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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