Typically, it is not possible to train people using active drug delivery devices as this requires subcutaneous or intra-muscular injection and administration of pharmaceutical drugs. To address common issues in patient onboarding, training devices are often used to create consistent training experiences for patients. Human Centred Designer, Amber, discusses just some of the benefits of developing training devices for injectable healthcare markets.

Studies suggest that without proper training during the onboarding process, patients are more likely to be less compliant with the therapy or, to incorrectly use drug delivery devices such as autoinjectors and prefilled syringes among other forms of self-administration.

When an active device and its application is new to the market, the best way to correctly train users is often to develop a safe trainer device which closely mimics the active device but without any sharps or drug content. Therefore, pharmaceutical companies often opt to develop trainers to safely mimic the active device for the training of users.

Recently, we developed two separate fully resettable trainer devices simultaneously, from concept through to manufacturing transfer in just 10 months. The new trainers were to be safe at all times and mimic the active devices as closely as possible. The devices were to be resettable so the drug administration process could be repeated numerous times to ensure users were adequately trained for emergency use of the active device.

It can be tempting to avoid developing a trainer in addition to an active device however, outputs of FMEA’s or risk assessments might determine there is a requirement to develop a trainer device. So, we thought we’d share some of the additional benefits of developing a training product that functions in almost an identical manner to a real-life use scenario without containing potentially dangerous drugs or sharp needles:

self-injecting-biologic-treatment

1. Training devices can be resettable and therefore reusable

Trainer devices can be mechanically designed and engineered so that they’re capable of being reset and therefore, reused, a high number of times making them both an economically and, an environmentally friendly option for training potential users. For example, in the case of the devices we have recently produced, they are capable of a minimum of 200 resets without the use of any additional tools.

 

2. Training devices can provide tactile, audible, and visual indication of activation

This makes the training experience much similar to the use case of the active device than simply watching a video or, reading IFUs might (that’s if a patient reads the IFUs at all!). This can also eliminate any unexpected feedback when using an active device for the first time and, signifies that a user has used the device correctly. Other elements which can be accurately replicated include the ergonomics, interaction, and injection time of the active device. Although the internal mechanics of trainers may differ to those within the active device, externally they are designed to perform as closely as possible to each other.

medical-training-device

3. Training devices are safe to use by novices and untrained personnel

While trainers are designed to mimic active devices as closely as possible in their form, function and aesthetic, typically, trainers do not incorporate glass syringes, hypodermic needles or contain active drugs so making them safe to use repeatedly by novices and untrained personnel. Additionally, there is no requirement for them to be sterile either.

 

4. Training devices can be developed in shorter timeframes than active devices

Although quality design standards are paramount when designing trainer devices, due to there being lighter regulatory requirements surrounding trainers, there is slightly less rigour involved in the development process. This can result in faster development times but importantly, without compromising on design robustness and closely mimicking elements such as cap release and activation forces of the active device.

5. Training devices can be developed and manufactured more cost effectively than active devices

Again, due to lighter regulatory requirements, trainers can be significantly cheaper to manufacture than active devices because alternative materials and processes can be used. They can also be manufactured with a minimal number of components, with easy to tool features and minimal assembly steps. This can ensure faster assembly times and reduced investment in tooling during the development process. Additionally, they can be packed and stored more easily, so often require reduced packaging materials compared to the active device.

 

6. Training devices can be protected by IP

Quite often, developing a new trainer also generates additional new IP to the active device due to the complexities in mimicking the internal mechanisms when the drug is excluded. Therefore, the design of the trainer can also be protected. All IP that we generate here at HD, is transferred to our clients to exploit upon project completion.

 

Training devices are becoming ever more sophisticated and used more prevalently in the pharmaceutical industry. With this trend, the engineering and capabilities of these devices to aid effective training will continue to advance. For trainer devices to meet expectations and work efficiently, it is important that a robust design process is adopted with strong emphasis on elements such as Human Factors throughout. If done properly, these advancements will encourage users to become more confident in their treatments, encourage adherence, overcome treatment barriers, and reduce risks among a variety of other benefits.

Here at HD, we fully understand device development and mechanical design to engineer robust training device solutions. Please get in touch to find out more or discuss how we could help with your new product or medical device development.

Amber Davies - Human Factors Design Engineer & Marketing Manager at Haughton Design Amber Davies 17 February 2022

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Get in Touch with Amber Davies

Human Factors Design Engineer & Marketing Manager

Amber graduated from Cardiff Metropolitan University with a degree in Product Design. She has a particular interest in the medical field stemming from her personal experience of using a medical device. She pairs her design background with her personal experiences to apply empathy and develop improved user experiences. Amber also combines this understanding to liaise with customers and create digital content at HD.

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