The clinical research landscape has never changed as fast as it does today. This fast-paced change is being driven by wearables, biosensors, digital health technologies (DHTs), performance-based devices, and remote monitoring tools.
Before endpoints captured by these devices during pivotal trials can be trusted, sponsors must prove beyond doubt that they generate reliable, accurate, and relevant data in humans. Meeting these evolving demands requires establishing robust clinical validation for wearable devices.
The FDA’s 2023 guidance on digital health technologies provides recommendations for the use of both the hardware and software technologies, must be rigorously tested and evaluated before being approved for clinical use. Relying solely on real-world testing is not a viable option for sponsors. Instead, they need a foundational step that establishes baseline validity. Human performance lab device validation studies are the ideal starting point for this.
Traditionally, device validation studies relied heavily on unmonitored home testing. However, this is changing quickly, replacing with structured clinical methodologies that deliver better results.
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What Is a Controlled Human Performance Lab?
A Structured Environment for Measuring Human Function
A highly regulated environment such as a human performance lab is designed to assess both physiological and biomechanical reactions. This allows researchers to monitor and measure movement, strength, endurance, cardiovascular activity, balance, recovery, and physical function effectively. Reference technologies such as metabolic carts and force plates allow these labs to provide precise baselines against which investigational devices can be compared.
More Than a Sports Testing Facility
Human Performance Labs are most frequently associated with elite athletes but their uses in clinical research extend far beyond sports. They are essential for validating tools in Medical Device CRO operations and support extensive medical device validation studies in areas such as digital health, metabolic health, ageing, mobility, cardiovascular health, and remote patient monitoring. When considering this, a specialized performance lab for medical device studies is a crucial asset for sponsors that want to launch compliant products.
Why Control Matters in Device Validation
Variability can affect the accuracy of clinical validation. Controlled settings minimize potential interference from external factors, including inconsistent movement, fluctuations in the environment, protocol variations, and improper device placement. Conducting a wearable sensor validation study in a noisy, unmonitored environment could undermine the validity of the resulting data. On the other hand, by standardizing these elements, wearable device validation becomes significantly more precise and scientifically accurate.
Device Types That Can Benefit from Human Performance Lab Validation
Wearable Sensors and Activity Trackers
These devices measure movement, step count, cadence, gait, heart rate, activity intensity, recovery, or total energy expenditure. Wearable device validation requires the capture of precise data across these parameters during structured exercise testing.
Digital Health and Remote Monitoring Devices
These devices are responsible for the collection of longitudinal, physiological, and behavioral data outside of controlled settings for the purpose of ensuring that hardware and software communicate effectively.
Cardiovascular and Fitness Assessment Devices
Devices that measure parameters such as resting and active heart rate, blood pressure fluctuations, aerobic performance, vascular function, exertion and recovery.
Rehabilitation and Mobility Devices
Tools used in physiotherapy such as fall-risk assessment, balance, gait analysis, range of motion, strength, and functional performance monitoring.
Metabolic and Weight Management Devices
These tools support the tracking of physical activity, exercise, lifestyle, behavior changes and continuous metabolic parameters.
Sports, Recovery and Human Performance Technologies
Products from this category are designed for use by athletes, active consumers, military staff and people working in other high-performance settings.
Neurological Stimulation Devices
Test outputs in neuromodulation both objectively and subjectively by using gold standard methods against a new device to be tested. These devices tend to be used for chronic pain, migraines, cluster headaches, etc.
What Sponsors Need to Prove in Device Validation Studies
Sponsors need to look beyond the basic metrics and collect robust proof across several strict categories in device validation studies.
Accuracy
In wearable device accuracy validation studies, the accuracy of the device is proven by comparing the device’s output against a recognized gold-standard reference method simultaneously. The question is whether the device measures what it claims to measure.
Repeatability
Can the device produce consistent results when the same test is repeated under identical conditions on different days?
Sensitivity to Change
Is the device sensitive enough to detect a meaningful change in performance, movement, physiological stress, and function? Is the detected change clinically relevant?
Usability
Can the device be used correctly, comfortably, and consistently without any operational errors?
Data Completeness
Datasets that are plagued by inconsistencies, gaps, signal quality issues, and motion artefacts are not usable, which is why the device must capture high-quality usable data throughout the protocol.
Performance Across Different User Groups
The question is, does the device perform consistently when diversity is taken into consideration. Do different age ranges, body types, fitness levels, and clinical profiles make a difference?
