In this article, we look at insulin pens, specifically the DoseGuard system, and discuss their importance for people with diabetes. We look at how verification and simulation help to make the delivery of insulin doses accurate and reliable.
I am pleased to invite you on a journey through the technology and science behind insulin pens, especially the DoseGuard system. This journey has several stops. And this first stop is designed to give you a basic understanding of insulin pens. As engineers, we are often faced with the challenge of communicating complex topics in an understandable way, so I would like to demystify the topic of insulin pens and explain why their verification and accuracy are literally vital. Welcome to the world of the DoseGuard system.
Insulin pens are fundamentally a cornerstone in the daily management of diabetes. They enable patients to accurately dose and administer their insulin. An insulin pen is basically a syringe that is already filled with insulin and delivered to patients. Users turn a dial on the pen to adjust the dose, with each click releasing a specific amount of insulin. This precise control is crucial as exact dosing is required to adequately regulate blood glucose levels.
However, the precision of the pen is not always constant. Various factors can influence the accuracy. An insulin pen that doses accurately once and then delivers too much or too little insulin the next time it is used could be problematic for the patient. And that’s putting it very trivially. The manufacturer must therefore prove that the pen does not exceed a certain level of inaccuracy. The challenge here is to ensure this accuracy across a wide range of pens and under different conditions. Verification must show that the pen is accurate even when it is full, half full or almost empty. But how can you ensure that each pen remains within the permitted tolerances without having to carry out thousands of tests?
With a simulation! Traditionally, physical testing would involve a large number of pens and insulin doses – a time-consuming and expensive method. However, simulation allows us to virtually test the accuracy of the pen in different scenarios without using physical resources. We can rigidly simulate the system to understand the ideal state and then introduce elasticities and temperature dependencies to model more realistic conditions.
Another aspect is the production tolerances. Even small deviations in the inner diameter of the syringe barrels can lead to different amounts of insulin being dispensed with the same stroke length. We can map these geometric variations in the simulation and analyse their effects on the dosage.
Temperature also plays a role. An insulin pen that is exposed to high temperatures will behave differently to one in colder conditions. Plastics expand and become more elastic when exposed to heat, which can lead to greater inaccuracy. These thermal effects must be taken into account in the verification process.
Once we have developed a simulation model, we need to compare it with real data to confirm its validity. This requires careful testing with physical pens that map the simulated scenarios in parallel. If the authorities accept the simulation as a reliable verification method, the manufacturer can save considerable(!) time and resources by using this simulation.
For our customers, this means leaner verification that protects the environment and brings products to market faster.
But there are also challenges: Setting up a precise simulation model requires extensive data and careful analysis. Every change in the production process, such as a new or revised injection mould, can influence the simulation results and requires a reassessment.
The decision to use a simulation for verification is not trivial. It requires careful planning and close co-operation with the regulating authorities. But the advantages outweigh the disadvantages. Reduced material consumption, fewer laboratory tests and more efficient development of safe and reliable insulin pens.
And so we have reached our first destination. This is the beginning of our series on insulin pens from our DoseGuard system. We will continue to look at the technical aspects, the challenges of production and the benefits for patients. I hope this post has given you a solid foundation for understanding this vital technology. In upcoming posts, we will dive deeper into the subject matter and continue to explore the fascination behind the technology and science of insulin pens. Until next time, stay curious and engaged.
