10.1080/17425247.2019.1637852
   PubMed Web of Science ®Google Scholar
• Lange J, Richard P, Bradley N. Usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population. Med Devices (Auckl). 2015;8:255–264. doi:10.2147/MDER.S85938
   PubMedGoogle Scholar
• Kivitz A, Baret-Cormel L, van Hoogstraten H, et al. Usability and patient preference phase 3 study of the sarilumab pen in patients with active moderate-to-severe rheumatoid arthritis. Rheumatol Ther. 2018;5(1):231–242. doi:10.1007/s40744-017-0090-2
   Web of Science ®Google Scholar
• Callis Duffin K, Bagel J, Bukhalo M, et al. Phase 3, open-label, randomized study of the pharmacokinetics, efficacy and safety of ixekizumab following subcutaneous administration using a prefilled syringe or an autoinjector in patients with moderate-to-severe plaque psoriasis (UNCOVER-A). J Eur Acad Dermatol Venereol. 2017;31(1):107–113. doi:10.1111/jdv.13768
   PubMed Web of Science ®Google Scholar
• Rho YH, Rychlewska-Hańczewska A, Śliwowska B, et al. Usability of prefilled syringe and autoinjector for SB4 (an etanercept biosimilar) in patients with rheumatoid arthritis. Adv Ther. 2019;36(9):2287–2295. doi:10.1007/s12325-019-01027-z
   PubMed Web of Science ®Google Scholar
• Dashiell-Aje E, Harding G, Pascoe K, et al. Patient evaluation of satisfaction and outcomes with an autoinjector for self-administration of subcutaneous belimumab in patients with systemic lupus erythematosus. Patient. 2018;11(1):119–129. doi:10.1007/s40271-017-0276-2
   PubMedGoogle Scholar
• Vermeire S, D’heygere F, Nakad A, et al. Preference for a prefilled syringe or an auto-injection device for delivering golimumab in patients with moderate-to-severe ulcerative colitis: a randomized crossover study. Patient Prefer Adherence. 2018;12:1193–1202. doi:10.2147/PPA.S154181
   PubMed Web of Science ®Google Scholar
• Kivitz A, Cohen S, Dowd JE, et al. Clinical assessment of pain, tolerability, and preference of an autoinjection pen versus a prefilled syringe for patient self-administration of the fully human, monoclonal antibody adalimumab: the TOUCH trial. Clin Ther. 2006;28(10):1619–1629. doi:10.1016/j.clinthera.2006.10.006
   PubMed Web of Science ®Google Scholar
• Hudry C, Lebrun A, Moura B, et al. Evaluation of usability and acceptance of a new autoinjector intended for methotrexate subcutaneous self-administration in the management of rheumatoid arthritis. Rheumatol Ther. 2017;4(1):183–194. doi:10.1007/s40744-017-0057-3
   PubMed Web of Science ®Google Scholar
• Matfin G, Van Brunt K, Zimmermann AG, et al. Safe and effective use of the once weekly dulaglutide single-dose pen in injection-naïve patients with type 2 diabetes. J Diabetes Sci Technol. 2015;9(5):1071–1079. doi:10.1177/1932296815583059
   PubMedGoogle Scholar
• Brooks CC, Martin LJ, Pilipenko V, et al. Usability of mepolizumab single-use prefilled autoinjector for patient self-administration. J Asthma. 2019;1–12. doi:10.1080/02770903.2019.1694941
   Web of Science ®Google Scholar
• Schiff M, Koo J, Jin E, et al. Usability and acceptability of the abatacept pre-filled autoinjector for the subcutaneous treatment of rheumatoid arthritis. Adv Ther. 2016;33(2):199–213. doi:10.1007/s12325-016-0286-9
   PubMed Web of Science ®Google Scholar
• Duffin CK, Bukhalo M, Bobonich MA, et al. Usability of a novel disposable autoinjector device for ixekizumab: results from a qualitative study and an open-label clinical trial, including patient-reported experience. Med Devices (Auckl). 2016;9:361–369. doi:10.2147/MDER.S113752
   PubMedGoogle Scholar
• Bode A. Development of the SoloSTAR ® insulin pen device: design verification and validation. Expert Opin Drug Deliv. 2009;6(1):103–112. doi:10.1517/17425240802636187
   PubMed Web of Science ®Google Scholar
