About Us

From websites to packaging, we design experiences that are beautiful and functional.

bridging the gap between clinical need and commercial reality.
about Boulder Solution

We don’t just list capabilities; we engineer confidence. In an industry defined by precision and regulation, Boulder Solution serves as a strategic med device contract partner, bridging the gap between clinical need and commercial reality.

We provide quality design & development solutions

Our mission

Our vision

While others see regulation as a roadblock, we utilize it as a design tool. Our infrastructure creates a “Trust Moat”—ensuring your device navigates the complex path from prototype to patient with absolute regulatory integrity.

Bright LED lighting setup in a modern facility.

Innovative orthopedic medical devices for improved patient outcomes.

Close-up of a modern laboratory equipment used in pharmaceutical manufacturing.

Extensive experience in the design and development of cardiovascular medical devices

High-tech laboratory equipment and team working in a modern facility in NE Ohio.

Proven expertise in designing and developing cutting-edge diagnostic medical devices.

our avengers

Meet our team

What began over coffee-fueled brainstorming sessions has grown into a thriving contract medical device manufacturing and consulting practice dedicated to helping get your project to market with minimal stress.

Eric Klumper

founder | head engineer

Kelsey Lee

Founder | Head of Regulatory Affairs

our history

Boulder Solution was born from a critical observation made inside the industry’s giants—including Medtronic, Stryker, and Terumo BCT.

2015

We saw too many breakthrough concepts fail in the ‘Valley of Death’—stalled by regulatory missteps or manufacturability gaps that should have been caught early.

2020

Co-founders Eric Klumper and Kelsey Lee combined their disciplines—Principal Engineering and Regulatory Affairs—to create a new breed of CDMO.

2024

Moving away from  compliance as a hurdle to viewing it as a design constraint.

2026

Boulder Solution was born and has quickly become one of the most sought after contract medical device and on-call regulatory specialists across the country.

kelsey-implementing-regulatory-procedures
combines creativity, technology
combines creativity, technology
combines creativity, technology
combines creativity, technology

How we works?

What started as a small idea has grown into a powerhouse of creativity and innovation.

Clear, concise, and professional communication to ensure project alignment and success.

Demonstrated regulatory pathway expertise, design control mastery, risk management capability, and relevant device experience.

Identify unmet clinical needs and translate them into user-centered designs that improve patient outcomes and clinical efficiency.

get in touch

Looking to book a consultation or just want to ask a few questions, we’d be glad to connect with you.

Head Engineer | Co-Founder

Eric Klumper

Mailing Address

Please let us know how we can help and we'll be back with you shortly

Close

Our approach is straightforward— We engineer bold, defensible regulatory strategies that push your device through the FDA and into the field.

WANT IT TO SOUND PLAYFUL, LUXURIOUS, OR MORE/