Kapstone Medical, LLC

About Kapstone Medical, LLC

Kapstone Medical, LLC was founded in 2007 by John Kapitan in Charlotte, North Carolina. After 15 years as a design engineer and regulatory affairs executive in the medical device industry—including a founding role at spinal implant company Altiva Corporation—Kapitan established the firm to provide a single-source solution for medical device commercialization. The company remains founder-led, with Kapitan serving as CEO alongside a management team that includes COO Mike Burgan, Director of Business Development Hayden Kapitan, and Director of Engineering David Considine. The company operates as a full-service partner covering the entire product lifecycle: Phase 0 feasibility, design and engineering, prototyping, testing, intellectual property, human factors engineering, quality system implementation, regulatory strategy and submission, and commercialization support. Through its subsidiary Kapstone Manufacturing, it added ISO 13485 contract manufacturing and in-house additive manufacturing with DLyte dry electropolishing, eliminating the need to outsource prototype fabrication. The Charlotte facility has supported over 200 customers, 150 product launches, and more than 100 regulatory submissions across U.S. and EU markets. Kapstone serves medical device startups, physician entrepreneurs, R&D firms, and established OEMs, with a focus on orthopedics, spinal implants, and surgical instruments. Notable engagements include a Phase 0 feasibility study for SealJect Medical, design and manufacturing of prone lateral spinal access instruments and spinal fusion implants for a medical device firm, and quality system development for an R&D company preparing for contract manufacturing. The firm’s differentiation stems from its integrated “one-stop” model, which Kapitan created after recognizing that outsourced prototyping was the primary friction point for clients. By bringing manufacturing in-house under the same quality system, Kapstone aims to reduce hand-offs, accelerate turnaround, and maintain regulatory continuity from prototype through commercial distribution.

Equipment

• DLyte Dry Electropolishing System

Company details

Location

Charlotte, North Carolina

Founded

2007

Certifications

ISO 13485, CE Marked

Listed under

• Medical Device Manufacturers in North Carolina

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