This week: an open AI model for materials that has more downloads than DeepSeek but still can’t touch a bioink, a Singapore clearance for a 3D-printed wound-care implant, three fresh bioprinting papers, and cartilage printing aboard the space station.

The big thing

AI Model for materials beat DeepSeek’s downloads. It still can’t help fill the biology gap.

At our Biomaterials Frontier event, a Johns Hopkins and NIST materials scientist Prof. Kamal Choudhary mentioned, almost in passing, that his open AI model (DiffractGPT) for materials had been downloaded more times on Hugging Face than DeepSeek. But that is hard not to notice.

Kamal Choudhary has built the tools that make AI-driven materials discovery real: an open database with 200,000 users, models that predict a material’s properties in seconds, and a “ChatGPT for materials” that plugs into Claude. Hand one an X-ray pattern and it will propose the atomic structure behind it, including for compounds that do not exist yet.

And almost none of it can help develop biomaterials. At least not yet.

That is the uncomfortable part, and Choudhary said it himself when the moderator Craig Rosenblum asked. The AI is fluent in the physics of hard, crystalline materials. It knows little about biology: how it degrades, whether cells like it, whether it heals. Good data barely exists, and the experiments that would create it are the slow, expensive bottleneck.

Which is exactly why it is an opportunity.

The moat in (bio)materials science is not just the model. It will be the biological data few have, and the company patient and strategic enough to generate it.

Read our more in-depth review and analysis based on Dr. Choudhary’s work at Hopkins here, and see where the money goes next, in the full piece: More downloads than DeepSeek: AI Model for Materials (Expert Corner) →

Regulatory watch

• UltiMaker and Bioactivx: a 3D-printed wound-care implant clears Singapore’s HSA — Bioactivx’s synthetic, animal-free Bioactiv Matrix, printed on UltiMaker systems in an ISO 13485 cleanroom, won Singapore HSA approval, with US, EU, Australia and ASEAN filings pending. A proof point that additive manufacturing can meet certified end-use device standards, not just prototyping. (This is a Singapore HSA clearance, not an FDA action; no new FDA 510(k) AM clearances surfaced this week.)

Clinical & research

• In-situ bioprinting builds a blood supply inside new bone (Acta Biomaterialia · via PubMed) — Targets bioprinting’s core bottleneck, keeping thick tissue alive by printing its vasculature in place. Preclinical (mouse).
• A bioprinted dentin-pulp model that mineralizes and grows vessel-like channels (Biofabrication · via PubMed) — Stiffer zones drive mineralization while softer zones form vessels, a tunable test bed for regenerative dentistry. In vitro.
• A 3D-printed scaffold plus engineered stem cells regrows injured nerves (Bioactive Materials · via PubMed) — Scaffold-guided peripheral-nerve repair restored function in a preclinical model. Proof of concept (rat).

Also this week

• An AI database pairs drugs with excipients for on-demand pharmacy printing (VoxelMatters) — University of Mississippi with Colorcon; in development, not yet deployed.
• Cartilage bioprinting tops the research schedule aboard the ISS (NASA) — Reported microgravity crew activity, not a published result.
• ‘Subvoxel’ multimaterial bioprinting co-extrudes several bio-inks at once (Technology.org) — Demonstrated in cultivated meat; the multimaterial technique may transfer to tissue engineering.

From 3DHEALS

• Biomaterials & 3D Printing in Healthcare: event recap — The write-up by our intern Peter Hsu from the Biomaterials Frontier panel behind this week’s lead.
• Episode 127: Lean compliance for medical 3D printing, with Erik Boelen — The latest Lattice Podcast, on making quality systems workable at the point of care.
• On-demand course: AI Updates for 3D Printing and Bioprinting — Goes deeper on AI across the print-to-clinic workflow.

Subscribe to The Lattice Brief

The post AI for Materials Has A Biological Gap | The Lattice Brief (9/19/26) appeared first on 3DHeals.

DiffractGPT, an open artificial intelligence (AI) model for materials design, has been downloaded roughly 240,000 times on Hugging Face “more than DeepSeek”, told its creator to the room during our recent 3DHEALS virtual event Biomaterials Frontier for Medical 3DPrinting. That creator is Kamal Choudhary, a materials scientist at Johns Hopkins University and a research associate at the National Institute of Standards and Technology (NIST). In fifteen minutes, he laid out what AI can already do in materials discovery: JARVIS, the open materials database he built at NIST; ALIGNN, a graph neural network that predicts material properties; and AtomGPT, a “ChatGPT for materials”. That said, almost none of these can directly benefit bioinks, implantable biomaterials, or medical 3D printing community. This article explains what AI-driven materials design can do today, why biology is the bottleneck, and where the commercial opportunity sits for bioprinting and medical device companies.

What AI can already do

Start with the model behind that download count. DiffractGPT reverses the usual workflow: give it an X-ray diffraction (XRD) pattern and it proposes the atomic structure that would produce it, including for compounds that do not yet exist in any database. Choudhary said at our recent event that it has been downloaded around 240,000 times on Hugging Face, “more than DeepSeek”, he noted. This is a remarkable reach for a tool built for crystallographers. And AtomGPT, his “ChatGPT for materials,” now connects to general chatbots, including OpenAI and Claude, through the Model Context Protocol (MCP), so a language model answers a materials question by querying a physics-grounded tool instead of inventing a plausible-looking wrong one. In a field where a confidently wrong number can send a lab down a six-month dead end, that plumbing matters more than it sounds.

Behind the generative models sits the data, and the scale is easy to underestimate. Choudhary built JARVIS (stands for: Joint Automated Repository for Various Integrated Simulations), an open repository of materials data while at NIST; he says it has around 200,000 users and roughly 100,000 materials. On top of that sits a family of models. ALIGNN, the Atomistic Line Graph Neural Network, was the one to pay attention to. Earlier graph models described a crystal as atoms joined by bonds. ALIGNN added the angles between those bonds, and that single change improved accuracy sharply, by his account up to 44 percent, while staying fast. Its reported error for formation energy is about 0.022 electron-volts per atom, close enough to first-principles calculations to work as a screening tool. His group used it to computationally pick superconductors and a metal-organic framework (MOF) for carbon capture, then synthesized and validated them. Prediction, then a real material. If you want the map rather than the demo, his group’s 2022 review in npj Computational Materials, now cited more than 1,200 times, is the standard reference.

Why biology is still outside

During the event, the moderator Craig Rosenblum asked if the same AI tool can be useful to characterize a material’s “inorganic properties like biocompatibility, the degradation rate, the bioactivity”.

“Great question,” answered Choudhary.

The lack of domain-specific data in biology is where the gap is.

The data problem is lopsided. There is a great deal of it for formation energy, bulk modulus, and band structure, the physical properties of inorganic, crystalline materials. There is very little for the properties that decide whether something belongs in a body, the behavior of a soft hydrogel or an absorbable polymer as it dissolves.

AI has gone deep in certain verticals but left the biological slice mostly untouched.

The loop problem is worse and more structural. Most of these models learn from simulation. To trust them, you check them against experiments, and the experiments are the bottleneck. Characterization tools like X-ray diffraction are slow. They generalize poorly to messy, defect-laden, biological systems. So, the theory-to-experiment loop that would let a model propose a bioink and then learn from how it performed does not close easily. Choudhary was candid that his cleanest results were for near-perfect systems, not for the heterogeneous reality of biomaterials. That said, Choudhary’s own showcase, the AI for Materials Design Laboratory at Hopkins, is a genuine closed-loop facility: robots move samples past automated X-ray, indentation, and laser-impact stations while AI decides what to test next. It is also built for materials in extreme environments, like defense and aerospace, not for biological systems. The machine that would do the same for biomaterials, feeding biological outcomes back into the model, mostly does not exist yet. (See our previous event focusing on AI and 3D printing, where NUS researchers have successfully created a ML-feedback loop to generate bioprinted gum tissue.)

Where the money is

That absence is the opportunity, and Choudhary said.

The winners in AI-driven materials, he argued, will not be whoever trains the biggest general model. They will be whoever owns a proprietary dataset in a specific domain, or builds the narrow, expert model for it. His half-joking example, a “collagen GPT,” is exactly the shape of the bet, knowing one of the speakers is an expert in human collagen. Sell the model no one else can train or sell the data no one else has.

For the 3DHEALS audience, that could be the strategy.

Bioink and biomaterial companies already sit on the scarce asset: batch after batch of biological performance data that never leaves their benches. Instrument the printers. Label the outcomes. Build the loop between what you printed and how the tissue responded. The company that does this for its niche, whether degradable polymers, bioinks, or regenerative materials, will own a moat that a foundation model cannot cross, because the model has never seen the data.

