Additive manufacturing has entered medical device development in the past 10 years. Currently, additive manufacturing is used for plastics, metals, and biologics in FDA cleared medical device applications. While the technology can sound enticing to rapidly create and market parts, there are many pitfalls when the technology is used in a regulated environment. The first question you should ask yourself is ‘why do I need additive manufacturing?’. If the answer is ‘it’s cool, it’s cheaper, it’s faster’, you may want to do your homework before committing to it.
Regulated manufacturing requires considerable process controls, verifications, and validations that drive up the cost to kick-start the process. Once started, the devices that require complex or specialized geometries really benefit from the technology. However, depending on the requirements of the device, post-processes for cleaning geometries, strength, or sterilization needs can take you back to more traditional machining and other methods, which may not be what you had in mind. If you are interested in disposables, the upside is that it is easy to design and print models, which comes with qualifying machines (we will discuss these steps in detail in future posts). If you are after cost cutting, unfortunately the materials you can use for additives in the medical device industry are limited and expensive.
To put it into perspective, a plastic molding operation can cost millions to bring online, but will drop your unit cost to next to nothing. If you invest in additive printers that are cheap to scale, you will still spend thousands of dollars on raw materials in the form of filaments or metal powders that transfer your fixed costs to variable costs.