This week’s Lattice Brief asks where 3D printing actually makes money: the listed printer makers lose money, while treatments with printing inside, medical software, consumables ecosystems and clinically priced devices earn the margins. Also inside: FDA clears a 3D printed porous titanium cervical system, an ARPA-H liver bioprinting award, robotic bioprinting for diabetic wounds, and the VDMA autumn survey. The Lattice Brief returns the week of November 2.

The big thing

Where 3D printing actually makes money

The industry feels better. VDMA’s autumn survey says 64% of German additive manufacturing firms grew sales over the past year, up from 45% a year ago. But costs still top their worries. Growth is not the same as profit.

Look at the listed printer makers. In Q2, Stratasys lost $16.9M and 3D Systems lost $12.9M. Creality grew first-half revenue 13% and still swung to a loss. Digital manufacturers do a little better: Proto Labs earned $9.2M, while its 3D printing revenue slipped and its CNC and molding grew.

Against sector benchmarks, the pattern is clear. Printer makers earn machinery-level gross margins but post losses. 3D printing companies beat their sector mainly in medicine.

The profits sit in four places.

Treatments with printing inside. Align prints a mold for every Invisalign tray and posted a 71.7% gross margin in Q2. The printer is a cost line, not the product.

Medical software and services. Materialise’s medical segment earned a 31.3% adjusted EBITDA margin. The whole company earned 5.5%.

Ecosystems that sell consumables. Formlabs says it has been profitable for two years. Creality’s consumables grew 48% while printer sales were flat.

Devices priced on clinical value. Stryker has printed more than two million Tritanium implants, and its orthopaedics segment ran a 34% operating margin.

My view: margin follows the patient, not the machine. Price the outcome, own the consumable, and secure payment early. That is why Trio Labs sells finished medical parts, not printers, as founder Adam Steege explains on Episode 130.

Read the full analysis on where profitability is, with the benchmarks, and leading public companies, ending with an FAQ. Which business model would you back? Better ideas?

Hit reply and tell us.

A note from Jenny: I’m taking a few weeks of vacation. The Lattice Brief will be back on its normal schedule the week of November 2. Thank you for reading.

From 3DHEALS

• Which 3D Printing Businesses Are Profitable? A Healthcare Focus in 2026. The full analysis behind this week’s big thing: sector benchmarks, Stryker, Xometry and Proto Labs, four profitable business models, and an FAQ.
• Episode 130: 3D Print Tiny Things with Adam Steege, Trio Labs. Why Trio sells finished micron-scale metal parts for medical devices instead of printers, and when printing beats CNC and metal injection molding.
• 3D Printed Drugs Guide (updated October 2026). Background for this week’s PharmaTher and St. Jude items: processes, players, evidence and the new point-of-care rules.

Regulatory watch

• FDA clears Providence Medical’s 3D printed porous titanium cervical system (ODT Magazine, Oct 13). A 510(k) for CORUS PCSS 3D-T, a printed porous titanium version of its posterior cervical stabilization system. Same design and indications; the lattice is meant to support bone ingrowth.
• ARPA-H awards Terasaki Institute up to $19.8M to bioprint liver tissue (EurekAlert!, Oct 2). The PRINT program’s Prometheus project combines stem-cell-derived liver cells, bioreactor culture and bioprinting to make tissue that avoids immune rejection. A catch-up item we missed two weeks ago.

Clinical & research

• Bioprinted scaffolds for leg ulcers: a systematic review of clinical trials (Frontiers in Bioengineering and Biotechnology, via PubMed). University of Hong Kong authors found 8 clinical studies with 139 patients. Both randomized trials showed faster complete healing than standard dressings, with no treatment-related serious adverse events. The studies are small with short follow-up.
• Custom 3D printed shoulder prostheses after tumor resection: 30 patients at three years (Journal of Shoulder and Elbow Surgery, via PubMed). Sun Yat-sen University Cancer Center reports mean functional scores of 84% (MSTS) and 85% (ASES) at a mean 37.7 months, with one loosening and two plate exposures. Retrospective, single center.
• Vision-guided robotic bioprinting onto diabetic wounds (Advanced Functional Materials, via PubMed). A Brigham and Women’s / Harvard team paired an oxygen-releasing stem-cell bioink with an autonomous robot that prints directly onto the wound. In animal models it sped closure. Physical AI meets bioprinting.

Also this week

Point of care and pharmacy

• How a Dutch trauma center built a roadmap for printing splints in house (3D Printing in Medicine, via Bioengineer.org). Radboudumc mapped technical, workflow and regulatory barriers, with owners for each.
• PharmaTher launches a national network of pharmacy printing sites (3D Printing Industry). Starts with US 503A compounding pharmacies; it will seek emergency-readiness contracts. A follow-up to last week’s big thing.
• 3D printing and automated compounding in pediatric pharmacy (Journal of Pediatric Pharmacology and Therapeutics, via PubMed). St. Jude Children’s Research Hospital pharmacy authors on bringing both into pediatric practice.
• 3D reconstruction beats 2D imaging for pediatric kidney surgery planning (VoxelMatters). Turin, 8 children. The models were virtual, not printed; the team cited cost.

Devices and dental

• IMDEA and UPM print braided nitinol for transcatheter devices (VoxelMatters). One-step braided stents recovered over 90% after compression to half their diameter.
• SprintRay adds a scanner and compact chairside print line (Med-Tech Insights). Foundation scanner and Nano Series ship from November, subject to regional approvals.
• GC launches a hybrid ceramic resin for SprintRay’s Midas press (PR Newswire). For permanent crowns, inlays, onlays and veneers; US availability from Nov 1.
• Limber Prosthetics sells a printed leg from $3,000 (Hoodline). Smartphone scan, one-piece print in about 12 hours; about 800 devices made, per the company.

