Use Case
Preparing a combination product for human factors validation and submission
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A sponsor nearing pivotal studies recognizes gaps between earlier development activities and anticipated submission requirements for human factors validation, risk management integration, and design documentation.
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Misalignment between URRA and UFMEA
Incomplete traceability
Unclear validation strategy
Documentation fragmentation across functions and suppliers
Late-stage remediation pressure
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Design Science — HF validation strategy and protocol development, heuristic analysis and formative testing refinement, participant recruitment and validation execution
Suttons Creek — DDF gap assessment and remediation, URRA–UFMEA reconciliation and traceability matrix, V&V integration, submission readiness review
ToxStrategies — Review of material and biological safety documentation gaps, assessment of changes impacting toxicological risk profile
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Improved alignment between usability, risk management, testing, and regulatory documentation prior to submission activities.