Recommended assembly process in medical device design

At the beginning of the medical device design process there is a white sheet of paper. Where to start when you know that the assembly of intricate components is challenging? Engineering strategies need to be adapted as devices become smaller and more flexible whilst showing highest performance.

So to help with that, I summarized below the critical milestones we have identified to be successful:

I’ve noticed the earlier you start talking about the right material and assembly process to an adhesive expert, the earlier you will know whether your design idea will come to fruition. It is paramount that you select an adhesive supplier that can work with you to design and produce the most robust medical device assemblies.

It is important thinking widely to new and more modern available adhesive technologies, even knowing that the internal process might sometimes be cumbersome or time consuming. The results can lead us to the discovery of better and more efficient solutions.

Early device design concepts can be evaluated through pull, flexion and pressure tests that are customized for the medical device industry. Such tests will stress the component to failure and determine if the combination of design and adhesive meets the defined requirements or if a redesign to the joint or the adhesive/substrate combination is warranted. This early collaboration reduces the risk of failures at a later DV or PV stage and ensures successful market implementation.

Adhesive-friendly designs manage the forces acting on a joint by maximizing tensile and compressive stresses while minimizing peel and cleavage. Target is to achieve a joint strength far above the requirements set by the related device standard.  Ideally, in case the joint breaks, you want the substrate to fail long before the adhesive bond is broken.

How do you know how much stress will make your device fail? And how do you know if failure will happen at the bond line? I will share more insights in my next blog.

As a recap, while at first, the task to define the assembly process can be a bit overwhelming, a structured approach and ideally a discussion with an expert can lead to a proper answer in a short period of time. Feel free to contact me for an introduction call or share your comments at the bottom of this article.

In the meantime, I invite you to look at our series of blog on “Flexibility in Medical Device Design” with blog 1 here on “Miniaturization in medical device”, and blog 2 here on “Choosing the right material for your device”.

Author: 

Esthefan Zumbado, Manager Medical Devices IA Latin America North