Research

• Support-bath bioprinting keeps mature human fat cells alive (Bioengineer.org). University of Stuttgart; a step toward better fat-tissue models for metabolic disease.

Industry and tools

• VDMA autumn survey: business improves, expectations cautiously positive (VDMA). 64% of German AM firms grew sales; medical technology is among the fastest-growing applications.
• UC Berkeley releases OpenCAL, an open-source volumetric printer (VoxelMatters). About $1,638 in parts, with resin from Formlabs and Prusa.
• NVIDIA open-sources a CAD modeling kernel (3D Printing Industry). USD BRep, Apache 2.0; a building block for AI-assisted design.
• A roller coaster, kidney stones and ultrasound: a decade later (Medical Daily). How a 3D printed kidney model on a Disney ride led to ultrasound devices for stones.

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The post Where 3D Printing Actually Makes Money | The Lattice Brief (10/19/26) appeared first on 3DHeals.

Short answer: In 2026, the most profitable 3D printing businesses mostly do not sell 3D printers. Margins concentrate in four models: treatments with printing built in (Align Technology, hearing aids, etc.), medical software and services (Materialise Medical), ecosystems that sell recurring consumables (Formlabs), and devices priced on clinical value (FDA-cleared implants). Industrial printer hardware remains the least profitable part of the industry. A note on scope: this analysis leans toward the medical sector. That is 3DHEALS’ focus, and it is also where the margin evidence points. Industrial and consumer companies appear mainly for comparison.

Is the 3D printing industry profitable in 2026?

The industry feels better than it did a year ago. The German engineering association VDMA published its autumn 2026 survey on October 19. It found that 64% of German additive manufacturing firms grew sales over the past twelve months, up from 45% in fall 2025. Only 15% reported declining sales, down from 29%. Two-thirds expect market growth over the next two years, and 94% plan to hold or increase investment.

But growth is not profit. The same survey ranks costs (57%) and process stability (50%) among the industry’s top concerns. VDMA’s own reading is careful: it is “premature to speak of a fundamental trend reversal.” The survey also notes that additive manufacturing is spreading fastest in aviation and medical technology. That second point matters more than the first.

Why do most 3D printer manufacturers lose money?

Look at the listed printer makers. In the second quarter of 2026, Stratasys reported $137.6M in revenue, a 47.2% adjusted gross margin, and a GAAP net loss of $16.9M. Its adjusted operating margin was close to zero. 3D Systems reported $94.6M in revenue, a 36.7% adjusted gross margin and a $12.9M net loss. Healthcare is now about half of 3D Systems’ revenue and was its growing part, up about 7%.

Consumer hardware is no easier. Creality grew first-half revenue 12.9% and still swung to a net loss of RMB 59.1M, as price cuts pushed its gross margin from 34.4% to 30.8%. China’s Bright Laser Technologies stayed profitable, but its net profit fell 33% in the first half.

Meanwhile, hardware keeps getting cheaper. This week UC Berkeley released OpenCAL, an open-source volumetric printer built from about $1,638 in parts, with resin supplied through Formlabs and Prusa.

When a capable printer costs less than a laptop, selling printers alone is a hard way to earn a margin. The trend of continued commoditization and maturing market works for the consumers but not so much for OEMs.

Do digital manufacturers like Xometry and Proto Labs make money?

Xometry and Proto Labs sell parts, not printers, and both route work through printing, machining and molding capacity. Their results sit between the printer makers and the medical leaders.

Xometry grew second-quarter revenue 41% to $229.3M, with a 38.0% gross margin and a 6.2% adjusted EBITDA margin. It still posted a GAAP net loss of $5.3M. Its quarterly filing shows where the margin sits: the marketplace earns a 34.7% gross margin, while its smaller Thomas advertising and services business earn about 88%. Matching buyers to machines pays less than selling ads to suppliers.

Proto Labs is the steadier earner. Second-quarter revenue rose 10.6% to a record $149.3M, with a 46.4% GAAP gross margin, a 7.6% GAAP operating margin and $9.2M of net income. But printing is not what drove it. 3D printing revenue fell 2.7% in constant currency to $20.7M, while CNC machining and injection molding each grew about 13%.

Owning the customer and the quoting software earns a modest margin. The printing step itself does not. Neither company is a medical specialist, and neither earns medical-device pricing.

How does 3D printing profitability compare with other industries?

Benchmarks help separate a 3D printing problem from an ordinary manufacturing problem. The table sets second-quarter 2026 company results against US sector margins compiled by NYU Stern’s Aswath Damodaran in January 2026. Sector figures are trailing aggregates for US-listed companies; company figures are single quarters, so read the comparison as directional.

Two patterns stand out. First, medical device makers as a group earn a 54% gross margin, well above industrial machinery makers at about 37% and the manufacturing average at about 34%. Align, Stryker, and Materialise’s medical segment with its 31.3% adjusted EBITDA margin, sit at or above that medical benchmark.

Second, the printer makers’ gross margins look like a machinery maker’s, but their net margins do not. US machinery companies net about 10.6% of sales. Stratasys and 3D Systems lose 12% to 14%. They have machine-maker pricing without machine-maker scale. Proto Labs, at 6.1% net, is close to the manufacturing norm; Xometry is approaching breakeven.

This analysis shows the 3DP advantage leans toward medicine. It is the one category where 3D printing companies beat their sector benchmark instead of trailing it.

Which 3D printing business models make money?

The profits sit outside of the printer. Four categories stand out.

