Integrating Human Factors into the product development process – development of BD Intevia™ 1mL two-step Disposable Autoinjector
TimeThursday, April 152:00pm - 3:00pm EDT
LocationMedical and Drug Delivery Devices
At BD, human factors activities are conducted throughout the phase-gated product development process and follow recommendations from both IEC 623661 and the FDA guidance on human factors2. This includes conducting studies in an iterative fashion to identify and analyze incidents that have occurred and build the learning so that corrective actions are put in place to improve the device design. The goal of these efforts is to provide a final BD validated design and IFU along with a body of research that our customers can use to inform development of the content and structure for their validation study with their final combination device.
This rigorous process was followed with the BD Intevia™ 1 mL two-step Disposable Autoinjector. It is designed to be compatible with viscous drugs up to 35cP and with different fill volumes up to 1 mL3,4. This is possible without customizing the components, permitting biotech companies to have a “platform” autoinjector device.
Case Study: Human Factors for BD Intevia™ 1 mL
For the BD Intevia™ 1 mL Disposable Autoinjector, 9 studies focusing on the device/user interface were conducted over the course of the project to identify and to eliminate or reduce the risk of error so the device can be used safely.
A wide user population was evaluated, both experienced and naïve, including healthcare practitioners (HCP’s), caregivers, and patients with a variety of conditions including Multiple Sclerosis (MS) and Rheumatoid Arthritis (RA). For the validation study5, the participants were split into both trained (n=16) and untrained groups (n=70) and were asked to perform 4 simulated injections. The training group included a training decay to avoid short-term memory bias, as recommended by the FDA2. Both groups had the instructions for use (IFU) included inside the device packaging but were free to determine on their own if they wanted to utilize them during the study. Sample sizes were chosen in accordance with FDA guidelines2.
From a human factors standpoint, BD Intevia™ 1 mL Disposable Autoinjector is considered safe and effective for its intended use by representative user groups.
• Participants gave high ratings for key product attributes such as overall acceptance, ease of use, feedback indicators, and confidence to control start of injection.
• Most participants are willing to use or switch from their current Autoinjector to the BD Intevia™ 1 mL Disposable Autoinjector.
• Overall, a robust population of users understand the device and handling steps.
1. IEC 62366-1:2015. Medical Products – Application of Usability Engineering to Medical Products.
2. Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff (February 3, 2016)
3. Design input specification for BD Intevia™ 1 mL [internal report]. Pont-de-Claix, FR: Becton Dickinson and Company; 2017
4. Activation gliding force and injection time on syringe filled with viscous solutions assembled in Intevia™ [internal report]. Pont-de-Claix, FR: Becton Dickinson and Company; 2017
5. PHS-19-POS06 Key Results [internal study]. Pont-de-Claix, FR: Becton Dickinson and Company; 2019