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Objective: The Aluetta™ reusable pen device and instructions for use (IFU) for growth hormone (r-hGH; Saizen®, Merck KGaA, Darmstadt, Germany) administration were tested for Human-Factors Usability, to ensure it could be used safely and effectively by the intended users in the intended use environment., Research Design and Methods: Usability testing was conducted under simulated conditions in three groups of participants: pediatric or adult patients with growth hormone deficiency (GHD), participants without GHD, and healthcare professionals (HCPs). The testing comprised a 45-minute training session, a 2-hour testing session, and a participant-feedback session., Results: Twenty-six participants completed the training session and performed all critical tasks related to the pen use across three scenarios. The most difficult tasks were related to the preparation, checking, and maintenance of the device; only 8% of use errors occurred during tasks related to the injection process. Eighty-five percent considered the pen safe and effective to use without further modifications and the training to be clear and effective., Conclusions: The pen device and associated materials benefited from Human Factors Engineering throughout the development process. These evaluations show that patients and HCPs could safely and effectively use the pen device, and the IFU and training were clear and effective.

Background : The recent development of high-volume subcutaneous drug delivery using handheld autoinjectors has resulted in longer injection durations. However, the usability of long injections has been neglected. This study aimed to investigate the effects of injection duration on users' ability to apply injections while holding the device against the skin at the injection site. Methods : Thirty-two participants among patients, caregivers, and health-care professionals simulated three injections with different injection durations to evaluate usability and user's force. Linear and quantile regression were then applied to determine the impact of the injection duration on response variables related to user's force. Results : A significant negative effect of injection time was found on both the minimum and mean user's force applied. Initial empirical evidence was also determined on the negative association being more pronounced for users exerting lower force to hold the device against the skin. Conclusions : The results that are subject to future clinical validation suggest the feasibility of injections lasting up to approximately 30 s using handheld autoinjectors. The participants of the simulated use study successfully applied long-duration injections regardless of disease states, age, or visual and dexterity impairments.

Background : This study compared preference ratings of women with infertility and nurses before and after simulated injection, and handling errors, with the GONAL-f®, Bemfola®, Ovaleap® and Rekovelle® pen injectors. Research design and methods : Injector-naïve women and injector-experienced fertility nurses tested injectors with masked labels in a randomized testing order. Injections were made into a foam pad and injectors were rated before and after use. Handling errors were recorded during the study. Ratings and errors were compared between pen injectors using ordinal or Poisson linear mixed models adjusted for testing order. Results : 120 women and 60 nurses participated. All participants tested GONAL-f and Bemfola injectors. Because of their similarity, participants tested either Rekovelle (71 women; 30 nurses) or Ovaleap (49 women; 30 nurses) injectors. The ratings from women were higher for GONAL-f vs other injectors after simulated use (p < 0.001 for all comparisons). Fertility nurses rated GONAL-f injector higher than other injectors both before and after use (p < 0.01 for all comparisons). Adjusted rates of total handling errors were lower with the GONAL-f vs other injectors (p < 0.001 for all comparisons) for both groups. Conclusions : GONAL-f injector was rated significantly higher than other injectors, which may be related to less handling errors observed with the GONAL-f injector.

Objectives: The multi-dose, pre-filled GONAL-f® RFF Redi-ject® (follitropin alfa injection) pen injector was updated following feedback on user experience and pen functionality, as part of a continuous assessment program. Human-factors engineering (HFE) evaluations were conducted to confirm that the updated pen injector could be used by intended users to safely and effectively perform critical tasks identified by the risk-management plan., Methods: Five rounds of formative evaluation and a simulated-use summative evaluation of the pen injector, instructions for use (IFU), and training video were conducted by HFE specialists or the intended users of the pen injector., Results: The IFU and training video were revised following formative evaluations. Summative evaluation of simulated-use involved 60 participants, each of whom performed six use-scenarios related to potential hazards, selected on the basis of the risk-management plan. Overall, participants found the pen injector easy to use and the IFU clear and effective., Conclusions: Through an iterative process involving a series of HFE evaluations, modifications were made to the injection mechanism, the dose display, the IFU and the training video. Summative evaluation confirmed that the updated pen injector and associated user materials can be used safely and effectively to perform critical tasks identified through the risk-management plan.

