Boulder Solution – Innovative medical solutions, engineered for excellence.

Precision Medical Devices. Realized.

Capabilities

Case Studies

Our Process

Your dedicated partner in contract medical device design, prototyping, and manufacturing.

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Our Core Capabilities.

Precision CNC Machining

CNC Machining

We transform digital designs into tangible, high-precision components with sub-micron accuracy. Our advanced CNC machining capabilities are optimized for complex geometries and medical-grade materials, ensuring perfect form and function every time.

Cleanroom Assembly

Our ISO-certified cleanroom provides a controlled environment for the meticulous assembly of your sterile and non-sterile medical devices. We ensure every product is assembled to the highest quality standards, free from contaminants and ready for final packaging and sterilization.

Medical Prototyping

Go from concept to clinical feedback faster with our rapid prototyping services. We utilize advanced 3D printing and traditional model-making to create high-fidelity prototypes for ergonomic testing, functional evaluation, and investor demonstrations.

ISO 13485 Compliance

Not sure where to start? Our experts in regulatory will plan and execute our compliance SOP to get you in full compliance.

A Team Built on Proven Expertise.

With over 30 years of combined expertise, Kelsey and Eric are the force behind turning groundbreaking medical technologies into market-ready solutions.

Kelsey is a regulatory strategist who has secured FDA approvals across orthopedics, monitoring, critical care, and diagnostics, guiding both startups and global giants through the toughest hurdles.

Eric is an engineer and product leader who has launched 10+ devices, mastering the path from concept to commercialization while building bulletproof quality systems.

Together, they fuse regulatory precision with engineering execution — a rare combination that gives this startup the power to innovate fast, scale smart, and win globally