The AI, increasingly, is the easy part. The wet-lab evidence is the hard (and expensive) part, and therefore the valuable one.

References

• Biomaterials Frontier (3DHEALS event): https://3dheals.com/biomaterials-frontier/

• Choudhary et al., “Recent advances and applications of deep learning methods in materials science,” npj Computational Materials (2022): https://www.nature.com/articles/s41524-022-00734-6

• AI for Materials Design Laboratory (AIMD-L), JHU HEMI / CAIMEE: https://hemi.jhu.edu/caimee/center-facilities/aimd-l/

•AtomGPT: https://atomgpt.org   • Choudhary demos (YouTube): https://www.youtube.com/@dr_k_choudhary

•Artificial Intelligence Updates For 3D Printing and Bioprinting (on-demand course)

Organizations

• Hopkins Extreme Materials Institute (HEMI): https://hemi.jhu.edu/

• Center for Artificial Intelligence and Materials Engineering (CAIMEE), Johns Hopkins: https://hemi.jhu.edu/caimee/

• National Institute of Standards and Technology (NIST): https://www.nist.gov/

• NIST JARVIS (Joint Automated Repository for Various Integrated Simulations): https://jarvis.nist.gov/

The post More Downloads Than DeepSeek: AI Model for Materials appeared first on 3DHeals.

Medical 3D printing has come a long way, but the regulations are still catching up. As personalized medical devices move into hospitals, how can labs innovate while staying compliant? Erik Boelen, founder of medical 3D-printing compliance consultancy Qase3D and former Chief Operations Officer of Xilloc Medical, has a solution. Boelen built an ISO 13485 quality system from scratch at Xilloc, which produced the world’s first complete 3D-printed titanium mandible in 2011. Today, he helps newer medical 3D-printing companies and hospital labs navigate the European Medical Device Regulation (MDR), emphasizing that MDR compliance does not necessarily require a full ISO 13485 system. Through Qase3D, Boelen has developed an MDR Management System with Waveland European Lawyers, an online portal that breaks down regulatory requirements into practical steps for custom-made device manufacturers. As hospitals increasingly become manufacturers themselves, Boelen integrates compliance systems that protect patients without creating unnecessary bureaucracy.

⚠️ Disclaimer:
This podcast is for educational and informational purposes only. The views expressed do not constitute engineering, medical, or financial advice. The technologies and procedures discussed may not be commercially available or suitable for every case. Always consult with a qualified professional.

Support our show and get premium and archived content anytime:

Subscribe to The Lattice Podcast

About Our Guest:

Dr. ir. Erik Boelen runs his consultancy, “Qase3D” (pronounced Case-three-dee) specializing in medical 3D printing and Quality Management. He assists 3D printing companies and hospital labs with ISO 13485 certification and MDR compliance. Erik served as Chief Operations Officer at Xilloc Medical B.V. for nine years (April 2012 – June 2021), where the company designed and manufactured some of the world’s first patient-specific, 3D printed medical devices. Before that, he held various roles at 3D printing pioneer Materialise NV: Marketing Manager (January 2011 – May 2012), Sales Manager Biomedical Asia- Pacific (February 2010 – January 2011), Product Specialist (June 2007 – February 2010), and Application Engineer (January 2007 – June 2007).

Key Topics

• Twenty years of medical 3D printing and the evolution of regulation
• Medical 3D printing before the MDR and the regulatory gaps of the MDD era
• Understanding the MDR, CE marking, custom-made devices, and ISO 13485
• Xilloc and the world’s first complete 3D-printed titanium mandible
• Patient safety and the shift from self-regulation to formal standards
• The 2017 MDR and its impact on custom-made medical devices
• Building an ISO 13485 quality management system from scratch
• How Qase3D helps medical 3D-printing companies and hospital labs navigate compliance
• Designing a quality management system that engineers will actually use
• Why smaller labs may not need the full weight of ISO 13485
• Where the MDR and ISO 13485 overlap, and where their requirements differ
• Lean compliance, documentation, and reducing the cost of regulatory management
• Implants, Class III devices, and when more rigorous quality systems are needed
• GDPR, lawyers, and protecting patient data in personalized medical devices
• The rise of hospital 3D labs and the future of hospitals as medical device manufacturers

Timestamps:

00:00:00 – Welcome To The Regulatory Reality
00:03:10 – MDR, CE Mark, And ISO 13485
00:06:30 – Making Implants Before Clear Rules
00:08:33 – What Custom Made Really Means
00:10:20 – From Engineer To Quality Builder
00:12:12 – A Lean QMS People Actually Use
00:17:33 – The MDR Portal And Lawyer Support
00:26:45 – Scaling Compliance Without Bureaucracy
00:30:40 – The Future Of Hospital 3D Labs
00:41:05 – How To Contact Erik
00:43:15 – Disclaimer

Resources

🔗 Contact Erik Boelen

• Erik Boelen on LinkedIn
• Qase3D on LinkedIn
• Qase3D
• About Qase3D & Erik Boelen
• Qase3D Quality BluePrint 5D Method

🔗 MDR, ISO 13485 & Point-of-Care Compliance

• EU Medical Device Regulation (MDR)
• Qase3D MDR Management System
• MDR Custom-Made Devices
• Waveland European Lawyers MDR Point-of-Care Platform
• Qase3D Point-of-Care Compliance
• Qase3D Custom-Made Devices and the MDR
• ISO 13485 Medical Devices Quality Management Systems

🔗 Xilloc & Medical 3D Printing

• Xilloc 
• World’s 1st complete 3D-printed titanium mandible in 2011
• Materialise Mimics
• Materialise Medical
• 3D Printing Industry: Qase3D and Waveland Introduce MDR Management System
• 3DHEALS: Updates on 3D Printed Medical Devices

🔗 Learn More About Medical 3D Printing from 3DHEALS!

• 3DHEALS
• Interview with Erik Boelen: Quality Management for Point-of-Care 3D Printing
• 3D Printing at Point-of-CARE with Quality
• Point of Care Additive Manufacturing
• 3D Printing in Hospitals: The Road to Reimbursement
• A World of Regulation: Updates on 3D Printed Medical Devices
• 3D Printing in Hospitals: A Beginner’s Guide
• Strategic Issues of 3D Printing in Hospitals
• 3DHEALS Policy Guide: Six Policy Areas Impacting Healthcare 3D Printing

The post Episode 127: Lean Compliance For Medical 3D Printing With Erik Boelen appeared first on 3DHeals.

This week’s Lattice Brief asks whether in-house hospital 3D printing is really going mainstream, or just thriving inside well-funded academic and government-backed centers. A five-year survey of European neurosurgeons shows printing moving decisively in-house, and increasingly into implants, even as a candid talk with a private-practice orthopedic surgeon suggests the everyday clinic hasn’t followed. Around that question, we cover the week’s standards and regulatory moves; three peer-reviewed advances, from a human jawbone-regeneration cohort to cartilage regrown in animals and a touch-sensing prosthetic skin; and two new pieces from 3DHEALS on metamaterials and university technology transfer.

The big thing

Will in-house 3D printing really scale?

A European survey says hospital printing moved in-house and up to implants. A veteran orthopedic surgeon says he barely touches it. So, what is the truth?

This week’s most consequential medical 3D printing story is a shift in who makes the devices. A five-year survey of European neurosurgeons, published in the International Journal of Bioprinting and covered by 3D Printing Industry recently, found departmental printing moved decisively in-house between 2020 and 2025. Neurosurgeon-led printing rose from 0% to 20.68%; reliance on an outside printing company fell from 21.81% to zero; implant fabrication climbed from 0% to 27.58% of reported uses. Caveat: two surveys, neurosurgery only. Several points still stand out:

1. Outsourcing 3D printing dropped to zero. In-house centers do win on turnaround, vendor markups, surgeon control, quality assurance, and data privacy, but zero is still surprising. I have observed biomedical engineers who used to work for vendors eventually end up in a hospital 3D printing center, working more intimately with the clinicians. Perhaps, this is the Way.
2. The cost paradox: About 80% of respondents reported better per-model cost efficiency due to cheaper desktop printers, cheaper materials, no vendor markups. Capital expenditure and staff time remain the top barriers. Only ~32% of departments received increased administrative funding or dedicated institutional budgets since 2020, highlighting a gap between clinical enthusiasm and hospital financial backing.
3. Knowledge gap: The hardware and software questions drew a striking share of “unknown” answers. In Figure 1K, regarding printing technique, “Unknown” represents the single largest category (~40–50% of responses) in both 2020 and 2025. Worse, it seems the percentage of surgeons aware of the software used is decreasing over time in these institutions. While one might imagine physician champaigns (and even “technical physicians”) now work closer with the engineering team than ever, the reality might be siloed departments or initiatives relying on individual “power users”. Maybe the technical mechanics don’t matter to day-to-day clinical work. Or maybe that gap is exactly what limits a program’s longevity.

