This week: China’s additive manufacturing build-out and what it means for medicine, a France-licensed supply chain for 3D-printed drugs, an FDA call for new evidence pathways, a randomized trial for 3D-printed surgical simulators, two bioprinting papers, and the rest of the week in healthcare 3D printing.

The big thing

China is printing more of everything. Is that a problem?

Addireen’s new Ganzhou plant can build up to 50 metal printers a month. Eplus3D’s Beijing factory is sized for 300+ large metal systems a year. China exported 2.46 million consumer printers in four months, up 44.7%.

Medicine is following. China’s share of PubMed papers on 3D printing and bioprinting has climbed to 28% over the past decade, while the US share fell to 17%. China registered 199 printed devices by late 2024, ten times the 2020 count; the US had cleared 357+ by 2023. Chinese hospitals now publish bigger series, like a 224-patient anatomic cage study last month.

Is it all subsidy? Partly. Beijing has favored domestic machines and powders since 2018. But procurement lists do not sell millions of printers to consumers who can choose.

Intellectual property is the constant worry. A Texas jury awarded Stratasys about $27.6M against Bambu Lab, which will appeal. Millions of printers shipped while the case ran.

So is it a problem? Cheap hardware helps buyers. The risk is that the learning curve follows the volume. The West’s defensible layer is high-value applications, qualified workflows, outcomes data and talent. Tell us what you think. Read the full analysis.

Regulatory watch

• FDA seeks new regulatory science framework for innovative tech (Medical Design & Outsourcing, Sept 25). FDA’s device center wants input on evidence pathways for autonomous AI, generative AI and implants that grow with the patient. Comments close Nov 24 (docket FDA-2026-N-8563).
• MB Therapeutics cleared to manufacture cartridges for 3D printed drugs (3D ADEPT, Oct 1). France’s medicines regulator (ANSM) licensed a GMP site for drug cartridges that hospital-pharmacy printers turn into personalized doses. Printed drugs now have a regulated upstream supplier; Finland’s CurifyLabs runs a different model.
• Xenix Medical clears NanoACTIV surface for its Riva screws (Business Wire, Sept 30). A 510(k) extends a surface first cleared on Xenix’s printed titanium implants to machined screws. Not a printed-device clearance; we found no new 510(k) for an additively manufactured device this week.

Clinical & research

• Skill transfer from 3D-printed temporal bone training to cadaveric mastoidectomy: a randomized controlled trial (Otology & Neurotology). Thirty novice ENT residents in Sao Paulo. Two hours on a printed temporal bone raised blinded cadaver scores by 4.2 points. Small and single-center, but randomized evidence for printed simulators is rare.
• Airflow controlled droplet bioprinting enables high-throughput generation of iPSC-derived thymic organoids (Biofabrication). Pittsburgh swapped manual encapsulation for air-jet droplet printing: about 21,500 aggregates per mL, and functional T cells in mice. A manufacturing paper as much as a biology paper.
• 3D bioprinted human vascular organoid sheets promote functional ischemic repair (BMC Medicine). Tsinghua’s printed vessel sheets joined the host circulation and improved limb salvage in mice. Single-cell data show grafted cells remodel heavily after implantation.

Also this week

Business & manufacturing

• Healthcare growth reshapes 3D Systems’ $94.6M quarter (3D Printing Industry). Revenue was flat; healthcare grew 6.9% to $48.1M and is now about half of sales.
• Tenon Medical moves its 3D-printed SI joint screw to full launch (Ortho Spine News). The printed titanium lateral screw brought in about $1.2M during its alpha launch.
• Addireen opens Ganzhou facility for up to 50 metal AM systems a month (3D Printing Industry). Green-laser printers for pure copper parts such as AI-server cold plates.
• Carbon’s dual-cure patent survives appeal in Europe (TCT Magazine). Worth watching for resin suppliers selling into European dental labs.
• DiFusion to define a therapeutic biomaterials category at NASS 2026 (GlobeNewswire). Positioning for its ZFUZE spine material, which can be printed from filament. Company messaging, no new data.
• The speed paradox in 3D printing (Engineering.com). A Boston job shop says AI routing cut order-to-print time from four minutes to two or three.
• Meshy 7 review: how can humans keep up? (VoxelMatters). AI image-to-3D is good for concepts and decorative prints, not device-grade CAD.
• OSU adds in-situ sensing to a multi-head composite printer (3D Printing Industry). NSF-funded fiber-plus-polymer printing with machine-learning quality checks. No medical use yet.

Devices, materials & models

• Vital3D and Cleveland Clinic partner on patient-specific brain stents (NeuroNews International). A license to develop printed Y-stents for bifurcation aneurysms at about 1-micron resolution. Early stage.
• MIT and Johns Hopkins build a 3D-printed living cell collection device (VoxelMatters). Fluid shear lifts viable cells from tissue without enzymes, tested on fallopian tube samples.
• MIT develops bioresorbable batteries for ingestible devices (Medical Design & Outsourcing). A 1.84 V magnesium battery that dissolves; it powered stimulation for three days in animals. Not printed.
• 3D printing enables custom rubber gloves in smaller batches (Medical Xpress). Cranfield sprays and cures natural rubber in place, making small runs of fitted gloves viable.
• Building a beating heart: how 3D bioprinting is changing cardiac medicine (MD+DI). Minnesota’s Brenda Ogle: drug testing comes first; thickness and integration block therapy.
• ATCC wins $8.3M for organ-on-chip and organoid models (GlobeNewswire). NIAID and FDA contracts, a funding signal after FDA’s nonclinical-testing rule.

Community

• University of Nottingham brings 3D printing to hospital schools (TCT Magazine). Printers and training for 25 schools serving children with long hospital stays.

From 3DHEALS

• Episode #129: Medical 3D printing adoption in the EU with Naomi Nathan. The head of healthcare at Mobility Goes Additive on why hospital successes stall before system-wide adoption: reimbursement, evidence and Europe’s fragmented health systems.
• Next-Gen 3D Printed Orthotics and Prosthetics (Oct 15, virtual)

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The post China Is Printing More of Everything | The Lattice Brief (10/4/26) appeared first on 3DHeals.

In 2026, China is turning 3D printing, or additive manufacturing, into a mass-production industry. A new Ganzhou plant can build up to 50 metal printers a month, and Chinese makers exported 2.46 million consumer printers in the first four months of the year. The shift is now reaching medical 3D printing.

