It starts with an idea
Identify gap. Problem statement. Napkin sketch. Literature review. Stakeholder survey.
Assumptions. Constraints. Materials. Dimensions. Properties. Models.
Low- and high-fidelity prototypes. Investigational devices. Minimum viable product. Manufacturing.
Materials research. Human factors and use testing. Clinical study design and execution.
Market research. Industrial design. User experience. Post-market surveillance.
User feedback. Variables. Performance for safety and efficacy. Constraints. Iterate.
Classification. Certification. Standards. Compliance. Licensing. FDA 21 CFR 820. ISO 13485.
IP. Priority markets. Marketing. Branding. Distribution. Logistics. Sales. Revenue.
Scale and Sustain
Financing. Venture capital. Partnerships. Competitors. Pivot. Growth. Innovation. Exit.