Durham, NC (Design Center)
Gilero’s design center in Durham, NC serves as our headquarters. This location allows us to serve many of our clients in close proximity in the rapidly growing Research Triangle Park. All things design and development are done here at this location, and our talented engineers have experience designing & developing everything from consumable medical devices to complex electromechanical drug delivery systems. Our Durham design center has many advanced machine shop capabilities, test labs, cleanrooms 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 Outputs (Phase 3)
- Transfer Design to Production (Phase 5)
- Design Verification & Validation (Phase 4)
- Design Inputs (Phase 2)
Human Factors
- Formative and summative human factors studies required for regulatory submission
- HFE 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
