About Us
From websites to packaging, we design experiences that are beautiful and functional.
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.
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.
Innovative orthopedic medical devices for improved patient outcomes.
Extensive experience in the design and development of cardiovascular medical devices
Proven expertise in designing and developing cutting-edge diagnostic medical devices.
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.
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.
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.
Eric Klumper
Mailing Address
Please let us know how we can help and we'll be back with you shortly