Case Studies
Continuous Vital-Signs Monitor for Acute Care
A mid-sized medical device company with clinical IP but no internal hardware engineering capability needed a partner to own the full hardware, firmware, and regulatory stack.
The Challenge
The client had a clinical concept validated in a university hospital setting but no internal engineering capability to take it to a manufacturable product. Their existing vendor had produced a proof-of-concept that failed EMC pre-compliance testing and consumed too much power to achieve the required 48-hour runtime.
They needed a partner who could own the full hardware, firmware, and regulatory stack simultaneously. Three engineering disciplines had to be coordinated in parallel: analog front-end design, firmware power optimisation, and regulatory strategy. None could be treated as sequential.
Ankh's technical due diligence of the failed PoC identified three root causes for the EMC failures: inadequate ground plane partitioning, an insufficiently filtered switching supply, and a radio antenna placement causing mutual coupling with the analog front-end. The power issue traced to an inefficient sensor duty-cycling scheme in firmware. All four problems required first-principles redesign.
Our Approach
Discovery & System Architecture
Ankh began with a two-week technical due diligence exercise reviewing the existing PoC schematics, firmware codebase, and regulatory pre-submission documentation. We produced a written risk register identifying every gap between the current design and FDA submission readiness. The program architecture was defined across all disciplines before any new hardware was designed — a sequencing decision that proved critical in avoiding costly late-stage redesigns.
Hardware Engineering
We designed the analog front-end from first principles, selecting a purpose-built medical-grade bio-sensing IC with integrated lead-off detection. The power architecture was redesigned around a multi-rail PMIC with adaptive load switching, achieving a 61% reduction in average current draw versus the original PoC. PCB layout was executed with full signal integrity analysis — analog and digital domains isolated, return currents controlled at board level, and RF ground plane segments sized to the antenna's near-field.
Firmware & Embedded Software
Firmware was written in C targeting an ARM Cortex-M4 running FreeRTOS. The sensor state machine was redesigned around interrupt-driven acquisition with carefully profiled sleep states. BLE stack integration used Zephyr with a custom GATT profile for clinical data telemetry. Embedded security was applied at the bootloader level: signed firmware images, encrypted flash, and a secure element for device identity. The companion app interface was co-designed with the clinical team to meet IEC 62366 usability requirements.
Regulatory & Validation
Ankh's regulatory team had managed the 510(k) pathway for three prior devices in this clinical class. We prepared the predicate analysis, performance testing protocols, and EMC test plan in parallel with hardware design — not after it. Pre-compliance testing was conducted in our own lab to catch issues before formal submission. The device cleared FCC Part 15 and IEC 60601-1-2 EMC testing on the first formal submission. The 510(k) was cleared 14 months from hardware freeze.
Results
The device entered clinical evaluation at two hospital networks 22 months from project kickoff — on schedule despite the full ground-up redesign. Battery life of 72 hours exceeded the original 48-hour specification by 50%, a direct result of Ankh's disciplined power architecture from the start of the program.
Zero EMC deficiencies were raised on formal submission. The client secured Series B funding three months after FDA clearance, with investors citing the device's technical maturity and regulatory-ready documentation package as key confidence factors.