Sharifah Omar

• • Act as embedded strategic partner to MedTech companies developing complex surgical systems,including surgical robots, intraoperative imaging (O-arm), and ophthalmic diagnostics, advising on adoption strategy, usability improvement, and stakeholder alignment across engineering, clinical, regulatory, and commercial teams.

• • Lead end-to-end evidence generation activities (formative research, validation studies, risk analyses) to anticipate use-related risks and strengthen implementation readiness prior to regulatory submission.

• • Support development of complex medical technologies, including surgical robotic systems, O-arm imaging platforms, and ophthalmic diagnostic devices, with a focus on improving safe use within real clinical workflows.

• • Work cross-functionally with engineering, clinical, regulatory, and commercial teams to align product development with patient pathways and clinical workflows.

• • Manage multi-stakeholder research programs and deliver regulatory-ready submissions across US, UK, and EU markets.

• • Author programme documentation including usability protocols, risk management reports, and benefit-tracking materials, ensuring measurable outcomes are captured and communicated to stakeholders.

• • Conducted 150+ qualitative and usability research sessions with surgeons, clinicians, patients, and caregivers to identify adoption barriers and inform the design of complex medical devices and digital interfaces.

• • Authored 100+ regulatory and scientific documents, including usability protocols, risk analyses, and validation reports supporting FDA and EU submissions.

• • Applied ISO 14971 and IEC 62366 principles to identify use-related risks and inform design decisions.

• • Contributed to development of products embedded within hospital and specialty care workflows.

• • Partnered with industrial design, engineering, and clinical teams to translate pathway requirements into validated product solutions.