PDA Universe of Pre-Filled Syringes and Injection Devices 2012

The scale of these events in the USA is always staggering – vast facilities with multiple aircraft hangar sized rooms for exhibition, conference speakers and dining. This year has seen over 700 delegates registered, the largest meeting in the history of these conferences. The meetings are attended by everyone in the supply chain of parenteral drugs from device designers and CMOs to specialist service agencies and pharmaceutical companies.

The main thrust of the meeting this year is human factors and manufacturing optimisation. Human factors is right at the heart of the work that we do at Team and it is encouraging to see just how seriously the industry is taking this issue. It doesn’t matter if your chemists have developed the greatest drug in the world, if the patient group can’t use the device safely and effectively, it will all be for nothing. This broader recognition of the importance of good human factors engineering can only be to the advantage of patients.

I have heard, however, some quite depressing conversations coming from this aspect of the conference with people annoyed that ‘this is another regulatory hurdle to clear’. This misses the point entirely. You don’t design a device and then slap an HF validation study on the end. You think about the user right from the very beginning and use their comments to inform and guide your design process. The burden of HF proof is not about adding an annoying, unnecessary stage to your product development – it’s about making sure that you have the right product before it gets to the validation stage.

So, it’s encouraging to see that Team are already working in line with best industry practice for both HF and design optimisation and let’s hope that the exasperated exclamation of the designer that ‘the patient is using it wrong!’ will soon be consigned to the past.