The scale of China’s build-out

This week Shenzhen-based Addireen opened a plant in Ganzhou that can build up to 50 metal printers a month. A week earlier, Eplus3D finished a Beijing factory sized for more than 300 large metal systems a year. China shipped 2.46 million consumer printers abroad in the first four months of 2026, up 44.7%. Metal leader BLT grew revenue about 40% last year, per company figures compiled by Tianxia Gongchang.

Now the West. 3D Systems posted a flat $94.6M quarter. (Healthcare, up 6.9%, carried it.) Stratasys won a patent case against Bambu Lab in court, but no sales ban followed.

Where it reaches medicine

Based on our internal research focusing on keywords related to “3D printing”, “additive manufacturing”, and “bioprinting”, the number of publications in PubMed has also grown significantly from China in the last 10 years (see graph below). The percentage share of articles published has steadily increased to 28%. Surprisingly, the percentage share of US publications has been declining to 17%. One could argue that the quality of the Chinese studies might not meet certain academic standards, and I agree with that skepticism especially given high retraction rate. However, these are numbers and trends to keep an eye on.  

Across the United States, the European Union, and China, the volume of academic medical device research, including hardware, diagnostic hardware, implants, and digital health software successfully reaching commercial channels reveals a steep translation funnel restricted by high capital demands and heavy engineering-to-clinical validation hurdles. In the United States, robust private venture networks and experienced technology transfer ecosystems drive an estimated 10% to 15% of university medical device disclosures to achieve commercial licensing or startup spin-out formation, although fewer than 15% of those entities successfully navigate the multi-tier testing and production scaling needed to achieve final market clearance. The European Union sees a lower medtech translation efficiency, with an estimated 4% to 8% of formal disclosures transitioning into commercial vehicles. While European universities excel in foundational bio-engineering and precision mechanics, early-stage spin-outs frequently hit funding gaps when attempting to navigate the complex pathways to secure a market entry mark, resulting in widespread early acquisitions by multi-national corporations rather than independent scaling. Meanwhile, China has accelerated its medical device and industrial engineering commercialization rate to an estimated 12% to 18%, fueled by an aggressive national pivot toward local manufacturing and high-end hospital hardware independence.

The underlying mechanics of this regional translation are dictated by highly distinct public policies that determine how medical technology is funded and regulated across its lifecycle. In the United States, the Bayh-Dole Act enables academic institutions to securely own and license federally funded intellectual property, creating a decentralized framework where universities work closely with private venture funds. We discussed this topic with UCLA Technology Transfer Office Mark Wisnieski in a recent episode.

However, hardware startups must carefully manage recent policy updates like the CMS substantial clinical improvement mandates, which place strict clinical evidence burdens on breakthrough medical devices seeking public insurance reimbursement. In Europe, the historic emphasis on academic publication metrics over technology transfer has been exacerbated by the structural rollout of the European Medical Device Regulation (MDR), whose increased compliance costs, data requirements, and notified body bottlenecks have significantly delayed spin-out timelines. Conversely, China’s state-directed model bypasses these traditional translation bottlenecks through centralized State Council patent conversion utilization plans and matching grants. These strict policies actively audit and penalize underutilized academic patents, forcing universities to liquidate dormant hardware property directly into industry partnerships while deploying fast-tracked domestic regulatory pathways to prioritize the manufacturing of homegrown medical machinery.

These are manifesting in the medical 3D printing market in these regions, though the data is currently spotty. The US has clearly had a head start in clearing 3D printed medical devices, with 357+ cleared by 2023 and 1900% increase between 2010-2022. Assuming the same rate of growth, cumulative 510(k) cleared devices could reach 1000+ this year. In comparison, according to the same Tianxia data, China had 199 registered 3D-printed medical devices by late 2024, about ten times the 2020 count. It certainly would be worthwhile to closely monitor more granular data from both regulatory bodies moving forward.

Large clinical series are now showing up from Chinese hospitals, like a 224-patient anatomic cage study in late September. That fits the wider trial environment. One 2025 analysis counted 16,612 registered trials in China in 2023 against 9,100 in the US, though that covers every trial type, not just devices, and Chinese registry data is less standardized. Volume follows patient concentration: a US investigator described a Shanghai hospital enrolling 240 patients in two months, a pace he said would take years in the US. Earlier published series on printed cages in this area were small, such as retrospective cohorts of 56 and 60 patients, so a multicenter comparison of 224 is a step up in scale. The regulatory split reinforces the gap. China often requires China-specific trial data for high-risk devices, while FDA accepts foreign data that meets its standards, and most printed spine cages in the US reached the market through 510(k), where only a minority of submissions include clinical data. That is consistent with the publication share above: Chinese hospitals are producing more of the clinical evidence, while the US pathway has not required it. Whether that evidence is rigorous enough, and whether FDA or payers will accept it, is still open.

State support or market logic?

The question underneath all of this: is China’s additive manufacturing (AM) success entirely state support, or is there a real market logic? The state case is strong. A 2017 action plan promised more fiscal support and a revenue target, and since 2018 Beijing has prioritized domestic purchases of machines and powders, per Metal AM. Tianxia Gongchang’s 2026 report lists priority procurement and tax credits of 8–10%. A US congressional commission’s review of Made in China 2025 found that the technologies meeting most targets combined long-term state support, integrated supply chains and scale.

But subsidies do not explain everything. A procurement list cannot account for 2.46 million printers sold abroad in four months, and Bambu Lab, founded in 2020 and backed by IDG Capital, sells to consumers who are free to choose. BLT and Farsoon grew revenue about 40% and 45% in 2025. At TCT Asia in Shanghai, 3DPrint.com reported that exhibitors had stopped selling lasers and build volume and started selling workflow, uptime and use cases.

State support also has gaps: Metal AM noted that lasers and scanners for high-end metal machines were still bought from IPG (US) and Scanlab (Germany). Even in consumer printing, one recent article credits both Chinese policy support and Bambu Lab for the surge in filament demand, without saying how much each contributed. Policy helped create the first buyers and lowered the risk, then the market did the rest, with metal 3D printers probably leaning more on policy and consumer 3D printers on markets. Either way, Chinese metal and consumer printers are steadily gaining ground on Western incumbents.

