Carlsbad, CA (Design Center)
Gilero’s design center in Carlsbad, CA has allowed for us to expand our presence to the West Coast. Our Carlsbad office provides our West Coast clients access to Gilero’s over 20 years of experience in the medical device design and development, as well as our leading local team of engineers, designers, and project managers. This design center has many advanced machine shop capabilities, test labs, and high- tech equipment to help you bring your medical device to market.
Our specialties and services through this office:
Strategy & Innovation
- Understand Requirements
- Research Existing Technologies
- Understand Patent Landscapes
Concept Development
- Brainstorming
- Concept Sketches
- Early CAD
- Technical Reviews
Design & Engineering
- Early-Stage Development (Phase 0)
- Design and Development Planning (Phase 1)
- Design Inputs (Phase 2)
- Design Outputs (Phase 3)
- Design Verification & Validation (Phase 4)
- Transfer Design to Production (Phase 5)
Human Factors
- Formative and summative human factors studies required for regulatory submissionHFE planning
- Contextual inquiry
- Focus groups
- Ethnographic research
- Participatory design sessions
- Task analysis
- Use-related risk analysis (URRA)
- Use failure modes and effects analysis (uFMEA)
- Label comprehension studies
- Comparative analysis
- Threshold analysis
- Instructions for use (IFU)
- HFE/UE summary reports
Prototyping
- Proof-of-concept
- Functional prototypes
- 3D printing
- Silicone and injection mold tooling
- PCB (printed circuit boards)
- Breadboarding
- IT integration simulation
Testing
- Proof of Concept Testing
- Design Verification Testing
Regulatory
- Regulatory Assessments
- Medical Device Classifications
- US FDA Strategy
- 510(k) submissions
- PMA (Pre-market approval) submissions
