3D printing in healthcare is advancing faster than the legal frameworks built to govern it, and the gap is wider than most people realize.
Dr. Modupe B. Adewale has spent her PhD at RMIT University’s College of Business and Law thinking about a question that most legal scholars have not yet got around to: when a hospital prints a human organ and it goes wrong, what does the law actually do?
Her research spans product liability, intellectual property, and bioethics. Dr. Adewale tells me that the frameworks governing each area were built for a world that bioprinting is already making obsolete, requiring her to build a new normative framework from scratch.
She calls it Moralist Bio-Utilitarianism, because neither pure utilitarian reasoning nor rights-based bioethics could hold the problem alone. “Pure utilitarian approaches can be very permissive,” she says. “They can justify strong forms of commodification or prioritize aggregate benefit in ways that underplay concerns about exploitation or unequal access.”
Deontological frameworks struggled with innovation. Bioprinting needed something that could assess outcomes in a consequentialist way while maintaining what she calls “a morally bounded space that prevents certain kinds of harm or unfairness from being justified purely on efficiency grounds.”
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The Murky Reality of Point-of-Care Liability
The liability question is the one courts will have to answer first, and the existing framework gives them very little to work with. Product liability law draws a firm line between manufacturers, who face strict liability, and clinicians, who are held to a negligence standard. That distinction has held up reasonably well for decades.
A hospital that uses a faulty hip implant is not the same legal actor as the company that made it. But “when a hospital designs, fabricates, and implants a bioprinted organ in-house,” Dr. Adewale says, “it is no longer merely using a product; it is actively creating it. In that sense, it begins to resemble a manufacturer and not just a mere incidental user.”
Bioprinted organs are patient-specific, not mass-produced, but Dr. Adewale argues they still trigger strict liability. “The operative question is whether the defendant is in the business of producing or supplying the product, notwithstanding the scale of production at a given time. A product may be individually tailored, yet still produced within a structured, repeatable, and scalable system.” Existing case law already holds producers of customized, patient-specific items strictly liable.
She also points to a detail that might seem mundane but carries real legal weight: itemized billing. Where a hospital separates the cost of a bioprinted organ from its general medical services on an invoice, that starts to look like a product sale, not clinical care. The upshot, she says, is “a doctrinal grey zone in which hospitals involved in bioprinting cannot be cleanly categorized as service providers, manufacturers, or commercial sellers,” and courts left to work that out case by case.
This uncertainty extends to the bioCAD designer, who carries “the most underexplored legal exposure” in the whole chain. Product liability law “still relies heavily on relatively traditional ideas of causation and physical manufacturing,” which tends to anchor liability to whoever physically makes the final product.
The bioCAD designer sits upstream of that, defining the organ’s structure and biological outcome, but potentially too remote from the physical act of printing to attract direct liability. “That creates a mismatch between functional control and liability,” she says. “The exposure is not absent. It is just legally under-theorised.”
Why Traditional Patents Fail Modular Technology
Intellectual property (IP) presents a similar problem. TRIPS flexibilities, including compulsory licensing, were designed to get generic drugs to patients in countries that could not afford patented versions. The mechanism assumes you can isolate the relevant IP, license it, and manufacture an equivalent. Bioprinting does not work that way.
“A functioning therapeutic output depends on the interaction of multiple patented layers, including bioink formulations, hardware systems, software design files, and pre- and post-processing protocols,” she says.
“A compulsory licence over one element rarely provides meaningful access to the technology as a whole. Even if one component is licensed, the absence of complementary inputs can prevent effective implementation.” The framework was simply not designed for a technology this modular.
This tension intensifies based on who resists harmonization. The strongest commercial incentives come from countries leading in bioprinting research and commercialization. “What you have is resistance coming from two different directions,” she says.
For the United States, China, and parts of the European Union, regulatory divergence is an advantage to be protected. It lets them tailor standards around domestic industries, retain first-mover advantage, and control how the technology diffuses globally.
Low- and middle-income countries (LMICS) are not resisting harmonization outright, but rather resisting forms of it that lock in high protection without flexibility, a concern that historically shaped the Doha Declaration. A fully uniform global model is unlikely to work. The realistic path is a baseline framework built on shared principles, with enough flexibility for countries to implement it on their own terms.
The Legal Fiction of Bodily Ownership
Before bioprinting, there was John Moore, who had his spleen removed in 1976 and later discovered his cells were used to develop a commercially valuable cell line. Before him, in a sense, Henrietta Lacks’ cancer cells were taken without consent in 1951 to become one of the most widely used lines in medical history. Both sued; neither won property rights.
Dr. Adewale does not think bioprinting changes that outcome. “Under current doctrine, a plaintiff in a Moore-type situation would still struggle to establish property rights in their cells. That has not fundamentally changed.” However, Moore established that a lack of informed consent could give rise to liability, an avenue that has since become considerably more developed.
It is now the stronger legal avenue for plaintiffs, though a different result on property requires something more fundamental. To bridge this gap, her framework advocates for “quasi-proprietary interests.” This would not grant patients full bodily ownership, but rather a narrow legal standing to negotiate benefit-sharing arrangements in advance or legally enforce those terms if breached.
Her empirical research, conducted through interviews in developing countries, turned up something that doctrinal analysis alone would not have reached. In many of the contexts she studied, people have never encountered bioprinting at the clinical or regulatory level.
In others, “questions around ethical, cultural, or religious acceptability influence whether the technology would be embraced even if it became available.” Crucially, her interviews revealed that practical deployment is heavily dictated by informal governance, meaning pathways to access are shaped by administrative discretion, institutional gatekeeping, and subjective relationships between hospitals, regulators, and suppliers.
Legal access is often the last barrier, not the first. “Global dissemination is not simply about making a technology available. It depends on whether the technology is understood, trusted, and seen as acceptable within local contexts.”
Bioprinting was supposed to solve organ scarcity. Dr. Adewale thinks it might instead create a parallel market for organs organized around production capacity and the ability to pay rather than clinical need.
“The core issue is therefore not whether bioprinting can produce organs, but whether it is able to structurally broaden access in a meaningful way. Where it cannot, it risks reproducing the same inequalities that define the current system, just through a different technological form,” she concludes.
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Featured image shows AMA Healthcare 2026. Image by 3D Printing Industry.