1. Treatments with printing inside

Align Technology may be the most profitable 3D printing operation in the world, though it never markets itself that way. It prints a custom mold for every Invisalign aligner, about a million custom parts a day. Its Clear Aligner segment was $870.9M, about 82% of revenue, in Q2 2026. The company posted a 71.7% gross margin and $108M in net income. Align bought Cubicure in 2024 to print aligners directly, which could remove the mold step altogether.

Hearing aids follow the same pattern. Custom in-ear shells are routinely 3D printed, and privately held WS Audiology reported a 19.1% EBITDA margin in its latest quarter. In both cases the patient buys a treatment. The printer is a cost line, not the product.

2. Medical software and services

Materialise shows the gap inside a single company. Its medical segment earned a 31.3% adjusted EBITDA margin on €36.9M of revenue in Q2 2026, growing 12%. The company as a whole earned a 5.5% adjusted EBIT margin. Regulated medical software and patient-specific services are worth more than general printing capacity.

Services also win on throughput. HP reports that orthotics maker iOrthotics grew from about 30 devices a day to more than 100 pairs after moving to a digital, printed workflow. These are company-reported figures, but the logic is clear: once the workflow is digital, volume drives margin.

3. Ecosystems that sell consumables

Formlabs, which is private, says it has been profitable for more than two years, with free cash flow above 10% on more than $250M of 2025 revenue. Its printers lock in sales of its own resins. At Creality, consumables grew 48% while printer sales were flat. Bambu Lab is reported to have passed RMB 10B in 2025 revenue, though it does not disclose profit.

Dental shows the model clearly. This week SprintRay added an intraoral scanner and a compact chairside print-wash-cure line to its platform, and GC launched a hybrid ceramic resin for its Midas press. Pharmacy is next: PharmaTher is building a network of CraftMake printers in compounding pharmacies, a model we examined in last week’s issue and in our updated 3D Printed Drugs Guide.

4. Devices priced on clinical value

FDA-cleared implants are priced on outcomes, not on print time. This week Providence Medical Technology received 510(k) clearance for a 3D printed porous titanium cervical system. Implant pricing reflects clinical value and reimbursement, not material cost.

Stryker shows what that pricing is worth. It has printed more than two million porous titanium Tritanium implants since 2013, across knees, hips and spinal cages. Stryker does not report a separate margin for printed implants, but its Orthopaedics segment, where 3D printing sits, earned a 34.0% operating margin on about $3.0B of sales in Q2 2026. That is roughly twice the 15.3% operating margin of the average US healthcare products company. Company-wide, Stryker reported a 68.3% gross margin and about $1.3B in net earnings on $6.6B of sales. The printing is invisible in the accounts. The clinical value is not.

Printing can cut prices too. San Diego’s Limber Prosthetics sells a one-piece printed leg from $3,000, scanned with a smartphone and printed in about 12 hours. That is good for patients and payers. For the business, it means margin depends on volume and on who pays.

What should founders and investors take from this?

Margin follows the patient, not the machine. Three practical rules follow.

• Price the outcome, not the print. Sell a treatment, a finished part or a cleared device.
• Own the consumable. Validated materials and software create recurring revenue that hardware alone does not.
• Secure payment early. A better device is not automatically a billable one.

This is why Trio Labs sells finished, micron-scale metal parts for medical devices instead of printers. Founder Adam Steege explains when printing beats CNC machining and metal injection molding on Lattice Podcast Episode 130. On reimbursement, read our analysis Better Isn’t Billable and listen to Naomi Nathan of Mobility Goes Additive on Episode 129.

Frequently asked questions

Are 3D printing companies profitable?

Most listed printer manufacturers, including Stratasys and 3D Systems, reported net losses in Q2 2026. Companies that embed printing in a medical product or sell recurring materials, such as Align Technology and Formlabs, are profitable.

What is the most profitable use of 3D printing?

Mass-customized medical and dental products. Align’s clear aligners, built on 3D printed molds, carry a 71.7% gross margin.

Is selling 3D printers a good business?

Rarely on its own. Printer prices keep falling, and margins come from consumables, software and services sold alongside the hardware.

Are Xometry and Proto Labs profitable?

Proto Labs is, with $9.2M of net income and a 7.6% operating margin in Q2 2026. Xometry is close: positive adjusted EBITDA, but still a small GAAP net loss. Both earn far less than medical device makers.

Which business model would you back? Email: info@3dheals.com, and tell us, and subscribe to The Lattice Brief for weekly analysis.

Company figures link to SEC filings or investor-relations releases where available; other figures are from press and the Damodaran sector dataset. This is not audited analysis. This is not investment advice.

The post Which 3D Printing Businesses Are Profitable? A Healthcare Focus in 2026 appeared first on 3DHeals.

The more minimally invasive medicine becomes, the smaller and more complex medical devices have to be. While that can mean better care and greater access for patients, it also creates a significant dilemma: how do you manufacture these devices at scale? Adam Steege, founder and CEO of Trio Labs, a Morrisville, North Carolina-based company, develops micron-scale metal parts for medical devices. He invented RIPL, or Resin Infused Powder Lithography, a lithography-based process that prints stainless-steel parts at five-micron resolution with tolerances as fine as 0.0005 inch and Ra32 surface finish, which are specifications normally associated with CNC machining. On The Lattice, Steege explains why Trio sells finished parts rather than 3D printers, how minimally invasive surgery and interventional cardiology push instruments smaller and more complex than machining or metal injection molding can economically produce, and why manufacturability is the third leg, alongside clinical need and design, of every successful device. Ultimately, Trio Labs aims to hit the sweet spot where complex, micron-scale designs lead the next generation of medical devices for patients.

