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Proof before promises.

Proposed development protocol. None of the laboratory, athlete-study or certification milestones below is presented as completed.

Proposed validation roadmap

From an interesting material
to defensible protection.

Each stage has a question and a decision gate. This is a development plan, not a claim that testing, certification or clinical validation has already been completed.

  1. Define the use case

    Choose the sport, body region, age group and intended use. Map hazards, fit requirements, existing equipment and the applicable current standards.

    Decision gate

    Proceed only with a documented specification, comparator and risk analysis. Avoid an unsupported universal-protection claim.

  2. Characterize the material

    Measure rheology across rates and temperatures, compression, recovery, force-displacement behavior and energy dissipation. Track batches, thickness and mass.

    Decision gate

    Predefine acceptable ranges and demonstrate reproducibility. An impressive single drop test is insufficient.

  3. Test the finished assembly

    Include repeated and oblique impacts, environmental conditioning, sweat, cleaning, aging, retention and leak or puncture testing where relevant. Compare at matched fit and declared mass/thickness.

    Decision gate

    Report linear and rotational head kinematics where relevant, transmitted forces and adverse trade-offs across the full test matrix.

  4. Replicate independently

    Use an independent laboratory and the applicable certification route. Check the complete helmet-plus-accessory configuration, not only the insert.

    Decision gate

    Passing a standard is not proof against concussion. NOCSAE warns that add-ons can change a certified model.

  5. Learn from athletes safely

    Begin with ethics-appropriate, non-impact wearability testing: comfort, heat, movement, fit and adherence. Calibrate any sensors before field use.

    Decision gate

    Address adverse effects before expansion. Do not ask participants to sustain deliberate potentially concussive impacts.

  6. Test clinical benefit separately

    Preregister a prospective comparison during ordinary play, with independent injury assessment, exposure denominators and a justified sample-size calculation.

    Decision gate

    Analyze clustering, missing data and predefined subgroups. Publish null findings too. Do not convert a small feasibility study into an efficacy claim.

Three different levels of proof

Material behavior is not whole-equipment performance. Whole-equipment performance is not automatically lower injury incidence. Each claim needs evidence at the level being claimed. Sensor-methods review · Third-party certification

Protocol decisions to lock before testing

Specify comparator models, size/fit conditions, tested construction, impact velocities and locations, environmental ranges, sample independence, calibration and acceptance rules. Use independent physical specimens, not repeated strikes on one specimen as independent samples.

Material and assembly pilot

A proposed screening design uses at least three manufacturing batches and independent specimens per condition. This is an engineering planning choice, not a certified standard or a powered clinical sample. Use pilot variance and measurement uncertainty to justify confirmatory sample sizes.

Predeclared outcomes

For material coupons: force-displacement response, transmitted peak force, absorbed/dissipated energy, residual deformation and repeatability. For helmet systems: linear acceleration, angular velocity/acceleration, pulse duration, retention and applicable standard metrics. Report every condition and adverse trade-off. Finite-element brain-strain estimates remain model outputs, not diagnoses.

Human research

Begin with a small, ethics-reviewed adult wearability pilot without experimental head impacts. Any subsequent efficacy study needs qualified independent clinical assessment during ordinary sport, equivalent concussion education, exposure denominators, trial registration and a statistician-led power calculation. A cluster-randomized team design may be appropriate; use clustering, attrition and baseline event-rate uncertainty in the calculation.

Go/no-go rules

Proceed only after the risk file and applicable standards are satisfied, predefined performance targets are met within uncertainty, no unacceptable new failure mode emerges, and independent replication agrees. Numerical efficacy targets must be chosen before testing, not retrofitted to favorable results.

Publication and accountability

Archive protocol versions, calibration files, coded sample assignments, raw traces, deviations and analysis code. Publish null or adverse findings as well as positive ones. Preserve the distinction between surrogate biomechanics and clinical concussion outcomes.

NOCSAE add-on position · World Rugby sensor specifications · Sensor methods evidence