# Bio-printing filaments (medical) Bio-printing filaments (medical) are bioresorbable polymer materials extruded into filament or fiber form for 3D-printed medical devices that dissolve in the body as natural tissue regrows: Singapore's Osteopore 3D-prints polycaprolactone-tricalcium-phosphate bone scaffolds, clinically used for critical-sized bone defects and now expanding into China. Germany's Evonik and the Netherlands' Corbion supply FDA-approved, GMP-grade bioresorbable polymer feedstock (RESOMER and PURASORB) to device makers, while South Carolina's Poly-Med vertically integrates polymer synthesis, filament extrusion and finished absorbable-device manufacturing under one roof. Source: https://en.bioecon.ru/technology/bio-printing-filaments-medical/ Updated: 2026-08-18 ## Overview and value chain Markers: [EC: US FDA medical device / bioresorbable implant clearance pathway | EU MDR & REACH chemical registration for bioresorbable polymer medical devices | China NMPA medical device approval | OECD: Bio-based materials | Regulator: FDA (USA), REACH (EU), NMPA (CN)] Bio-printing filaments (medical) are bioresorbable polymers — chemically distinct from the general-purpose PLA filaments covered elsewhere in this catalog — extruded into filament, fiber or feedstock form specifically for 3D-printed medical devices designed to dissolve inside the body as natural bone or tissue regrows around them. The Industry splits into device-maker and feedstock-supplier layers: Singapore's Osteopore 3D-prints polycaprolactone-tricalcium-phosphate (PCL-TCP) bone scaffolds via fused deposition modeling, with clinical case reports documenting use in critical-sized bone defects and a first custom implant delivered to a Hainan, China hospital in July 2026; Germany's Evonik supplies its RESOMER and LACTEL bioabsorbable polymer portfolio — built over 30+ years — to device makers for orthopedic, dental and parenteral drug-delivery applications; the Netherlands' Corbion supplies FDA-approved, GMP-grade PURASORB bioresorbable polymer grades used in additively manufactured bioresorbable stents and implant prototyping; and South Carolina's Poly-Med vertically integrates polymer synthesis with extrusion into 3D-printing filaments, monofilament fibers and biomedical textiles, offering device makers a single CDMO partner from raw polymer to finished absorbable implant. The key directions of bio-printing filaments (medical) are: 1. **Bioresorbable PCL FDM bone scaffolds:** Osteopore 3D-prints polycaprolactone-tricalcium-phosphate scaffolds via fused deposition modeling, documented in clinical case reports for critical-sized bone defect repair (including a calcaneal fracture case), and delivered its first custom orthopaedic implant to the Hainan branch of Shanghai Ruijin Hospital in July 2026. 2. **Bioresorbable polymer feedstock for medical additive manufacturing:** Evonik's RESOMER and LACTEL portfolios supply bioabsorbable polymer excipients and biomaterials to medical technology companies across orthopedics, dental care and parenteral controlled-release drug delivery, drawing on over 30 years of biomaterials development. 3. **FDA-approved bioresorbable implant polymer grades:** Corbion's PURASORB polymer grades (including PDLG copolymer formulations) are FDA-approved, GMP-grade materials increasingly used in additively manufactured bioresorbable stents and other implant prototypes, where polymer-grade selection is a device-performance design decision, not just a procurement one. 4. **Vertically integrated bioresorbable filament-to-device manufacturing:** Poly-Med extrudes its bioresorbable polymers directly into 3D-printing filaments, multifilament yarns, monofilament fibers and electrospun nanofibrous materials, and offers device makers vertically integrated CDMO services spanning absorbable orthopedic implants, craniomaxillofacial devices and biomedical textiles from a single polymer source. ### Sectoral value chain ``` [bioresorbable polymer synthesis (PLA/PLGA/PCL grades)] ──> [extrusion into 3D-printing filament / fiber form] │ (FDM/FFF 3D printing into device or scaffold geometry) │ ▼ [surgical implantation & clinical use] <─── [sterilization & regulatory clearance] <─── [device fabrication & finishing] ``` ### Value chain levels | Level | Description | Key inputs/outputs | |:---|:---|:---| | **Bioresorbable polymer synthesis** | PLA, PLGA and PCL polymer grades (Evonik RESOMER/LACTEL, Corbion PURASORB, Poly-Med's own polymer synthesis) | **In:** lactide, glycolide, caprolactone monomers. **Out:** implant-grade, FDA-approved or GMP-grade bioresorbable polymer resin. | | **Filament / fiber extrusion** | extrusion of bioresorbable polymer resin into 3D-printing filament, monofilament fiber or