4.1 Technical verification
Verification is a foundational step of V3+
Verification confirms that the sDHT’s hardware and firmware correctly capture and transmit data according to design specifications.
This involves testing the sensor’s accuracy, precision, consistency, and other performance metrics through bench testing and, where appropriate, computational simulations (in silico), prior to any testing in human subjects.
Verification asks:
“Is the sensor system performing according to its technical specifications?”
In the V3+ framework, verification is an engineering test that tells you about the quality of the sample-level data generated by the sensor.
Is my sensor good or garbage?
Verification will also provide the necessary information to help you decide whether the sample-level data produced by the sensor is suitable for use as input data to your algorithm.
Is my sensor fit-for-purpose?
Example: You may have an accelerometer that measures at 50Hz exactly (it’s good!). This may generate data that works for measuring a gross movement like walking (fit-for purpose). But, even high quality data at 50Hz might not be sensitive enough for measuring tremor (not fit-for-purpose).
Source: Verification, analytical validation, and clinical validation (V3), Playbook team analysis
By establishing that the sDHT faithfully measures the construct it claims to (be it acceleration, temperature, pressure, etc.), verification guards against the “garbage in, garbage out” risk of digital measurements. It ensures that subsequent validation efforts are built on a sound technical foundation rather than flawed sample-level data.
in practice
Methods & requirements
Verification is typically carried out by the sDHT developer through rigorous engineering tests, including:
Bench tests and calibration
For example, placing an accelerometer-based wearable on a shaker table with known motion profiles to verify its output against the expected acceleration. Other sensors might be tested with known signal inputs (voltage, light, pressure) to assess measurement accuracy and noise.
Performance standards compliance
Whenever applicable, sDHTs are verified against consensus technical standards (e.g. IEC 60601 and 80601 series for medical electrical equipment) that specify baseline performance criteria for certain sensor types. For instance, an ECG patch might be verified per IEC 60601-2-25 for signal quality requirements. Adhering to such standards or industry benchmarks streamlines regulatory review and provides adopters with an objective performance reference.
Failure modes and stress testing
Verification can include analyses like Failure Modes and Effects Analysis (FMEA) to identify how the sDHT might fail and under what conditions. Environmental testing (temperature, humidity, motion) defines the operating conditions under which the DHT remains within spec. For wearable sensors, battery life and durability (e.g., drop tests, sweat resistance) are also verified to ensure the sDHT will function reliably throughout the intended use.
Regulatory bodies expect this evidence
Verification activities and results should be thoroughly documented, including test protocols, acceptance criteria, and outcomes. For medical devices, regulators like the FDA (and EU Notified Bodies for CE marking) require specific design verification testing as part of evaluation.
FDA SPOTLIGHT
FDA guidance indicates even if an sDHT is not formally regulated as a medical device, trial sponsors should address verification to satisfy regulators that the tool is fit for collecting data remotely.
key takeaways
Strategic value
Verified technical performance is the bedrock of trust in a digital measure. Without it, downstream validation efforts may be misleading or invalid. Robust verification gives adopters confidence that sensor data are accurate, precise, and stable under expected operating conditions, rather than distorted by measurement bias, noise, or data capture failures. This reduces the risk of erroneous trial results and potential patient harm arising from technically unsound data.
From a developer’s perspective, thorough verification signals engineering maturity and readiness for clinical use. This transparency reduces due diligence burden for adopters, supports efficient evaluation against internal standards, and lowers barriers to adoption by establishing a trusted technical baseline for subsequent validation activities.
From an adopter’s perspective, relying on manufacturer-provided verification evidence can substantially reduce duplicative testing burden. Trial sponsors typically do not have the facilities, specialized expertise, or mandate to repeat bench-level evaluations that are best addressed by developers. Obtaining and reviewing the sDHT’s verification documentation therefore becomes a key step in confirming baseline technical performance before trial deployment.
4.1 Technical verification
Library resources to guide you
The sDHT roadmap library gathers 200+ external resources to support the adoption of sensor-based digital health technologies. To help you apply the concepts in this section, we’ve curated specific spotlights that provide direct access to critical guidance and real-world examples, helping you move from strategy to implementation.
Features essential guidance, publications, and communications from regulatory bodies relevant to this section. Use these resources to inform your regulatory strategy and ensure compliance.
Gathers real-world examples, case studies, best practices, and lessons learned from peers and leaders in the field relevant to this section. Use these insights to accelerate your work and avoid common pitfalls.