• Bailey T, Campos C. FlexTouch(R) for the delivery of insulin: technical attributes and perception among patients and healthcare professionals. Expert Rev Med Devices. 2012;9(3):209–217. doi:10.1586/erd.12.13
   PubMed Web of Science ®Google Scholar
• Schwartz SL, Ignaut DA, Bodie JN. Humalog((R)) KwikPen: an insulin-injecting pen designed for ease of use. Expert Rev Med Devices. 2010;7(6):735–743. doi:10.1586/erd.10.63
   PubMed Web of Science ®Google Scholar
• Yuen KCJ, Amin R. Developments in administration of growth hormone treatment: focus on Norditropin(®) Flexpro(®). Patient Prefer Adherence. 2011;5:117–124. doi:10.2147/PPA.S10985
   PubMed Web of Science ®Google Scholar
• Mahony MC, Patterson P, Hayward B, et al. Human factors engineering and design validation for the redesigned follitropin alfa pen injection device. Expert Opin Drug Deliv. 2015;12(5):715–725. doi:10.1517/17425247.2015.1033395
   PubMed Web of Science ®Google Scholar
• Mahony M, Dwyer A, Barkume R, et al. US human factors engineering evaluation of an updated follitropin alfa pen injector (GONAL-f® RFF redi-ject®) and instructions for use. Expert Opin Drug Deliv. 2018;15(1):5–15. doi:10.1080/17425247.2018.1402886
   PubMed Web of Science ®Google Scholar
• Schwartz S, Vlajnic A. Validation of the SoloSTAR insulin pen. Diabetes Technol Ther. 2008;10(5):351–357. doi:10.1089/dia.2008.0079
   Web of Science ®Google Scholar
• Lange J, Richard P, Bradley N. Usability of devices for self-injection: results of a formative study on a new disposable pen injector. Med Devices (Auckl). 2014;7:195–203. doi:10.2147/MDER.S63918
   PubMedGoogle Scholar
• Van der Burg T. Injection force of SoloSTAR(R) compared with other disposable insulin pen devices at constant volume flow rates. J Diabetes Sci Technol. 2011;5(1):150–155. doi:10.1177/193229681100500120
   PubMedGoogle Scholar
• Haak T, Edelman S, Walter C, et al. Comparison of usability and patient preference for the new disposable insulin device Solostar versus Flexpen, lilly disposable pen, and a prototype pen: an open-label study. Clin Ther. 2007;29(4):650–660. doi:10.1016/j.clinthera.2007.04.003
   PubMed Web of Science ®Google Scholar
• Pfutzner A, Forst T, Niemeyer M, et al. Assessment for ease of use and preference of a new prefilled insulin pen (FlexTouch degludec U100/U200) versus the SoloSTAR insulin pen by patients with diabetes and healthcare professionals. Expert Opin Drug Deliv. 2014;11(9):1381–1389. doi:10.1517/17425247.2014.927438
   PubMed Web of Science ®Google Scholar
• Bohnet J, Schmitz M, Kamlot S, et al. Dosing accuracy and insulin flow rate characteristics of a new disposable insulin pen, FlexTouch, compared with SoloSTAR. J Diabetes Sci Technol. 2013;7(4):1021–1026. doi:10.1177/193229681300700426
   PubMedGoogle Scholar
• Ignaut DA, Opincar M, Lenox S. FlexPen® and KwikPen™ prefilled insulin devices: a laboratory evaluation of ergonomic and injection force characteristics. J Diabetes Sci Technol. 2008;2(3):533–537. doi:10.1177/193229680800200327
   PubMedGoogle Scholar
• Schneider AE, Lange J. Pen devices for self-injection: contrasting measured injection force with users’ perceived ease of injection. Expert Opin Drug Deliv. 2018;15(2):115–125. doi:10.1080/17425247.2018.1415884
   PubMed Web of Science ®Google Scholar
• Wang T, Conrad KA, van Brunt K, et al. Attributes influencing insulin pen preference among caregivers and patients with diabetes who require greater than 20 units of mealtime insulin. J Diabetes Sci Technol. 2016;10(4):923–931. doi:10.1177/1932296816633232
   PubMedGoogle Scholar
• Dou Z, Eshraghi J, Guo T, et al. Performance characterization of spring actuated autoinjector devices for Emgality and Aimovig. Current Med Res Opin. 2020;36(8):1–12.
