Research suggests that patients are less likely to adhere to their treatment plan or correctly use medication delivery devices (such as autoinjectors or prefilled syringes) if they are not given adequate training before starting treatment for their condition. Patients are more likely to make mistakes when using these devices.
When an active device and its application are new to the market, it is typically the ideal way to create a safe trainer device that closely mimics the active device but does not include any sharps or medications. This is often the most effective approach to training users correctly. Because the actual device can be harmful, most pharmaceutical companies opt instead to develop “trainers” that are only simulations of the real thing.
Recently, researchers finished developing two entirely resettable training devices in parallel, which took around ten months from the beginning of design to the transfer to manufacturing. The newly developed simulators were required to be risk-free and accurately depict the actual devices. It was important for the active devices to have the capability of being reset so that the procedure of administering the medicine could be carried out several times. This was done to ensure that users received the appropriate training for the emergency use of the active device.
The findings of an FMEA or risk assessment likely show that an additional training device, in addition to the actual product, needs to be developed. We have produced a training product that simulates the bulk of real-world application experience without the use of dangerous drugs or sensitive equipment, and we wanted to give some of the additional benefits that come with it here.
Because of the ease with which they may be reset, medical training device can be utilized several times.
Trainer devices can be mechanically created and engineered to be reset and frequently reused, making them an efficient, cost-effective, and environmentally friendly solution for training new users. Our most up-to-date items, for instance, can be reset at least 200 times without utilizing any specialized apparatus.
2. Training devices can signal activation by various senses, including sight, sound, and touch.
This brings the training experience far closer to the use case of the active device than other methods, such as watching a film or reading the instructions for usage (assuming a patient ever reads the instructions for use!). This verifies that the user is making appropriate use of the device and lessens the possibility that they will receive unexpected input while learning how to use it. It is possible to faithfully duplicate the active device, including its usability, interaction, and injection time. Even though their underlying mechanisms may be different, trainers are externally designed to operate in a manner that is as comparable to that of the active equipment as is practically possible.
3. Personnel and users with little to no expertise should not be concerned when operating training equipment.
Because their shape, function, and appearance are designed to be as similar to those of active equipment as is humanly conceivable, trainers are perfectly safe for use, often by unskilled pros and novices in the professional world. Trainers often do not contain active drugs, glass syringes, or hypodermic needles. They also do not need to be sterile if it is not something that you place high importance on.
4. In most cases, the time required to build a training device is far less than that needed for an active device.
Although adhering to quality design standards is of the utmost importance when developing trainer devices, the overall development process is less stringent due to the less strict regulatory regulations that pertain to trainers. This is even though quality design standards are of the utmost importance. Creating a design that is functionally identical to the actual thing, right down to the cap release and activation pressures, is one way to cut down on time required for development while maintaining the product’s high quality.
5. Compared to active ones, passive training gadgets provide more potential for cost savings in production and dissemination.
Alternate materials and production methods can be used to construct trainers because the regulatory standards governing their creation are less severe than those controlling active devices. As a result, the production of trainers is far more cost-effective than active devices. Because of their low component count, straightforward design, and easy assembly, they are ideally suited for production in large quantities. The amount of time spent on the development cycle and money spent on tools could be cut down due to implementing this method. Due to the ease with which they may be packaged and stored; they often need a lower quantity of the materials used for their packaging than the active device.
6. Protecting training equipment through the use of IPR is possible.
When the drug is removed from the equation, it may be challenging to recreate the underlying mechanisms; hence, developing a new trainer frequently creates additional intellectual property for the existing device. This indicates that the trainer’s configuration can, in fact, be protected as well. When a customer’s project is completed here at HD, that customer becomes the owner of all intellectual property developed while working on the project.
The pharmaceutical business is one of the many industries that is seeing an increase in the utilization of technologically enhanced training equipment. This new information speaks to a bright future for the efficient application of devices of this kind in training. When they are built utilizing a rigorous procedure that emphasizes elements like Human Factors, the instruments used in the training process have a much better chance of success. The successful application of these innovations may increase patient trust, raise treatment adherence, remove obstacles to care and reduce the chance of adverse events across a wide variety of population types.