David Belton is Founder and Director of Quentis, a medical device engineering consultancy specialising in providing design assurance and industrialisation know-how throughout the product lifecycle. Mr Belton has a degree in mechanical engineering from Loughborough University (Loughborough, UK) and has spent 20 years in both the electronics and drug delivery industries, bringing new products to market ranging right from the world’s first 3G phone network to world-class dry powder inhalers.
David Belton discusses the meaning of quality by design in novel respiratory drug delivery device development. He covers how, with more novel devices, prior knowledge may be insufficient for a standard FMEA-style risk analysis, and alternate science-based methods, such as functional mapping and knowledge scoring, can help in achieving QbD.
David Belton highlights an often undiscussed aspect of the move towards connected drug delivery devices, the impact on manufacturing. Using inhalers as a reference point, he runs through several of the concerns and decisions that will need to be addressed for successful mass production of such devices.