The constant worry: intellectual property

On Sept. 18 a Texas jury found that Bambu Lab infringed four Stratasys patents and awarded about $27.6M in past damages. Bambu disputes the verdict and plans to appeal, no injunction has been announced, and a Hague court declined in April to block its H2C in Europe, so this is one case, not a verdict on an industry. The clock keeps on running: Stratasys sued in August 2024, and Chinese makers exported millions of consumer printers while the case ran. Courts can protect an inventor, but they move slower than a competitor that scales. The system sometimes works: the European Patent Office upheld Carbon’s dual-cure resin patent on Sept. 24, though that fight did not involve China.

The AI race meets the factory floor

While artificial intelligence remains a central focus of US-China relations, broader technological competition and cooperation are also reshaping the AM industries in both nations. The AI boom is actively influencing the AM sector; for instance, Addireen’s Ganzhou plant focuses on producing pure copper parts like AI-server cold plates, directly generating new demand for printed hardware.

At the shop-floor level, a recent Engineering.com interview highlights how local manufacturers are adapting. Roman Arkhangelskiy, founder of the Boston-area job shop Upside Parts, explains that AI-driven intake and routing have accelerated order-to-print startup times from four minutes down to two or three. Arkhangelskiy notes that his business was established to outperform the three-week turnaround times once common among Chinese suppliers two years ago, warning that the efficiency gap between nations will only widen unless US manufacturing adopts more AI and robotics.

A positive precedent: Meshy

Meshy is perhaps a case for an optimistic read. Founder Yuanming Hu came through Tsinghua and MIT and wrote the open-source Taichi graphics library. The company has roots in both Beijing and Silicon Valley, recently raised about $400M in July at a reported $1.5B valuation and with both Bambu Lab and Creality as customers. One team, two ecosystems, one tool used on both sides of the Pacific. That is the race compounding instead of splitting, and it is the kind of outcome worth protecting.

So, is it a problem?

Depends on whom you ask. Cheap, fast, high-quality hardware is mostly good news for the consumers and hospitals that buy it. The risk sits elsewhere. When machines, materials and clinical volume all scale in one country, the learning curve moves with them. A cleared device is a snapshot. The know-how to make the next one lives with whoever prints the most parts.

The defensible layer for US and European players should not be just the hardware. It is perhaps even more important to focus more on high-value applications, qualified workflows, outcomes data, talent pools, and innovation ecosystems.

A better question we should ask is whether we are investing strategically or still just competing on selling printers.

References

1. 3D Printing Industry. “Addireen opens Ganzhou facility with capacity for up to 50 metal AM systems per month.” Sept. 30, 2026.
2. 3DPrinting Journal. “China Watch #9: PLA makers hit stock market records as 3D printing drives demand, while Eplus3D opens Beijing factory for 300+ large metal printers a year.” Sept. 2026.
3. 3DPrint.com. “AM Asia Watch: China exported 2.46 million 3D printers in four months.” June 11, 2026.
4. Tianxia Gongchang Research. “2026 China Additive Manufacturing and 3D Printing: Market Scale, Competitive Landscape & 5-Year Outlook.” 2026. Accessed Oct. 4, 2026.
5. 3D Printing Industry. “Healthcare Growth Reshapes 3D Systems’ $94.6M Quarter.” Oct. 1, 2026.
6. TCT Magazine. “Stratasys awarded $27.6M in damages in first of two patent infringement cases against Bambu Lab.” Sept. 18, 2026.
7. The Lattice Brief. “PubMed publication share of China and US papers on 3D printing, additive manufacturing and bioprinting (internal analysis, ten-year trend).” 2026.
8. C&EN. “How China seeks to solve its quality control conundrum.” Sept. 2025.
9. 3DHEALS (The Lattice Podcast). “Episode 125: Inside Technology Transfer at UCLA with Mark Wisniewski.” Accessed Oct. 4, 2026.
10. BONEZONE (Dan Cook). “Top Trends in Additive Manufacturing for FDA-cleared Orthopedic Devices.” Sept. 29, 2023.
11. Operative Neurosurgery. “Lateral Mass Fusion Using 3D-Printed Anatomic Cages for Atlantoaxial Dislocation: A Multicenter Comparison With Iliac Crest Autograft.” Sept. 2026.
12. PubMed. “Efficacy of a Lateral Mass Fusion Device Combined with a Three-Dimensional-Printed Model in the Treatment of Craniovertebral Junction Abnormalities.” 2021.
13. Journal of Neurosurgery: Spine. “Comparison of outcomes between 3D-printed porous titanium alloy and polyetheretherketone cages for atlantoaxial intra-articular fusion in craniovertebral malformations.” 2025.
14. MedFlux. “China NMPA Medical Device Registration: NMPA vs FDA Guide (2026).” 2026. Accessed Oct. 4, 2026.
15. Emergent CRO. “Medical Device Clinical Trials: Comprehensive FAQ and Guide.” Accessed Oct. 4, 2026.
16. 3D Printing Industry. “China state Action Plan aims to make 3D printing worth $3 billion by 2020.” 2017.
17. Metal AM. “An inside perspective on China’s thriving metal additive manufacturing industry.” Accessed Oct. 4, 2026.
18. US-China Economic and Security Review Commission. “Made in China 2025: Evaluating China’s Performance.” Nov. 14, 2025.
19. Wikipedia. “Bambu Lab.” Accessed Oct. 4, 2026.
20. 3DPrint.com. “At TCT Asia 2026, China’s AM Industry Looked Ready for Scale: Part 1.” 2026. Accessed Oct. 4, 2026.
21. 3D Printing Industry. “New Update in Stratasys v Bambu Lab Patent Infringement Action: Stratasys Awarded $27.6 Million in Damages, Bambu Lab Disputes.” Sept. 2026.
22. TCT Magazine. “Foundational Carbon dual-cure patent survives challenge from competitor in Europe after appeal.” Sept. 29, 2026.
23. Engineering.com (Ian Wright). “The speed paradox in 3D printing.” Sept. 28, 2026.
24. VoxelMatters. “Meshy 7 review: how can humans keep up?” Sept. 30, 2026.
25. Taichi Graphics. “Project website.” Accessed Oct. 4, 2026.
26. BigGo Finance. “Meshy Closes Nearly $400 Million Series B, Shattering AI 3D Generation Funding Record at Over $1.5 Billion Valuation.” July 2026.
27. China AI Dispatch (Yuzu Xu). “The Third Dimension.” 2026. Accessed Oct. 4, 2026.

Glossary

510(k): The US FDA clearance route in which a device is shown to be substantially equivalent to a legally marketed predicate device. Clinical data are required only in a minority of cases.