multifilament yarn (Poly-Med); polymer supplied to device makers as feedstock for their own extrusion (Evonik, Corbion) | **In:** bioresorbable polymer resin. **Out:** 3D-printing filament, fiber or yarn feedstock. | | **Medical 3D printing / device fabrication** | fused deposition modeling of PCL-TCP bone scaffolds (Osteopore); additive manufacturing of bioresorbable stents and implant prototypes (using Corbion's PURASORB grades); CDMO device fabrication from filament to finished implant (Poly-Med) | **In:** 3D-printing filament or fiber. **Out:** printed scaffold, implant or biomedical textile. | | **Sterilization & regulatory clearance** | FDA clearance pathways for bioresorbable implants (US); EU MDR conformity assessment alongside REACH chemical registration (EU); NMPA medical device approval (CN, relevant to Osteopore's China delivery) | **In:** fabricated device. **Out:** sterilized, regulatory-cleared implantable medical device. | | **Surgical implantation & clinical use** | critical-sized bone defect repair, craniomaxillofacial reconstruction, orthopedic hard-tissue anchoring and tendon-healing augmentation, bioresorbable vascular stenting | **In:** cleared device. **Out:** implanted device supporting tissue repair. | | **Bioresorption & tissue integration fate** | the polymer scaffold or device gradually degrades in vivo over a period of months to years as it is replaced by the patient's own regenerating bone or tissue, eliminating the need for a second surgery to remove hardware | **In:** implanted device. **Out:** resorbed polymer, regenerated native tissue, avoided implant-removal surgery. | Cross-cutting technologies of the sector: - **Bioresorbable PCL FDM bone scaffold (Bioresorbable PCL FDM Bone Scaffold):** Osteopore's fused-deposition-modeling process for polycaprolactone-tricalcium-phosphate scaffolds, clinically documented for critical-sized bone defect repair. - **Bioresorbable polymer feedstock for medical additive manufacturing (Bioresorbable Polymer Feedstock for Medical Additive Manufacturing):** Evonik's RESOMER and LACTEL bioabsorbable polymer portfolio, supplied as biomaterial feedstock across orthopedic, dental and drug-delivery device manufacturing. - **FDA-approved bioresorbable implant polymer grade (FDA-Approved Bioresorbable Implant Polymer Grade):** Corbion's PURASORB polymer grades, FDA-approved and GMP-grade, used in additively manufactured bioresorbable stents and implants. - **Vertically integrated bioresorbable filament-to-device manufacturing (Vertically Integrated Bioresorbable Filament-to-Device Manufacturing):** Poly-Med's single-source pipeline from bioresorbable polymer synthesis through filament/fiber extrusion to finished absorbable medical device and biomedical textile manufacturing. --- ## US The US contributes the vertically integrated feedstock-to-device layer of this Industry: South Carolina's Poly-Med extrudes its own bioresorbable polymers into 3D-printing filament and offers device makers a single CDMO partner from raw polymer to finished absorbable implant. ### Poly-Med's vertically integrated bioresorbable polymer-to-filament-to-device pipeline - **Poly-Med, Inc. (Anderson, South Carolina, USA):** provides fully traceable, implant-grade bioresorbable polymers that can be processed by injection molding, extruded into multifilament yarns, monofilament fibers, films and 3D-printing filaments, or electrospun into nanofibrous materials; the company's vertically integrated model — "from polymer to finished device" — extends to absorbable orthopedic and craniomaxillofacial implantable medical devices and absorbable biomedical textile manufacturing, positioning it as a CDMO partner rather than a filament-only supplier. - **US FDA bioresorbable implant clearance:** bioresorbable orthopedic and craniomaxillofacial devices fabricated from Poly-Med's filament and fiber feedstock are subject to FDA medical device clearance pathways specific to absorbable implants, distinct from the general consumer-product regulatory framing that applies to non-medical 3D-printing filament. --- ## CN Singapore's Osteopore delivered its first custom orthopaedic implant into China in July 2026 — to the Hainan branch of Shanghai Ruijin Hospital — marking an early cross-border expansion of bioresorbable 3D-printed bone scaffold technology into the Chinese market, though live sourcing this cycle did not confirm a China-headquartered company-specific bioresorbable medical filament or scaffold producer at a comparable scale, so no China-based producer is tabled this cycle. ### Osteopore's first China delivery and China's medical device import pathway without a confirmed domestic originator - **Osteopore's Hainan delivery:** Osteopore Ltd (ASX: OSX), a