⚠️ 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:

Adam Steege founded his first company, Agile EndoSurgery in 2010 which focused on development of a laparoscopic surgical device. This experience made starkly clear the need for better micro-scale manufacturing technologies and served as the inspiration for the invention of RIPL, the technology behind Trio Labs. To date Adam has over 80 pending and issued patents.

Key Topics

• Why manufacturing, not design, has become a bottleneck for next-generation medical devices
• Adam Steege’s journey from Agile EndoSurgery to founding Trio Labs
• The clinical push toward smaller, more complex devices for minimally invasive medicine
• The “three-legged stool” of clinical need, design solution, and scalable manufacturing
• Inventing RIPL, or Resin Infused Powder Lithography, for micron-scale metal manufacturing
• What conventional metal 3D printing gets wrong about resolution, tolerances, surface finish, and material performance
• Five-micron resolution and CNC-equivalent performance for medical device components
• Why Trio sells finished parts instead of 3D printers
• Trio’s “half ASML, half TSMC” vision for specialized manufacturing
• How design flexibility can unlock new possibilities for minimally invasive surgical devices
• ISO 13485 certification and why Trio Labs is focused exclusively on medtech
• Trio’s stainless-steel materials today and its path toward additional medical-grade materials
• Finding early customers and transitioning from R&D projects to volume production in 2027
• When 3D printing makes economic sense compared with metal injection molding and CNC machining
• Combining manufacturing processes and scaling from R&D to production
• The challenges and “growing pains” of building a scalable medical manufacturing company
• Where Trio Labs sees opportunities in surgical, cardiac, bronchoscopy, and stroke intervention

Timestamps:

00:00:00 – Welcome And A Parts-First Thesis
00:01:20 – Founder Lessons From A First Startup
00:04:45 – Minimally Invasive Devices Hit Manufacturing Limits
00:09:36 – Why RILP Had To Be Invented
00:11:48 – Selling Parts Instead Of Printers
00:17:06 – RIPL Explained And Where It Wins
00:19:58 – Finding Customers And Building To Production
00:22:50 – Unit Economics Versus CNC And MIM
00:27:19 – Scaling Challenges And The 2027 Goal
00:29:50 – Disclaimer And Closing

🔗 Contact Adam Steege and Trio Labs

• Adam Steege on LinkedIn
• Trio Labs
• Trio Labs RIPL Technology

🔗 Companies and Technologies Mentioned

• Fabric8Labs
• Incus
• Holo / PureForm
• Autodesk

🔗 Learn more about Trio Labs and RIPL

• 3Dnatives: Trio Labs and Its Microscopic Metal 3D Printing Technology
• 3DPrint.com: 3DPOD with Adam Steege and Scott Schiller
• 3D Printing Industry: Trio Labs Approaches MIM-Based Binder Jet 3D Printing Market
• NC Tweener Talks: Adam Steege, Founder & CEO of Trio Labs
• Chamfr: Trio Labs Supplier Directory
• Tiny Tech Fund: Triotin Labs
• VisionTech Partners: Adam Steege, Trio Labs

🔗 Micro-Metal Manufacturing & Micro-Precision 3D Printing

• Small Scale, Large Impact: How Micro-3D Printing Is Enabling Manufacturers to Win Big
• How Micro 3D Printing Is Transforming Medical Device Innovation
• How Micro 3D Printing Improves Medical Device Accuracy
• How Micro 3D Printing Is Making Medical Devices Smaller and Less Invasive
• Confined Electrodeposition in Localized Liquid Electrolyte Microzones for Microscale Metal Additive Manufacturing
• Additive Manufacturing of Superelastic NiTi Braided Metamaterials for Minimally Invasive Vascular Medical Devices
• MICRO: Medical Device Manufacturing

🔗 Learn More from 3DHEALS!

• Interview with Adam Steege: 3D Printing Small Things
• 3DHEALS: Metal 3D Printing for Healthcare
• 3D Microfabrication: Medical Applications
• Interview with Alan Dang: Metal 3D Printing for Medical Devices
• Interview with Craig Rosenblum: 3D Printing Post Processing
• Interview with Peter Mercelis: Investing in Medical 3D Printing
• Metal 3D Printing in Dentistry
• Metal 3D Printing Medical Devices
• 3DHEALS Healthcare 3D Printing Resource Center

The post Episode #130 | 3D Print Tiny Things with Adam Steege, Trio Labs appeared first on 3DHeals.

This week’s Lattice Brief looks at three bets on printing medicines in the pharmacy: PharmaTher’s CraftMake roll-out to US compounding pharmacies, CurifyLabs’ dose-accuracy work, and France’s first license for drug-printing cartridges. Also inside: FDA clears a patient-specific 3D-printed radiation bolus, a one-year randomized trial of printed vs zirconia crowns, and our updated 3D Printed Drugs Guide.

The big thing.

The pharmacy wants to be the factory

Three companies made the same bet in two weeks. PharmaTher says it expects the first orders for its CraftMake pharmaceutical 3D printer this quarter, with up to 50 installations in US compounding pharmacies within a year and a New Drug Application for a rare pediatric therapy by late 2028. A doctoral thesis from Åbo Akademi University and spin-off CurifyLabs reported on dose accuracy for pharmacist-dispensed gels. And France’s medicines regulator licensed MB Therapeutics to make printing cartridges as a pharmaceutical manufacturer.

The bet: 3D printing can scale in compound medicine.

The clinical case is real but thin. A 2026 review counted 10 clinical studies of printed medicines made at the point of care. Most were single-centre and short. The best known comes from Santiago de Compostela, where four children with maple syrup urine disease took printed chewable isoleucine for six months. According to the study, indexed in PubMed, their blood levels sat closer to target and varied less than on hand-filled capsules (DOI). Children and rare diseases are where tailored doses matter most, so that is where this market starts.

