IN Brief:
- ETS returns a 0–10 Signal Quality Score supported by settle time, beat validation and noise measurements.
- Its scoring engine draws on ten years of B-Secur laboratory data and characterisation of more than 300 electrode materials.
- Separate electrode and device workflows support material screening, prototype comparison, production validation and sustaining engineering.
B-Secur has launched its ECG Test System, a reference measurement platform designed to compare electrode materials and complete wearable devices using the same acquisition method across a characterised subject cohort.
ETS returns a Signal Quality Score from zero to ten for each recording, supported by settle time, beat validation and noise measurements. The score reflects how closely the candidate performs against a known reference, while subject and cohort results expose both average performance and cases where an electrode or device behaves differently for particular users.
ECG signal quality is determined before an algorithm begins interpreting the waveform. Electrode material, geometry, skin contact, analogue front end design, component selection, PCB layout and mechanical construction can all change the signal delivered to the software. A weak trace can therefore originate in the sensing hardware even when the ECG algorithm itself is operating correctly.
B-Secur’s method uses paired measurements to reduce the number of variables changing between the candidate and reference. Both are assessed across the same defined cohort using a controlled protocol, allowing the comparison to focus on the hardware or material under test. That does not remove physiological variation between people, but it makes the variation visible instead of averaging it away in a single headline result.
The company has split ETS into electrode and device workflows. ETS Electrode uses a B-Secur jig and reference plaque to compare materials, coatings, finishes and geometries before a complete wearable prototype exists. Developers can therefore screen electrode choices while other parts of the product are still being designed, rather than discovering a signal limitation after the mechanical tooling and electronics have been fixed.
ETS Device applies the reference method to complete hardware. A reference device and the device under test are compared across the cohort, with controlled configuration changes and noise measurements used to isolate possible causes of poorer performance. That makes the approach relevant during engineering validation, design validation and production validation, when changes to the analogue front end, electrode assembly or enclosure can alter the recorded signal.
The scoring engine draws on ten years of B-Secur laboratory results and characterisation of more than 300 electrode materials across wet, dry, textile and metal substrates. B-Secur says the resulting database allows different materials to be ranked through a common objective score rather than through separate internal test methods. The value of that comparison depends on maintaining the acquisition protocol and reference configuration consistently as new candidates are added.
Production use extends the same method beyond initial design. Electrode suppliers can change coatings or finishes, component substitutions can alter the analogue signal path, and manufacturing variation can shift contact pressure or mechanical alignment. Repeating a known reference test after a change provides a direct comparison with the earlier configuration and can reveal drift before it becomes a field problem.
ETS does not replace clinical or regulatory validation of the finished wearable. B-Secur separately develops its FDA-cleared HeartKey ECG algorithm suite and provides hardware, signal capture and regulatory engineering services. The test platform sits earlier in that process, where the objective is to determine whether the sensing hardware is producing a signal of comparable quality before clinical performance is assessed.
The company is ISO 13485:2016 certified and positions ETS for development, production and sustaining engineering. That range of use reflects a practical difficulty in wearable ECG programmes: signal quality can change whenever the electrode, electronics, mechanics or supplier changes, even if the product’s intended function stays the same.
A reference method gives engineering teams a consistent baseline against which those revisions can be measured. Its usefulness will depend on how rigorously the same protocol is applied from prototype work through production, but ETS provides a defined set of measurements for comparing changes that would otherwise be judged through separate test setups or subjective waveform inspection.
