In designing a new product, few things are as important as the materials you decide to use. This is especially true in the case of medical devices, which must perform at an even higher standard and meet even more rigorous qualifications than most other products. In order to help you source and choose the best materials to use in your medical device design, as well as choosing a medical component manufacturer, here are the top criteria you will want to consider:
In both choosing your materials and medical device component manufacturer, cleanliness and sanitation are two of the most crucial factors for you to consider. Many components inside medical devices either come into direct contact with the patient or direct contact with fluids and/or objects that are going inside the patient's body. With this being the case, every component used in a medical device must be manufactured using the strictest possible cleanliness and sanitation standards.
The performance properties you will need your materials to exhibit will vary depending on how you are using them within your medical device and what task they must perform. In most cases, though, you will want to choose materials that have a high strength and a high temperature resistance. Since medical devices will often be sterilized using harsh chemicals, you will also want to ensure that the material you are using has a high chemical resistance as well. Along with these factors, determine what other ways your components will need to perform well and conditions they will need to perform in, then choose a material that is up to the task.
In choosing which materials you use to build your device, you will want to pay close attention to the availability of the materials you are considering. Choosing to work with materials that are not readily available can drastically increase the time it takes you to get your device on the market and end up costing you a lot more money as well. While you certainly want to choose the best material for the job, how easily attainable that material is needs to be taken into consideration as well.
No matter how sanitary they are, some materials simply are not compatible for use in contact with the human body. A simple, obvious example of this is the fact that you wouldn't want to make a medical device that went inside a patient's body out of lead. Biocompatibility, though, is often a lot more nuanced than this example, and to determine whether or not a material is biocompatible enough to be used in the manner you intend for it you will want to do your research on the material and work closely with your manufacturer to ensure everyone is on the same page about what is required.
As with any new device, careful consideration must be given to the materials used to create its various components, especially in the case of medical devices. By the same token, careful consideration must also be given to the component manufacturer you choose to work with, as working with a qualified, professional manufacturer will make sourcing the right materials much simpler than it would otherwise be otherwise.
If you would like to learn more about the materials we use in our medical components or would like to learn more about partnering with us to produce components for your medical device, please contact us today.