The business model of choice is razor and blade. Place the printer once. Sell validated formulations, cartridges and software every week.

On the regulatory front, the rules are arriving unevenly. The UK’s point-of-care framework has been in force since July 2025. FDA’s July proposal would let a distributed manufacturing network register as one establishment, but it does not cover compounding, which is where US printed doses live today.

Again, the printer is not the hard part. Batch release, adverse-event reporting and recalls across 50 sites are. Taking responsibilities for a bad batch is required to own the market.

What do you think? Is 3D printed drugs incremental improvement or transformational to the future of medicine?

We have updated our 3D Printed Drugs Guide with everything that changed since August 2025: processes, players, clinical evidence and regulation. For the people building it, listen to FABRX’s Alvaro Goyanes on Lattice Podcast Episode 112, or watch our panel with FABRX, Craft Health, CurifyLabs and NIST on demand.

From 3DHEALS

• 3D Printed Drugs Guide (updated October 2026). Processes, players, clinical evidence and the new UK, US and French rules for printing at the point of care, with a summary of everything that changed since August 2025.
• Episode 112: Automating Compounding Pharmacies with FabRx 3D Printing. FABRX co-founder Alvaro Goyanes on built-in quality checks, pediatric dosing and point-of-care regulation.
• 3D Printed Pharmaceuticals (on demand). Our panel with FABRX, Craft Health, CurifyLabs and NIST on polypills, pediatric formulations and compounding economics.
• Episode 129: Medical 3D Printing Adoption in the EU with Naomi Nathan. Dr. Naomi Nathan of Mobility Goes Additive on reimbursement hurdles for hospital point-of-care printing and building evidence through registries and multicenter studies.

Regulatory watch

• FDA clears Myrava’s patient-specific 3D printed bolus (3D Printing Industry, Oct 2). A 510(k) for a printed layer that shapes radiation dose at the skin. It is the former Ricoh 3D for Healthcare’s first clearance beyond anatomical models, made from treatment-plan files at FDA-registered point-of-care sites. Hospital printing is moving from models to devices that change treatment.
• FDA to prioritize guidance on AI and surgical robots next year (MedTech Dive, Oct 2). CDRH’s fiscal 2027 A-list puts final guidance on AI-enabled devices and robotic surgery submissions at the top. 3D printing is not on the list.

Clinical & research

• Printed resin crowns vs zirconia: a one-year randomized trial (Journal of Dentistry, via PubMed). In 56 patients at Yonsei, fracture-free survival was 78.6% for printed resin crowns vs 92.9% for zirconia, a difference that was not statistically significant. Fit and patient satisfaction were similar. Printed crowns wore about six times more, and 7 of 8 fractures were on the back-most teeth. Fine for some cases; not yet a zirconia replacement for molars.
• Printed vs thermoformed finger orthoses (3D Printing in Medicine, via VoxelMatters). In a pilot with 20 occupational therapy students, printed trigger-finger orthoses scored higher on fit, comfort and durability and cut hands-on labor. They took more total time and material cost. Small and not randomized.
• MLATE V3: open-source AI for printable scaffolds (Biofabrication, via PubMed). A Polish Academy of Sciences team released an open dataset of 2,646 samples and a free tool that predicts printability and cell response before printing, then ranks bioink formulations. Fewer failed prints, if it generalizes.

Also this week

Dental and devices

• Graphy signs a $1.3M dental resin supply deal with MegaGen (VoxelMatters). High-ceramic resin for long-term crowns. Cleared in Korea; FDA and CE marking pending.
• IOT and VisionLab sell volumetric 3D printed progressive lenses (VoxelMatters). Each lens cures in one light exposure, on sale in Spain since Oct 6.

Research

• Light-based bioprinting for clot-prone vessels in women (Science Advances, via PubMed). A Sydney perspective on patient-specific vessel models for cerebral venous sinus thrombosis and carotid web.
• 3D printed lattices that map their own damage (Engineer Live). Glasgow and Sydney locate damage to about one strut before failure. Implants are a possible future use.

Industry and physical AI

• Stryker CEO Kevin Lobo to step down (MedTech Dive). COO Spencer Stiles takes over Jan 1. Stryker is a major maker of 3D printed orthopedic implants.
• Neura Robotics brings a logistics robot to hospitals (Robotics & Automation News). Moves beds and sterile goods, leased as a service.
• The physical world is AI’s next bottleneck (3D Printing Industry). Opinion: physical AI lacks internet-scale data, so hospitals and factories will have to make it.

Community

• Bambu Lab and seven accessibility groups launch an assistive-device challenge (3DPrint.com). 24 design briefs, including from e-NABLE France and Rancho Los Amigos. Entries due Nov 15.

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The post The Pharmacy Wants to Be the Factory | The Lattice Brief (10/11/26) appeared first on 3DHeals.

3D-printed drugs are medicines made layer by layer, allowing you to tailor each tablet’s dose, shape, and release profile to a single patient, sometimes combining several drugs into one tablet. This guide to pharmaceutical 3D printing covers how 3D-printed medicines are made, their uses and benefits for patients, the technical, regulatory, and financial challenges, the key companies, and how the FDA, the UK, and the EU now regulate point-of-care printing.

Updated October 2026. New developments are marked “Update (October 2026)” in each section, and summarized in the last section, “What has changed since August 2025?”

