By Simon Kaar.
I am a Mechanical Engineer. During the previous fifteen years I have specialised in the design and development of medical devices. Typically, hand held devices used by diabetics to monitor blood glucose and asthma sufferers to administer drug to the lungs.
The medical device industry is highly regulated. This has traditionally assured safety for the patients by tightly regulating manufacturing processes, design change controls and the efficacy of the the device in a patients hands. More recent trends within the regulatory bodies has been towards quality-by-design. Meaning better and more thoroughly developed products. However, device companies would like to be quick to market for the usual reasons, and regulators too would like patients to have early access to life saving products. Safety however, is paramount and so improved ways of developing are the means to satisfy the conflicting requirements put on a device development program.
Quality by design requires a more thorough and prescribed development approach. Key to this, is to construct a detailed and accurate theoretical model of a proposed medical device. A mathematical model.
The high level of analytical skill required has lead companies to employ specialised design consultancies. During my time leading R&D device teams, I increasingly employed such help. More recently, I employed MACSI to carry out work in this field, to do the same type of analytical work packages albeit looking into some of the deeper physical aspects effecting device performance.
On a personal level, my own interests in mathematical modelling has lead me into spending more of my time with these analytical aspects of a project, to the point where I decided to spend most of my time occupied so. For this reason I stepped out of industry to peruse a PhD in math modelling. The goal to significantly upgrade my skills.
Industrial and academic collaborations are not apparently the norm, however, as ways are found to achieve their individual goals, then, in the end, patients will only benefit from the best that industry and academia can offer.
My two years to date researching in MACSI has convinced me, that the coming together of device engineers and math modellers in collaboration with companies and academia, opens up many possibilities. MACSI are at the forefront in this movement.