MES

With all the focus on new technologies and how the world of manufacturing is digitally transforming, it is easy to lose sight of what the repercussions will be with regards to how people will do their job. One thing is certain – it will be different!

Instead of a painful, time-consuming and costly process, what if being audited by the FDA, or any other regulatory body, was just part of the day to day routine? For the MedTech industry this makes perfect sense – it would not only reduce the financial overheads associated with being audited, it would also substantially reduce time and business risk.

Perhaps the most important feature of the smart factory, its connected nature, is also one of its most crucial sources of value. Smart factories require the underlying processes and materials to be connected to generate the data necessary to make real-time decisions. In a truly smart factory, assets are fitted with smart sensors so systems can continuously pull data sets from both new and traditional sources.

To bake a good cake, you must get the processes right. These include mixing to the right consistency and baking at the correct temperature for the appropriate length of time – but fundamental to your success is the recipe. To create your masterpiece, you must add the right ingredients in the proper quantities. The same is true for the MedTech manufacturers producing combination medical devices.

Speed, efficiency and effectiveness. These are three very different things but are often associated with each other. According to folklore, the fastest doesn’t always finish first – so is efficiency and effectiveness what you should be striving for? Design of Experiments (DOE) is like this. You can conduct experiments fast, but what if you miss an important interaction because you can only experiment with one factor at a time?