Singapore company, delivered its first custom orthopaedic device to the Hainan branch of Shanghai Ruijin Hospital on 14 July 2026, an early signal of Chinese clinical demand for bioresorbable 3D-printed bone scaffold technology entering via import rather than domestic manufacturing. - **China's NMPA medical device pathway without a confirmed domestic originator:** China's National Medical Products Administration governs the approval of imported and domestic bioresorbable implantable devices; live sourcing for this Industry found academic literature on 3D-printed bioceramic and biodegradable scaffolds originating from Chinese research institutions, but no confirmed China-headquartered commercial producer of bioresorbable medical 3D-printing filament or finished scaffold devices at the scale of Osteopore, Evonik, Corbion or Poly-Med; a domestic Chinese producer is a candidate for a future enrichment pass. --- ## EU The EU supplies two of this Industry's leading bioresorbable polymer feedstock suppliers: Germany's Evonik and the Netherlands' Corbion, both selling FDA-approved, GMP-grade bioresorbable polymer grades to medical device manufacturers worldwide. ### Evonik's RESOMER/LACTEL portfolio and Corbion's PURASORB polymer grades - **Evonik (Germany):** supplies the RESOMER® and LACTEL® bioabsorbable and bioresorbable polymer portfolios, marketed as degradable medical implant-grade 3D-printing material and as functional excipients for parenteral controlled-release drug delivery; Evonik's biomaterials business spans orthopedic implants (temporary and permanent), dental implants and bone graft substitutes, and dental crown/bridge composite materials, drawing on more than 30 years of biomaterials development. - **Corbion (Gorinchem, South Holland, Netherlands):** supplies the PURASORB® line of FDA-approved, GMP-grade bioresorbable polymers — including PDLG copolymer grades — for medical device formulations; Corbion frames polymer-grade selection as a device-performance design decision (mechanical behavior, in-tissue degradation rate, device survival) rather than a simple procurement choice, and its polymers are increasingly referenced in additive-manufacturing research on bioresorbable vascular stents. - **EU MDR & REACH:** the EU's Medical Device Regulation governs the conformity assessment and clinical-evidence requirements for bioresorbable implantable devices placed on the EU market, while REACH governs the chemical registration of the underlying bioresorbable polymer substances Evonik and Corbion place on the market. --- ## Leading companies and research institutes | Company / Institute | Country | Key products / platforms | Tech features | Status 2026 | |:---|:---|:---|:---|:---| | **Osteopore** | 🇸🇬 Singapore | *PCL-TCP FDM-printed bone scaffolds* | Clinical bone-defect use; first China (Hainan) delivery Jul 2026 | commercial | | **Evonik** | 🇩🇪 Germany | *RESOMER® / LACTEL® bioabsorbable polymers* | 30+ yr biomaterials; orthopedic, dental, parenteral drug delivery | commercial | | **Corbion** | 🇳🇱 Netherlands | *PURASORB® bioresorbable polymer grades* | FDA-approved, GMP-grade; bioresorbable stent additive manufacturing | commercial | | **Poly-Med** | 🇺🇸 United States | *Bioresorbable filament/fiber + device CDMO* | Vertically integrated polymer-to-device; 3D-printing filament extrusion | commercial | --- ## Tech stack and innovations The bio-printing-filaments-medical stack spans the device-maker and feedstock-supplier layers of bioresorbable 3D printing — turning a synthesized polymer into filament, and filament into a clinically deployed device — unified by the requirement that the material resorb safely inside the body. 1. **Bioresorbable PCL FDM bone scaffolds:** - Osteopore's polycaprolactone-tricalcium-phosphate scaffolds are fabricated by fused deposition modeling — the same extrusion-based printing family as general-purpose desktop 3D printing — but with a bioresorbable, tissue-compatible polymer-ceramic composite rather than a permanent plastic, directly enabling clinical use documented in peer-reviewed case reports for critical-sized bone defects. - The company's first custom implant delivery into China (Hainan, July 2026) signals bioresorbable scaffold technology expanding via cross-border clinical adoption ahead of any confirmed domestic Chinese manufacturing competitor. 2. **Bioresorbable polymer feedstock for medical additive manufacturing:** - Evonik's RESOMER and LACTEL portfolios decouple polymer synthesis expertise from device fabrication, letting medical technology companies formulate their own implants, dental devices or drug-delivery systems on a common, decades-proven bioabsorbable polymer base rather than developing bioresorbable chemistry in-house. - Spanning orthopedic, dental and parenteral drug-delivery applications from one polymer portfolio shows bioresorbable polymer feedstock functioning as horizontal infrastructure across multiple medical device categories, not a single-application material. 