It starts with an idea
Identify gap. Problem statement. Napkin sketch. Literature review. Stakeholder survey. MRS. Verification plan.
Assumptions. Constraints. Materials. Dimensions. Properties. Models. Design inputs. Traceability matrix. DFMEA. DMR. DHF.
Low- and high-fidelity prototypes. Investigational devices. Minimum viable product. Manufacturing. Production samples.
Materials research. Bench testing. Human factors testing. Use testing. Clinical studies.
Market research. Customer interviews. Industrial design. User experience. Post-market surveillance. CAPA.
Beta testing. User feedback. Variables. Performance for safety and efficacy. Constraints. Iterate.
Classification. Certification. Standards. Compliance. Licensing. FDA 21 CFR 820. ISO 13485. ISO 9001. IEC 62304. Labeling.
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.