In the third instalment of our blog series on insulin pens, I will focus on a topic that is of central importance to us engineers at B&W: the validation of insulin pens and acceptance by authorities. This step is crucial as it ensures the safety and reliability of our products. It makes sense if you have read Part 1 and Part 2 in advance.
Current practice requires extensive physical tests – around 5000 for each medicine to be dosed! These tests are time-consuming and also resource-intensive. Our aim is to replace these physical tests with precise simulations. This not only saves time and resources, but also reduces the environmental impact.
Our solution: replacing physical tests with precise simulations.
This change is based on a careful comparison of the simulation results with real verification data. The correspondence between simulated conditions and actual test results is the key to proving the reliability of our models. By demonstrating that our simulations can accurately represent the real tests, including the consideration of extreme values, we are taking a decisive step towards being recognised by the authorities.
The dialogue with the regulatory authorities is another critical point in this process. We convincingly demonstrate that our simulations are suitable for verifying the functionality and accuracy of insulin pens. The acceptance of our simulation data by the authorities can not only revolutionise the validation process for our customers, but also use resources more efficiently and accelerate the development of insulin pens.
By using advanced simulation techniques, our mission is to maximise the safety and effectiveness of our products while minimising their environmental impact.