Key Endpoints in Human Performance Device Validation Studies
Physiological Endpoints
Relevant for wearables, cardiovascular devices, fitness technologies, metabolic platforms, and remote monitoring tools:
• Heart rate and heart rate recovery
• VO₂ max or aerobic capacity
• Oxygen uptake during exercise
• Blood pressure response
• Perceived exertion
• Exercise tolerance
• Recovery metrics
Strength and Power Endpoints
Important for musculoskeletal health and rehabilitation devices:
• Grip strength
• Isometric strength
• Lower-limb strength
• Jump height and force production
• Rate of force development
• Muscle fatigue thresholds
• Functional strength measures
Mobility, Gait, and Functional Performance Endpoints
Relevant for devices tracking patient independence:
• 6-minute walk test
• Chair stand test
• Gait speed and symmetry
• Balance (static and dynamic)
• Range of motion
• Functional capacity
• Fall-risk-related measures
Biomechanical and Movement Endpoints
Used for Inertial Measurement Unit (IMU) based devices, motion sensors, and digital MSK (musculoskeletal) platforms:
• Joint range of motion
• Movement symmetry
• Jump mechanics and landing force
• Postural control
• Cadence and step dynamics
• Movement variability
Cardiovascular and Vascular Endpoints
Used for specific heart and blood vessel health tools:
• Heart rate and blood pressure responses
• Pulse wave velocity (PWV)
• Flow-mediated dilation (FMD)
• Recovery response
• Exercise-related cardiovascular markers
Device Performance and Data Quality Endpoints
Applicable for the technical validity of the hardware/software:
• Signal quality and missing data rate
• Sensor drift
• Device agreement with reference measures
• Algorithm output consistency
• Data capture success rate
• User error and technical failure rates
Why Controlled Protocols Improve Device Validation
Standardized Testing Conditions
When protocols are controlled, variation in warm-up routines, test duration, exercise intensity, movement type, rest periods, and environmental conditions are reduced. This ensures that tests follow uniform parameters.
Defined Intensity Levels
In a dedicated performance lab for medical device studies, devices are tested at varying intensities. This includes resting, low intensity, moderate intensity, high intensity, and recovery. This data is valuable for the validation of sensors that may suffer from signal degradation under specific conditions, such as movement, sweat, fatigue or changing physiological demand.
Reference Measurements for Comparison
High standards in clinical validation for wearable devices require comparison against well-established and medically accepted reference measurement methods. This provides the necessary statistical grounding.
Repeat Testing for Reliability
When protocols are strictly managed, it allows researchers to conduct repeat assessments under exact parameters that remain consistent over time.
Supervised Device Placement and Use
In a controlled setting, the placement of a device is supervised by researchers. This ensures that the device is correctly positioned and that it is used exactly according to the instructions before data collection begins.
Controlled Lab vs Real-World Validation: Why Sponsors Often Need Both
Controlled Lab Studies Show Whether the Device Works Under Defined Conditions
Real-world tracking might be excellent for long-term user habit analysis, but controlled lab testing for wearable devices shows whether the device works accurately under defined, standardized conditions. Due to the highly structured nature of these studies, they prove accuracy, evaluate repeatability, maintain protocol control, and allow for direct reference comparisons.
Real-World Studies Show Whether the Device Works in Everyday Use
These studies assess long-term adherence, real-world data capture, user behavior, and device performance in natural, uncontrolled settings.
Hybrid Study Designs Can Combine Both
Participants can undergo baseline validation in a controlled human performance lab and then transition to extended real-world remote monitoring, seamlessly combining both models.
When Should Sponsors Use a Human Performance Lab?
Before a Larger Clinical Investigation
Sponsors should use a human performance lab before embarking on a large-scale sensor-based device validation clinical investigation. This ensures that protocols are refined, device performance is deeply understood and the feasibility of the device is properly tested.
Validating a New Sensor or Algorithm
Lab validation is the first step for devices that measure complex movement, dynamic exercise, physiological responses, and recovery.
Comparing Device Outputs Against Reference Measures
The only way to accurately compare device outputs against reference measures for regulatory purposes is to use a controlled lab with structured test conditions.
Testing Across Activity Intensities
Critical for devices that must perform reliably across a broad spectrum of activity intensities. Measured intensities include resting, walking, running, cycling, fatigue, resistance exercise or recovery phases.
Supporting Claims Around Performance, Function, Mobility, or Recovery
Lab-tested and controlled biomechanical data should back specific claims regarding mobility, strength, or recovery.
How Atlantia’s Human Performance Lab Supports Device Validation Studies
As a specialized CRO for wearable device validation studies, Atlantia offers an end-to-end solution: from protocol development and targeted participant recruitment to onsite assessments, complex data collection, and sponsor-ready reporting. By choosing a dedicated CRO for wearable device validation studies, you ensure your clinical data meet international submission standards.
Sponsors rely on our lab for hardware and software performance evaluation across multi-access movement, peak exertion, recovery, strength, function, and physiological response. Our team is highly experienced when it comes to designing and executing every phase of a wearable sensor validation study. With fully integrated clinic operations in Cork, Ireland, and Chicago, USA, Atlantia supports European and North American sponsors, designing validation protocols with applicable European and US regulatory expertise to meet EU MDR and FDA expectations.
Atlantia’s infrastructure pairs highly controlled onsite lab assessments with excellent remote monitoring. This dual model allows sponsors to establish baseline accuracy in the clinic before capturing longitudinal real-world evidence at home.
Conclusion: Better Validation Starts With Better Control
As clinical research embraces digital health, regulatory agencies demand robust evidence that devices are accurate, reliable and valid. Ultimately, combining real-world trials with initial controlled lab testing for wearable devices protects sponsors from costly protocol failures. Leveraging human performance lab device validation studies is the most reliable way to secure regulatory trust. By reducing external variability, testing devices under defined conditions, and connecting outputs to meaningful human performance outcomes, sponsors ensure their data and their devices are fully trial-ready.