Additive manufacturing (AM): Industrial term for 3D printing: parts are built layer by layer from a digital model rather than cut or molded.

Anatomic cage: An implant, typically used in spinal fusion, shaped to match a patient’s anatomy.

Bioprinting: 3D printing with living cells and supporting materials (“bioinks”) to build tissue-like structures.

CAD (computer-aided design): Software files that define a part’s exact geometry. “Dimensionally accurate” means the printed or modeled part matches the design measurements within tolerance.

Cold plate: A metal plate with internal channels that carries liquid coolant past hot chips. Copper is used for its thermal conductivity, and printing can create complex internal channels.

Dual-cure resin: A photopolymer resin hardened in two steps, first by light and then by heat.

European Patent Office (EPO): The body that grants European patents. Its Board of Appeal reviews opposition decisions.

Filament: Plastic wire, such as PLA, fed into desktop extrusion printers.

Frenemy: A rival that also cooperates where interests overlap.

Generative AI (3D): Software that creates 3D models from text prompts or images, as Meshy does.

Injunction: A court order stopping a party from selling or using a product. It is a separate remedy from damages.

Job shop: A contract manufacturer that makes custom parts for other companies.

Made in China 2025: A 2015 national plan to upgrade Chinese manufacturing. The 2017 additive manufacturing action plan formed part of it.

Metal AM: Printing metal parts, often by fusing metal powder with lasers.

Past damages: Money awarded for infringement that has already happened. It does not cover future royalties or sales bans.

Physical AI: Our shorthand for AI that acts on the physical world: robots, automated production cells and the hardware they make.

Series B: A second major venture funding round, usually raised after a company shows product and revenue traction.

Taichi: Open-source programming language for high-performance graphics and physics simulation, created by Meshy’s founder.

Tianxia Gongchang: The Chinese research publisher behind the 2026 AM market report cited here.

Starting draft. Edit freely and upload your version; it will run verbatim.

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Are we ready to commit to showing the value of 3D printing? Medical 3D printing is already used in hospitals, but turning individual success stories into systemic healthcare adoption takes more than the technology. Dr. Naomi Nathan, Head of the Healthcare Division at Mobility Goes Additive e.V. (MGA), knows what it will take to bring 3D printing into healthcare systems at scale. Nathan breaks down the challenges standing between innovation and adoption, from reimbursement and clinical evidence to regulation, procurement, and political commitment. Healthcare requires a long-term approach to investment. Europe’s decentralized healthcare systems make adoption particularly complex, and national clinical studies are needed to demonstrate patient and economic value. Nathan discusses MGA’s role in bringing together industry, hospitals, researchers, and policymakers to move medical 3D printing beyond isolated applications and toward broader healthcare adoption.

⚠️ 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.

About Our Guest:

Naomi Nathan is a trained medical doctor, public health specialist and business executive with over eleven years of experience across health policy, health systems strengthening, healthcare innovation, and now 3D printing for healthcare. She currently serves as Head of Healthcare Division at Mobility goes Additive e.V, a leading European network advancing additive manufacturing (3D printing) in healthcare, where she works with experts in working groups on various topics to bolster AM in healthcare, as well as policy positioning, evidence, and strategy, addressing various stakeholders including the European Parliament on their adoption. Previously, a Technical Officer/Consultant at the World Health Organization, she has worked on various health systems governance and policy initiatives with WHO/Europe member states, and stakeholders and served as secretariat member to the Pan European Commission on Health and Sustainable Development chaired by Mario Monti. Her interests centre on access to health innovation, at the intersection of emerging technologies with public health.

Key Topics

Dr. Naomi Nathan’s journey from medicine to public health and health economics

Mobility Goes Additive (MGA) and its expansion from mobility into healthcare

MGA’s European role and engagement with policymakers

Cross-sector learning between healthcare, rail, and additive manufacturing

Why Europe’s nationally governed healthcare systems complicate 3D-printing adoption

Moving medical 3D printing from technical capability to healthcare system adoption

Point-of-care 3D printing and the reimbursement challenge

Building clinical evidence through registries and multicenter studies

Regulation, procurement, and reimbursement as barriers to adoption

Creating pathways for healthcare innovation through the WHO

Policy commitment and investment needed to scale medical 3D printing

Communicating additive manufacturing’s value to policymakers

The reality of bioprinting and why “we are not printing organs yet”

The established role of 3D printing in orthopedic medical devices

MGA’s “collabor-action” approach and vision for the future of medical 3D printing

Timestamps:

00:00:00 – Welcome And Quick Disclaimer
00:01:09 – From Medical Doctor To Systems
00:02:48 – What MGA Does And Why
00:08:37 – Why EU Healthcare Is Complex
00:11:00 – Hospitals And Point Of Care Printing
00:14:04 – Building Registries And Better Evidence
00:16:35 – Reimbursement As The Real Blocker
00:20:13 – When Innovation Outruns The System
00:21:54 – What Policymakers Must Commit To
00:28:38 – Startup Signals Bioprinting Reality Check
00:35:08 – MGA Strategy Collaboration With Action
00:38:36 – Five Year Vision And How To Join
00:42:43 – Closing Thanks And Full Disclaimer

Resources

🔗 Contact Naomi Nathan

• Naomi Nathan on LinkedIn
• Naomi Nathan at Mobility Goes Additive
• Mobility Goes Additive (MGA)
• European Healthcare Forum for Additive Manufacturing (EHFAM)
• Naomi Nathan’s EHFAM Speaker Profile

🔗 Medical 3D Printing, Healthcare Systems & Policy

• Interview with Naomi Nathan: Getting 3D Printing into Healthcare Systems
• Interview with Naomi Nathan on 3DPrint.com
• HealthCapital Berlin: Interview with Naomi Nathan
• CECIMO
• RSNA-ACR 3D Printing Registry
• ACR 3D Printing Registry
• EHFAM and 3D Printing for Life Sciences at 3D Print Basel

🔗 European Additive Manufacturing & Healthcare

• MGA: Reflecting on 2025 and Looking Ahead to 2026
• Talk3D
• WHO Europe Public Health Innovation Platform
• WHO Guidance on Scaling Health Innovations

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

3DHEALS Healthcare 3D Printing Resource Center

Interview with Erik Boelen: Quality Management for Point-of-Care 3D Printing

Episode 127: Lean Compliance for Medical 3D Printing with Erik Boelen

Episode 114: Interview with Brigitte de Vet-Veithen, CEO of Materialise

3D Printing in Hospitals: A Beginner’s Guide

3D Printing in Hospitals: The Road to Reimbursement

Idea to Implementation: Reimbursement, the Elephant in the Room

Exploring Six Policy Areas Impacting Healthcare 3D Printing and Bioprinting

Event Recap: Advancing 3D Surgical Planning

Episode 113: How 3D Printing Explains the Unexplainable with Dr. Tristan Ramcharan

The post Episode #129: Medical 3D Printing Adoption in the EU with Naomi Nathan appeared first on 3DHeals.