Back in 2017, 3DHEALS published a cost model for an in-house hospital printing service, using a cardiothoracic example with a $300,000 Stratasys Objet500 Connex3, roughly $367,600 in acquisition cost, and a 125-print breakeven that left year one in the red. The verdict then: build it only with real volume and patience.

So, who cleared that bar? The survey’s respondents were mostly university hospitals, and its authors concede the pattern may widen the gap between academic and community centers. The other showcase examples of compliant in-house implant manufacturing are both public money: the U.S. Walter Reed military medical center, the first point-of-care institution with an FDA 510(k) clearance for an implant it makes itself, and Madrid’s public Hospital 12 de Octubre, now ISO 13485-certified. In-house printing is growing, but so far inside academic and government-funded systems with the staff, capital, and quality apparatus to carry it.

Then there’s the ground truth. Last week I asked a seasoned private-practice orthopedic surgeon how often 3D printing enters his routine knee cases. His answer: rarely and only for the genuinely complex ones. Feel free to do your own field survey. That’s striking, because orthopedics is supposedly the field where 3D printing already won: the major implant makers have printed porous titanium at industrial scale for over a decade. But that is centralized manufacturing the surgeon never experiences as “3D printing.” At the point of care, for the everyday case, patient-specific printing can still feel more like a marketing term than a tool.

Our view: “Point-of-care 3D printing” has three tribes. One thrives in academic and public institutions, one inside the implant industry’s own factories. The third and largest, the community private practitioner isn’t yet totally on board. The real question was never whether this group will adopt 3D printing (in-house or outsourced) but when reimbursement, standards, and outcome evidence will finally line up.

If you work in orthotics and prosthetics, help our super fan Dr. Jade Ward map the field: fill out our short O&P survey.

Sources: Özdemir D, Middelkamp M, et al. “The development of three-dimensional printing in neurosurgical departments across Europe: A five-year perspective.” Int. J. Bioprint. 2026;12(3):026090076. DOI: 10.36922/IJB026090076. Trade coverage: 3D Printing Industry, Sept 3, 2026. Historical reference: 3DHEALS, “In-House Cost Consideration for 3D Printing for Surgical Applications, Part 2,” 2017. Orthopedic observation: author’s own conversation, Sept 2026.

Regulatory watch

• Advancing European standards and regulations for 3D bioprinting — Trends in Biotechnology – the European Commission’s Joint Research Centre and CEN-CENELEC argue clear standards and regulatory frameworks are the gating step to safe clinical bioprinting. (No new FDA 510(k) additive-device clearance surfaced this week.)
• ASTM International launches Critical and Emerging Technologies (CET) Division — Additive-manufacturing standardization stays the flagship as ASTM broadens its remit; standards convergence is a gating factor for medical AM qualification.

Clinical & research

• Alveolar bone regeneration using 3D-printed, patient-specific, resorbable PCL scaffolds (J. Clin. Periodontol.) — A 10-patient prospective cohort – a rare human clinical readout, with mean regenerated volume ~112% of the original defect.
• BIO INX material enables functional cartilage regeneration in a rabbit study (European Polymer Journal) — First in vivo proof for multiphoton-printed DEGRAD INX microscaffolds; repaired tissue reached ~91% of native cartilage thickness.
• 3D-printed electronic skin gives prosthetics touch and temperature sensing (Cell Reports Physical Science) — A scan-model-print e-skin reportedly senses at ~10x the resolution of commercial glove sensors – a step toward truly sensate prosthetics.

From 3DHEALS

Metamaterial and 3D Printing — Jenny Chen on why metamaterials – structures whose properties come from designed micro/nano geometry rather than their base material – are a natural partner for 3D printing: implants tunable for strength and resorption, higher-sensitivity printed sensors, and more responsive soft-robotic surgical tools.

The Lattice, Episode 125 – Inside Technology Transfer at UCLA with Mark Wisniewski — Innovation as a chess game: UCLA’s Mark Wisniewski on how technology transfer turns a university-lab idea into a company, a breakthrough, or a treatment – essential listening for anyone pushing medical 3D printing research toward the clinic and the market.

The post Will in-house 3D printing really scale? |The Lattice Brief (9-13-26) appeared first on 3DHeals.

Metamaterials could be one of the most consequential ideas in materials science, and 3D printing is what turned them from theory into objects you can hold, implant, and build a company around. This piece explains what they are, how the field has evolved, and why they matter for medicine’s future. Unlike conventional materials like wood or metal, which derive their properties from their atomic structure, metamaterials derive their unique properties from their design at the microscopic or nanoscopic level. In other words, there could, in theory, be infinite kinds of metamaterials, not limited by natural resources but only by human creativity. One recent example of a metamaterial is “auxetic materials” presented by Dr. Jeong Hun Park. (See video below.) Scientists create these materials by arranging small, often repeating structures (like tiny coils or patterns) in a specific way. The precise structure allows metamaterials to manipulate waves, such as light or sound, or mechanical forces in unusual ways.

What is a brief history of metamaterials?

The prefix “meta” means beyond, and metamaterials earn the name by achieving behaviors that go beyond what any natural material can do, not through their chemistry but through the way their internal structure is arranged.

The intellectual roots run back more than a century. Early work on how waves interact with periodic structures dates to around 1904. In 1967, Soviet physicist Victor Veselago worked out the theory of a material with a negative refractive index, a substance that would bend light “the wrong way”, decades before anyone could make one. [5] Roger Walser coined the term “metamaterials” in 1999, and in the early 2000s the first practical, microwave-frequency metamaterials were finally demonstrated in the lab. [7]

What matters for medicine is what happened next. For its first two decades, the field was dominated by electromagnetic metamaterials, the stuff of optical cloaking, superlenses, and antennas. Much of the historical research related to metamaterials is rooted in microwave engineering and antenna beam shaping that emerged after World War II.[17]

Over the past several years, the center of gravity has shifted to mechanical and acoustic metamaterials, where the engineered property isn’t how a material bends light but how it bends, absorbs energy, changes shape, or transmits force. That mechanical branch is the one now reshaping biomaterials and 3D printing.[1]

View this post on Instagram

A post shared by 💡Healthcare 3D Printing💡 (@3dheals)

What are the key features of metamaterials?

Three ideas define a metamaterial:

Structure determines behavior.

In an ordinary material, properties come from its atoms and bonds. In a metamaterial, they come from a designed repeating unit. The geometry of the building block, repeated in a precise lattice, is what produces the property. Change the geometry, and you change the material, without changing the chemistry at all.

Properties that natural materials don’t have.

Classic examples include a negative refractive index (bending waves backward). In the mechanical world, metamaterials with a negative Poisson’s ratio, so-called auxetic materials, get fatter when you stretch them instead of thinner [6]. A negative index also underpins the “superlens”, an optic that could in principle resolve features smaller than the wavelength of light, long thought impossible [16]. Others can have near-zero or even negative stiffness, or absorb specific frequencies of sound or vibration.

Tunability.

Because the property lives in the geometry, it can be dialed in: stiff here, compliant there, gradient in between — across a single part. This programmability makes metamaterials so attractive for engineering the human body, where tissues vary continuously in their mechanical properties.

View this post on Instagram

A post shared by Parametric House (@parametric.3d)

What is the relationship between metamaterials and 3D Printing?

The two are deeply intertwined because a metamaterial’s magic lives in microarchitecture that is often impossible to make any other way. Building thousands of precisely shaped, interconnected unit cells, sometimes at the scale of hundreds of microns, with internal features no drill or mold could reach, is exactly what additive manufacturing does well. In practice, 3D printing is the manufacturing method that made metamaterials real, and metamaterials are one of the most compelling reasons to print rather than machine [3].

That relationship has recently gained a fourth dimension. 4D printing produces metamaterials whose geometry changes over time in response to a stimulus (heat, moisture, light, or even acoustic waves), so a flat 3D-printed sheet can fold into a stent, or a scaffold can stiffen as tissue grows into it [4]. When the printed architecture is designed to interact with living cells, researchers increasingly call these structures meta-biomaterials: architected biomaterials whose geometry itself is the functional element [3].

Metamaterials in healthcare: current applications

This is where the field is moving fastest, and it deserves the spotlight. The common thread is control: the ability to program a material’s mechanical response down to specific regions of a single part is what makes metamaterials so powerful for interfacing with the human body.

