The first strategy is to design your own bespoke device from scratch, or as a variant of an existing technology you already own the IP for. Alternatively, the second is to purchase an off-the-shelf platform that is already in production with an CDMO (Contract Device Manufacturing, Organisation).
In many instances, using an off-the-shelf solution can save a significant amount of time as the majority of the design and manufacturing issues should have already been resolved along with an increased confidence built that the complex mechanisms that are in these devices will work repeatably. Parts of the design history file should also already exist which reduces the time required to prove that you fully understand how a device functions.
However, it is important to be aware that the drug delivery platform is a component within your product and not the whole package. The product which is certified is a combination of drug and delivery platform or, combination product. Therefore, the perceived time saving of using an off-the-shelf platform can be deceptive and with a lot of new drug products, they may have characteristics that mean they can’t be used with an off-the-shelf platform. This may relate to the drug itself (viscosity, molecular makeup, storage requirements, etc.) or, relating to the use of the device (human factors, etc.).
As well as the product itself, there is also the infrastructure to support the manufacture of a device whether it’s an off-the-shelf or bespoke platform, it is likely that there will be new assembly lines to set up, new quality systems to install as well as assembly tooling to develop and validate. When you start to factor in the overall package, the device itself is a relatively small component within a much larger system.
A common approach to navigating the regulations is to prove substantial equivalence to an existing device. For example, with an emergency use autoinjector, existing devices have a repeatable activation force which to show equivalence, your device would have to match.
It may not be possible to find an off-the-shelf solution that has the specific requirements which you desire and the CDMO may not be willing to make the required design changes as the knock-on effect, with custom tooling and revalidation of the design may outweigh the benefits of a bespoke design.
Having your own platform with projected IP of which you have full ownership can be a powerful tool in making it more difficult for competitors to release competing products. Using mechanisms that you own the IP for, where there isn’t another simple way of getting the same results, would likely force competitors to have to prove via human factors trials that different forces/characteristics are acceptable or, prevent being able to release a competing product at all.
If you have specific aesthetic requirements, many off-the-shelf devices don’t have the flexibility to change things other than labels. However, there are more and more off-the-shelf solutions that offer customers the ability to change things like needle covers, safety caps and colours to give a level of customisation.
One of the hardest parts in any project is ramping up volumes. Typically, when designing your own devices, you will produce prototypes on soft or cartridge tooling to prove out the design. Often, it’s not as simple as stepping from low-volume to high-volume tooling and production teething issues are likely to occur at this stage. Off-the-shelf solutions will have already gone through this stage which can be a valuable area to save time in your project.
Whether you have a clear vision of how you want your bespoke device designed or, you’re unsure whether to use an off-the-shelf platform as part of your development strategy, please get in touch for more advice or to discuss your project.
Engineering Director
Jacks is responsible for the engineering aspects of projects to ensure technical risk is minimised. With expertise in simulation, drug delivery devices, and electronics, Jack guides your project team on all related deliverables.
Jack is a Chartered Engineer with a Master’s Degree in Mechanical Engineering. He has over 10 years’ experience working in both the medical sector and on complex machinery.
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