From Prototype to Production
Metal and polymer additive manufacturing (3D printing), plus precision metal finishing, under one ISO 13485-certified quality system in Charlotte, NC.
While many projects start with flexible prototyping using additive manufacturing, the Kapstone team has the experience needed to validate and scale additive processes and materials for production.
What Does it Mean to Be a CDMO+?
To the team at Kapstone Medical and Kapstone Manufacturing it means we are set up to streamline the process of getting new medical devices to market and to scale production as demand grows. We don't limit our customers to build-to-print or high-volume manufacturing.
For example, a medical device startup may choose to begin with an additive manufacturing method for certain components for prototyping, bridge production, and even low-volume ongoing production to take advantage of flexibility before design lock and to avoid tooling cost. However, when the demand and production volumes reach a certain level higher volume production methods may be economically justified.
The Single-Source Advantage
One benefit of working with Kapstone Medical and Kapstone Manufacturing as a single-source partner is the ability to design for and manage multiple manufacturing processes without managing multiple vendors. We are process and material agnostic, meaning that we help our clients identify the right fit for their medical device whether that be through additive or traditional manufacturing methods or both.Capabilities
Metal Additive Manufacturing
We print metal parts on an SLM 280 2.0 laser powder-bed fusion system, which produces dense, functional components in medical-grade alloys, such as those used for surgical instruments. We provide finished metal AM components from functional prototypes to production.
| SLM 280 2.0 | Metal Laser Powder-Bed Fusion (PBF-LB/M) |
| Optics | Twin 400W IPG fiber laser |
| Build Envelope | 280 × 280 × 365 mm |
| Layer Thickness | 20–75 µm |
| Minimum Feature | 150 µm |
| Materials | 316L & 17-4 stainless steel printed in-house; Additional alloys such as Ti6Al4V ELI (Grade 23); CP titanium (Grade 2); cobalt chrome; and more available on request. |
Typical applications: orthopedic and spinal implants, surgical instruments, and other load-bearing metal components.
Polymer Additive Manufacturing
For polymer additive manufacturing we match the process to your application requirements. We have several processes in-house and will evaluate additional processes and materials as needed.
| Printer | Process | Build Envelope | Typical Resolution | Typical Materials | Best for |
| Formlabs Form 4B | Masked stereolithography (MSLA) | 200 × 125 × 210 mm | 50 µm XY; 25–200 µm Z | BioMed Elastic 50A; 38 Formlabs materials (15 biocompatible) & third-party | Biocompatible functional prototypes & end-use parts |
| Formlabs Fuse 1 | Selective laser sintering (SLS) | 165 × 165 × 300 mm | 200 µm spot; 110 µm layer | Nylon 12 (PA12), Nylon 11 (PA11), Nylon 12 GF, TPU 90 | Durable, support-free nylon parts; jigs & fixtures |
| EnvisionOne cDLM XL | Continuous digital light mfg. (cDLM) | 180 × 101 × 175 mm | 60 µm XY; 50–150 µm Z | Loctite 3843, Loctite Med 413, Loctite IND405, E-Rigidform, medical-grade photopolymer | High-throughput, fine-feature photopolymer parts |
Metal Finishing
Additively manufactured metal parts almost always require post-processing steps for critical features and surface finish requirements. For small parts requiring smooth surfaces up to a mirror finish without losing critical dimensions and features we bring finishing in-house with DLyte dry electropolishing (DLyte 100Pro) and vibratory finishing. This means that metal AM components can go from print up to a mirror surface under the same roof and the same quality system. DLyte uses a dry electrolyte (no liquid baths) and is non-abrasive, refining the surface while preserving fine additive features and edges.
Three ways we put DLyte Dry Electropolishing to work:
- Additive finishing: post-process SLM 280 metal parts from raw print to a clinically ready surface.
- Contract finishing: send us machined, cast, or printed parts in any DLyte-compatible alloy for a uniform, repeatable finish across the cycle.
- Feasibility & evaluation: run your own geometries on a production-class 100Pro to benchmark surface finish, throughput, and process fit before you invest in the equipment. Deliverables include before/after Ra and dimensional metrology, process documentation, and photos.
| DLyte 100Pro | Dry Electropolishing |
| Surface finish | < 0.1 µm Ra (mirror) |
| Finish envelope | Ø 180 mm × 115 mm |
| Max load / cycle | 8 kg (17.6 lb) |
| Compatible alloys | Stainless, cobalt chrome, titanium, Nitinol, copper-, nickel-, aluminum-based |
| Process | Dry electrolyte — no liquid baths; non-abrasive |
| Quality system | ISO 13485 |
Application Highlight — Metal Additive Manufacturing and Finishing for the DanaMed Pathfinder™ ACL Guide
Kapstone Manufacturing produces this reusable surgical guide in 316L stainless steel on our SLM 280 metal 3D printer and does final surface finishing to obtain mirror finish with DLyte dry electropolishing — a single-source workflow under one ISO 13485 quality system, for a fellow Charlotte, NC medical device company.
Ready to get to work?
If Kapstone sounds like the right fit for your business or you have further questions, please reach out to our team.