A few of the most active areas:

Orthopedic and dental implants.

Solid titanium is far stiffer than bone . Ti-6Al-4V has an elastic modulus around 110 GPa, versus roughly 10–30 GPa for cortical bone and under 2 GPa for trabecular bone [10]. That mismatch causes stress shielding: the implant carries the load the bone should, and the surrounding bone weakens and resorbs. 3D-printed lattice and auxetic metamaterials let engineers lower and tune an implant’s effective stiffness toward that of the host bone, while porous architecture invites bone ingrowth for better fixation [2]. Because the same print run can also match a patient’s individual anatomy, the promise is an implant that is simultaneously stiffness-matched, better tolerated, and less likely to fail over a lifetime of loading.

Tissue-engineering scaffolds.

Architected and auxetic scaffolds don’t just hold cells. Their geometry provides mechanical cues that steer stem-cell differentiation down bone or cartilage pathways, a field known as mechanobiology [9]. Newer work uses acoustically responsive architected biomaterials to guide chondrogenic and osteogenic differentiation, aiming at hard-to-treat conditions like osteoarthritis [12].

Biodegradable implants and scaffolds.

Metamaterial architecture also gives designers control over how a temporary implant disappears. A printed scaffold can support healing tissue and then degrade at a rate set by its geometry as much as its chemistry, so the body gradually takes over the load without a second surgery to remove hardware.

Wearable, in-vitro, and implantable devices.

Mechanical metamaterials are being designed into flexible sensors, conformal wearables, and soft implants [1] — a whole class of “mechanical metamaterials for bioengineering.”

Diagnostics and imaging.

Acoustic and electromagnetic metamaterials can sharpen sensitivity in ultrasound and other sensing modalities, enabling smaller, more precise diagnostic devices. Printed sensors built on metamaterial structures can track physiological parameters with higher sensitivity and specificity than a conventional sensor of the same size [19].

Soft surgical robotics.

Metamaterial structures give soft robots programmable flexibility and shape change, useful for minimally invasive tools that must navigate delicate anatomy [13].

View this post on Instagram

A post shared by 💡Healthcare 3D Printing💡 (@3dheals)

The frontier, and the catch

Metamaterials are a genuine new frontier in materials science, and 3D printing is the key that unlocks them. But turning a striking lattice into an approved medical device is its own challenge: a geometry-defined, load-bearing material has to prove it fatigues and performs predictably [11], batch after batch, in terms a regulator can evaluate. That is the harder, less glamorous work of turning a printed structure into a regulator-legible material system. Much of the real progress over the next few years will happen here. A second reason to get fluent in this now: the narrow palette of qualified printing materials is one of the real constraints on healthcare 3D printing, and metamaterials offer a way around it—designing the property you need rather than waiting for a material that happens to have it [15]. (See our companion piece, “Regulator-Legible Material Systems.”)

If you want to go deeper on where architected meta-biomaterials are heading, this is exactly the terrain of 3DHEALS’ “Biomaterials Frontier for 3D Printing” virtual event — where speaker Ebrahim Yarali (MERLN Institute, Maastricht University) presents his work on auxetic, acoustic-responsive architected biomaterials for skeletal regeneration [12]. Details and free registration [8]: https://3dheals.com/biomaterials-frontier/.

View this post on Instagram

A post shared by 💡Healthcare 3D Printing💡 (@3dheals)

References :

1.  Kazim, M., Pal, A., & Goswami, D. Mechanical Metamaterials for Bioengineering: In Vitro, Wearable, and Implantable Applications. Advanced Engineering Materials, 2025;27(7):2401806. https://advanced.onlinelibrary.wiley.com/doi/10.1002/adem.202401806

2.  Shirzad, M., Zolfagharian, A., Bodaghi, M., & Nam, S.Y. Auxetic metamaterials for bone-implanted medical devices: recent advances and new perspectives. European Journal of Mechanics – A/Solids, 2023;98:104905. https://www.sciencedirect.com/science/article/abs/pii/S0997753822003357

3.  Zadpoor, A.A. Meta-biomaterials. Biomaterials Science, 2020;8(1):18–38. https://pubmed.ncbi.nlm.nih.gov/31626248/

4.  Alanazi, B.N., Ahmed, H.A., Alharbi, N.S., Ebrahim, N.A.A., & Soliman, S.M.A. Exploring 4D printing of smart materials for regenerative medicine applications. RSC Advances, 2025;15(39):32155–32171. https://pmc.ncbi.nlm.nih.gov/articles/PMC12412672/

5.  Veselago, V. The electrodynamics of substances with simultaneously negative values of ε and μ. Soviet Physics Uspekhi, 1968 (orig. 1967). https://iopscience.iop.org/article/10.1070/PU1968v010n04ABEH003699

6.  Kolken, H.M.A., & Zadpoor, A.A. Auxetic mechanical metamaterials. RSC Advances, 2017;7:5111–5129. https://doi.org/10.1039/C6RA27333E

7.  Ziolkowski, R.W. Metamaterials: the early years in the USA. EPJ Applied Metamaterials, 2014. https://epjam.edp-open.org/articles/epjam/full_html/2014/01/epjam140003/epjam140003.html

8.  3DHEALS — Biomaterials Frontier for 3D Printing (virtual event, Sept 10, 2026). https://3dheals.com/biomaterials-frontier/

9.  Yarali, E., Zadpoor, A.A., Staufer, U., Accardo, A., & Mirzaali, M.J. Auxeticity as a Mechanobiological Tool to Create Meta-Biomaterials. ACS Applied Bio Materials, 2023;6(7):2562–2575. https://doi.org/10.1021/acsabm.3c00145

10.  Reimagining Orthopaedic Implants: Mechanobiochemical Innovations to Overcome Stress Shielding (review of implant–bone modulus mismatch and stress shielding). https://www.sciencedirect.com/science/article/pii/S0079642526000290

11.  Zadpoor, A.A. Mechanical performance of additively manufactured meta-biomaterials. Acta Biomaterialia, 2019;85:41–59. https://doi.org/10.1016/j.actbio.2018.12.038

12.  Ebrahim Yarali — researcher profile, MERLN Institute for Technology-Inspired Regenerative Medicine, Maastricht University. https://merlninstitute.com/discover-merln/find-a-merln-member/ebrahim-yarali

13.  Zheng, X., Jiang, Y., Mete, M., Li, J., Watanabe, I., Yamada, T., & Paik, J. Metamaterial robotics. Science Robotics, 2025;10(108):eadx1519. https://doi.org/10.1126/scirobotics.adx1519

14.  Interview with Dr. Jeong Hun Park: Auxetics for Soft Tissue Engineering. 3DHEALS. https://3dheals.com/interview-with-dr-jeong-hun-park-auxetics-for-soft-tissue-engineering/

Related Links:

Regulator-Legible Material Systems: The Real Frontier in 3D-Printed Biomaterials

3D Printing & Biofabrication For Breast Reconstruction (On Demand, 2024)

3DHEALS Biomaterials 2024 (On Demand, 2024)

Interview with Dr. Jeong Hun Park: Auxetics For Soft Tissue Engineering

Interview with Julien Payen: Lattice Medical
Interview Dr. Mohit Chhaya: BellaSeno
Interview with Esther Valliant: Bioglass for 3D Printing

The post Metamaterial and 3D Printing appeared first on 3DHeals.

This week: why the real frontier in 3D-printed biomaterials is regulatory legibility, not geometry; European neurosurgery quietly moves its printers in-house; a first-in-human 3D-printed cartilage implant; fresh calls for bioprinting standards; and titanium lattices that float. Plus our free Sept 10 Biomaterials Frontier event.

The big thing

The material is the frontier now

For a decade, 3D printing in medicine was a story about shape — patient-specific anatomy, geometries no mold could make, “complexity for free.” In 2026, the center of gravity has moved. The question that decides whether a printed part reaches a patient is no longer “what shape can we print?” but “what material can we print, and will a regulator accept it?” Call it the move toward regulator-legible material systems.

“Legible” is not a metaphor. A regulator approves evidence: documentation that a material behaves the same way every time, degrades on a predictable schedule, releases nothing harmful, and is made to a specification you can point to. For years, printed biomaterials failed that test — beautiful one-off scaffolds with no agreed test methods, batch-to-batch drift, and properties that shifted with every machine setting. Brilliant science a reviewer couldn’t sign off, and no basis for a product.

