Clinical validation roadmap
From synchronized platform to validated digital-therapy pathway.
The roadmap is staged to protect scientific credibility: first validate timing, safety, adherence and objective endpoints; then expand toward controlled studies, productization and future digital-therapy pathways.
Validation path
Six phases, each with a clear evidence objective.
Scientific concept note
Population, protocol logic, device stack, safety/adherence plan, endpoints and PI model.
Output: 2–3 page scientific concept package.Engineering synchronization validation
Bench and human-factors validation of multisensory timing, RF pathway integration, device usability and sensor capture.
Output: device stack and technical validation dossier.Feasibility study
30–50 subjects over a 12-month concept, designed for safety, adherence, endpoint selection and signal detection.
Output: manuscript and next-trial design.Controlled pilot
Randomized or matched-comparator study in MCI, aging-associated cognitive decline, stress/cognition or neurorehabilitation.
Output: efficacy signal and effect-size estimation.Digital therapy productization
Refine UX, adherence engine, clinical workflow, data model, AI personalization and patient-safety controls.
Output: product candidate ready for regulatory planning.Regulatory and clinical expansion
Pathway analysis for Software as a Medical Device and digital-therapeutic claims in selected indications.
Output: formal clinical and regulatory strategy.Digital therapy vision
Training and neuronal learning for cognitive deficits.
After validation, Mentalness can evolve into a digital-therapy product designed to deliver structured neuronal-learning sessions, track objective response and support clinical programs for cognitive deficits.
This roadmap describes planned development. It is not a guarantee of clinical effect, regulatory clearance, timeline or reimbursement.