Additive manufacturing, commonly called 3D printing, is the term used to describe methods for the creation of three-dimensional objects. During the process, computers control the successive layering of a material by a 3D printer to produce the required object. The printers work in a similar way to conventional printers, with the addition of moving up and down in the z-axis.
History of 3D printing
The first additive manufacturing equipment was created in the 1980s. It didn’t take long for the medical profession to visualise the many uses of 3D printing: prosthetic limbs, replacement bones and joints, and even organs. Recently, the US FDA released new guidance for manufacturers of medical devices using 3D printing. To date, the FDA has authorised over 85 applications for 3D printed items, including in March 2016 for the first ever 3D printed drug.
The guidelines aim to outline initial thoughts regarding 3D printing devices for medical use, specifically in the design, production and testing of devices. The guidelines, based on feedback from a workshop in 2014, do not address the use of items consisting of biologics.
There are huge advantages in 3D printing for creating complex structures that anatomically match a specific patient. However, the FDA has noted that it considers adherence to quality systems requirements as vital in additive manufacturing techniques, in order to ensure that devices work as expected. The FDA also state that it is important for manufacturers to ‘clearly identify each step in the printing process’. Currently items may be manufactured for the medical industry based on Plastic Moulding like that provided by www.meadex.co.uk/materials/plastic/#moulding and are well regulated.
The FDA clearance process
The FDA 510k clearance process is the initial stage of FDA accreditation, and it is also referred to as Premarket Notification. Legally, it is not an approval process. For more information, see http://www.devicewatch.org/reg/510k.shtml. Third party review companies, are accredited to review Medical Device Submissions on behalf of the FDA. They then manage the submission through the FDA’s final review and determination. Passage of a device through such companies can speed up 510k submissions by approximately three to four months.
3D printing is a fast moving industry that is going to grow to dominate medical science in the future. A reduction in the time taken for the accreditation process can offer huge competitive advantages that would benefit any commercial company.