This week FDA rewrote its drug and biologics rules to treat animal-free testing as equal to animal studies, and we look at who gains: pharma, NAM providers, and the biotools investors who back them. Also: Smith+Nephew’s knee with a fully 3D-printed femoral component won 510(k) clearance, FDA drew its first line around surgical robots, two new clinical series on patient-specific printed implants, and KLS Martin nears 500 printed bioceramic implants.

The big thing

FDA changed one word. Biotools just got a bigger market.

On September 21, FDA replaced “animal tests” with “nonclinical tests” across its drug and biologics rules (Federal Register). Nonclinical now means in vitro, in silico, in chemico, or nonhuman in vivo. It takes effect February 4, 2027, unless significant objections arrive by December 7. See our full analysis here: How the FDA’s New Nonclinical Testing Rule Affects Animal Testing, NAMs and CROs.

For those who are busy, here is the gist.

FDA calls it vocabulary. It is likely more than that. Animal-free methods, often known as new approach methodologies (NAMs), now sit in the rules as equals rather than exceptions. (For those interested in learning more about NAMs, my recent conversation with Dr. Curley can provide some insights.)

Pharma companies may get a better early screen. FDA’s own number: more than 90% of drugs that look safe in animals fail in humans. That said, expect parallel animal studies for a while.

NAM providers lose a barrier, not a validation burden. Emulate’s Liver-Chip still sets the bar: 87% of liver-toxic drugs flagged, no false alarms, across 27 blinded drugs (Ewart et al., 2022). Relevant to 3DHEALS audience, 3D bioprinted tissue is absent from FDA’s first 25 precedent cases. See our analysis on why that could be the case.

Investors should notice who sells into this shift. Organ chips, bioprinted tissue models and assay platforms are tools, not drugs. On Lattice Podcast Episode 128, Jim West of BioTools Innovator argues that tools can beat therapeutic moonshots: 5-10X outcomes instead of 100X, better odds, lighter regulation, roughly five-year timelines. FDA just widened the customer base for exactly those companies.

We are taking that conversation in person. 3DHEALS and BioTools Innovator will co-host a reception during JPM week on January 10, 2027, for biotools founders, investors and strategic partners (details). It is mostly invitation-only, with limited general tickets. Subscribe to The Lattice Brief to hear first when registration opens.

Regulatory watch

• Smith+Nephew’s LANDMARK Total Knee System gets FDA 510(k) clearance (GlobeNewswire, Sept 22). The femoral component is fully 3D printed with the company’s CONCELOC porous technology, and the system is built for robotic-assisted surgery. First cases are done; phased launch runs through 2027. A large-cap orthopedic company now treats a printed femur as a standard catalog part.
• FDA issues first draft guidance on robotically-assisted surgical devices (MD+DI, Sept 25). It covers system architecture, motion control, safety mechanisms and performance testing. It excludes remote teleoperation and autonomous robots doing significant parts of a procedure. The physical-AI frontier is left for later.
• FDA updates regulations to advance alternatives to animal testing (FDA via GlobeNewswire, Sept 21). The direct final rule behind this week’s big thing. FDA also launched a database of 25 NAM use cases.

Clinical & research

• 3D-printed titanium implants for chest wall reconstruction: a digital-to-surgical workflow (npj Biomedical Innovations, Sept 24, via PubMed). Swansea surgeons ran CT-to-titanium-print planning in six consecutive patients. Every planned resection and reconstruction went ahead without intraoperative changes. Small series, but it is a full point-of-care playbook.
• Custom 3D-printed implants for severe acetabular defects: early multicentre outcomes (Medicina, via PubMed). Four Polish centers, 62 revision hip patients with Paprosky 3A/3B defects, mean follow-up 27 months. Retrospective, but these are the hardest revisions, where off-the-shelf options run out.
• KLS Martin to deliver its 500th Lithoz-printed bioceramic implant (3D Printing Industry, Sept 19). Patient-specific resorbable tricalcium phosphate implants are now a standard order through KLS Martin’s IPS Gate platform. 500 units is the point where a research collaboration becomes a product line.

Also this week

• Telerobotic surgery is advancing around the world. Will the US embrace it? (MedTech Dive). China and India lead clinical use. The US has not authorized remote procedures, which matches FDA’s new guidance scope.
• 3D printing speeds up prosthetics for Syria’s wounded (3D Printing Industry). Two Idlib centers fit 100-150 patients a month. Production time fell from weeks to a day, and cost from about $500 to $100.
• AmeraLabs launches three dental 3D printing resins (3DPrint.com). Impression tray, surgical guide and try-in resins at about $170 per liter, for open printer platforms.
• Auburn team 3D prints a $150 camera laryngoscope (3D Printing Industry). Built for veterinary teaching, so a whole class can watch an intubation in real time.
• Steakholder Foods puts 3D-printed plant-based meat on US shelves (Steakholder Foods, Sept 3). Perfecta launches in the Northeast through KeHE Distributors. Not healthcare, but a rare case of printed biology-adjacent products reaching retail. No sales figures given.

From 3DHEALS

• Episode 128: BioTools Can Beat Moonshots with Jim West. BioTools Innovator’s Jim West on why tools and diagnostics can offer better risk-adjusted returns than therapeutics, and what separates founders who make it.
• How the FDA’s New Nonclinical Testing Rule Affects Animal Testing, NAMs and CROs. The full analysis behind this week’s big thing, stakeholder by stakeholder, including why bioprinting is not yet on FDA’s precedent list.

3DHEALS and BioTools Innovator are co-hosting a reception during JPM week on January 10, 2027. Subscribers hear first when registration opens.

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The post Did FDA just increased the biotools market | The Lattice Brief (9/27/26) appeared first on 3DHeals.

