Carefully considering these factors early in the design process will result in systems that are safe, effective, and commercially viable:
Typically, the drug itself leads the development process and the delivery device is designed around it to deliver the drug to the target site. There are many drug properties that need to be considered such as; stability (does it need to be cold stored?), viscosity (strength of device to push drug through needle), dose requirement, shelf life, as well as many others.
What are the drug delivery routes? Oral, ocular, parenteral, transdermal, vaginal or anal, pulmonary/nasal? The answer to this question will affect the design of the device. For example, transdermal patches may be selected over other methods due to the increased chance of treatment compliance with smooth and consistent drug delivery. In this scenario, a designer must consider elements such as size – is the patch discrete and comfortable?, and environmental factors – how well does the device adhere to the skin during sport, hot, or cold weather?
With the FDA reporting more than 80,000 deaths and 1.7 million injuries linked to medical devices in the past decade , designers and engineers must consider safety and efficacy to prevent injury, under/overdosing, and increase adherence to treatment plans. The device itself must be designed to safely deliver the correct dose to the target site, and multi-dose devices specifically must be designed in a way that makes it clear to the user what they are administering. In doing so, the risk of under/overdosing, which can result in adverse patient outcomes such as relapse, exacerbation of the condition, and other side effects and injury, is minimized.
To increase the safety and efficacy of a drug delivery device, it’s paramount to ensure that it’s usable by everyone who will interact with the device, and in all environmental settings. However, designing a device to be useable does not guarantee that it will be used. It also must be desirable to the user, the user must want to naturally use the device. Increasing the useability and desirability of a device will ultimately increase medication adherence and persistence.
Typically, the quantities of drug delivery devices being manufactured are very high. The components designed need to be reliably manufacturable at these quantities and consideration for how the quality of the devices will be checked. Consideration of these early on, and involving the manufacturers as soon as possible, can lead to simpler industrialisation.
The drug delivery system market is highly competitive with many ideas being protected by patents, making it difficult for designers to design novel devices that don’t infringe on patents. In some instances, it may be more beneficial to select a device from companies such as Nemera and BD, and work with designers to make this suitable for your drug.
All medical devices require regulatory approval, it is important early in the project to identify which markets you intend to sell the product into and the regulatory strategy for each. Not doing this early on could result in costly redesigning to meet regulatory requirements.
The cost of developing a new drug is substantial, the design and development costs of the drug delivery system is an incredibly small percentage, relative to the formulation R&D. However, it’s essential for device designers to consider the cost implications of the device throughout the development process and to design the delivery system to be cost-effective, to ensure that the device is not over engineered, and affordable to the masses.
As designers and engineers, it is important we question ourselves throughout the design process. Medical device development is an expensive process, with novel therapeutic complex medical devices costing $54million to develop. By considering all of these factors, and questioning if you are designing the correct device will lead to safe, effective, and commercially viable solutions.
Throughout HD’s approach, our team are considering all of these factors to ensure our clients get the best possible results.
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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