Andreas Meliniotis, Director of Device Development, writes about the process, opportunities and challenges of designing devices for inhaled drugs, in the October 2020 issue of Drug Development & Delivery. Andreas finds: “Not all medicines are suitable for delivery via a tablet or capsule, or even by injection or infusion. Some are best delivered via inhalation, often because they are treating a condition that affects the lungs, but with this route of delivery comes the requirement for a suitable device.”
“The device development process typically follows a stage-gate process in which the project is reviewed with a board of representatives from across the relevant disciplines. The development is structured so that initially, the Target Product Profile (TPP), user requirements, including the user needs and intended uses, are reviewed at the first stage-gate, followed by the concepts at the second stage-gate, formal designs, device verification, manufacturing equipment, validation, and finally preparation for market.”
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