We translate high stakes user needs and regulatory requirements into differentiated, certifiable products and systems.
What We Do
• Requirements capture & traceability: user, clinical/mission, regulatory, performance, cost, sustainability.
• System architecture & modular platform design enabling product families & configuration variants (civil, military, spacehard, clinic vs. home use, etc.).
• Rapid prototyping, simulation, and iterative user validation (alpha, beta, usability, human factors, environmental stress).
• Design for X (DFX): manufacturability, reliability, calibration/service, ruggedization (shock, vibe, thermal), sterilization compatibility (medtech), radiation tolerance (space), EMI/EMC (telecom & defence).
• Safety & risk engineering (e.g., FMEA, hazard analysis, cybersecurity threat modeling for connected devices).
• Design controls documentation aligned to regulated submissions (DHFs, tech data packages, configuration baselines).
Outcomes for Stakeholders
• Rightsized Minimum Viable Product (MVP) or Minimum Certifiable Configuration (MCC) to reach field validation faster.
• Clear cost BOMs with target vs. actual tracking.
• Verified/validated subsystems ready for industrial transfer; TRL advancement evidence.
