A Trusted Partner in
Electromechanical Medical Device Design and Development
Blur designs and develops electromechanical medical devices, bringing mechanical, electrical, firmware, and software engineering together under one roof. We build most prototypes in-house, solve the hardest integration problems first, and design for manufacturing from day one. When the design is ready, our ISO 13485 contract manufacturing team in Cary, NC builds it, so the team that designed your device is the team that makes it.
We have developed devices for ophthalmology, neurology, urology, cardiology, wearables, pediatrics, robotics, and organ transplant, and we verify and validate every design to the standards each specialty requires, including IEC 60601 for electrical safety and EMC.
One Team, Every Discipline
Our mechanical, electrical, firmware, and software engineers work side by side in our Cary R&D facility, with industrial design and human factors in the same room. No juggling vendors. No finger-pointing. When a problem crosses disciplines, the engineers who can fix it are right there, and decisions get made in minutes, not days.
Prototypes Built In-House
We build most of our prototypes in-house, plus the test and assembly fixtures that go with them. That means faster turns and more learning for every dollar you spend. And the fixtures are useful long term. They roll straight into manufacturing.
Find the Risks Early
Electromechanical devices fail at the margins. Heat, noise, power, tolerances, and the timing between hardware and firmware. We go after the riskiest problems first, so the surprises show up early, when they’re cheaper to fix.
Built to Applicable Standards
We design and test to IEC 60601 and all other applicable standards, which vary with the type of device, its intended use, and where it is used, from the hospital and clinic to home healthcare. We identify the applicable standards at the start of every project and build them into the design, with ISO 14971 risk management running throughout.
Designed to Be Built
Thinking about design for manufacturing starts on day one. When the design is ready, our ISO 13485 contract manufacturing team builds it, from pilot builds to production. The team that designed your device builds it, so nothing gets lost in the handoff.
Complex Electromechanical Systems
Some problems are just tough. Small, robust devices that have to work in or on the body on very little power. Robotic systems that have to move precisely around a patient. Imaging the eye and turning noisy sensor data into something a clinician can trust. That’s the work we like best, and we’ve done it in OCT and meibomian gland imaging, retinal eye tracking, robotics, microfluidics, and wearables.
Firmware and Software That Ship
The code is half the device. Our firmware and software engineers write what drives the motors, reads the sensors, and runs the user interface, and they work alongside the hardware team every day. We develop software to IEC 62304, with the full design controls that Class B and C software requires, and we build in cybersecurity from the start, the way the FDA now expects.
Start to Finish
A working prototype is only the beginning. A university team brought us retinal eye-tracking technology that worked in the lab, and we turned it into an FDA-cleared device and ramped it into manufacturing. We did everything, from industrial design and engineering through algorithms, design controls, and testing.
Meet the Engineers
You’ll work with the people who lead this work every day: partners Scott Liddle in mechanical engineering, Jeff Rosino in electrical engineering, and Nathan Luck in software and firmware, along with technical project directors Dustin Simons and Erin Simons, David Moody, Director of Electrical Engineering, and Kyle Matthews, Director of Firmware Engineering. Come meet them.
Frequently Asked Questions
Why are electromechanical medical devices so tough to develop?
An electromechanical medical device combines mechanical components, electronics, firmware, and software, and every one of those has to work with the others, every time. A design change in one ripples through the rest. Add tight size and power limits, patient safety, the rigor of medical device design controls, and testing to the applicable standards, and small problems get complex fast, which can drive up development costs. That’s why one team that owns the whole system matters so much.
What does electromechanical medical device design include?
Everything it takes to get from an idea to a device you can build and sell. That means mechanical design, electronics, firmware, software, industrial design, and human factors, plus prototypes, verification and validation testing, and the design controls the FDA expects. We do all of it under one roof, so nothing falls between the cracks.
What standards apply to electromechanical medical devices?
It depends on the device, its intended use, and where it’s used. Most electromechanical devices are designed and tested to IEC 60601 for electrical safety and EMC, with added requirements for environments like home healthcare. Software follows IEC 62304, and risk management follows ISO 14971. We identify the applicable standards at the start, so there are no surprises at the end.
Is your design and development process ISO 13485 certified?
Yes. We are certified to ISO 13485:2016 through Intertek under the Medical Device Single Audit Program (MDSAP), and the certification covers design and development, not just manufacturing. The design controls we write for your project, and the SOPs behind them, are audited by an independent registrar and by our customers. When a submission review or an FDA inspection looks at your design history file, it was built on procedures that have already held up to outside audits.
How long does it take to develop an electromechanical medical device?
Most programs reach design freeze in about 9 to 24 months, depending on complexity and where you’re starting. After testing and the FDA submission, pilot production typically follows 6 to 12 months later, based on manufacturing ramp and supply chain needs.
How much does it cost to develop an electromechanical medical device?
Costs swing wildly depending on the device, its complexity, and where you’re starting. Feasibility work alone can range from tens of thousands to hundreds of thousands of dollars, and taking a complex Class II or III device to design freeze can run from several hundred thousand to several million. We give every company a detailed cost estimate that line-items each step, including outside costs like test labs, tooling, and purchased components, so there are no surprises.
How do I make sure my device can be manufactured?
Bring manufacturing in at the start, not the end. We avoid manufacturing problems by designing for them early: realistic tolerances, parts you can actually source, and assemblies that can be built the same way every time. Our ISO 13485 contract manufacturing team reviews the design as it develops, and pilot builds prove it out before production. Because the team that designed your device builds it, nothing gets lost in a handoff.
How do I choose an electromechanical medical device design partner?
Look for one team that does it all: mechanical, electrical, firmware, software, and manufacturing. Ask to meet the engineers who will actually do the work, and ask what they’ve taken all the way to FDA clearance and production. Check that their quality system is ISO 13485 certified. And watch out for firms that hand your design off between vendors. That’s where schedules slip and budgets blow up.
Can we audit your quality system?
Yes, any time. Our customers audit us regularly, and we welcome it. Seeing our procedures, records and floor firsthand is the best way to know your device is in good hands.
By Keith Gausmann, Partner, Blur Product Development. Last updated November 6, 2026.