Ballpark Questionnaire v1209.1
Medical Device R&D Questionnaire | For Ballpark Assessment
This questionnaire and calculator are specifically tailored for small to medium-sized, clinician-patient devices that are mechanical or electromechanical, with a focus on low to moderate-risk categories. These tools are ideal for projects with development budgets between $100,000 and $3 million, spanning a 3- to 5-year timeline. Please note, using this tool outside these specified categories may yield inaccurate or irrelevant results.
The answers to these questions help estimate a medical device's development time, cost, and complexity.
1. Is the device portable, stationary, or an accessory?
2. What is the size of the device?
3. What kind of material is the device made from?
4. Does the device need to be waterproof or heat-resistant?
5. Does the device require electronics or software?
6. What is the power source of the device?
7. Does the device have moving parts?
8. What is the intended use of the device?
9. Is the design optimized for manufacturability (DFM)?
10. How complex is the supply chain for the components and materials needed?
The answers to these questions help estimate a medical device's technological readiness and market potential.
11. What is the maturity level of the technology?
12. How many physical iterations has the technology undergone?
13. How well documented is the technology?
14. Does the technology have IP protection?
15. What is the scope of the IP protection?
16. Are there existing patents related to the technology?
17. Are there any patent litigation concerns?
The answers to these questions help estimate a medical device's compliance needs.
18. Does the device have clinical and/or institutional support?
19. What is the risk classification and regulatory pathway of the device?
20. Is the device reusable or disposable?
21. Is the device used inside or outside the body?
22. What is the highest level of testing planned before seeking final approval?
23. Will the device need customization for different markets or user groups?
24. How unique is the functionality compared to existing devices?
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