With advances in 3D printing technology, materials, and formulations, the number of research publications [Figure 1] and startups in the space has increased. The intrinsic advantages of additive manufacturing include mass customization and complexity for free, empowering pharmaceutical professionals in creating innovative solutions. Spritam by Aprecia, a seizure medication with a quick-release profile approved in 2015, remains the only FDA-approved 3D-printed medication, but more newcomers are successfully challenging the regulatory barriers. For example, Chinese startup Triastek received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its first 3D-printed drug product, T19, a rheumatoid arthritis medication. Triastek’s gastric-retention anticoagulant T20G received FDA IND clearance in February 2025. An upcoming European/UK regulatory update on point-of-care 3D printing may enable widespread adoption of 3D printing in extemporaneously compounded medications, per Anna Worsley from FabRx at a recent 3DHEALS conference on the same subject.

Update (October 2026): The UK update is now in force (July 23, 2025), and FDA has proposed its own distributed manufacturing pathway. See the regulatory section below. Our August 14, 2025 webinar, 3D Printed Pharmaceuticals, brought together Alvaro Goyanes (FABRX), Seng Han Lim (Craft Health), Niklas Sandler (CurifyLabs) and Thomas Forbes (NIST). Read the event recap or watch the full session on demand.

In this guide, we will address the major questions related to 3D-printed drugs. This guide does not include discussion related to other 3D-printed drug delivery medical devices. The following main questions will be addressed:

1. What additive manufacturing processes are used to 3D print pharmaceuticals?
2. What are the major additive manufacturing applications of 3D-printed drugs?
3. How can 3D-printed drugs benefit patients?
4. Some of the major technical challenges facing the industry
5. What are the key regulatory questions and challenges facing the industry?
6. What are the main financial challenges facing the industry?
7. Who are the major players in the space?
8. What are some of the latest industrial trends?
9. What has changed since August 2025? (new)

Figure 1. Number of publications focusing on “3D printed drugs” by year

Which additive manufacturing process has been used to 3D print pharmaceuticals?

About seven major manufacturing processes are used to 3D-print pharmaceuticals. Startups working in the area are indicated next to the process types below:

1. Vat Photopolymerization
   1. SLA
   2. DLP – FabRx
2. Material Jetting
3. Binder Jetting – Aprecia (ZipDose, used for Spritam)
4. Powder bed fusion
   1. SLS – FabRx, Sinterit
5. Material Extrusion:
   1. FDM (Fused Deposition Modeling) – FabRx, CraftHealth, Nourish3d
   2. DPE (Direct Powder Extrusion) – FabRx
   3. MED (Melt Extrusion Deposition) – Triastek
   4. SSE (Semisolid Extrusion) – FabRx, Craft Health (CraftMake), CurifyLabs, MB Therapeutics
6. Direct Energy Deposition
7. Sheet Lamination
8. 3D Screen Printing – Laxxon Medical

A new 3D printing method, 3D Screen Printing, was recently introduced to the market by Laxxon Medical, branded as SPID (Screen Printing Innovative Drug). For those interested, you can find the publication here.

Update (October 2026): Semi-solid extrusion has become the main printing process in pharmacies and hospitals because it runs at low temperatures and suits chewables and small batches. GMP-certified printers built on this platform, such as FabRx’s M3DIMAKER and Craft Health’s CraftMake, are now being placed in hospitals and pharmacies. FABRX co-founder Alvaro Goyanes compares the M3DIMAKER to a single-serve coffee machine for the compounding pharmacy in Lattice Podcast Episode 112.

What are the major applications of 3D-printed drugs? 

The greatly increased design freedom in 3D-printed tablets allows more customization across many aspects of existing pharmaceuticals. Here we list some of the major applications and potential markets as follows:

1. Well-controlled complex release profile by design. This largely depends on the complexity of geometry, according to Professor XiaoLing Li (Triastek) during the 3DHEALS conference.
2. Polypills
3. Pattern (e.g. Braille, data matrix)
4. Color
5. Taste
6. Different formulations (e.g., chewable tablets)
7. Dosage

Update (October 2026): Dosage is where most clinical activity now sits: exact doses for one patient, printed in the hospital or pharmacy, mostly for children and rare diseases. Polypills are next: at our 3D Printed Pharmaceuticals event, FABRX described combining several extrusion methods in one printer to make them.

How can 3D printed drugs (potentially) benefit patients?

1. Personalization of tablets with unique release profiles that fit a patient’s unique biometrics (i.e. weight, size, metabolism, renal function, etc.) For example, the team at Craft Health published a paper on an in vitro study of targeted release at different locations in the colon.
2. Improved compliance – For example, better flavor, color, and texture for pediatric patients. For example, this published meta-review summarized a variety of pediatric medications that can be 3D printed via various processes to improve patient palatability/compliance.
3. Decentralized drug delivery process – For example, researchers at FabRx published a paper demonstrating a smartphone based 3D printing process that can allow patients to create variable tablets fitting their treatments at home.
4. Significant reduction in formulation development time, i.e. “rapid prototyping”
5. Reducing batch manufacturing cost, perfect for personalized medicine.
6. Revival of some abandoned drugs due to small target market
7. “Endless (design) possibilities”
8. Extension of expiring patents or generics for pharmaceutical companies.

Update (October 2026): what the clinical evidence shows so far. The 2026 review by Gioumouxouzis and colleagues counted 10 clinical studies and one community-pharmacy study. The best-known comes from Santiago de Compostela, Spain. Four children with maple syrup urine disease took printed chewable isoleucine for six months. Their blood levels sat closer to target and varied less than with hand-filled capsules (Goyanes et al., 2019). A follow-up at the same hospital used a GMP-compliant printer for six children with three metabolic disorders. Other studies include a non-randomized comparison in 91 premature infants receiving levothyroxine, and bioequivalence studies in healthy volunteers. In a Madrid community pharmacy, FabRx reported cost reductions of up to 35% for printed minoxidil capsules compared with manual compounding (nine patients). In October 2026, a doctoral thesis from Åbo Akademi University and its spin-off CurifyLabs examined dose accuracy for pharmacist-dispensed printed gels. At our August 2025 event, FABRX said it has taken part in more than 30 hospital clinical trials (recap). In Episode 112, Goyanes also describes a printed hydroxyurea project for children with sickle cell disease, in collaboration with a team in Montreal.