The reason they are hard to read is that, in additive manufacturing, the material and the process are inseparable. A resin cured layer-by-layer on a specific printer, wavelength, and post-cure is effectively a different material each time. So the field now talks about material systems, feedstock, validated print parameters, post-processing, sterilization, and standardized tests, all made legible through standards such as ISO/ASTM 52900, ASTM F42 and F04, ISO 10993, and ISO 13485. We walk through what each of those standards actually asks of a printed material and where the gaps still are in the full article.

This should be an investment thesis, not a chore. The moment a printed biomaterial becomes regulator-legible, it crosses from research risk to a fundable product. With the healthcare 3D-printing market projected to reach roughly $33 billion by 2031, the binding constraint could shift from the printer to the material.

That is the subject of our next event. “Biomaterials Frontier for 3D Printing,” a free 3DHEALS virtual session on September 10, 2026, convenes the people making materials legible fastest — a bioresorbable-polymer and ASTM standards leader, a human-collagen biofabrication founder, an AI materials-discovery researcher, and more.

Register free: 3dheals.com/biomaterials-frontier

Regulatory watch

• Nanochon begins first-in-human study of its 3D-printed Chondrograft knee implant — The 3D-printed cartilage implant, which holds FDA Breakthrough Device Designation, treated its first patient; it targets “pre-replacement” knees. Not a 510(k), but the week’s clearest AM-device regulatory milestone. (Sep 3)
• Advancing European standards and regulations for 3D bioprinting — A Trends in Biotechnology perspective argues that clinical and preclinical adoption of 3D bioprinting hinges on developing European standards and a regulatory pathway. Peer-reviewed. (Sep 3)

Clinical & research

• European neurosurgery survey finds 3D printing shifting in-house as implant use grows (Int. J. Bioprinting / 3D Printing Industry) — 2020-vs-2025 survey: neurosurgeon-run printing rose from 0% to ~21%, external providers fell to zero, and implant fabrication climbed from 0% to more than a quarter of departments — raising the quality and regulatory stakes as hospitals become manufacturers.
• Three-dimensional bioprinting in reconstructive plastic surgery: a comprehensive review (Cells) — Maps translational readiness tissue by tissue — skin, cartilage, bone, osteochondral, vascularized and craniofacial constructs — with bioink-selection guidance. Peer-reviewed.
• Systematic review of 3D-printed surgical devices for austere environments (Frontiers in Medical Technology) — Imperial College London and UK Defence Medical Services reviewed 15 studies and found evaluation wildly inconsistent — little standardized strength testing, sparse sterilization data, no biocompatibility testing — and propose an ISO/ASTM-aligned framework. Peer-reviewed.

From 3DHEALS

The Lattice Podcast, Ep. 125: Inside technology transfer at UCLA with Mark Wisniewski — How university tech transfer moves medical innovation from the lab bench toward a fundable product — a fitting companion to this week’s “research risk to product” theme.

Also this week

• How RMIT researchers made 3D-printed titanium float on water — Foam sealed inside the hollow struts of Ti-6Al-4V lattices makes the first buoyant metal lattice. The demo is a marine buoy, but the hollow-strut titanium-lattice method maps onto load-bearing implant design. (Sep 4)

Subscribe to The Lattice Brief

The post The material is the frontier now| The Lattice Brief (9/5/26) appeared first on 3DHeals.

For most of the past decade, the story of 3D printing in medicine was a story about shape. Patient-specific anatomy, impossible geometries, surgical guides tailored to a single body, frequently touted as “complexity for free”. The printer’s magic was that it could make forms that would be impossible or very expensive to make by mold injection. In 2026, the center of gravity has moved. The defining question is no longer “What shape can we print?” but rather “What material can we print, and will a regulator ever accept it?” That shift has a name worth adopting: the move toward regulator-legible material systems.

What “legible” actually means

A regulator does not approve a material just because it is “cool”. A regulator approves evidence, or documentation, that a material behaves the same way every time, degrades on a predictable timeline, releases nothing harmful, and can be manufactured to a specification you can point to. If a material cannot be described in those terms, it is effectively illegible to an agency like the FDA or a European notified body operating under the EU MDR. They have no framework within which to say yes. “Legibility,” then, is the property of being readable by the people who decide whether something can be used in a human body.

For years, printed biomaterials sat squarely in the illegible zone. A laboratory could print a stunning scaffold, but the material was a one-off: no agreed test methods, batch-to-batch variability, a degradation profile no one had fully characterized, and mechanical properties that shifted with every change of machine or setting. It was brilliant science that a reviewer had no way to sign off on, and just as importantly, no way for a company to build a product or an investor to underwrite a business around.

Why 3D printable biomaterials are uniquely hard to read

The core difficulty is that in additive manufacturing, the material and the process are inseparable. A conventional implant polymer arrives with a datasheet; you can reason about it in isolation. A photopolymer resin cured layer-by-layer on a specific printer, at a specific wavelength, with a specific post-cure and wash step, is a different material depending on how it was made. Residual monomer, degree of cure, layer adhesion, porosity, and even sterilization can each move the biological and mechanical outcome. The FDA’s 2017 guidance, Technical Considerations for Additive Manufactured Medical Devices, makes exactly this point: it asks manufacturers to control and document the entire workflow — design, build parameters, post-processing, cleaning, and testing, because the finished device’s safety is a function of the whole chain, not the starting resin alone.

This is why the field has begun talking about material systems rather than just materials. A material system is the full package that makes a printed biomaterial usable and clearable: the feedstock chemistry plus the validated print parameters, the post-processing and sterilization steps, and the standardized test methods that prove the finished part performs. Change one link, and you may have changed the material; the system is the unit that must be defined, controlled, and, importantly, reproduced.

The machinery of legibility: standards

Legibility is manufactured by standards. They are the shared language that turns a private lab result into something an outside reviewer can trust. Several bodies of work matter here. ISO/ASTM 52900 and the broader 52900 series provide additive manufacturing with common terminology and process definitions. ASTM Committee F42 develops additive manufacturing standards, while ASTM Committee F04 governs medical and surgical materials and devices, including the absorbable polymers at the heart of many printed scaffolds. ISO 10993 defines how the biological safety of a material is evaluated (cytotoxicity, sensitization, and the rest), and quality-system standards such as ISO 13485 wrap the whole operation in documented process control. When a new absorbable polymer gains an agreed test method through F04/F42, it crosses a threshold: it stops being “interesting research” and becomes something a regulator can read.

Legibility across the three material tracks

The push toward legibility is playing out simultaneously across the field’s three frontiers. In the soft track, function-first bioresins and degradable photopolymers, the challenge is characterizing the degradation and drug-release behavior of materials that are, by design, changing over time. In hard-track ion-releasing ceramics and bioactive glass, legibility means controlling surface chemistry and post-processing to ensure that a printed or coated implant integrates with bone predictably. In the structural track, titanium and architected lattices mean proving that a geometry-defined, load-bearing material fatigues and performs as its design promises. Each track has the same underlying task: converting a novel material into a documented, reproducible, testable system.

Why this is an investment thesis, not just a regulatory chore

The commercial consequence is the part founders and investors should internalize. The moment a class of printed biomaterial becomes regulator-legible, it crosses from research risk into a fundable, buildable product. Legibility is what lets a material become the “investment-grade core” of a device rather than a promising figure in a paper. As the healthcare 3D-printing market races toward roughly $33 billion by 2031, the binding constraint is shifting from the printer to the material and the surrounding system. The companies that win will be the ones that make their materials legible fastest.

Where this conversation is happening

These are exactly the questions on the table at 3DHEALS’ “Biomaterials Frontier for 3D Printing” virtual event (September 10, 2026), which convenes the researchers, founders, and industry leaders defining the shift — including a bioresorbable-polymer and ASTM standards leader from Poly-Med, a biofabrication founder scaling human collagen (Arrakis Bio), an AI-driven materials-discovery pioneer from Johns Hopkins, a 4D-materials founder, an architected-meta-biomaterials researcher, and a calcium-phosphate bioceramics veteran in the moderator’s chair. If the frontier of 3D-printed medicine is the move from printing structure to printing function, and from lab novelty to regulator-legible systems, then this is a session built around the people making that move real. Details and free registration: https://3dheals.com/biomaterials-frontier/.