Introduction: Diabetes is growing in prevalence internationally. As more individuals require insulin as part of their treatment, technology evolves to optimize delivery, improve adherence, and reduce dosing errors. Insulin pens outperform vial and syringe in simplicity, dosing accuracy, and user preference. Bolus advisors improve dosing confidence and treatment adherence. The InPen System offers a novel approach to treatment via a wireless pen that syncs to a mobile application featuring a bolus advisor, enabling convenient insulin dose tracking and more accurate bolus advice among other features. Areas covered: Existing technology for insulin delivery and bolus advice are reviewed. The mechanics and functionality of the InPen device are delineated. Findings from formative testing and usability studies of the InPen system are reported. Future directions for the InPen system in the treatment of diabetes are discussed. Expert opinion: Diabetes management is complex and largely data-driven. The InPen System offers a promising new opportunity to avail insulin pen-users of features known to improve treatment efficacy, which have otherwise primarily been available to those using pumps. Given that the majority of insulin users do not use insulin pumps, the InPen System is poised to improve glucose control in a significant portion of the diabetes population.

Objectives: The prefilled, multidose, GONAL-f (®) (follitropin alfa) pen injector was redesigned to improve ease of use and pen functionality. This usability engineering evaluation aimed to demonstrate that the redesigned pen injector could be used by the intended users to safely and effectively deliver follitropin alfa., Methods: Formative and summative usability engineering evaluations of the pen injector, training and instructions for use (IFU) were conducted. This included an expert review, and formative and summative evaluations involving patients with infertility and fertility nurses. For the summative evaluation, participants received training and subsequently performed tasks based on three selected hazard-related use scenarios to evaluate real-world use, including simulated injections., Results: The formative evaluations confirmed that the pen injector was ready for summative evaluation. Task performance was high in the summative evaluation for both patients and nurses; the tasks that were observed to be most difficult to complete were priming the pen, completing an incomplete injection and completing the treatment diary. Participants rated the device as having above average usability. Most patients ranked the overall system (pen injector, device training and IFU) and its individual components to be either 'extremely easy' or 'somewhat easy' to use., Conclusions: These usability engineering evaluations demonstrated that patients and nurses could safely and effectively use the redesigned GONAL-f pen injector, and that they also found the IFU and device training to be easy to use.

Objectives: To demonstrate, using human factors engineering (HFE), that a redesigned, pre-filled, ready-to-use, pre-asembled follitropin alfa pen can be used to administer prescribed follitropin alfa doses safely and accurately., Methods: A failure modes and effects analysis identified hazards and harms potentially caused by use errors; risk-control measures were implemented to ensure acceptable device use risk management. Participants were women with infertility, their significant others, and fertility nurse (FN) professionals. Preliminary testing included 'Instructions for Use' (IFU) and pre-validation studies. Validation studies used simulated injections in a representative use environment; participants received prior training on pen use., Results: User performance in preliminary testing led to IFU revisions and a change to outer needle cap design to mitigate needle stick potential. In the first validation study (49 users, 343 simulated injections), in the FN group, one observed critical use error resulted in a device design modification and another in an IFU change. A second validation study tested the mitigation strategies; previously reported use errors were not repeated., Conclusions: Through an iterative process involving a series of studies, modifications were made to the pen design and IFU. Simulated-use testing demonstrated that the redesigned pen can be used to administer follitropin alfa effectively and safely.

Objective: Human growth hormone (hGH) delivery systems differ in the size of the dose increments that can be set by the patient, affecting proximity to the target (i.e., prescribed) dose which can be attained. We investigated differences in dosing increment granularity in NordiFlex®, FlexPro®, NordiPen® (all multiple dose devices) and MiniQuick® (single dose) delivery systems., Methods: A simulation model was developed to project hGH dosing in pediatric patients with growth hormone deficiency, small for gestational age or Turner syndrome, calculating the nearest dose above the target dose administrable by each device in typical EU and US cohorts and projecting the excess dose (hGH wastage) over 1 year of typical use., Results: The device with the smallest dosing increment (FlexPro 5 mg; 0.025 mg dosing increment) was projected to administer doses < 1% above the target across all indications. MiniQuick (0.2 mg dosing increment) was projected to deliver between 5 and 6% above the target dose. None of the sensitivity analyses changed the conclusion that larger dosing increments result in more hGH wastage., Conclusions: In addition to increasing dosing accuracy, finer dosing increments may result in reductions in unnecessary hGH usage, which may in turn result in reductions in the cost of hGH treatment borne by the health-care payer.

