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

The big thing

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

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

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

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

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

Regulatory watch

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

Clinical & research

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

Also this week

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

From 3DHEALS

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

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