The evolution of treatment options from oral therapies to biologic and biosimilar self-injectables has helped many patients suffering from chronic conditions. Although these new therapies may provide relief, remission or even a cure the pharmaceutical industry still has the challenge of identifying effective solutions for overcoming patient self-administration errors that result in poor adherence and low compliance of treatment.
For drug delivery devices, such as autoinjectors, complementary training devices are being utilized more often during the patient onboarding experience and are seen as the most impactful education tool in the first 30 to 90 days of treatment. Although a patient receives in-office training conducted by a healthcare practitioner, studies suggest 40 to 80 percent of information obtained is immediately forgotten upon leaving the physician’s office.1 A patient’s inability to effectively recall and utilize information may lead to a higher probability of incorrect administration technique when using a combination product at home. Continued incorrect administration may ultimately have a snowball effect, leading to nonadherence and discontinuation of treatment due to the belief of the therapy being ineffective.
According to a study conducted by the University of Texas Medical Branch at Galveston (UTMB), 84 percent of patients failed to demonstrate correct use of an autoinjector, with more than half of users missing four steps for correct administration. 2 Furthermore, research published by Elsevier Science Ireland reported that anxiety of injections is associated with a decrease in compliance, with 45 percent of patients skipping or avoiding injections due to anxiety or fear.3 These research findings demonstrate that the patient learning process, in addition to emotional and environmental factors, could greatly impact the process for understanding how to correctly perform treatment.
Research has found that mechanical training devices benefit patients by creating familiarity with the operation of a device and reducing critical errors when used during the onboarding process. Studies also suggest training devices increase patient confidence and decrease user anxiety. However, for training devices to effectively produce these outcomes they must accurately replicate the look, feel and function of the real device. Eighty-nine percent of users reported that it is very important to have the most realistic training device possible, and 69 percent said it’s very important to have a trainer that looks and feels similar to a real needle.4
Design and engineering considerations for training devices
While training devices may appear simple in their design and execution, these devices are complex. The unique features utilized within the devices require detailed planning and careful engineering. Actual injectable devices are designed to dispense medication once and then be discarded, but training devices must house additional mechanical features that reset, allowing patients to train with the device for multiple cycles.
The aforementioned UTMB study also notes that the most common device error made by patients is the “wet injection.” Seventy-six percent of users failed to hold the device in place for the proper amount of time to receive the full dose with other errors including choosing an unsuitable injection site and not applying enough force to actuate the drug delivery device. 1 Issues like this may cause adherence and compliance challenges for patients, leading to discontinuation of treatment. In order to ensure patients understand how to properly self-inject, training devices are made to accurately simulate plunger speed and force application. Other features taken into consideration include: cap removal force, safety shield lockout, syringe retraction, unlock and audible click mechanisms, as well as the tactile feel of the device.
The external characteristics of training devices are also an important element for achieving optimal training results. The training device needs to match the original device on a 1:1 ratio while staying consistent in terms of material, size, shape and tactile elements. Features such as the geometry, barrel dimensions, viewing window, size and shape of the actuation button, needle shield and end cap are all carefully studied and analyzed prior to manufacturing. Creating an accurate proxy of an actual device helps patients familiarize themselves with a device prior to beginning treatment, better prepares users for what to expect through injection simulation and increases confidence prior to using a real injection device.
Quality control process and testing standards
Quality control requirements for training devices differ from those of the delivery devices they support primarily in the fact that training devices are not typically subject to the regulatory requirements governing medical devices. This offers some latitude in the approach to quality compliance. However, product quality remains a paramount concern.
Manufacturing quality begins in the design phase by engaging the manufacturing organization to ensure that the design, in addition to meeting functional requirements, is also highly manufacturable. This means the specifications for each component and assembly must fall well within the capabilities of the manufacturing processes, tooling and equipment. This discipline is often called Design for Manufacturing (DFM).
When the design has been validated and frozen, manufacturing implementation can begin in earnest and the first step is tooling. Tooling includes molds, dies and other product-specific tools and fixtures required to manufacture the product. A Quality Control Plan (QCP) is developed which includes inspection criteria and testing standards. Once the tools are built, they must be qualified through a series of pre-production sample runs to ensure that each component and assembly meets specification and functional performance requirements established in the QCP. This is an iterative process whereby the tooling and process parameters are adjusted from one run to the next to achieve optimal results with ample margins to ensure repeatability. After all tooling is qualified, one or more longer pilot runs are conducted to evaluate all aspects of the manufacturing process and the resulting product to ensure production readiness.
The manufacturing process is controlled by establishing documented Standard Operating Procedures and Work Instructions which detail every step of the manufacturing process and provide production line standards for component production, assembly, testing and packaging. Rigorous quality control testing in accordance with the QCP is used to assess features and functions such as plunger speed, which is one of the most important characteristics of an autoinjector training device.
To ensure the autoinjection times and other important functions of device trainers are consistent with those in the actual drug delivery device, samples are tested and inspected throughout the production process. The final step in assembly is a 100 percent inspection and test of all functions. The ability to test each production unit is an important distinction between resettable trainers and the drug delivery devices they mimic. This ability shifts the focus of the quality process from validation to verification and provides a great deal of confidence in the trainers’ conformity to product requirements.
Meeting the needs of a growing market
As training technology becomes more widely used in the pharmaceutical industry, the technologies and capabilities of these devices will continue to advance, creating a more complex and intricate engineering process. In order for training devices to work efficiently, it is imperative that the devices are tested with stringent quality control standards. As a touchstone in the onboarding process, training devices provide patients with the same experience they would have using a real drug delivery device and allows users the opportunity to learn and anticipate the steps necessary for proper drug administration.
In today’s market, a growing number of patients are being prescribed self-administered injectable treatments. Pharmaceutical companies that prioritize the patient experience by using training technology to help patients properly onboard to therapy, will continue to benefit through competitive advantages and the value they create within the industry.
Ryan Hall, Quality Manager at Noble International, Inc., is responsible for quality management systems and compliance to 21 CFR 820, ISO 13485 and ISO 9001. He holds a BS in Industrial Engineering from North Carolina State University.
Chris Chung, is an industrial designer with almost 18 years of experience ranging from toys to I.T consumer electronic products, packaging and now Pharmaceutical products. Chris graduated from University of Canberra in Australia, 1998.
1. Kessels, R. P. (2003, May). Patients’ Memory for Medical Information. Retrieved from http://www.ncbi.nlm.nih.gov/ pmc/articles/PMC539473/
2. Bonds RS, Asawa A, Ghazi AI. “Misuse of medical devices: a persistent problem in self-management of asthma and allergic disease”. Annals of Allergy, Asthma & Immunology, 2014, Vol 114(1), pp 74-76e2. doi:10.1016/j.anai.2014.10.016 4. The UTMB Newsroom, UTMB Health, UTMB.edu. 2014. Retrieved from http://www.utmb.edu/newsroom/article10169.aspx
3. Zambanini, A., Newson, R. B., Maisey, M., & Feher, M. D. (1999). Injection related anxiety in insulin-treated diabetes. Diabetes Research and Clinical Practice, 46(3), 239-246. doi:10.1016/s0168-8227(99)00099-6
4.Noble. (2016, October). The relationship between anxiety, injections and device training. Poster session presented at PDA The Universe of Prefilled Syringes and Injection Devices, Huntington Beach, CA.