Everyone wants to fund the next miracle drug. Jim West thinks differently. In this episode, the Associate Director of BioTools Innovator makes the case that life-science tools and diagnostics are the better risk-adjusted venture bet than many therapeutics: you trade the 100X biotech moonshot for a 5-to-10X return with better odds, little regulatory risk, and a roughly five-year horizon. He backs it with the accelerator’s own numbers: 95% of the companies through its six cohorts are still operating or acquired, out of roughly 2,800 applications — and explains why focus (not technology) is what most tool founders get wrong, what strategic acquirers actually pay for, and why private equity and family offices are reshaping how these companies get funded.

About the Guest: Jim West

Jim West has spent his career at the intersection of health, business, and technology serving as an engineer, advisor, consultant and CEO to early stage and growing companies. Currently he serves as the Associate Director at BioTools Innovator, the world’s premier accelerator for life science companies. As former co-founder and CEO of Clara Biotech, Jim has been pivotal in pioneering patented breakthroughs in exosome purification and sample preparation, helping address some of the most challenging issues in the field. Prior to Clara Biotech, Jim worked on developing medical products from prototyping through manufacturing. Jim’s expertise and leadership were instrumental in securing FDA approval for one of the first mobile medical devices in 2016 using an iPhone as a stethoscope. Jim has dual master’s degrees in Biomedical Engineering (from the University of Kansas) and Entrepreneurship (Nanyang Technological University, Singapore).

TIMESTAMPS:

00:00:00 – Why Tools Can Beat Moonshots
00:01:18 – Jim West’s Nonlinear Path To Startups
00:03:55 – Clara Biotech And The Exosome Problem
00:06:38 – Standards And Sample Prep Bottlenecks
00:08:15 – Inside BioTools Innovator’s Selection Engine
00:12:55 – Focus And Coachability Define Winners
00:16:05 – Mentorship Plus Nonprofit Funding Levers
00:19:32 – What Strategics Want Before They Buy
00:23:28 – Returns Outlook With PE And Family Offices

GUEST’S LINKS

Jim West on LinkedIn: https://www.linkedin.com/in/jim-west-iii/
BioTools Innovator: https://biotoolsinnovator.org
MedTech Innovator: https://medtechinnovator.org
Clara Biotech: https://clarabio.tech

MENTIONED IN THIS EPISODE

2026 BioTools Innovator Capstone (Oct 14, San Diego — $250K finals): https://biotoolsinnovator.org/2026-bti-capstone/
2026 BioTools Innovator finalists: https://biotoolsinnovator.org/biotools-innovator-announces-the-2026-finalists/
BioTools Innovator program overview: https://biotoolsinnovator.org/program/
MedTech & BioTools Innovator BARDA Accelerator Network hub: https://medtechinnovator.org/medtech-innovator-selected-to-lead-the-enabling-technologies-hub-in-the-next-generation-of-the-barda-accelerator-network/
Jim West on the exosome sample-prep bottleneck (Technology Networks): https://www.technologynetworks.com/diagnostics/blog/releasing-the-handbrake-on-exosome-applications-317602
BioTools Innovator featured on Lab to Startup: https://www.labtostartup.com/medtech-innovator-and-biotools-innovator-accelerator-for-medical-device-digital-health-and-diagnos/

FROM 3DHEALS

Investing at 3DHEALS: https://3dheals.com/tag/investing/
Fundraising, Venture Capitalists & Angel Investors in Healthcare 3D Printing: https://3dheals.com/startup-fundraising-in-healthcare-3d-printing/
Pitch3D, connecting startups to investors: https://3dheals.com/pitch3d/
3DHEALS events & webinars: https://3dheals.com/events/

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At the J.P. Morgan Healthcare Conference in January 2027, 3DHEALS and Biotools Innovator will co-host an exclusive reception tailored specifically for founders and investors in the biotools sector. While JPM Week traditionally prioritizes therapeutics, this evening offers a dedicated space for the companies building the instruments, platforms, and enabling technologies that power modern biopharma and life science research and development. The gathering is primarily invitation-only for selected founders, investors, and strategic partners, with a limited number of general reception tickets available to the broader biotools community. Designed to foster high-value networking, the event will center on the future of biotools innovation, including but not limited to lab automation, 3D bioprinting, advanced manufacturing, and data-driven discovery.

Stay tuned for the announcement of an exciting in-person event on Jan 10th, 2027.

Subscribe here to get updates.

The post 3HEALS & BioTools Innovator At JPM 2027 🗓 appeared first on 3DHeals.

On September 21, 2026, the U.S. Food and Drug Administration (FDA) issued a rule that, on paper, only changes vocabulary. It replaces “animal tests” and “animal studies” with “nonclinical tests” and “nonclinical studies” throughout its rules for drugs and biologics. The FDA says the rule adds no new requirements or costs. Both statements are true. They are also beside the point. Regulatory lawyers, FDA reviewers, and procurement committees read regulations, and the words they read often shape what they are willing to pay for. This piece walks through what the rule does, and its impact from four seats at the table: the drug companies that must prove their products are safe, the companies selling animal-free testing tools (NAMs), the contract research firms that run most safety studies, and the companies that breed and supply research animals.

What the rule says

The rule amends five parts of Title 21 of the Code of Federal Regulations (CFR), the rulebook the FDA uses to regulate food, drugs and medical products. The parts affected (312, 314, 315, 361 and 601) cover the application to start human trials, new drug approvals, biologic licenses, and two narrower areas dealing with radioactive drugs used in diagnosis and research.

It also adds a definition. A “nonclinical test” can now be done in a dish of cells (in vitro), on a computer (in silico), with chemical reactions alone (in chemico), or in a living nonhuman animal (nonhuman in vivo). That tracks a 2022 federal law, the FDA Modernization Act 2.0, passed alongside the Food and Drug Omnibus Reform Act, which listed cell-based assays, organ chips, computer models and bioprinting as acceptable ways to show a drug is safe enough to try in people. The industry’s umbrella term for these animal-free tools is new approach methodologies, or NAMs.

Three details matter for timing and scope:

• Timing. The rule takes effect February 4, 2027, unless the FDA receives “significant adverse comments” by December 7, 2026. If it does, the agency withdraws the rule and moves forward with a companion proposed rule that says the same thing. Objections can delay the change; they are unlikely to kill it.
• A precedent library. The FDA also published a database of 25 real examples in which non-animal data was accepted in past drug reviews. For cautious companies, precedent is often more persuasive than policy.
• What it does not do. Animal testing is not banned. Evidence standards do not change. Also, medical device rules are not among the amended parts, so makers of 3D-printed implants get nothing from this rule directly.

