About • Occam Design

The principle of Occam’s Razor states that often times the simplest solution to a problem is the best one.
We’ve built our company around this philosophy.

About Us

Established in 2009, Occam Design is a “one-stop-shop” medical device development company based in Louisville, Kentucky.

We approach every project with the simple approach of keeping it on objective, on time, and on budget, while also keeping you informed every step of the way. With over 20 years of experience, our full suite of engineers, technicians, and machinists handle your product’s design, prototyping, documentation, regulatory, and manufacturing needs as you scale up.

As an FDA registered, GMP compliant, and ISO 13485: 2016 certified facility, we are equipped with Class VII clean rooms, injection molding machines, 3D printers, and machining–all in house. Our team is suited to develop and manufacture your Class I, II, or III medical device and is uniquely located by UPS Worldport for fast shipping.

Why Work With Us

Our project managers support lean operations as they pull engineering/manufacturing/quality/etc. resources as needed–allowing you to focus on a successful device launch.
From simple silicone devices to catheters, electromechnical devices, and even blood manipulation devices, our dynamic team keeps up with innovation demands.
We are familiar with all IEC 60601 standards, and related CISPR-11 RFI/EMI requirements for electro-medical equipment
Our team understands timeline, constraints, and regulatory challenges as we not only develop other companies’ devices, but our stellar steam has developed our own Intellectual Property (I.P.) related products and have been awarded over $5 million in NIH SBIR Phase II grants
Occam Design do not touch clients’ I.P.
Ongoing routine volume production services
Short-run production services for clinical and animal testing
24,000 sq ft production area, including multiple Class VII cleanrooms

Meet Our Managers

Dakota Waldecker

Project Manager Lead

Evgeniya Moiseeva

Project Manager

Andreas Vu

Project Manager

Matthew Rutledge

Manufacturing Manager

Caleb Taylor

Lead Electrical Engineer

Frequently Asked Questions

What sets Occam Design apart from other development firms?

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What medical devices do you work on?

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What medical devices are out of your specialty?