It’s often a taboo subject to discuss Reverse Engineering medical devices – it’s not a simple case of copying! Safety and efficacy still need to be demonstrated.
The process starts with a Product Characterisation exercise, followed by reverse engineering of an existing medical or drug delivery device. This can be done for many reasons and it’s not just due to the proliferation of generics around in the pharmaceutical world. Sometimes companies might not have all of the data they need to ensure their design is truly robust and under full design control. Or maybe they are considering a change of supplier and there’s some work to be done, honing the design to suit a different manufacturing facility. The reasons can be many, it’s not always for negative reasons.
Device characterisation typically starts with analysing the materials and some basic measuring and CAD modelling of the components. It may require some more advanced metrology work or MRI scanning too, but we’ve found even the most sophisticated scanners sometimes don’t provide the precise results we require. Therefore we typically hand measure and produce well-controlled CAD models, which can then be adjusted to suit metrology reports we obtain. It should also be considered if metrology will add value if the device is based around a syringe and dose tolerance which needs to dictate how the CAD model is built and critical features are controlled. It’s then a case of considering the correct engineering principles and robust design techniques, to carefully build up the models to a point ready for prototyping. If the manufacturer’s process capability figures can be obtained soon enough during the model engineering, then it’s possible to consider this in the tolerance stacks associated with the critical features and controlled dimensions. Otherwise there is then a requirement for a separate round of tolerance analysis to suit the selected manufacturers process capability which adds further costs and additional time.
The whole process is usually far more challenging and time consuming than many people realise – it’s not just a simple case of copying the design. Therefore, if you need a medical device characterised or reverse engineered, you need to select a company with enough knowledge and experience of DfM (Design for Manufacture) and robust design engineering to ensure the final manufacturing data pack meets the full needs of your company and its suppliers.