Rapid prototyping by additive manufacturing — otherwise known as 3-D printing — stands poised to revolutionize healthcare in everything from regenerative medicine to cancer research by facilitating cost-effective technological innovation on a scale never before thought possible.
In many ways, the revolution has already begun. Knee implants and hearing aids are already being manufactured. Life-saving biocompatible 3-D-printed tracheal splints have been successfully implanted. In 2013, a team at Princeton printed a bionic ear. In 2014, researchers at Harvard created blood vessels embedded within tissue structures. The goal, someday, is a fully functioning, solid, transplantable organ. That may be closer than anyone thinks.
It is a revolution a long time in the making. Invented by Charles Hull in 1984, commercial rapid prototyping initially struggled to find widespread application, given the relatively high investment required. Today the technology is used in such varied fields as toys, foodstuffs and rocket engines. In 2000, Thomas Boland, while tinkering in his lab, happened to reconfigure an old printer to work with collagen. Bioprinting was born. Since then, the healthcare industry hasn't looked back.
The theory behind 3-D bioprinting is relatively simple. Very small amounts of polymer are deposited by additive process layer-by-layer upon a pre-shaped supporting scaffold — which is also 3-D-printed. The scaffold is then dissolved, and the biological material is treated in a variety of ways to condition the cells into functional body parts. The result is extraordinarily precise, on-demand implantable tissue with no chance of rejection.
With 120,000 Americans currently awaiting organ transplant, the most pressing application of 3-D printing is the reliable manufacture of complex organs like hearts, kidneys and livers. But this is also very complicated. Engineering organs is not a particularly new practice. In 2006, Anthony Atala, MD, director of the Wake Forest Institute for Regenerative Medicine, successfully grew and implanted seven bladders by hand. But bladders are only composed of two cell types; livers consist of more than 40. Additive manufacturing offers the opportunity to scale and automate the processes of regenerative medicine as scientists improve their understanding of deep cell biology and vascular architecture. It is currently thought rapid prototyping will yield solid organs within ten years.
3-D bioprinting technology is gradually shifting the healthcare market as a whole. By December of this year, industry leader Organovo plans to submit its first bioprinted liver tissue sample for commercial use in pharmaceutical and biotechnological research and development. Using what is essentially human tissue in early-stage drug development will reduce the industry's reliance on outdated animal models used to approximate efficacy in humans.I In the long run, this development will save a lot of money. Creating a new drug is a lengthy, expensive process: on average, it costs 1.2 billion dollars, and takes 12 years. Organovo's 3-D commercial tissues will enable pharmaceutical companies to determine the toxicities of potential new drugs before undertaking expensive and time-consuming clinical trials. The end result: a faster and safer drug discovery process with savings passed on to the consumer.
Ultimately, given the substantial regulatory hurdle of FDA approval, one of the more robust current applications of 3-D printing lies in medical training and specific pre-surgical planning. Traditionally, surgeons used to learn on live pigs. Today they are able to rehearse surgical approaches in realistically textured environments on anatomically precise 3-D printed molds generated from MRI and CT scans. This application has a particularly granular dimension: In being able to practice on models of organs that reproducibly simulate complex structures and individualized medical defects, surgeons can practice specific procedures on specific patients before setting foot in the operating room. The learning curve is getting shorter all the time.
"Bioprinting," is a rapidly developing field of science that obviously has many potential applications in medicine," Dr. Atala writes. "Even five years from now, I suspect researchers will be pursuing potential treatments that are unimaginable today."
3-D printing has created a world in which life-saving medical procedures and important pharmaceutical research are faster, more efficient and safer than ever before. The commercial potential of this young field is formidable. By 2030, the bioprinting sector alone is forecast to be worth 10 billion dollars. With the medical applications of rapid prototyping just now beginning to be unlocked, the only force that will drive this nascent industry is continued innovation. It is widely believed the medical start-up sector will play an increasingly important role in this growth, particularly medical technology incubators that specialize in lending expertise and early-stage investment to small businesses and experienced inventors. The future of medical technology is here, and it's wide open, ready for anyone with the right vision.
Ultimately, only the market will decide the limits of innovation. While there might be some growing pains along the way, the eventual upside is clear: cheaper and more reliable medications, better trained surgeons, and no more people on transplant lists anywhere, ever again.
Bobby Grajewski is President of Edison Nation Medical, a healthcare product, medical device incubator and online community for people who are passionate about healthcare innovation. Mr. Grajewski holds a MBA from The Wharton School at the University of Pennsylvania, a MPA from Harvard Kennedy School and a BA from Harvard University.
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