By David R. Somers, Senior Industry Analyst, Axendia Inc – August 5, 2016
Not since the development of electron beam (e-beam) evaporation and thin layer epitaxy for silicon wafer manufacturing has the industry of small-scale (down to the nano-substrate level) applied technology been so exciting for the development of products that, until now, were very difficult to even produce, much less improve. The technology I refer to is that of 3D printing.
The FDA is seeking to understand the applicability of 3D printing for medical devices. Their recent offering on July 14th made a presentation through a Grand Round webcast as part of a larger program sponsored by the U.S. Navy and FDA to present a frame of reference and thinking behind the effects of such technology within the context of medical devices.
This article seeks to present the essence of that presentation within an historical context leading up to the latest in technological innovation and where the regulatory perspective fits in with these new developments.
Historical Context
As mentioned previously, the e-beam evaporation was one of a source material being evaporated onto a substrate; the other was thin layer epitaxy constructing a thin “epitaxial” layer of single-crystal material deposited on single-crystal substrate to grow a crystallographic structure. Industry is exploring a variety of manufacturing techniques and technologies creating potential physical objects that can enable small scale (and volume) of manufacturing processes, develop a unique and personalized object based on computer graphic specifications, and incorporate a wide variety of materials (e.g., plastics, metals, carbon-based high density polymers). With 3D printing, the technique can involve both the additive method (building layer upon layer to form an object), as well as the reductive method (elimination of material from a material blank) with a pre-programmed outcome, as a sculptor on marble or wood.
