SBA Administrator Kelly Loeffler and Kapstone CEO John Kapitan Discuss MedTech Innovation

Watch: U.S. SBA Administrator Kelly Loeffler & CEO John Kapitan on Domestic MedTech Manufacturing

Introduction

The medical device supply chain is shifting. For years, the industry relied on fragmented offshore production, leading to regulatory delays, quality control issues, and intellectual property risks. Today, the focus is rapidly returning to end-to-end domestic commercialization.

Recently, the Kapstone Medical and Kapstone Manufacturing team was honored to host Kelly Loeffler, the 28th Administrator of the U.S. Small Business Administration (SBA), at our ISO 13485-certified facility in Charlotte, North Carolina.

During her visit with Kapstone CEO John Kapitan and our leadership team, Administrator Loeffler highlighted the critical importance of keeping medical device innovation and production within the United States.

With fair trade and tax cuts, small businesses like Kapstone Medical aren’t just designing and selling their products in America – they're finally building them here, too. — Kelly Loeffler, U.S. SBA Administrator

Full Video Transcript

(For accessibility and clarity, the full transcript of the conversation between Administrator Loeffler and John Kapitan is provided below).

• John Kapitan: In the last 20 years, we have not been in a better time to expand our manufacturing than we are today.
• Kelly Loeffler: We're here at Kapstone Manufacturing in North Carolina, a two-generation business that's doing manufacturing innovation of medical devices.

• John Kapitan: Our conversations with our customers have significantly changed. They used to be design here, make in Asia, and come back here to sell. Now we're looking at design here, build here, sell here. In the last year, under the Trump Administration, being pro-America, pro-business, pro-manufacturing, allows us to expand.

• Kelly Loeffler: That's the strength of the America First Agenda. Putting Americans first. This is about Fair Trade, tax cuts, deregulation, energy dominance, and manufacturing strength. Thanks for bringing it John.  Appreciate it. Appreciate you. Thank you.
  
•  John Kapitan: Thanks for your visit.

Why "Built in America" Matters for Medical Devices

Administrator Loeffler’s observation cuts to the core of Kapstone’s mission: eliminating the handoff risk between engineering and production.

Historically, physician-inventors and MedTech startups would hire a design firm in one state, a regulatory consultant in another, and a contract manufacturer overseas. This fragmented approach inevitably leads to stalled FDA 510(k) submissions, misaligned Design History Files (DHF), and costly manufacturing rework.

Kapstone was built to solve this exact problem by acting as a true Single-Source Commercialization Partner. By integrating our teams under one roof, we ensure that:

• Phase 0 Feasibility is immediately informed by regulatory strategy.

• Human Factors Engineering (IEC 62366) is seamlessly integrated into formal Design Controls.

• Design Transfer moves directly into our dedicated, U.S.-based Kapstone Manufacturing facility—avoiding the delays and IP risks of overseas outsourcing.
  

Looking Forward

We are incredibly grateful to Administrator Loeffler and the U.S. Small Business Administration for their continued support of domestic manufacturing and MedTech innovation. As the industry adapts to the new FDA QMSR and evolving global supply chains, Kapstone remains committed to designing, clearing, and building the next generation of medical devices right here in America.

To learn more about transitioning your medical device from concept to commercial production, explore our New Product Development Roadmap or contact our team today.