Case Study: Opus KSD achieves FDA approval and market launch of the SubQ It! bio-absorbable surgical stapler with Protolabs

Digital Manufacturing Helps Medtech Company Revolutionize Surgical Stapler

OPUS, a Massachusetts-based medtech company led by Chuck Rogers and Kenneth Danielson, developed the SubQ It! — a disposable handheld stapler that delivers bio‑absorbable subcutaneous fasteners — and needed to turn tiny, delicate fasteners and a multipart delivery device into manufacturable, sterile, end‑use products. OPUS partnered with Protolabs for rapid prototyping and low‑volume production, using 3D printing (FDM and SLA), CNC machining and injection molding to iterate parts and validate form, fit and function.

Protolabs milled prototype components with molding‑intent design, helped OPUS refine the nine plastic parts, and transitioned successful designs into injection‑molded, FDA‑grade materials; this accelerated development, enabled trademark and patent protection, secured FDA approval for multiple surgical applications, and supported a commercial launch. Protolabs continues to help OPUS ramp production to meet rising demand and support planned expansion into veterinary use.

OPUS

Chuck Rogers

Chief Executive Officer