References

1.  U.S. Food & Drug Administration. Technical Considerations for Additive Manufactured Medical Devices — Guidance for Industry and FDA Staff. December 2017. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-considerations-additive-manufactured-medical-devices

2.  ISO/ASTM 52900:2021. Additive manufacturing — General principles — Fundamentals and vocabulary. https://www.iso.org/standard/74514.html

3.  ASTM International, Committee F42 on Additive Manufacturing Technologies. https://www.astm.org/committee-f42

4.  ASTM International, Committee F04 on Medical and Surgical Materials and Devices. https://www.astm.org/committee-f04

5.  ISO 10993-1:2018. Biological evaluation of medical devices — Part 1. https://www.iso.org/standard/68936.html

6.  ISO 13485:2016. Medical devices — Quality management systems — Requirements for regulatory purposes. https://www.iso.org/standard/59752.html

7.  European Union. Regulation (EU) 2017/745 on medical devices (MDR). https://eur-lex.europa.eu/eli/reg/2017/745/oj

8.  Mordor Intelligence. Healthcare 3D Printing Market — Size, Share & Forecast (2026–2031). https://www.mordorintelligence.com/industry-reports/global-3d-printing-market-in-healthcare-industry-industry

9.  3DHEALS. Biomaterials Frontier for 3D Printing (virtual event, Sept 10, 2026). https://3dheals.com/biomaterials-frontier/

The post Regulator-Legible Material Systems: The Real Frontier in 3D-Printed Biomaterials appeared first on 3DHeals.

Innovation is a chess game. The right move can turn an idea in a university lab into a company, a breakthrough, or even a treatment for patients. On this episode of The Lattice, we sit down with Mark Alan Wisniewski, Senior Director of Biopharmaceuticals at the UCLA Technology Development Group (TDG), to explore how universities navigate the complex game of turning research into real-world impact. Mark Alan Wisniewski makes the argument that a university technology transfer office is an investment thesis, not a cost center. UCLA receives more than $1.5 billion in federal research grants to its medical school each year, generating 300 to 400 invention disclosures that TDG can patent and license. Wisniewski explains how the office converts early-stage faculty research into startups, why it writes “use it or lose it” development milestones into licenses so inventions are not shelved, and how the 1980 Bayh-Dole Act let universities own and commercialize federally funded intellectual property (IP). He cites concrete outcomes: two of the top five prostate cancer drugs, a licensed cure for ADA-SCID gene therapy from Dr. Donald Kohn’s lab, and UCLA’s $1.14 billion sale of its Xtandi royalty interest in 2016.

⚠️ Disclaimer:
This podcast is for educational and informational purposes only. The views expressed do not constitute engineering, medical, or financial advice. The technologies and procedures discussed may not be commercially available or suitable for every case. Always consult with a qualified professional.

Support our show and get premium and archived content anytime:

Subscribe to The Lattice Podcast

About Our Guest:

Mark Wisniewski is the Senior Director of Biopharmaceuticals. He is responsible for the life science and biopharma intellectual property developed at UCLA, including managing licensing and marketing staff, financial management of the portfolio and outreach to inventors and industry. His career spanned multiple roles in biotech management, entrepreneurship and product commercialization in both start-up to Fortune 100 companies. Prior to his role at UCLA TDG, Mark was the Head of Special Projects at Prolacta Bioscience, a producer of human milk nutritional products for premature infants in the neonatal intensive care unit, leading the strategic planning and business development functions. He was also a Principal Advisor to the National Institutes of Health and National Cancer Institute’s Commercialization Accelerator Programs which provides business strategy, product commercialization, fund raising and strategic partnership guidance to hundreds of early stage biotech and life science companies. Mark began his career at Baxter Healthcare where he held positions in business development, strategic planning, marketing and R&D. Mark received his MBA from the UCLA Anderson School of Management and his Masters of Immunology and Microbiology at the UCLA School of Medicine.

Key Topics

How a technology transfer office connects academic research to entrepreneurs and industry

The Bayh-Dole Act of 1980 and its impact on university innovation

UCLA’s invention pipeline, from 300 to 400 disclosures to patents, licenses, and startups

UCLA’s prostate cancer drugs and ADA-SCID gene therapy breakthrough

Mark Wisniewski’s journey from immunologist to biopharma dealmaker

Why faculty researchers often become startup founders

The role of technology transfer in patents, licensing, startup formation, and commercialization

Exclusive vs. non-exclusive licenses and how licensing terms are structured

The “use it or lose it” approach to preventing promising research from being shelved

Intentional competitive shelving and how universities respond

UCLA TDG’s proximity effect and the ingredients of a successful innovation ecosystem

Why technology transfer should be viewed as an investment thesis, not a cost center

UCLA’s $1.14 billion royalty sale and the economics of university innovation

Measuring innovation over the long term, from invention to startup to exit

Serial founders, untapped talent, and the potential for the next Amgen in Los Angeles

LABEST and the effort to build Los Angeles into a leading biotech ecosystem

From accelerator to catalyst and the future of university-driven innovation

Timestamps:

00:00:00 – Welcome And The Tech Transfer Mystery
00:00:56 – What A Tech Transfer Office Licenses
00:02:06 – Bayh-Dole And The Innovation Pivot
00:04:59 – Mark’s Chess Like Career Path
00:08:10 – Why Faculty Startups Lead Licensing
00:13:10 – Exclusive Versus Nonexclusive License Strategy
00:15:02 – Preventing IP Shelving With Diligence
00:21:40 – UCLA’s Scale Startups And Proximity Effect
00:27:00 – Tech Transfer As Long Term Investment
00:36:40 – LA BEST And Building Biotech In LA
00:39:50 – The Future Beyond “Tech Transfer”

Resources:

🔗 Contact Mark Alan Wisniewski

• Mark Alan Wisniewski, UCLA Technology Development Group
• Mark Alan Wisniewski on LinkedIn
• UCLA Technology Development Group
• UCLA Technology Development Group Staff
• LABEST
• Amir Naiberg, UCLA TDG

🔗 University Innovation, Technology Transfer & the LA Biotech Ecosystem

• UCLA Sells Royalty Rights Connected with Cancer Drug to Royalty Pharma
• LABEST 2026: Scientific Innovation and the Future
• LABEST, Los Angeles Bioscience Ecosystem Summit
• Los Angeles Bioscience Ecosystem Summit 2021
• The UCLA Research Park
• California Institute for Immunology and Immunotherapy
• Magnify Incubator at CNSI
• California NanoSystems Institute at UCLA
• UCLA Entrepreneurship Hub
• Gilead Sciences Acquires Kite Pharma for $11.9 Billion
• Amgen
• Prolacta Bioscience
• J.P. Morgan Healthcare Conference

🔗 Technology Transfer, Licensing, Commercialization

• From Bench to Bedside, ASH Clinical News
• UCLA Inks Two Research Deals Around Cancer, MS Therapeutics
• Xtandi
• The Future Is Now: Mark Wisniewski of UCLA TDG
• Authority Magazine Interview with Mark Wisniewski
• BCLA’s 10th Annual Bioscience Talent Connection
• Alliance for SoCal Innovation, Research Commercialization
• Baxter

🔗 Learn More About 3D Bioprinting from 3DHEALS!

• 3DHEALS
• 3DHEALS Ultimate Resource Center for Healthcare 3D Printing
• Bench to Bedside: Bioprinting Innovations
• 3D Bioprinting for Drug Discovery and Development
• In Silico Simulation for Medtech and Biopharma
• 3DHEALS Startup Showcase
• The Fabrication of Microfluidics, 3D Cell Culture & Organ-on-a-Chip
• An Introduction to 3D Bioprinting

The post Episode 125: Inside Technology Transfer At UCLA With Mark Wisniewski appeared first on 3DHeals.

This week: why clearing the FDA is not the same as getting paid for a 3D-printed stent, a world-first metamaterial bone prosthesis out of Madrid, fresh bioprinting and bone-repair research, and 3DHEALS’s Biomaterials Frontier event on September 10.

The big thing

A better 3D-printed stent is the easy part. Getting paid is the hard part.

New York University’s newest stent, BRIDGE, is a good device. It is 3D-printed and biodegradable, built to drain gastric leaks after weight-loss surgery. Its lattice drains about twice as much, bends far tighter without kinking, then dissolves with no removal endoscopy. So, if I am the patient, this is a better device. In US medical devices, being “better” is just the price of admission, not the payout. As our recent piece focusing on reimbursement puts it, better isn’t billable. Entrepreneurs beware.

Start with who gets paid. Medicare pays for the procedure, not the stent. A better bundled supply inherits the price of the thing it replaces. Endoscopic leak drainage doesn’t even have a billing code that fits, with cases falling back on a pseudocyst code or an “unlisted” one. A 3D-printed stent adds “nothing extra” just for being better. Furthermore, a stent that dissolves removes the retrieval endoscopy that a doctor currently bills. So, the first buyers are integrated, bundled-payment systems that keep the savings, and not fee-for-service proceduralists. Healthcare economics in America is complicated. A regular mental exercise on reimbursement early in a device’s life cycle could protect innovators and investors from future heartaches. Similar evaluation will be equally important to a device’s viability in other global markets, depending on the target patient population. With a trend toward point-of-care 3D printing in healthcare systems, in-house production of small batches of innovative devices could be economically viable. Read our case study on this and let us know what you think.

