By Pete Evans, Director of Device Development, Oval Medical Technologies, and Meredith Canty, Director Drug Delivery Systems, SMC Ltd.
In this article, Pete Evans, Director of Device Development at Oval Medical Technologies, and Meredith Canty, Director Drug Delivery Systems at SMC Ltd., explore how integrating design and industrialisation teams can optimise the cost, quality and time of developing a novel drug delivery system.
There is a well-known adage in the pharmaceutical industry: “Cost, quality or time – choose two.” In other words, when considering the cost of a development programme, the quality of the end product and the time to bring a new product to market, you have to choose which two of the three to optimise as the third will inevitably suffer.
With quality necessarily taking first place, time and cost are left to fight it out, with time generally being the winner on the assumption that an earlier launch will recoup the increased costs of accelerated development. Because of this, pharmaceutical product development programmes tend to be expensive. Add to this the fact that all product development programmes face quality hurdles, which can take considerable time to resolve, and the costs tend to only move in one direction.
When considering a novel drug delivery system, potentially combined with a novel formulation – and with either element potentially requiring the development of novel manufacturing processes – there are considerable challenges involved in meeting the required quality standard, let alone optimising cost and time.