Spotlight on drug deliveryPosted: May 18, 2010. Category: Articles.
Spotlight on drug delivery
One of the areas in which Coalesce has significant experience is Drug Delivery Devices. The market is highly regulated and often the intellectual property landscape is crowded. The key to successful device design is to thoroughly understand the innovation space and to focus efforts where they are most likely to gain advantage.
One recent client had a reasonably mature device but they were having reliability issues with a particular sub-system. The challenge was to improve the sub-system whilst minimally impacting on the rest of the device. The physical envelope and performance criteria were tightly defined, so at first glance, there seemed little scope for new ideas. However, by challenging some of the seemingly fixed constraints, and with some lateral thinking, the team was able to consider a wide range of solutions which lead to some valuable insights. Concepts were analysed against a number of criteria so that a range of scenarios could be considered – least change, lowest cost, lowest risk and so on.
The most promising concepts were prototyped and tested and, within a short space of time, the client was able to choose from three credible solutions.
Of course the requirements are not always so well defined.
Another client was developing a portfolio of device technologies to complement some of its emerging therapies. Coalesce was tasked with developing concepts for one of these technologies. Such an open brief can be daunting, but the team quickly realised that the problem could be looked at analytically before embarking on the ideation process. The first step was to research the prior art and a novel, highly visual and quite powerful mapping technique was developed which ensured that the concepts thoroughly covered the innovation space. New concepts could now be mapped onto the IP landscape so that the client’s attorneys could take an early view on Freedom To Operate and the potential novelty of a given concept, something this company had not done hitherto. A large number of mechanisms were developed to a conceptual level and the client chose some of the more intriguing and technically challenging for further development. With something as critical as a drug delivery system, a rigorous mathematical understanding is vital to make turn a concept into a compelling proposal. Knowing at what stage in the process to use advanced computational methods such as FEA and CFD or when conventional engineering calculations are more appropriate ensures that development timescales are not inflated. In this case, the latter was chosen and the fundamental parameters of each concept were modelled mathematically in parallel with the development of the 3D CAD models.
Within weeks, the first prototypes were being assembled and bench tested and the insights gained were fed back into the models to produce more refined Proof of Principle models. This combination of imagination, rigour and pragmatism enabled the team to deliver working models of three entirely novel concepts supported by engineering calculations and guidance on intellectual property within ten weeks of starting the project.
There are a number of reasons why Coalesce is a good choice for companies who develop Drug Delivery Devices. We have the experience and the technical nous to understand your requirements and to build the optimal team to deliver results on time. Our efficient structure and network of independent experts gives us the flexibility to be involved at any stage in the development process, whilst still providing excellent value. Finally, our Quality System and professional approach, garnered from years at the highest level in technical consulting, ensure that we can provide the traceability and continuity which are crucial in this highly regulated market.