
Medical Device Engineering
We specialize in developing ISO 60601-compliant microelectronics and safety-critical embedded firmware tailored for medical applications. From ultra-low-power solutions optimized for implantable devices to robust RTOS-driven architectures for patient monitoring systems, our software engineering practices adhere to IEC 62304 design and lifecycle standards. Collaborating seamlessly within our customers' ISO 13485 quality systems, we also offer expertise in ISO 14971 risk assessment to streamline your certification process.
Medical Solutions We Developed

Intervertebral Disc Implant
We designed the microelectronics and embedded firmware for an artificial disc. This implant incorporates embedded diagnostics that continuously monitor device integrity, providing early alerts for potential displacement or subsidence issues. The implant includes an ultra-low-power microcontroller capable of real-time motion sensing, and bi-directional telemetry using the MICS communication standard. The system includes an inductive coupling solution to wirelessly recharge its integrated Lithium-Ion battery.

Patient Monitor
We developed a robust network communication module for a patient monitoring system deployed in hospital environments. This mission-critical device supports both Ethernet and Wi-Fi connectivity, providing seamless and reliable access to remote drug libraries essential for infusion therapy.

Blood Pressure Monitor
We wrote the firmware for an acute-care hemodynamic monitoring device. This is a specialized oscillometric blood pressure system utilizing a pressure cuff placed around the patient's finger. This advanced system continuously measures and reports systolic and diastolic blood pressure, providing accurate, real-time insights critical for patient care.
Ready to build your next intelligent device?
Let's discuss your project and how Cole Design & Development can bring your idea to life.
Founded in 2008 · Hudson, Ohio · info@coledd.com