Some of the major technical challenges facing the industry:

As with any emerging technology in healthcare, there are several challenges before the industry can be widely adopted and scaled. These are identified as some of the major challenges: 

1. Lack of 3D-printable, safe materials for 3D-printed drugs. Importantly, many 3D printing processes involve heating, which limits the number of APIs to non-thermally sensitive ones.
2. There is limited knowledge on matching 3D printing processes with APIs (Active Pharmaceutical Ingredients). However, we have made a lot of progress then. The creative design also helps. For example, it is hard to 3D print insoluble APIs, but some startups are tackling this challenge by creating compartments that can contain the insoluble components. 
3. Lack of long-term clinical validation.
4. Inability to scale to the same level as conventional mass manufacturing methods. While none of the current 3D printing drug manufacturing processes can achieve the same production volume as traditional powder compression techniques, MED (Triastek) and SPID (Laxxon) seem most promising for high-volume production.
5. Lack of well-defined quality control process

Update (October 2026): Two further challenges stand out as printing moves into pharmacies. First, quality control for a batch that is one patient’s supply needs non-destructive testing, such as near-infrared or Raman spectroscopy, and those methods still need validation. Second, results depend on trained operators, written procedures, and validated cleaning between products. Early hospital studies used food-grade or non-GMP printers, so their results are proof of concept only. Vendors are building checks into the machine: FABRX’s printers carry a balance, a pressure sensor, a camera, and AI-based monitoring (Episode 112), and CraftHealth uses pre-mixed inks that need no heating or UV curing. NIST is applying FDA’s Quality by Design framework to measure dose variability at point-of-care sites (event recap).

What are the key regulatory questions and challenges facing the industry?

While FDA-approved 3D-printed drugs are currently scarce, as noted at the beginning of this article, the uptick in research activity [Figure 1] suggests more commercialization in the space. In fact, the FDA CDER (Center for Drug Evaluation and Research) already has dedicated resources in the space, indicating a cleaner future drug approval process. 

The top questions FDA wanted to address also parallel the top regulatory challenges. Drug and equipment developers should pay close attention to the following technical questions: 

1. What critical parameters affect the printability of various materials for drug products? 
2. What are the critical process parameters for each 3D printing technology? 
3. How can we assess the performance of 3D-printed drug products? 
4. Can we use traditional in vitro testing methods for 3D-printed drug products? 
5. How can we determine when and how a specific 3D geometric design may not perform as expected? 
6. What are the critical characteristics of intermediate products for 3D printing, such as 3D-printing inkjet inks, filaments, substrates, and cartridges? 
7. What critical factors in 3D-printed design affect drug release rates and mechanisms?

Additional regulatory challenges from the FDA perspective also include the following: 

1. To what extent can the 3D-printing process be controlled to ensure the quality of 3D-printed drug products? For example, consider the multiple components associated with 3D printing processes, namely 3D printers, printing materials, and intermediate products and processes. 
2. What are the best ways to address existing questions while recognizing that the technology is changing rapidly? 

Update (October 2026): new rules for printing at the point of care.

• United States. On July 13, 2026, FDA proposed a registration pathway for distributed manufacturing. A central hub’s quality unit would control a network of identical manufacturing units registered as one establishment. Comments closed September 11, 2026. The proposal does not cover pharmacy compounding. Printed doses made by a pharmacy for an individual prescription remain compounded drugs, which are not FDA-approved, and the pharmacy carries the quality burden.
• United Kingdom. The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations came into force on July 23, 2025. A licensed control site holds a Decentralised Manufacturing Master File and oversees the point-of-care sites under it. Centralised manufacture remains the default, and each designation needs a justified clinical benefit (MHRA).
• France. In October 2026, ANSM authorized MB Therapeutics as a pharmaceutical establishment to make printing cartridges for hospital pharmacies.
• European Union. 3D printing is on the European Medicines Agency’s list of enabling technologies followed by its Quality Innovation Group, but there is no EU-wide point-of-care framework yet.

The open questions are now practical. Who releases each batch? Who reports adverse events? Who runs a recall across many sites? At our 3D Printed Pharmaceuticals event, CurifyLabs argued that printing dosage forms already listed in pharmacopeias may ease regulators’ concerns, and that a shared formulation library lets pharmacies reuse validated templates.

Some of the main financial challenges facing the industry:

1. Extemporaneously compounding may not be a profitable enough business model for technology startups to survive. 
2. Larger pharmaceutical players are still hesitant to adapt. Partly, this is because the 3D-printed drug industry is still early with many technical and regulatory challenges mentioned above. However, this attitude is clearly changing lately due to a combination of expiring patents and new U.S. Medicare pricing legislation shortening the pricing power of new small molecule drugs.

Update (October 2026): Startups are answering the first point with a razor-and-blade model: place printers in pharmacies, then sell validated formulations, cartridges, and software. PharmaTher’s CraftMake network and CurifyLabs’ Pharma Printer, with its formulation library, follow this pattern. Published cost estimates for hospital-printed hydrocortisone run from about €1.58 to €3.11 per formulation, depending on batch size and quality assurance (Gioumouxouzis et al., 2026). Our speakers also discussed the economics of compounding pharmacies as demand for GLP-1 medications grows (on-demand session), and FABRX is expanding into the US through Pete Pharma (Episode 112).

Who are the major players in space? 