Objective: The objective of this study was to assess and compare the features of the Bemfola, Gonal-f and Puregon injection pens., Methods: Females who intended to undergo hormonal treatment received the three different pens in a randomized, consecutive sequence. For each of the pens, the potential patients completed an Injection Pen Assessment Questionnaire, as well as a questionnaire comparing the handling, convenience and preference among the three pens., Results: The mean score on the visual analogue scale (VAS) for the Bemfola pen (BP) was 77.8 ± 14.0; for the Puregon pen (PP), 72.1 ± 12.4; and for the Gonal-f pen (GP), 68.6 ± 16.4. The BP was superior to both competitor devices in pen size, inconspicuousness, ease of use and dose changing; no significant differences to both competitor pens were observed in the way the pen looks, the way the pen feels and the ease of injection of the volume. The 'overall' assessment was significantly better for the BP when compared to the GP (p = 0.0019), while no significant difference was observed between the BP and the PP., Conclusions: This study demonstrated significantly higher ratings for pen size, inconspicuousness, ease of use and dose adjustment for the BP compared to other marketed pens.

Objectives: A sub-study to evaluate safety, tolerability, ease-of-use and patient satisfaction with a single-use autoinjector administering subcutaneous peginterferon-β1a (a pegylated interferon-β1a in clinical development) in a subset of relapsing-remitting multiple sclerosis (MS) patients participating in ATTAIN, a long-term dose-frequency blinded extension of the Phase III randomized ADVANCE study., Methods: Over 8 weeks, patients self-administered peginterferon-β1a 125 µg or placebo every 2 weeks (two injections via manual pre-filled syringe [PFS]; two injections via single-use autoinjector). Primary end points were incidence of adverse events (AEs), patient assessment of injection pain score (10-point Visual Analog Scale), and clinician assessment of injection site reactions (ISRs). Secondary objectives included patient assessment of ease-of-use and satisfaction with the autoinjector and evaluation of autoinjector training materials., Results: In 39 patients, the safety profile of peginterferon-β1a was similar when delivered via autoinjector or PFS; AEs were mostly mild or moderate in severity. Clinicians and patients reported a similar tolerability profile using both PFS and autoinjector, and pain scores were low (< 1), with no reports of clinician-assessed ISRs after administration with the autoinjector. Patients perceived the single-use autoinjector to be easy to use and convenient; overall patient satisfaction with the autoinjector and accompanying training materials was high., Conclusion: The safety and tolerability profile of peginterferon-β1a delivered via autoinjector was similar to delivery via PFS. Patients found the autoinjector easy to use and convenient; this device may simplify the injection process for MS patients who require long-term therapy, thereby potentially improving patient's quality of life and adherence.

Objective: FlexTouch® (FT) is a new prefilled insulin pen with no push-button extension and a low injection force used to deliver several basal insulins, including insulin degludec across a wide dose range (1 - 80 units with FT 100 IU/ml [FT100] and 2 - 160 units with 200 IU/ml [FT200]). This study was carried out to evaluate whether the novel features of FT affect the preferences of the device among patients with diabetes and healthcare professionals compared with the widely used SoloSTAR® pen., Research Design and Methods: A multicenter, randomized, open-label, crossover study compared FT100 and FT200 with SoloSTAR. The study included patients with either type 1 (n = 22) or type 2 diabetes (n = 42), nurses (n = 32) and physicians (n = 32). Subjects were randomized to test each of the FT100, FT200 and SoloSTAR pens in a crossover set up. Subjects performed injections into a foam cushion at 4 - 6 different doses per device (2, 20, 40, 80, 120 and 160 IU)., Results: Overall, a significantly higher proportion of subjects, including dexterity-impaired and pen-naive patients, preferred to use FT100 (93.0%; 119/128) and FT200 (91.4%; 117/128) compared with 2.3% (3/128) and 3.9% (5/128) who preferred SoloSTAR (p < 0.001), respectively., Conclusion: FT100 and FT200 were preferred over SoloSTAR by nurses, physicians and patients with diabetes. This may be due to the novel design of FT, which improves ease of use, preference and confidence in delivering a complete, accurate dose of insulin, even at high doses.

