3D printing brings unique considerations for medical device engineers. But when used well, FDA’s additive manufacturing guidance can give you a competitive advantage.
In October 2014, the US Food and Drug Administration (FDA) held a public workshop to gather feedback from the manufacturing and medical device communities with regards to additive manufacturing. The insights from that workshop eventually led to the FDA guidance on Technical Considerations for Additive Manufactured Medical Devices.
There are many unique and vital questions that medical device engineers need to answer with regards to additive manufacturing. While they are not difficult, it is new work compared to traditional applications. While the 30-page FDA guidance covers a number of important topics such as biocompatibility, software security, and acceptance testing, there are three key areas of risk and where implementation struggles exist that are worth delving deeper into.
Additive manufacturing, or 3D printing, is a growing market and one that is shifting away from traditional prototyping and into the world of direct manufacturing, as a range of industries begin to recognise its potential.
Andreas Saar, VP manufacturing engineering solutions and additive manufacturing programme lead at Siemens PLM Software, said: ‘Every industry can benefit from additive manufacturing. It is a disruptive technology that transforms every aspect of the design, simulation and the manufacturing of products. The complexity of additive manufacturing, not just over the entire lifecycle of a product but across the range of industries, is a challenge.’
A number of economic barriers must also be overcome, as Dr Jean Sreng, marketing business development manager for additive manufacturing at the ESI Group, explained: ‘Additive manufacturing is, today, a process which is cost effective at low volume and high complexity geometries. Even though we are all working to decrease this cost effectiveness ratio to achieve high volumes, more traditional manufacturing techniques such as stamping, welding, casting, will always have a complementary effectiveness with additive manufacturing.’
Multiple file-format choices exist, but you might want to consider taking additional steps when saving your parts for 3D printing.
One can choose from a number of file formats for 3D printing, and in general they all work fine. However, understanding what mesh resolution is needed for each part can affect the size of the file, which may create lag when transferring data. In addition, not everything transfers smoothly from a CAD drawing to the printer. This article will look at file resolution, clearance between moving parts, geometric interferences, and more things to keep in mind when moving your CAD drawing to a 3D printer.
I remember when I was planning my first 3D printer purchase. These were endless hours of browsing phrases like “3D printer choice criteria” or “the most important 3D printer details/parts”.Almost every article’s main point was “it depends on what do you want your 3D printer to be used for”.And this is obviously true. Of course, I know that this is not what you are looking for, so in this article I would like to introduce you to a list of the seven most-important features of 3D printers which you need to look at before buying a new one of your own.
- Build volume
This is usually the first parameter given by 3D printer manufacturers. It determines the maximum size your printed element can be. It involves three numbers. The first two are the length and width of your printing, and the third is height. So, at the beginning you should think about the biggest thing that you might want to 3D print with your device, and reject all the 3D printers whose build volume is too small. You should also pay attention to the units used. Some manufacturers use inches, others use millimetres or inches, so be careful.
One of the original purposes of Supercharg3d is to bring pragmatism and balance to what is all-too-often a hyped technology (not that it isn’t disruptive and already changing supply chains!). This is a good summary of some of the key issues preventing it’s wider adoption.
You’re probably groaning by now, but hear me out. Yes, prices for the maker/desktop/DIY category of machines have dropped, the quality of their output has increased, and promotional materials abound with printers creating beautiful and delicate objets d’art.
But like the movie montage where the kids clean up the house before their parents get home, they are glossing over the details. What isn’t shown is the effort, the sweat, the tinkering, the trial and error, and the screaming to the gods themselves to please, please let it work this time.