One hero of this story we did not talk much about is the biodegradable feature of this drainage stent. The combination of 3D printing design plus a stereolithography-printable biodegradable resin made the stent a differentiated device with a defensible “moat.” However, this moat also carries the most risk. Acidity, degradation profile, mechanical properties, softness versus hardness, immunogenicity, and thrombogenicity are all intricately related to the materials science within a new device. The industry learned that the hard way with Abbott’s Absorb bioresorbable coronary stent, which was withdrawn in 2017 after safety signals. Granted, something in the heart carries higher risk than in the gut. Ultimately though, what earns payment and what earns trust are the same thing: good outcomes across real patients.

That said, we will highlight the exciting advancements made in 3D printable biomaterials in 3DHEALS’s next virtual event, Biomaterials Frontier, on September 10. This world-class panel covers topics not just on bioabsorbable materials and relevant applications (like breast implants for lumpectomy), but also metamaterials for orthopedic implants, human collagen produced in bioreactors for bioprinting, ML/AI for new biomaterial development, and more.

Regulatory watch

No new FDA 510(k) clearances for additive-manufactured devices this week.

Clinical & research

• A 3D-Printed Microvascular Surgery Training Platform With High-Fidelity, Biomimetic Properties (Small (PubMed)) — A UC San Diego group prints suturable, patient-specific vascular grafts with a machine-learning-tuned bioink. The near-term use is low-cost microsurgery training; the longer game is personalized vascular repair.
• Extrusion bioprinting of FibMA-fibrin semi-IPN hydrogel filaments for enhanced skeletal muscle cell alignment (Biofabrication (PubMed)) — A fibrin-based bioink prints muscle-cell filaments that align on their own, with no sacrificial polymer and no second gelation bath. A step toward printable, functional skeletal muscle.
• Instrumentalized 3D printed scaffolds enable bone regeneration and fracture healing monitoring in critical size bone defects (APL Bioengineering (PubMed)) — 3D-printed bone scaffolds with built-in sensors both heal critical-size defects and report on the healing. Dynamization improved union in the animal model.

Also this week

• Gregorio Marañón Hospital Implants World’s First Personalized Metamaterial Bone Prosthesis (AdvancedManufacturing.org / SME) — A Madrid hospital designed it, printed it in titanium in-house, and implanted what it calls the first personalized metamaterial bone prosthesis, saving a sarcoma patient’s leg.
• 3D-Printed Expandable Wedge Spacer Shows Promise for Atlantoaxial Reduction (3D Printing in Medicine) — An expandable titanium spacer cut the force needed to realign the C1-C2 vertebrae by about 70% in a patient-specific test model. Preclinical.
• 4D Printed Implants Could Make Tissue Reconstruction Less Painful (3DPrint.com (Mass General Brigham / UW-Madison)) — A 4D-printed hydrogel expander swells over weeks on its own, aiming to retire the saline-injection balloon used in breast reconstruction.
• Team effort puts 3D anatomy models in the hands of health care students (Yakima Herald-Republic) — Two Washington universities make low-cost, markable anatomy models to widen access for health-training programs.
• Why Silicone 3D printing still struggles to find its place in healthcare (3D ADEPT) — A clear-eyed read on why a well-suited material still lags in healthcare: thermoset chemistry, Class III hurdles, and no process standard.
• Materialise Reports Second Quarter and Half-Year 2026 Results (Business Wire) — Q2 revenue EUR 70.1M, up 8.1%; the Materialise Medical segment grew 12.2%, and the company raised full-year operating-profit guidance.
• Hike Medical Raises $22.5 Million As AI and 3D Printing Platform Targets $100 Billion Medical Device Market (Pulse 2.0) — An AI-plus-printing platform for orthotics, prosthetics, and durable medical equipment raised $22.5M. The delivery-time and remake-rate gains are the company’s own figures.
• AI-Driven Bioprinting Emerges as a High-Conviction Investment Theme as Corporate AI Spending Surpasses $252 Billion (BCC Research) — A market-research firm frames AI plus bioprinting as an investment category. Positioning, not primary research.
• HeyGears G1 Passes $14M on Kickstarter with Full-Color 3D Printing (3DPrint.com) — Off-beat: a consumer full-color desktop printer from a dental-roots company. Not a medical device, but a marker on where printing hardware is going.
• NASA-backed research makes 3D printed cookie out of plastic waste (VoxelMatters) — Off-beat: engineered yeast turns PET waste into edible protein for a NASA Deep Space Food Challenge project. Food and space, not healthcare.

From 3DHEALS

• Better isn’t billable: how a new 3D-printed medical device actually gets reimbursed — Jenny Chen, M.D. walks through why a better, cleared device still may not get paid, using the BRIDGE stent as the worked example.
• Biomaterials Frontier (virtual event, September 10) — A panel on bioabsorbables, metamaterials for orthopedic implants, bioreactor-grown collagen for bioprinting, and ML/AI for new biomaterials.
• The Lattice Podcast, Ep. 121: Absorbable biomaterials with Dr. Rao Bezwada — The chemistry of absorbable polymers: degradation, strength, and why timing decides safety.
• Guide: 3D-printed stents — The 2023 primer on stents beyond the artery: airways, gut, biliary, and ureteral tubes.

Subscribe to The Lattice Brief

The post Getting paid is the hard part | The Lattice Brief (8/30/26): appeared first on 3DHeals.

A biodegradable, 3D-printed pigtail stent for gastric leaks can be a valuable teaching tool for medical 3D-printed device entrepreneurs. This mental exercise with a recent novel design shows the reimbursement logic every device team should learn before they fall too deep in love with their own inventions. Medical device reimbursement in the United States often rewards factors other than clinical performance. A recent preprint makes the gap easy to see. It describes BRIDGE, a 3D-printed, biodegradable double-pigtail stent for draining gastric leaks after sleeve gastrectomy. The design is clever. Its lattice mid-section is built from a triply periodic minimal surface (TPMS). It bends around a radius that is roughly seven times tighter than that of a commercial biliary stent, without kinking. It drains about twice the fluid. And because it is printed from a biodegradable resin, it is designed to dissolve on its own rather than be removed during a second endoscopy.¹

So it is better.

However, the question that decides whether it becomes a product is a different one. What gets paid, and to whom? In the United States, clinical superiority and payment are only loosely related. The space between them is where most device companies get their education. An endoscopic leak drain is a good place to learn the lesson. Here are some of the steps to reason it out.

What the procedure pays today

Start with the problem the device treats, because the money follows the problem. Gastric leak occurs in 1% to 3% of primary sleeve gastrectomies and as many as 10% of revisions. It is the complication surgeons fear most. It turns a routine bariatric case into weeks of drainage, repeat procedures, and sometimes an intensive-care stay. The mainstay treatment is endoscopic internal drainage with double-pigtail stents. It closes most leaks. And it does so with stents designed for the bile duct and pressed into service off-label because nothing better is available.¹

Here is the first thing to absorb. Medicare pays the physician for the procedure, not for the stent.

And the procedure it covers depends on how the pigtail is placed. If an interventional radiologist places it through the skin into the collection, the claim is a percutaneous drainage code with its own predictable payment. If an endoscopist deploys it transluminally across the leak, the claim is coded as an upper-GI endoscopy code. That is the route BRIDGE is built for, and the coding gets murkier. The closest listed option, 43240, is written for draining a pseudocyst.² A post-surgical leak is not a pseudocyst. So many of these cases land on 43499, the “unlisted” upper-GI code a payer reviews and prices by hand.³ That invites delay and denial.

Either way, the stent itself is a supply. Its cost is buried inside the facility payment for the procedure. That is an outpatient APC. Or, for the septic inpatients, most of these are DRGs. A percutaneous drain runs a hospital somewhere between $28 and $55 apiece.⁶ A fancier printed device might cost more to make. But the hospital’s payment does not move to cover it. Build a better version of a bundled supply, and it inherits the price of the thing it replaced.

(See Glossary section for all abbreviations.)

What actually changes the payment

If a superior device does not automatically earn more, what does? Three things, from the flimsiest to the most durable.

The first is a temporary top-up.