Introduction: First-line disease-modifying drugs for the treatment of multiple sclerosis (MS) are mostly administered by injection. Although these treatments can control the symptoms and progression of the disease to some extent, patients often fail to adhere to their therapy in the long term, so may not obtain the maximum clinical benefits. As injection-related problems are common barriers to adherence, autoinjectors have been developed to improve the ease and convenience of self-injection., Areas Covered: This article discusses RebiSmart™, an electronic autoinjector for the subcutaneous administration of interferon β-1a, focusing on the device features and data from clinical trials of the device. An overview of other available autoinjectors for first-line MS therapies is provided for context., Expert Opinion: The device is the first electronic autoinjector for use in MS and offers several innovative features, including adjustable injection settings and an electronic dosing log, which may improve adherence. The dosing log can be reviewed with the patient, allowing the physician to open a dialogue to discuss possible issues with treatment adherence. The use of multidose cartridges also provides a softer impact on the environment and easier disposal. The hidden needle helps avoid needle phobia and reduces the risk of needle stick injury.

Objective: Usability of a new prefilled insulin pen, FlexTouch® (FT; Novo Nordisk A/S, Bagsvaerd, Denmark), with no push-button extension and low injection force, was compared with vial and syringe (V&S)., Research Design and Methods: People with diabetes, and healthcare professionals with diabetes management experience conducted test injections and answered questions on preference, ease of use, confidence, ease of learning and teaching., Results: The study involved 30 needle-naïve patients (naïve to any diabetes injection therapy), 30 V&S-experienced patients, 30 physicians and 30 nurses. In the total population, FT was preferred to V&S for teaching or learning to use (both p < 0.001). Nurses (100 vs. 0%) and physicians (87 vs. 7%) preferred FT to V&S for ease of teaching. V&S-experienced (73 vs. 7%) and needle-naïve patients (83 vs. 7%) preferred FT to V&S for ease of learning. The remainder chose "equally easy/difficult." More participants in each group rated FT "very/fairly easy" for ease of depressing the push-button/plunger (FT vs. V&S: physicians, 93 vs. 80%; nurses, 97 vs. 80%; V&S-experienced patients, 93 vs. 90%; needle-naïve patients, 100 vs. 77%), and injecting three doses. More participants were "very/rather confident" in managing daily injections using FT (FT vs. V&S: physicians, 100 vs. 60%; nurses, 100 vs. 70%; V&S-experienced patients, 93 vs. 90%; needle-naïve patients, 90 vs. 40%)., Conclusions: FT was rated easier to use, learn to use or teach to use than V&S by patients with or without experience of insulin injection with V&S, and by physicians and nurses with diabetes management experience.

Objective: FlexTouch® (FT) (Novo Nordisk A/S, Bagsværd, Denmark) is a new prefilled insulin pen with a novel injection mechanism encompassing no push-button extension at any dose-setting. This study assessed the dose accuracy and injection force of FT compared with the established Next Generation FlexPen® (NGFP) (Novo Nordisk A/S Bagsværd, Denmark)., Research Design and Methods: Dose accuracy was measured at the minimum, medium and maximum doses (FT, 1, 40 and 80 international units (IU) and NGFP, 1, 30 and 60 IU). Injection force was measured during the injection of the maximum dose (FT, 80 IU; NGFP, 60 IU)., Main Outcomes: FT and NGFP delivered insulin accurately and consistently at all doses (mean ± s.d., FT at 1 IU, 0.98 ± 0.07; 40 IU, 39.86 ± 0.33; 80 IU, 79.76 ± 0.64; NGFP at 1 IU, 1.02 ± 0.08; 30 IU, 29.69 ± 0.30; 60 IU, 59.50 ± 0.51). FT had a significantly (p < 0.0001) lower injection force than NGFP., Conclusions: The study demonstrated that FT and NGFP deliver insulin accurately and consistently at low, medium and high doses. The novel torque spring injection mechanism of FT results in a significantly lower injection force than NGFP and a pen requiring less thumb-pressure to inject insulin may be welcomed by many people with diabetes.