Predicting an individual’s timing of the menopausal transition remains an unmet clinical need. Conventional biomarkers (AMH, FSH) cannot provide long-range forecasting. LifeAhead applies a validated stochastic follicle-depletion model (Lawley et al., Science Advances, 2024) to generate individualized menopause forecasts from ovarian reserve markers and patient demographics. As a Class II SaMD, FDA Human Factors Engineering guidance mandates formative and summative usability evaluation before marketing submission. HITLAB conducted this independent two-round formative HFE evaluation on behalf of LifeAhead, with three clinicians from diverse clinical backgrounds. Using semi-structured interviews, think-aloud protocols, and the System Usability Scale (SUS), the study assessed forecast interpretability, clinical workflow alignment, patient safety, and counselling efficacy — with Round 1 findings directly shaping Round 2 refinements. Round 1 identified 9 major thematic areas; Round 2 yielded 30+ actionable recommendations. Together, these findings provide an evidence-based roadmap for platform refinement ahead of summative evaluation and FDA submission.