1. Researchers (complete list to come)
   1. UCL
   2. NUS

2. Startups – (Updated version of this group can be found in 3DHEALS Company Directory)
   1. Aprecia
   2. Triastek
   3. Crafthealth
   4. FabRx
   5. Laxxon
   6. Nourished
   7. Natural Machines
   8. CurifyLabs
   9. Doser
   10. Amply Discovery
   11. goatAM
   12. MB Therapeutics

3. Larger pharmaceutical Companies
   1. GSK
   2. Procter and Gamble
   3. Merck
   4. Evonik

Update (October 2026): PharmaTher (Canada) became Craft Health’s exclusive North American distributor on October 1, 2026, and is placing CraftMake printers in US compounding pharmacies. MB Therapeutics became the first company licensed in France to make printing cartridges as a pharmaceutical manufacturer. Universidade de Santiago de Compostela, working with FabRx, has run the best-known hospital studies of printed medicines in children. In the UK, University Hospital Southampton acquired a GMP-certified FabRx M3DIMAKER in March 2025 for pharmacist-led research. We have tracked PharmaTher’s move in The Lattice Brief (August 8, 2026), when it began testing GMP peptide printing on Craft Health’s platform for 503A compounding pharmacies, and in The Lattice Brief (August 14, 2026).

What are some of the latest industrial trends? 

1. Holistic innovation process – Almost all the companies at the recent 3DHEALS conference described a holistic approach to scaling up their technologies. These include:
   1. Software/Database innovation
      1. Heavy reliability on existing materials, design database
      2. Artificial intelligence and machine learning in future formulation development
      3. Software development:
         1. FabRx in fact has a currently free software researchers can try out: https://m3diseen.com/predictions/
         2. Many companies have dedicated software targeting both formulation development and manufacturing process.
   2. Design to scale up manufacturing using other emerging technologies such as robotics and automation to achieve continuous manufacturing processes.
2. Orphan drug – Given current limitations in mass quantity production, most companies are now focusing on orphan drugs which could be a perfect economical fit. 
3. Nutrition – While personalized nutrition has been a past innovation target in the space, with the advancements in 3D printing technologies and digital health at large, the chance of succeeding in the space economically is potentially higher. 
4. Personalization 
5. More decentralized delivery – For example, patients can create personalized tablets at home with a smartphone as described earlier in this article. 
6. Patent extension of expiring drugs or generics.

Update (October 2026): A seventh trend is printing moving into the pharmacy. GMP printers, licensed cartridges and formulation libraries are turning point-of-care printing into a product. Regulators in the UK, the US and France have all acted in the past 15 months. At the industrial end, Triastek’s second US IND (T20G, February 2025) and Laxxon’s new formulation data keep the scale-up route alive.

What has changed since August 2025?

A quick summary of the updates made throughout this guide:

• The UK point-of-care rules are now in force. The “upcoming European/UK regulatory update” we mentioned took effect on July 23, 2025. The UK Medicines and Healthcare products Regulatory Agency (MHRA) now runs a decentralised manufacture framework in which a licensed control site oversees point-of-care sites. MHRA lists 3D-printed products that can only be made at the point of care as one example.
• FDA proposed a distributed manufacturing pathway (July 13, 2026). A network of identical manufacturing units could register as one establishment under one quality system run by a central hub. Comments closed September 11, 2026. The proposal does not address pharmacy compounding.
• France licensed the first cartridge maker (October 2026). France’s medicines agency (ANSM) granted MB Therapeutics pharmaceutical establishment status to make semi-solid cartridges that hospital pharmacies load into its printers. GMP compliance at the facility was still in progress at the time.
• Printers are heading into US compounding pharmacies. PharmaTher became Craft Health’s exclusive North American distributor on October 1, 2026, and plans a network of CraftMake printers starting with 503A compounding pharmacies. It is targeting up to 50 placements in 12 months and a New Drug Application for a rare pediatric therapy by late 2028 (company targets).
• The clinical evidence has been counted. A 2026 review in Drug Delivery and Translational Research (Gioumouxouzis et al.) found 10 clinical studies and one community-pharmacy study of printed medicines. Most were single-centre and short, with small cohorts.
• Laxxon reported new data. In August 2025, Laxxon Medical announced a development milestone for a modified-release form of Veru’s enobosarm made with SPID. In December 2025, it reported higher bioavailability for its levodopa/carbidopa form (LXM.5) than Sinemet, in a study published in Pharmaceutics (company-reported).
• From 3DHEALS. Our August 2025 3D Printed Pharmaceuticals event (now an on-demand course), Lattice Podcast Episode 112 with FABRX’s Alvaro Goyanes (May 2026), and ongoing coverage in The Lattice Brief.
• Spritam is still alone. We found no second FDA-approved 3D-printed drug as of October 2026 (2015 approval).

Related Articles:

Upcoming 3DHEALS events

3D Printed Pharmaceuticals (Course, 2025 panel with FABRX, Craft Health, CurifyLabs and NIST)

Event Recap: 3D Printed Pharmaceuticals

Episode 112: Automating Compounding Pharmacies with FabRx 3D Printing

3D Printed Drugs (Course)

3D Printing of Drugs (3DHEALS conference)

3D Printing Pharmaceuticals and Drug Delivery Devices (From Academia)

Interview with Tom Bradbury: Aprecia

Interview with Dr. Wei Jiang GOH: Crafthealth

Interview with Prof. Huang Dejian: Kosmodehealth

Interview with Kyle Von Hasseln: 3D Printing Food

The post 3D Printed Drugs – Guide (Updated 10-12-2026) appeared first on 3DHeals.

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.

Subscribe to The Lattice Brief

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/

The post Episode #128 | BioTools Can Beat Moonshots with Jim West appeared first on 3DHeals.