3. **FDA-approved bioresorbable implant polymer grades:** - Corbion's framing of PURASORB grade selection as a design decision — not a procurement decision — reflects how a bioresorbable polymer's degradation rate and mechanical profile are engineered into the specific clinical application, particularly for demanding uses like additively manufactured bioresorbable vascular stents. - FDA-approved, GMP-grade sourcing gives device makers a regulatory head start, since the base polymer's safety and manufacturing-quality profile is already established before device-specific clinical evidence is generated. 4. **Vertically integrated bioresorbable filament-to-device manufacturing:** - Poly-Med's single-source model — synthesizing the bioresorbable polymer and then extruding it directly into 3D-printing filament, fiber, yarn or electrospun nanofibrous form — removes the hand-off between polymer chemistry and filament production that otherwise separates feedstock suppliers like Evonik and Corbion from device-fabrication customers. - Extending vertical integration into finished absorbable orthopedic implants, craniomaxillofacial devices and biomedical textiles positions Poly-Med as a full CDMO rather than a materials supplier, a distinct business model from the feedstock-only approach of Evonik and Corbion. --- ## Value chains and production pipelines ### Industrial pipeline of bio-printing filaments (medical) (from bioresorbable polymer synthesis to resorbed clinical implant) ``` ┌───────────────────────────┐ ┌───────────────────────────┐ │ 1. Bioresorbable polymer │ ───> │ 2. Filament / fiber │ │ synthesis │ │ extrusion │ └───────────────────────────┘ └───────────────────────────┘ │ ▼ ┌───────────────────────────┐ ┌───────────────────────────┐ │ 4. Sterilization & │ <─── │ 3. Medical 3D printing / │ │ regulatory clearance │ │ device fabrication │ └───────────────────────────┘ └───────────────────────────┘ │ ▼ ┌───────────────────────────┐ ┌───────────────────────────┐ │ 5. Surgical implantation │ ───> │ 6. Bioresorption & │ │ & clinical use │ │ tissue integration fate │ └───────────────────────────┘ └───────────────────────────┘ ``` #### Stage 1: Bioresorbable polymer synthesis Lactide, glycolide and caprolactone monomers feed Evonik's RESOMER/LACTEL polymer synthesis in Germany, Corbion's PURASORB polymer synthesis in the Netherlands, and Poly-Med's own bioresorbable polymer synthesis in South Carolina, USA. #### Stage 2: Filament / fiber extrusion Poly-Med extrudes its bioresorbable polymer directly into 3D-printing filament, monofilament fiber, multifilament yarn or electrospun nanofibrous material; Evonik and Corbion supply their polymer grades as feedstock to device makers such as Osteopore, who perform their own extrusion and printing. #### Stage 3: Medical 3D printing / device fabrication Osteopore fabricates polycaprolactone-tricalcium-phosphate bone scaffolds via fused deposition modeling in Singapore; Corbion's PURASORB grades are additively manufactured into bioresorbable vascular stents and implant prototypes in research and device-development settings; Poly-Med fabricates finished absorbable orthopedic, craniomaxillofacial and biomedical textile devices from its own filament and fiber feedstock. #### Stage 4: Sterilization & regulatory clearance Osteopore's scaffolds and Poly-Med's devices proceed through FDA and equivalent regulatory clearance pathways specific to bioresorbable implants; Evonik's and Corbion's polymer grades carry FDA-approved, GMP-grade status as feedstock; Osteopore's Hainan delivery proceeds through China's NMPA medical device import pathway. #### Stage 5: Surgical implantation & clinical use Osteopore's scaffolds are surgically implanted for critical-sized bone defect repair, documented in case reports including a calcaneal fracture and now in clinical use at Shanghai Ruijin Hospital's Hainan branch; Corbion's PURASORB-based devices are researched and developed toward bioresorbable vascular stenting; Poly-Med's devices are implanted for orthopedic hard-tissue anchoring, tendon-healing augmentation and craniomaxillofacial reconstruction. #### Stage 6: Bioresorption & tissue integration fate Osteopore's PCL-TCP scaffolds, Evonik's and Corbion's polymer-based devices, and Poly-Med's absorbable implants and textiles all gradually degrade in vivo over months to years as the patient's own bone or tissue regenerates in their place, eliminating the need for a second surgery to remove permanent hardware.