Prototyping
- Functional Prototyping & CAD Design
- Industrial Design
- SLA (Stereolithography)
- FDM (Fused Deposition Modeling)
- SLS (Selective Laser Sintering)
- CNC (Computer Numerically Controlled)
Customer/User Research
- Collect Initial User/Patient Requirements
- Understand Market needs/impact
- Surgeon Training & Feedback
Component & System Level Validations/Testing
- Mechanical & Electrical Safety Testing
- Benchtop tasing, Biocompatibility, Cleaning, and Sterilization Testing
- Final System Validations & Bug Tracking
- Pre-clinical testing
Production Engineering
- Design for Manufacturing
- Project and scale costs/designs accordingly
- Final Cost of Goods (COG)
- Machining, injection molding, and tooling design
- Packaging development
Operational Support
- Help with identifying deficiencies
- Estimate overall burn rate, Plan for new personnel, supplies, and equipment
- Establish supply chain
- Find and audit critical vendors
Grants & Funding
- Writing, administration, and execution of government grants
- NIH, SBIR, DARPA
- Position company towards Venture Capitalists
- Raise funds via proof of concept or position for an eventual exit
Quality Management System
- Initial OMS architecture and implementation
- ISO 9001 and ISO 13485 Compliance
- NCMR, CAPA, Supplier Corrective Actions
Regulatory Planning
- Ensure development strategy aligns with market goals & Regulatory Strategy
- Class I, II, and III devices
