Invention Disclosures for Medical Devices

Not legal advice. Coordinate with counsel and regulatory teams.

Clinical Context and Safety

• Indications for use (high‑level), user population, environment of use.
• Risk classification context (e.g., IMDs vs. wearables) and safety constraints.
• Human‑factors considerations and misuse scenarios.

Technical Parameters

• Materials and biocompatibility notes; sterilization method.
• Sensors/actuators with ranges (LED wavelengths, sampling rates, torque, pressure).
• Power budgets, thermal limits, latency bounds for control loops.

Testing and Validation

• Bench test setups, calibration procedures, acceptance criteria.
• Simulations and in‑vitro/in‑silico validation before clinical contexts.
• Data logging formats and analysis methods.

Diagrams and Drawings

• Exploded views, signal chains, enclosure drawings with labeled components.
• Reference figures in text consistently; maintain versioned CAD links.

Regulatory Considerations (High‑Level)

• Applicable standards to be aware of (EMC, electrical safety, software lifecycle, usability).
• Cybersecurity posture: secure boot, updates, encryption, audit logging.

Handoff Package

• Disclosure PDF, drawings (SVG/PNG), bench/validation data, risk table, change log.
• Related: Template, Enablement.