Formative and Validation Human Factors studies of a new disposable autoinjector for subcutaneous delivery of chronic disease therapies

References

• Bernstein CN. Summing up: quality of life in chronic immune-mediated inflammatory diseases. J Rheumatol. 2011. DOI:https://doi.org/10.3899/jrheum.110908.
   Google Scholar
• El-Gabalawy H, Guenther LC, Bernstein CN. Epidemiology of immune-mediated inflammatory diseases: incidence, prevalence, natural history, and comorbidities. J Rheumatol. 2010. DOI:https://doi.org/10.3899/jrheum.091461.
   Google Scholar
• Kuek A, Hazleman BL, Östör AJK. Immune-mediated inflammatory diseases (IMIDs) and biologic therapy: a medical revolution. Postgrad Med J. 2007;83(978):251–260.
   PubMed Web of Science ®Google Scholar
• Mead J, Dammerman R, Rasmussen S. Patient reported ease-of-use with a disposable autoinjector in individuals with migraine. Patient Prefer Adherence. 2020. DOI:https://doi.org/10.2147/PPA.S248584.
   Google Scholar
• U.S. Food and Drug Administration, usability engineering to medical applying human factors and devices. FDA Guid., 2016.
   Google Scholar
• Hung DA, Seddighzadeh A, Liu S, et al. Safety, tolerability and patient evaluation of peginterferon beta-1a administered via a single-use autoinjector in relapsing multiple sclerosis: data from the Phase 3b ATTAIN sub-study. J Neurol. 2013;260:S74.
   Web of Science ®Google Scholar
• Wray S, Armstrong R, Herrman C, et al. Results from the single-use autoinjector for self-administration of subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis (MOSAIC) study. Expert Opin Drug Deliv. 2011. DOI:https://doi.org/10.1517/17425247.2011.628656.
   Google Scholar
• Martin A, Lavoie L, Goetghebeur M, et al. Economic benefits of subcutaneous rapid push versus intravenous immunoglobulin infusion therapy in adult patients with primary immune deficiency. Transfusion Medicine. 2013;23(1):55–60.
   Web of Science ®Google Scholar
• Turner MR, Balu-Iyer SV. Challenges and opportunities for the subcutaneous delivery of therapeutic proteins. J Pharm Sci. 2018;107(5):1247–1260.
   Web of Science ®Google Scholar
• Bittner B, Richter W, Schmidt J. subcutaneous administration of biotherapeutics: an overview of current challenges and opportunities. BioDrugs. 2018;32(5):425–440.
   PubMed Web of Science ®Google Scholar
• Hedayati E, Fracheboud L, Srikant V, et al. Economic benefits of subcutaneous trastuzumab administration: a single institutional study from Karolinska University Hospital in Sweden. PLoS One. 2019;14(2):e0211783.
   Web of Science ®Google Scholar
• Walsh CAE, Minnock P, Slattery C, et al. Quality of life and economic impact of switching from established infliximab therapy to adalimumab in patients with rheumatoid arthritis. Rheumatology. 2007;46(7):1148–1152.
   Web of Science ®Google Scholar
• Ziemssen T, Sylvester L, Rametta M, et al. Patient Satisfaction with the New Interferon Beta-1b Autoinjector (BETACONNECT™). Neurology and Therapy. 2015;4(2):125–136.
   PubMed Web of Science ®Google Scholar
• Schiff M, Jaffe J, Freundlich B, et al. New autoinjector technology for the delivery of subcutaneous methotrexate in the treatment of rheumatoid arthritis. Expert Review of Medical Devices. 2014;11(5):447–455.
   PubMed Web of Science ®Google Scholar
• Kleiter I, Lang M, Jeske J, et al. Adherence, satisfaction and functional health status among patients with multiple sclerosis using the BETACONNECT® autoinjector: a prospective observational cohort study. BMC Neurol. 2017;17(1). DOI:https://doi.org/10.1186/s12883-017-0953-8.
   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 Opinion on Drug Delivery. 2014;11(11):1713–1720.
   PubMed Web of Science ®Google Scholar
• Freundlich B, Kivitz A, Jaffe JS. Nearly pain-free self-administration of subcutaneous methotrexate with an autoinjector: results of a phase 2 clinical trial in patients with rheumatoid arthritis who have functional limitations. JCR: Journal of Clinical Rheumatology. 2014;20(5):256–260.
   PubMed Web of Science ®Google Scholar
• Lugaresi A, Florio C, Brescia-Morra V, et al. Patient adherence to and tolerability of self-administered interferon β-1a using an electronic autoinjection device: a multicentre, open-label, phase IV study. BMC Neurol. 2012;12(1). DOI:https://doi.org/10.1186/1471-2377-12-7.
   Google Scholar
• ISO, ISO - IEC 62366-1:2015 - Medical devices — part 1: application of usability engineering to medical devices. ISO, 2015.
