3D Printing: Funding, Legal Issues, and Medical Technology

AJ Strout

In the ongoing quest to familiarize myself with unique uses of technology at the Claremont Colleges I joined Steven Casper, Dean at the School of Applied Life Sciences, for a 3D print demonstration at Keck Graduate Institute. Leading the casual event was Anna Hickerson, Professor and Program Director, who offered a presentation and discussion on 3D printing. Among the discussed topics were an abridged history of 3D printers, the types of 3D printers currently on and off the market, and their uses and legal complications. Whether for capitalistic enterprise, medical use, or the growing DIY printing community, the 3D printer is a versatile and rapidly evolving machine that’s gaining a lot of attention. Our discussion got me thinking about the humanist qualities of the machine and the roadblocks it faces.

The device now referred to as the “3D Printer” has had a rather short history relative to other manufacturing technologies. In the 30 years that 3D printing technology has existed, it has shifted from producing rapid prototyping plastic parts usually intended for engineering, to nearly every type of object imaginable—parts for hip replacement surgery, game board pieces, figurines, etc.

The first additive manufacturing technique was a process called stereolithography which was developed by 3D Systems Corp. in 1987.[1] Stereolithography is an expensive process because the plastic it requires must be malleable for mixing and has a bonding process. The complexity of using this kind of plastic leads to intense wear and tear on the machines, making maintenance costly.[2] Many other 3D technologists have tried their hand at building a simpler, more cost effective machine but the one that has had the most success uses a process called extrusion printing. It was first developed by Stratasys in 1996.[3]

Building upward from the Stratasys design, Zachary Smith created the first RepRap 3D extrusion printer in 2007 and named it Darwin.[4] RepRap can print a portion of it’s own parts. Additional parts are generic and can be purchased at retail stores–screws, metal rods, and micro-controller boards, for example. Darwin was released as an open-source project under the GNU license which allowed anyone to expand on Darwin. A variety of improvements and purpose-built printers were developed as a result. Whether driven by hobby or small business needs, an entire community has grown up around RepRap. Improvements made to Zachary Smith’s original design were eventually folded into commercial offerings for those without the time or knowledge to build their own. Chief among these are the high-end offerings of the company MakerBot and PrintrBot. The former manufactures sleek, attractive, and reliable printers for around $2,000. PrintrBot produces $600 printers which are fully functional, easily built, and can be serviced by their customers—a hybrid DIY product.

As far as manufacturers go, three disparate groups dominate the 3D printing landscape. Open-source groups value open access, offering interested parties the ability to build their own or tinker with existing designs without the hefty price tag that comes with patented materials. Open hardware groups sell products that are manufactured to high quality standards, but still contribute the designs they’ve developed to the open source community. Capital driven groups, like 3D systems, produce technology which is proprietary. This allows them to raise the funding needed to potentially test officially printed products for medical and scientific uses. Regulations in the US, after all, are an intense obstacle for the implementation of creative, cutting edge medical technology. The flip side of this, of course, is that consumer products like The Cube, are developed. The Cube requires the use of branded 3D plastic delivered by proprietary cartridges much like printers on the Laser Printer market. This kind of disposable cartridge is not only wasteful, but costly. The need for profit is passed on to consumers, rendering the product exclusionary based on its price.

The distinct groups within the realm of 3D printing are not at peace. Profit-driven corporations are currently in litigation with open source groups because their 3D printers make use of certain types of 3D printing, like stereo-lithography, a process which 3D Systems patented.[5] Despite this, open-source and open-hardware groups are determined to keep the DIY community alive and growing. Access, affordability, and non-profit uses seem to be the main goals for open-source, regardless of legal trouble.

The unstable nature of 3D printing leads to a set of complicated questions. Does open-sourcing 3D printers cut into the profit-making abilities of major corporations who market to largely wealthy consumers? If so, are the profit-driven companies concerned only with profits and share holders? Or are they protecting their ability to produce capital meant for funding the production, testing, and legal implementation of important (and possibly life-saving) devices and parts—medical parts for Arthoplasty, hip surgery, or jaw surgery? And if corporations are, in fact, protecting their ability to progress necessary medical science, then why are so many refusing to look into 3D printing, leaving us to run on the fumes of hope? In an interview with US News on the possibilities of 3D printing prosthetics, Thomas Most says, “The biggest hurdle is getting major orthotics companies to get on board.”

Even as many projects are currently taking place in the scientific communities funded by major corporations, the most effective and affordable work seems to be taking place at the grassroots, indie level. Plastic jaws, prosthetic hands, and parts for new limbs are being printed and put to use immediately wherever grassroot 3D operations are determined to assist those in need.

It seems to me that something larger than protecting potential business is at play in this situation. This is the same kind of systematic malady that medicine in the US has seen. Issues of access, cost, and effectiveness are caused by profit-seeking manufacturers and insurance carriers, the high price of equipment due to patenting, and stringent regulations which protect consumers but raise the cost of production and slow down efficiency with bureaucracy. It’s not difficult to stumble onto news about how broken US medical research and regulation practices are. US News is hopeful that other modes of medical technology will offer cost-cutting advances. Meanwhile, there are people in need today.

Additionally, government-funded medical research has been cut to such a level that the development of new medical technologies has come to a halt. Believe it or not, DARPA, our defense research project, is conducting more prosthetic research than our medical industry is.

One solution being discussed is the possibility of directing the NIH and FDA to identify and fund open-source products or technologies which would benefit society. This would allow innovations to proceed with the full force of large community cooperation while ensuring full safety testing of potential medical technologies. The current model of relying on large profit-driven corporations to fund, test, and select which technologies are used in medicine inevitably results in only the most profitable technologies being developed. This could leave special needs patients without new technologies since they are a minority compared to the number of people looking for elective cosmetic surgery. Open-source groups, on the other hand, historically focus on need, efficiency, and affordability of the technologies they develop. If the RepRap project has taught us anything, it’s that large open-source groups are far more effective at developing necessary, cost-effective technologies in cutting edge areas than for-profit organizations are. In the end, however, the NIH itself has seen major cuts in its budget, leaving us to wonder where open source funding for 3D printing will come from at all.

Citations

[1] http://www.redorbit.com/education/reference_library/general-2/history-of/1112953506/the-history-of-3d-printing/

[2] http://honeybuild.com/guides/stereolithography/

[3] http://plasticsengineeringblog.com/2014/10/27/micro-extrusion-for-the-masses/

[4] http://freetinkers.com/blog/2014/05/28/open-source-and-3d-printers/

[5] http://www.insidecounsel.com/2014/01/07/ip-3d-printing-patent-litigation-now-the-shape-of

Articles on defunded medical research

Huffington Post

Pacific Standard

Boston Globe

Elsevier Connect

Washington Post

Articles on independent 3D operations producing Prosthetics and medical materials

Forbes

3Ders Org

ARS Technica

Enabling The Future Org

Metro

NEWSELA

3D Printing Industry

Articles highlighting 3D printing issues

CNBC

Architectural Review

Science Direct

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One comment

  1. Heh.. Everyday we can read, hear about new technologies and how they can change the world and something like “it will be a big breakthrough…” Hopefully 3D printing and especially 3d bioprinting will really help many people in the nearest future. I guess most of us heard about Organovo and their 3d printed liver cells project. Now they are also planning to work on 3d printed kidney – http://3dprintingfromscratch.com/2015/04/first-3d-bioprinted-kidney-tissue-from-organovo/
    I hope that this company and many others will succeed in their work.

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