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.

Conceptualize

Identify gap. Problem statement. Napkin sketch. Literature review. Stakeholder survey. MRS. Verification plan.

Design

Assumptions. Constraints. Materials. Dimensions. Properties. Models. Design inputs. Traceability matrix. DFMEA. DMR. DHF.

Build

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

Verify

Materials research. Bench testing. Human factors testing. Use testing. Clinical studies.

Validate

Market research. Customer interviews. Industrial design. User experience. Post-market surveillance. CAPA.

Optimize

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

Regulate

Classification. Certification. Standards. Compliance. Licensing. FDA 21 CFR 820. ISO 13485. ISO 9001. IEC 62304. Labeling.

Launch

Packaging. IP. TM. Liability insurance. Priority markets. Marketing. Branding. Distribution. Logistics. Sales. Revenue.

Scale and Sustain

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