   Google Scholar
• Wiklund ME, Kendler J, Yale AS. Usability testing of medical devices (1st ed.). Boca Raton: CRC Press. 2010. DOI:https://doi.org/10.1201/b10458.
   Google Scholar
• Peyko V, Cohen V, Jellinek-Cohen SP, et al. Evaluation and treatment of accidental autoinjection of epinephrine. American Journal of Health-System Pharmacy. 2013;70(9):778–781.
   PubMed Web of Science ®Google Scholar
• Arora S, Moclair B, Murphy K, et al. Summative Usability Evaluation of the SCTE-AI Device: a Novel Prefilled Autoinjector for Subcutaneous Testosterone Administration. The Journal of Sexual Medicine. 2018;15(12):1707–1715.
   Web of Science ®Google Scholar
• Lange J, Nemeth T. Formative usability evaluation of a fixed-dose pen-injector platform device. Medical Devices: Evidence and Research. 2018;11:105–112.
   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. Medical Devices: Evidence and Research. 2015;255. DOI:https://doi.org/10.2147/MDER.S85938.
   Google Scholar
• Guerlain S, Hugine A, Wang L. A comparison of 4 epinephrine autoinjector delivery systems: usability and patient preference. Annals of Allergy, Asthma & Immunology. 2010;104(2):172–177.
   PubMed Web of Science ®Google Scholar
• Berteau C. Evaluation of performance, safety, subject acceptance, and compliance of a disposable autoinjector for subcutaneous injections in healthy volunteers. Patient Preference and Adherence. 2010;379. DOI:https://doi.org/10.2147/ppa.s13132.
   Google Scholar
• Lim WH, Chan D, Boudville N, et al. Patients‘ perceptions of subcutaneous delivery of darbepoetin alfa by autoinjector prefilled pen versus prefilled syringe: a randomized, crossover study. Clinical Therapeutics. 2012;34(9):1948–1953.
   Web of Science ®Google Scholar
• Simons FER, Lieberman PL, Read EJ, et al. Hazards of unintentional injection of epinephrine from autoinjectors: a systematic review. Annals of Allergy, Asthma and Immunology. 2009;102(4):282–287.
   Web of Science ®Google Scholar
• Frew AJ. What are the ‘ideal’ features of an adrenaline (epinephrine) auto-injector in the treatment of anaphylaxis? Allergy: Eur J Allergy Clin Immunol. 2011;66(1):15–24.
   Google Scholar
• Simons FER, Edwards ES, Read EJ, et al. Voluntarily reported unintentional injections from epinephrine auto-injectors. Journal of Allergy and Clinical Immunology. 2010;125(2):419–423.e4.
   Web of Science ®Google Scholar
• Weinhold T, Del Zotto M, Rochat J, et al. Improving the safety of disposable auto-injection devices: a systematic review of use errors. AAPS Open. 2018;4(1). DOI:https://doi.org/10.1186/s41120-018-0027-z.
   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. Rheumatology and Therapy. 2017;4(1):183–194.
   PubMed Web of Science ®Google Scholar
• Duruöz MT, Poiraudeau S, Fermanian J, et al. Development and validation of a rheumatoid hand functional disability scale that assesses functional handicap. J Rheumatol. 1996;23(7):1167-72.
   PubMed Web of Science ®Google Scholar
• ISO. ISO 23908 - Sharps injury protection — requirements and test methods — sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling. ISO. 2011.
   Google Scholar
• Food US, Administration D. Medical Devices with Sharps Injury Prevention Features. FDA Guid. 2011.
   Google Scholar
• Guerlain S, Wang L, Hugine A. Intelliject’s novel epinephrine autoinjector: sharps injury prevention validation and comparable analysis with EpiPen and Twinject. Annals of Allergy, Asthma & Immunology. 2010;105(6):480–484.
   PubMed Web of Science ®Google Scholar
• Mathaes R, Koulov A, Joerg S, et al. Subcutaneous injection volume of biopharmaceuticals—pushing the boundaries. J Pharm Sci. 2016;105(8):2255–2259.
   Web of Science ®Google Scholar
• Deokar V, Sharma A, Mody R, et al. Comparison of strategies in development and manufacturing of low viscosity, ultra-high concentration formulation for IgG1 Antibody. J Pharm Sci. 2020;109(12):3579–3589.
   PubMed Web of Science ®Google Scholar
• Badkar AV, Gandhi RB, Davis SP, et al. Subcutaneous delivery of high-dose/volume biologics: current status and prospect for future advancements. Drug Design, Development and Therapy. 2021;15:159–170.
   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 Opinion On Drug delivery. 2020;17(2):225–236.
   PubMed Web of Science ®Google Scholar
• MHRA. Human factors and usability engineering - guidance for medical devices including drug-device combination products. Med. Healthc. Prod. Regul. Agency. 2017. DOI: https://doi.org/10.1016/j.molliq.2015.09.041.
   Google Scholar