Table 3.
Startup Maturity Index questions and score from 16 companies
| Questions | Average score | SD |
|---|---|---|
| Business Vision | 3.0 | 0.69 |
| 1. Have you defined your business purpose and mission/vision statement? | 2.8 | 1.23 |
| 2. Have key milestones been identified? | 3.2 | 0.85 |
| 3. Has a leadership team been established? | 3.2 | 0.70 |
| 4. Do you have a Target Product Profile (TPP) outlining desired product characteristics? | 3.0 | 1.32 |
| 5. Have disease prevalence and/or market positioning been identified? | 3.4 | 0.63 |
| 6. Have you surveyed the defined customer population? | 3.0 | 0.83 |
| 7. Have you performed a SWOT analysis for your company? | 2.8 | 1.00 |
| Business Logistics | 2.8 | 0.82 |
| 8. What intellectual property protection do you have, if applicable? | 3.4 | 0.89 |
| 9. What types and amounts of funding do you have? | 2.6 | 0.89 |
| 10. Have you determined the structure of your business entity, for example, LLC, INC, S-corp? | 3.0 | 0.97 |
| 11. Do you have a physical location and if so, have you determined the required permits and licenses? | 2.0 | 0.88 |
| 12. Are you aware of accounting needs and practices? | 2.8 | 0.88 |
| 13. What is the governance structure of your business? | 2.8 | 1.25 |
| Design and Production Capabilities | 2.6 | 1.06 |
| 14. Do your facility/utility/storage requirements & capabilities match your office & manufacturing needs? | 2.3 | 1.07 |
| 15. How is your equipment for manufacturing and testing validated and maintained? | 2.7 | 1.49 |
| 16a. Do you understand and document processes for producing the product? | 2.5 | 1.29 |
| 16b. Do you understand and document processes for developing and validating the software? | 3.2 | 0.84 |
| 17. What are the environmental, health, and safety considerations for your production facility? | 2.7 | 1.60 |
| 18. Do you control the specifications and sourcing of major raw materials/ components/ supplies? | 2.8 | 1.03 |
| 19. What is the state of your IT & network infrastructure? | 2.2 | 1.17 |
| Regulatory and Clinical Readiness | 2.6 | 0.72 |
| 20. Do you understand how to develop and register medical devices in accordance w/US medical device regulations? | 3.0 | 0.87 |
| 21. Do you have a QMS to formally document processes and procedures to attain high reproducibility? | 2.6 | 0.99 |
| 22. Do you have staff to develop an insurance reimbursement strategy? | 2.5 | 1.08 |
| 23. Are you familiar with permissible promotion and sales practices for medical devices? | 1.8 | 0.89 |
| 24. Has a clinical focus group evaluated the medical need and design concept for your device? | 2.8 | 1.02 |
| 25. Do you have clinical assistance or formal partnerships in the development of the device? | 2.9 | 1.06 |
| Do you have access to clinical partnerships? (round 1 only) | 2.6 | 1.19 |
| Human Resources and Role Evolution | 2.4 | 1.07 |
| 26. Do you have Human Relations (HR) structures and policies? | 1.7 | 1.07 |
| 27. Have you defined the roles, titles, and responsibilities of the staff? | 2.8 | 0.90 |
| 28. Are you compliant with federal, state, and local labor laws? | 2.6 | 1.26 |
| 29. Do you have a system to ensure that staff are paid on time and appropriate taxes are withheld? | 2.7 | 1.23 |
| 30. Do you keep employee records, and if so, how do you keep this information confidential? | 2.2 | 1.20 |
| How do you recruit, hire, and fire employees? (round 1 only) | 1.6 | 1.13 |
| SMI Overall Score | 2.7 | 0.72 |
SD = Standard deviation; SWOT = Strengths, Weaknesses, Opportunities, Threats; IT = Information Technology; QMS = Quality Management System.