Medicare will pay a little extra for a while. Outpatient, this comes through pass-through. Inpatient, it comes through the New Technology Add-on Payment (NTAP). The price of entry is the same for both. The device has to be new. It has to be expensive enough that the existing bundle can’t absorb it. And the hard part is that it has to be a substantial clinical improvement over what’s already in use.⁴ There is a gate hidden inside the word “new.” CMS also asks whether the device is already adequately described by an existing payment category. This is where a genuinely new design earns its keep. A better plastic pigtail looks like every other pigtail and gets waved into the bundle, but a device that dissolves in the body is harder to call the same thing you already pay for. Even after clearing the bar, the money is just temporary. Pass-through runs up to three years. Then the device drops back into the bundle.⁵

The second is a dedicated device code. A new CPT code is the more durable move. But it follows a new service, not a better instrument. That is the quiet opportunity here. Endoscopic internal drainage of a leak has no code that actually fits it. That is why the field is stuck between a pseudocyst analogy and an unlisted code. A device built specifically for the procedure gives the device maker something to hang a Category III code on. That is the emerging-technology tier. It records that the procedure is happening. With utilization and outcomes data behind it, that code can grow into a paying Category I code. The process is slow, measured in years. Like it or not, it will help the competitors too. It is the only lever that fixes billing for the whole field rather than renting a payment for one product.

The third isn’t a billing lever. For a device like this, it is often the one that matters most. A leak admission is expensive and long. Under a fixed DRG, the hospital swallows every extra day and every repeat scope. A device that empties the cavity faster, keeps the patient off a second or third procedure, or shortens the septic stay puts real money back in the hospital’s pocket. No code change required, but value is added. This lever sells on a spreadsheet the hospital keeps.

Which features carry weight

Sorting BRIDGE’s advantages against the clinical-improvement test is a useful exercise, but it doesn’t weigh them equally.

Biodegradability can be a strong one. Today, a patient undergoes roughly three endoscopies over about eight weeks. A stent designed to dissolve in six to eight weeks eliminates the need for a retrieval trip entirely.1 “One fewer procedure per patient” is a true improvement, and it is easy to measure.

That said, there is a potential wrinkle to the economics. The retrieval the new device deletes is a procedure the endoscopist currently bills. Innovation improves the system’s economics, partly by reducing a provider’s revenue. That is exactly why early adopters will be integrated systems and bundled-payment programs, not fee-for-service proceduralists. (Remember what Charlie Munger’s theory behind “incentives” is.) Less migration comes next. Every stent that stays put is a retrieval, and a failed-drainage rescue that the hospital doesn’t have to do. Better flow and easier placement are real but soft. “Easier for the endoscopist” isn’t something Medicare rewards unless it results in a shorter procedure or fewer complications that can be easily measured.

There is a catch a reviewer will find first and can sink the thesis. Once a device can’t be removed, its degradation timing is its safety profile. Dissolve too early, and it fails while the leak is still open. Linger too long, and it becomes the source of granulation, obstruction, or a fragment that drifts somewhere you can no longer reach it. So the elegant “no removal” story and the “less migration” story have to be proven together. The evidence that carries weight is the degradation curve’s reliability. Not just its average, but how much it varies across real patients. That is where the clinical dollars go. It is also where a printed polymer either earns trust or loses it. The industry has learned expensive lessons on resorbable stents very recently. 8

The 3D printing angle

The 3D printing that enables the lattice and patient-specific fit does not qualify for a reimbursement category. Nobody pays more because a device was printed. What changes with 3D printing is the regulatory road. A biodegradable, architected, possibly patient-matched implant probably won’t slide through on a 510(k) predicate. It is more likely to face a de novo or PMA review. That costs time and money. And, awkwardly, it also strengthens the payment case. Devices that clear the more rigorous regulatory pathways have historically fared better when they request a separate payment from CMS. The higher bar and the better lane turn out to be the same door.

Conclusion

For a device like this, here are some potential strategies to think about. Sell to hospitals on avoided cost now, while collecting the migration, reintervention, and length-of-stay numbers. Take those numbers into a pass-through or add-on application next. Aim at a moving target. CMS has proposed requiring even breakthrough-designated devices to demonstrate substantial clinical improvement again, starting with 2028 applications.7. Finally, go earn a real code. It is the only step that changes billing for good rather than borrowing it.

The lesson under all of it: better is the price of admission, not the final payout. In US device reimbursement, the money follows evidence of a difference a patient and a payer can both feel.

Which lever is your particular improvement actually pulling?

This piece is an educational illustration of US reimbursement concepts for new medical devices, not legal, coding, or reimbursement advice. Codes, rates, and CMS policies change; confirm current figures against primary CMS sources before relying on them.

Glossary

• 510(k) FDA clearance route for a device shown to be substantially equivalent to an existing (predicate) device. The fastest, lowest-burden pathway.
• Additive manufacturing / 3D printing: Building a part layer by layer. Enables lattice geometries and patient-specific shapes that extrusion can’t produce.
• APC (Ambulatory Payment Classification): The bundled unit Medicare uses to pay hospitals for outpatient procedures. Devices used are packaged into it.
• Bundled supply: A device whose cost sits inside a broader procedure payment instead of being reimbursed on its own.
• Category I / Category III CPT codes: Category I codes are established procedure codes with set payments. Category III codes are temporary for emerging services that track usage before potentially becoming Category I.
• CMS (Centers for Medicare & Medicaid Services): The federal agency that sets Medicare payment rules and rates.
• CPT (Current Procedural Terminology): The AMA code set that identifies procedures for billing. The code, not the device, usually drives payment.
• De novo FDA: pathway for novel low-to-moderate-risk devices with no predicate, creating a new device classification.
• DPS (double-pigtail stent): A drainage stent with curled ends that anchor it. Used off-label for endoscopic internal drainage of leaks.
• DRG (Diagnosis-Related Group): The bundled unit for an inpatient stay. The hospital receives a fixed amount regardless of individual supply costs.
• EGD (esophagogastroduodenoscopy): Upper-GI endoscopy. The procedure family under which transluminal leak drainage is coded.
• EID (endoscopic internal drainage): Placing a pigtail across a leak so one end sits in the cavity and the other in the GI lumen, draining internally.
• FDA (Food and Drug Administration): The agency that authorizes devices for marketing. Clearance is separate from payment.
• HCPCS Level II (C-code): Codes that can identify a specific device for tracking or pass-through. They do not by themselves add payment.
• NTAP (New Technology Add-on Payment): A temporary inpatient add-on above the DRG for qualifying new technologies.
• Pass-through (Transitional Pass-Through, TPT): A temporary outpatient add-on (up to three years) for qualifying new devices before they are folded into the APC.
• PMA (Premarket Approval): The most rigorous FDA pathway for high-risk devices. Requires clinical evidence of safety and effectiveness.
• SCI (substantial clinical improvement): The CMS test asking whether a technology meaningfully improves diagnosis or treatment over existing options. The gate for add-on payments.
• TPMS (triply periodic minimal surface): A class of mathematically defined lattice geometries (for example, the Gyroid) used here to tune a stent’s flexibility and flow.

References

1. Phowarasoontorn P, Ko Y, Makhambetova Z, et al. Biodegradable Architected Stents for Endoscopic Internal Drainage. bioRxiv; posted May 12, 2026. doi:10.64898/2026.05.08.723751. Preprint. Not peer reviewed.
2. American Society for Gastrointestinal Endoscopy / American Medical Association. CPT code 43240: Esophagogastroduodenoscopy, flexible, transoral; with transmural drainage of pseudocyst (includes placement of transmural drainage catheter[s]/stent[s], when performed, and endoscopic ultrasound, when performed). ASGE EGD Coding Sheet. asge.org
3. American Gastroenterological Association. Coding Corner (Clinical Gastroenterology and Hepatology): where no specific CPT code exists for an endoscopic procedure, report the unlisted code 43499 and verify coverage with the carrier in advance. cghjournal.org
4. Centers for Medicare & Medicaid Services. New Medical Services and New Technologies (NTAP eligibility: new, costly, and a substantial clinical improvement over existing technologies). cms.gov
5. Gettysburg Healthcare Consulting. Medicare Transitional Pass-Through Payment (criteria; up to three-year duration before bundling). policypros.net
6. IndexBox. Percutaneous Drainage Catheters Price in the United States, Market Insights (2026). indexbox.io
7. Kelly S. CMS proposes repeal of add-on payment path for breakthrough devices. Healthcare Dive / MedTech Dive; April 17, 2026. healthcaredive.com
8. https://www.tctmd.com/news/fda-warns-risk-major-adverse-cardiac-events-absorb-bvs

The post Better Isn’t Billable: How a New (3D-Printed) Medical Device Actually Gets Reimbursed appeared first on 3DHeals.