With news that 3D printing (without question one of the coolest technologies to come down the road in quite some time) can be used to produce guns, we must now ask ourselves what other things might be built using a 3D printer. What about, say, a medical device? Or human tissue? Or body parts?
Some folks are batting around billion dollar numbers, imagining that the official market for these breakthroughs will be the big story in the years to come. And, to be sure, that “official” marketplace will be an important element in the new world of bio-mechanical printing. But as an IP lawyer, my first thought was this is going to be crazy.
So what is 3D printing, and why is it such a big deal? 3D printing is, as you might imagine from the name, a technology that permits three-dimensional objects to be fabricated using a printer that “prints” an item layer by layer (the official term is “additive manufacturing.”) This video from a recent TED Talk by Lisa Harouni does a pretty good job of explaining how you can build a physical object from a bunch of plans that show the geometric form and proportions of the proposed item. This is revolutionary – you do not need someone to “build” your item, and tooling and dyes are irrelevant. Rather, you need a machine (and these machines, like the Maker-Bot Replicator™ 2 are now small enough to fit on your desktop and cost as little as $2199), and you need some plans. And that’s about it.
The potential for customized medical devices are obvious – they can be made to exacting tolerances to match the exact need in the person who requires the device. But perhaps just as intriguing is the fact that plans for these items may rapidly become widely available, and outside the control of the traditional “rights” owner. Similarly, the potential for open source medical device manufacturing becomes real, as doctors and researchers can collaborate on the creation of devices across borders, and with regulators unable to track it all through “normal” means. What happens when a human organ can be assembled on a 3D printer? Moreover, advances in printed electronics are making similar advances right now, and the potential to combine them will likely be real far sooner than people realize. How does this all fit into a regulatory scheme where companies and academia are presumed to be the only sources of biomedical innovation?
As is typically the case, science fiction got here first. William Gibson’s classic 1984 SF noirNeuromancer (best known for introducing the world to cyberspace) also included some dramatic set pieces at the “black clinics” of the near future, where radical innovation in the life sciences was uncontrolled, unregulated and profoundly in demand. The cutting edge of medical technology was hidden in the shadows, and available only to those who knew where to find it. Is that dystopian vision our future? If not, we need to think about how we can ensure that the history of the future is written today.
3D printing and the open source availability of fabricating technology must be a focus of serious consideration by anyone who cares about IP (the whole notion of “counterfeiting” becomes problematic when the item being created is exactly the same) regulation (who exactly is empowered to address the unregulated development of medical devices and pharma when the plans are being assembled in the ether of a world-wide electronic network, and then downloaded for execution by anonymous people in untraceable locales?) These are not the idle speculation of prophets, but serious questions that will become inescapable in a few short years. The brave new world of 3D printing is just the first step towards a far less centralized future. Will you be ready for it?©2014 Drinker Biddle & Reath LLP. All Rights Reserved