   Web of Science ®Google Scholar
• Schwarzenbach F, Dao Trong M, Grange L, et al. Results of a human factors experiment of the usability and patient acceptance of a new autoinjector in patients with rheumatoid arthritis. Patient Prefer Adherence. 2014;8:199. doi:10.2147/PPA.S50583
   PubMed Web of Science ®Google Scholar
• LaRue S, Springer J, Noderer M, et al. Evaluation of the use of exenatide once-weekly suspension autoinjector among patients with type 2 diabetes mellitus and health care professionals. J Diabetes Sci Technol. 2019;13(2):226–234. doi:10.1177/1932296818798376
   Google Scholar
• Valentine V, Newswanger B, Prestrelski S, et al. Human factors usability and validation studies of a glucagon autoinjector in a simulated severe hypoglycemia rescue situation. Diabetes Technol Ther. 2019;21(9):522–530. doi:10.1089/dia.2019.0148
   PubMed Web of Science ®Google Scholar
• Peláez SS, Mahler H-C, Matter A, et al. Container closure integrity testing of prefilled syringes. J Pharm Sci. 2018;107(8):2091–2097. doi:10.1016/j.xphs.2018.03.025
   Web of Science ®Google Scholar
• US Food and Drug Administration. Applying Human Factors and Usability Engineering to Medical Devices. Guidance for Industry and Food and Drug Administration staff; 2016.
   Google Scholar
• Hupperts R, Becker V, Friedrich J, et al. Multiple sclerosis patients treated with intramuscular IFN-β-1a autoinjector in a real-world setting: prospective evaluation of treatment persistence, adherence, quality of life and satisfaction. Expert Opin Drug Deliv. 2015;12(1):15–25. doi:10.1517/17425247.2015.989209
   PubMed Web of Science ®Google Scholar
• Seddighzadeh A, Hung S, Selmaj K, et al. Single-use autoinjector for peginterferon-β 1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the phase IIIb ATTAIN study. Expert Opin Drug Deliv. 2014;11(11):1713–1720. doi:10.1517/17425247.2014.944159
   PubMed Web of Science ®Google Scholar
• EPMR Association. EphMRA 2017 Code of Conduct V4.indd. European Pharmaceutical Market Research Association; 2017.
   Google Scholar
• UP Association. UPA Code of Professional Conduct for Usability Practitioners. Usability Professionals’ Association; 2005.
