Developing a new drug delivery system is a complex and costly process that requires careful planning and consideration. Engineering Director, Jack, shares some of the important things to consider when developing a new drug delivery system.
Carefully considering these factors early in the design process will result in systems that are safe, effective, and commercially viable:
Safety and Efficacy
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.
Usability and Desirability
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.
Manufacturing and Quality Control
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.
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.