Nearly 106,000 Americans are currently on waiting lists for donor organs and 17 die each day while waiting. The holy grail for rising to meet this demand and end this suffering will be the ability to “print” the organs, muscles, and tissues from individually grown cells, lowering the need for human donors and the complicated and sometimes unbearable stress that goes along with donor wait lines.

There have been recent advancements in the field that have produced several different skin, bone, muscle and vascular structures, and even whole non-human organs, such as a functional porcine pancreas and a rabbit-sized heart. The most recent use of 3D printing in humans was in 2022 where Dr. Arturo Bonilla constructed and implanted an outer ear structure for a woman born without one. The implant was made from the woman’s own cartilage cells and made using a 3D bioprinter.

In its most basic terms, bioprinting is a process where individual cells are generated and instructed to become a specific cell type. They are then made into a “bioink,” which can be loaded into a bioprinter and laid down in layers with other cell types, resulting in a structure resembling a naturally occurring tissue. Once connected to oxygen and other necessary nutrients, the printed structure matures and develops higher function.

The promise of scaling up this process to create whole organs that can be readily used in humans comes down to accuracy, precision, and reduced costs. The process of making 3D printed organs can eventually be automated and can build cell structures to exact specificity using the patient’s own cells, which dramatically decreases the likelihood of organ rejection.

While estimates on when these 3D printed organs will become commonplace in health practices ranges from a decade to several decades, the experts appear to all agree that this is no longer a science-fiction fantasy, but a real inevitability. What has yet to be seen or broadly discussed, however, is the legal ramifications of artificial organs. How will these be treated by the FDA? Who will be liable when an artificial organ fails? Will companies that produce artificial organs be subject to product liability in the same way as automakers and toymakers? As 3D printing is on the rise, all eyes should be on Congress and the federal agencies responsible for oversight in the coming decades to see how they respond to a new era in regenerative health care.