Interoperability is not a new concept for infusion pumps. But in many cases hospitals have been slow to embrace the full potential of connectivity. When is this likely to change? What will hospitals need when it does? And where should infusion pump manufacturers focus innovation efforts in the meantime? Tim Frearson considers the options.
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.
Tom Lawrie-Fussey and Lucy Sheldon introduce “Wizard of Oz” testing, named after the classic novel and film, whereby experimenters can field test concepts at a very early stage by giving the illusion of a finished product, saving potential costly and time-consuming changes further along the development process.
John Pritchard discusses the history of the nebuliser, its fall in popularity with the advent of DPIs and pMDIs, and its current resurgence due to the success of the mesh nebuliser, continuing on to how changing the development paradigm to utilise nebuliser technology more effectively can have significant benefits.
It is difficult to successfully scale-up a product to industrial production and launch, but it is much harder if design fundamentals are not adhered to. Beth Blackburn details the need for setting down requirements early in device development in order to avoid inadvertently undermining a product’s successful commercialisation.
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.