It starts with an idea

Develop

/dəˈveləp/
verb
1. grow or cause to grow and become more mature, advanced, or elaborate.
2. start to exist, experience, or possess.

Ideate

Identify gap. Problem statement. Napkin sketch. Literature review. Stakeholder survey.

Design

Assumptions. Constraints. Materials. Dimensions. Properties. Models.

Build

Low- and high-fidelity prototypes. Investigational devices. Minimum viable product. Manufacturing.

Verify

Materials research. Human factors and use testing. Clinical study design and execution.

Validate

Market research. Industrial design. User experience. Post-market surveillance.

Optimize

User feedback. Variables. Performance for safety and efficacy. Constraints. Iterate.

Regulate

Classification. Certification. Standards. Compliance. Licensing. FDA 21 CFR 820. ISO 13485.

Launch

IP. Priority markets. Marketing. Branding. Distribution. Logistics. Sales. Revenue.

Scale and Sustain

Financing. Venture capital. Partnerships. Competitors. Pivot. Growth. Innovation. Exit.