Why vocabulary matters

The FDA issued this as a “direct final rule,” a fast-track process reserved for changes the agency considers noncontroversial. To qualify, the FDA said it does not expect the rule to affect industry practice. That is the legal framing. The commercial reality is different.

Under the old wording, an animal study was the default and anything else was an exception a company had to argue for. Under the new wording, animal and non-animal methods sit in the same sentence as equal options. The burden of proof has not moved: a company must still show that its chosen method is reliable for the specific question it is answering, which regulators call “context of use.” What has moved is the starting point of the conversation.

The rule also caps a string of related steps. In April 2025, the FDA announced a plan to phase out animal testing requirements for monoclonal antibodies, a large class of lab-made antibody drugs. It followed with draft guidance in December 2025 on reducing monkey studies for those drugs and broader draft guidance on NAMs in March 2026. Taken together, the direction is clear.

Pharmaceutical companies: more options, same homework

The case for moving. The FDA’s own framing is that more than 90% of drugs that look safe and effective in animals go on to fail in human trials. Every one of those failures is a sunk cost. A human-cell model that catches a liver problem before a drug reaches people saves money and time. The most cited evidence remains the Emulate Liver-Chip study: across 27 drugs tested blind, the chip correctly flagged 87% of drugs known to injure the liver and raised no false alarms on the safe ones (Ewart et al., Communications Medicine, 2022).

Biology adds a second argument. Many modern drugs, including antibody drugs and gene therapies, are built to act on human-specific targets. Often the only animal that responds is a monkey, and monkeys are expensive, slow to source and in short supply. For those drugs, a human-based model is not just an ethical preference; it may be the more relevant test.

Where do NAMs pay off first? At a recent 3DHEALS panel on NAMs, Graham Craig of VoxCell named four decisions they can inform earlier than clinical trials: whether a drug engages its target in human tissue, whether it has the intended effect, what side effects it may cause, and whether it reaches the right tissue. Framing a model around one of those questions is easier to defend than claiming it captures all of human biology.

The case for caution. Regulatory teams are paid to avoid delay, and the costliest delay is an FDA order that pauses a human trial. No one has lost their job for running the standard rat study. Drug companies also file in Europe, Japan and elsewhere, and international safety guidelines still expect animal data for many endpoints. So, in the near term, most companies will run NAMs alongside animal studies rather than instead of them. That raises costs before it lowers them.

Bottom line. Drug companies gain an option, not an obligation. Expect early adoption where animal models are weakest (human-specific biologics, liver and heart safety screens) and where NAMs are used early to weed out bad compounds before the formal safety package. Expect animal studies to stay in the final submission for years.

NAMs providers: from pilot projects to purchase orders

The case for optimism. Makers of organ chips, organoids (tiny lab-grown organ-like tissues), bioprinted tissue and computer models have spent a decade selling into research budgets, not regulatory budgets. Every sale came with the same question: will the FDA accept this? The rule does not answer that question for any specific product, but it removes the hardest version of it. The category is now written into the regulation, and the 25-case database gives sales teams real examples to point to. Clearer rules also lower perceived risk for investors, which should help fund the unglamorous work of scaling up manufacturing and automation.

The case for realism. The bar is still validation, and the first 25 examples mostly involve standardized skin and eye irritation tests that took years to validate, not organ chips or bioprinted tissue. The Emulate study is one organ, one type of harm and a company-led study. Buyers will now ask harder questions: Does the model give the same answer in different labs? Does one batch behave like the next? How many compounds can it test per week, and at what cost per data point? Providers that cannot answer with data will find that the rule changed the conversation but not the purchase decision.

The view from founders. On Episode 122 of The Lattice Podcast, Lowry Curley, PhD, founder of Luna LifeSci and of 28bio (formerly AxoSim), argues the FDA is at an inflection point where organ chips and lab-grown mini-brains move from niche to routine. He notes that failure rates for drugs that pass animal testing climb to about 94% in neurology, and he frames the open question for investors as who will consolidate the field. On the same 3DHEALS panel, Mike Clements of Axion BioSystems cautioned that flexibility cuts both ways: the scientific bar has not changed, and more choice of methods can mean more variability unless the industry standardizes how models are built and checked.

Bottom line. The rule is a marketing asset. Revenue will follow validation data, not vocabulary. Providers that publish head-to-head comparisons against known drugs will pull ahead.

Contract research organizations: the integrators in the middle

The case for gaining. Contract research organizations (CROs) run most of the outsourced safety testing in drug development. Drug companies generally buy a finished safety package, not individual technologies, and that plays to the CROs’ strength. A large CRO can bundle computer models, cell-based tests and animal studies into a single program and tell the client which mix a reviewer is likely to accept. Several of the largest CROs have publicly invested in alternative methods for exactly this reason.

CROs also hold something NAMs start-ups lack, which is decades of animal data on known drugs. That history is what a new method must be measured against, which makes CROs natural partners for validation work. And during the transition, validation means running the new test and the old test side by side. That is more work, and CROs get paid for work.

The case for strain. Animal facilities are expensive fixed assets. If study volumes decline, the cost of each remaining study rises. Smaller CROs that only run animal studies and lack the capital to build cell-culture or computing teams, face slow margin erosion as early screening work moves to faster, cheaper platforms.

Bottom line. Large CROs are likely to win the transition, provided they manage the gradual shrinking of their animal capacity. The squeeze falls on smaller, animal-only labs.

Animal model providers: less volume, more specialization

The case for resilience. Nothing is banned. Many questions remain hard to answer outside a living body: how a drug spreads through and leaves the body over time, effects on fertility and pregnancy, cancer risk from long-term exposure, and interactions between organs. Demand may even grow for specialized animals, such as genetically engineered or “humanized” mice carrying human genes or cells, because they answer questions that chips cannot yet handle.

The case for concern. The FDA’s recent guidance targets monkey studies for antibody drugs first. Monkeys are the most expensive research animal, so any drop in that segment hits revenue harder than a similar drop in rodents. Routine rodent studies used for early screening are also exposed, as that work is the easiest to move onto cell-based and computer tools. Animal suppliers could file objections before December 7, but because the backup proposed rule is identical, objections would mostly buy time, and the public relations cost of opposing an “alternatives to animal testing” rule is high.

Bottom line. Expect a slow erosion rather than a cliff, with monkeys most exposed. The providers best placed to adapt are those moving toward well-characterized, specialized models and partnering with NAMs companies to offer combined evidence packages.