   Google Scholar
• Schneider A, Mueller P, Jordi C, et al. Hold the device against the skin: the impact of injection duration on user’s force for handheld autoinjectors. Expert Opin Drug Deliv. 2020;17(2):225–236. doi:10.1080/17425247.2020.1704730
   PubMed Web of Science ®Google Scholar
• Sautner J, Andel I, Rintelen B, Leeb BF. Development of the M-SACRAH, a modified, shortened version of SACRAH (Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands). Rheumatology. 2004;43(11):1409–1413. doi:10.1093/rheumatology/keh360
   PubMed Web of Science ®Google Scholar
• Xiao X, Li W, Clawson C, et al. Evaluation of performance, acceptance, and compliance of an auto-injector in healthy and rheumatoid arthritic subjects measured by a motion capture system. Patient Prefer Adherence. 2018;12:515–526. doi:10.2147/PPA.S160394
   PubMed Web of Science ®Google Scholar
• Pfutzner A, Schipper C, Niemeyer M, et al. Comparison of patient preference for two insulin injection pen devices in relation to patient dexterity skills. J Diabetes Sci Technol. 2012;6(4):910–916. doi:10.1177/193229681200600423
   PubMedGoogle Scholar
• Domanska B, VanLunen B, Peterson L, et al. Comparative usability study for a certolizumab pegol autoinjection device in patients with rheumatoid arthritis. Expert Opin Drug Deliv. 2017;14(1):15–22. doi:10.1080/17425247.2016.1256283
   PubMed Web of Science ®Google Scholar
• Thakur K, Biberger A, Handrich A, et al. Patient perceptions and preferences of two etanercept autoinjectors for rheumatoid arthritis: findings from a patient survey in Europe. Rheumatol Ther. 2016;3(2):245–256. doi:10.1007/s40744-016-0048-9
   PubMed Web of Science ®Google Scholar
• Haward BM, Griffin MJ. Repeatability of grip strength and dexterity tests and the effects of age and gender. Int Arch Occup Environ Health. 2002;75(1–2):111–119. doi:10.1007/s004200100285
   PubMed Web of Science ®Google Scholar
• Martin JA, Ramsay J, Hughes C, et al. Age and grip strength predict hand dexterity in adults. PLoS One. 2015;10(2):e0117598. doi:10.1371/journal.pone.0117598
   PubMed Web of Science ®Google Scholar
• Phillips JT, Fox E, Grainger W, et al. An open-label, multicenter study to evaluate the safe and effective use of the single-use autoinjector with an avonex® prefilled syringe in multiple sclerosis subjects. BMC Neurol. 2011;11(1):126. doi:10.1186/1471-2377-11-126
   PubMed Web of Science ®Google Scholar
• Imrhan SN, Sundararajan K. An investigation of finger pull strengths. Ergonomics. 1992;35(3):289–299. doi:10.1080/00140139208967814
   PubMed Web of Science ®Google Scholar
• Andre AD, Brand-Schieber E, Ramirez M, et al. Subcutaneous sumatriptan delivery devices: comparative ease of use and preference among migraineurs. Patient Prefer Adherence. 2017;11:121–129. doi:10.2147/PPA.S125137
   PubMed Web of Science ®Google Scholar
• Egeth M, Soosaar J, Nash P, et al. Patient and healthcare professionals preference for Brenzys vs. Enbrel autoinjector for rheumatoid arthritis: a randomized crossover simulated-use study. Adv Ther. 2017;34(5):1157–1172. doi:10.1007/s12325-017-0523-x
   PubMed Web of Science ®Google Scholar
• Di Cantogno VE, Tomlinson M, Manuel L, et al. Autoinjector preference in multiple sclerosis and the role of nurses in treatment decisions: results from an international survey in Europe and the USA. Pragmat Obs Res. 2014;5:53–64. doi:10.2147/POR.S72012
   Google Scholar
• Blauvelt A, Prinz JC, Gottlieb AB, et al. Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE). Br J Dermatol. 2015;172(2):484–493. doi:10.1111/bjd.13348
   PubMed Web of Science ®Google Scholar
• Paul C, Stalder JF, Thaçi D, et al. Patient satisfaction with injection devices: a randomized controlled study comparing two different etanercept delivery systems in moderate to severe psoriasis. J Eur Acad Dermatol Venereol. 2012;26(4):448–455. doi:10.1111/j.1468-3083.2011.04093.x
   PubMed Web of Science ®Google Scholar