Case Study: TraTek Inc achieves rapid, precision medical-device machining and ISO 13485 compliance with 3D Systems

Medical Start-Up Builds Healthy Practices with GibbsCAM CNC Software

TraTek Inc., founded by Paul Beckwith in 2010 in Noblesville, IN, is a small medical‑device machining start‑up focused on implantable devices and surgical instruments. The primary challenge was entering a tightly regulated market: TraTek needed ISO 13485 certification, documented repeatability and part traceability, and the capability to machine complex five‑axis parts while keeping lead times and costs competitive.

TraTek met that challenge by hiring ISO and machining experts, equipping the shop with four CNCs (Willemin‑Macodel and Citizen), and standardizing on GibbsCAM for programming and simulation. Doing heat‑treating, finishing and inspection in‑house shortened turnarounds, improved process control, and earned one of the best first audits the auditor had seen. The result: fast, fully documented prototype and short‑run production for FDA testing and approval, solid traceability, lower costs, and a platform for measured growth.

TraTek Inc

Paul Beckwith

Founder