What it means for 3D bioprinting

Bioprinting is named in the 2022 law, but it does not appear among the first 25 examples in the FDA database. Today it is used mostly inside companies for early drug discovery, not in the safety packages submitted to regulators. The obstacles are practical: keeping printed cells alive and functioning over time, making each batch behave like the last, and producing tissue at a scale and price that drug companies will buy. Reviewers currently trust standardized organ chips and established tissue models more than custom-printed tissue.

Early examples show what the path looks like. At the 3DHEALS NAMs event, FluidForm Bio described bioprinted human heart tissue that beats, can be pushed into an irregular rhythm, and returns to normal with a standard drug (lidocaine). Pranav Joshi of Bioprinting Laboratories argued that the real burden for customers is preparation, and that quality checks with clear pass/fail criteria need to run through the whole life of an organoid, not just at the end.

For a bioprinted model to reach a regulatory filing, it will need a clearly defined question it answers, results that repeat across batches and labs, benchmarking against drugs with known effects, and a data package a reviewer can easily follow.

What to watch

• December 7, 2026: Whether the FDA receives significant objections, which would delay but likely not stop the change.
• February 4, 2027: The rule’s scheduled effective date.
• Growth of the use-case database: Whether organ-chip or bioprinted examples join the skin and eye tests.
• Final guidance: How much detail the final versions of the 2025 and 2026 draft guidances give on validation.
• Devices: Whether the FDA extends similar language to medical device rules, which this rule leaves untouched.

References

1. Food and Drug Administration. “Nonclinical Testing Terminology” (direct final rule). Federal Register, 91 FR 59988, September 22, 2026. https://www.federalregister.gov/documents/2026/09/22/2026-19350/nonclinical-testing-terminology
2. Food and Drug Administration. “FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing” (press release). September 21, 2026. https://www.fda.gov/news-events/press-announcements/fda-updates-regulations-advance-innovative-alternatives-animal-testing
3. Food and Drug Administration. “New Approach Methodologies (NAMs).” https://www.fda.gov/science-research/science-and-research-special-topics/new-approach-methodologies-nams
4. Food and Drug Administration, Center for Drug Evaluation and Research. “New Approach Methodologies (NAMs) Database: Use Case Examples.” https://www.fda.gov/drugs/cder-streamlined-nonclinical-studies-and-acceptable-new-approach-methodologies-nams/new-approach-methodologies-nams-database-use-case-examples
5. Food and Drug Administration. “FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs” (press release). April 10, 2025. https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs
6. U.S. Congress. S.5002, FDA Modernization Act 2.0, 117th Congress (2022). https://www.congress.gov/bill/117th-congress/senate-bill/5002
7. Regulatory Affairs Professionals Society (RAPS). “FDA to remove ‘animal testing’ terminology from its regulations.” September 2026. https://www.raps.org/resource/fda-to-remove-animal-testing-terminology-from-its-regulations.html
8. Pharmaceutical Technology. “The FDA Finalizes Rule Recognizing Non-Animal Testing Methods, Building on Year-Long Reduction Push.” September 2026. https://www.pharmtech.com/view/the-fda-finalizes-rule-recognizing-non-animal-testing-methods-building-on-year-long-reduction-push
9. BioPharm International. “FDA Formalizes Non-Animal Testing Methods in New Rule.” September 2026. https://www.biopharminternational.com/view/fda-formalizes-non-animal-testing-methods-new-rule
10. AllSci. “FDA modernizes drug regulations to formalize support for NAMs.” September 2026. https://allsci.com/news/regulatory-policy/fda-nonclinical-testing-terminology-issues-direct/
11. BioBuzz. “FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing.” September 2026. https://biobuzz.io/news/fda-updates-regulations-to-advance-innovative-alternatives-to-animal-testing/
12. Ewart L, et al. “Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology.” Communications Medicine 2022;2:154. doi:10.1038/s43856-022-00209-1. https://doi.org/10.1038/s43856-022-00209-1
13. 3DHEALS. “Episode 122: New Approach Methodologies (NAMs) with Dr. Lowry Curley.” The Lattice Podcast, August 8, 2026. https://3dheals.com/episode-122-new-approach-methodologies-nams-with-dr-lowry-curley/
14. 3DHEALS. “Event Recap: New Approach Methodologies (NAMs).” August 26, 2026. https://3dheals.com/event-recap-new-approach-methodologies-nams/

Glossary

• Biologic: A medicine made from living cells, such as an antibody, vaccine or gene therapy, rather than from chemical synthesis.
• Bioprinting: Using a 3D printer to lay down living cells and support materials in layers to build tissue-like structures.
• Clinical hold: An FDA order that delays or pauses a human trial until safety concerns are resolved.
• Code of Federal Regulations (CFR): The official collection of U.S. federal rules. Title 21 covers food, drugs and medical products.
• Context of use: The specific question a test is meant to answer, and the conditions under which its results can be trusted.
• Contract research organization (CRO): A company that runs laboratory studies or clinical trials on behalf of drug developers.
• Direct final rule: A fast-track rule for changes an agency expects to be noncontroversial. It takes effect unless significant objections arrive.
• In vitro, in silico, in chemico, in vivo: Tests done in cells or tissue outside the body, on a computer, through chemical reactions alone, and in a living organism.
• Monoclonal antibody: A lab-made antibody designed to lock onto one specific target in the body.
• New approach methodologies (NAMs): Testing methods that do not rely on animals, including cell-based tests, organ chips, organoids and computer models.
• Nonclinical test: Any safety or effectiveness test done before or outside human trials, with or without animals.
• Organ chip: A small device lined with human cells that mimics how an organ works, including fluid flow and tissue interaction.
• Organoid: A tiny, self-organizing cluster of lab-grown cells that resembles part of an organ.
• Validation: Evidence that a test gives accurate, repeatable results for its intended context of use.

3DHEALS Archives:

• Event Recap: New Approach Methodologies (NAMs)
• New Approach Methodologies (course)
• The Lattice Podcast Episode 122: NAMs with Dr. Lowry Curley
• Interview with Graham Craig
• The Lattice Brief: 3D Printing Materials, NAMs & Dental M&A
• Lattice Newsletter archive

The post How the FDA’s New Nonclinical Testing Rule Affects Animal Testing, NAMs and CROs appeared first on 3DHeals.

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.

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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.