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Zewski Report Questionnaire Ballpark Questionnaire v1209.1 Medical Device R&D Questionnaire | For Ballpark Assessment Confirm the Following Assumptions 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. My device is NOT: - Life-sustaining - A long-term implantable - Designed with biological or chemical components - Classified as Class III Engineering Questions 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? Handheld or portable Cart or pole-mounted Fixed or stationary Accessory to another device 2. What is the size of the device? Very small Small Medium Large 3. What kind of material is the device made from? Plastic Plastic (with tubing) Silicone Metal Combination 4. Does the device need to be waterproof or heat-resistant? None Heat-resistant Waterproof Waterproof and heat-resistant 5. Does the device require electronics or software? No electronics Basic electronics Basic electronics with firmware Complex electronics with software Complex electronics with advanced software 6. What is the power source of the device? No electrical power Battery-powered Wall-powered Rechargeable battery Dual power source 7. Does the device have moving parts? None Simple mechanical parts Complex mechanical parts Simple electromechanical parts Complex electromechanical parts 8. What is the intended use of the device? Diagnostics Therapeutic Surgical Monitoring 9. Is the design optimized for manufacturability (DFM)? Not considered yet Basic DFM principles applied Advanced DFM principles applied Fully optimized for manufacturing 10. How complex is the supply chain for the components and materials needed? Simple, with mostly off-the-shelf components Moderate complexity, with some custom components Highly complex, with many custom components Technology Questions 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? In the concept phase with an idea or proof-of-concept In the prototype phase with a working prototype In the advanced prototype phase with production material prototype Completed verification testing and ready for pilot production or IRB submission 12. How many physical iterations has the technology undergone? No iterations 1-2 iterations 3-5 iterations 6 or more iterations 13. How well documented is the technology? No documentation Basic documentation Detailed documentation Comprehensive documentation 14. Does the technology have IP protection? No current protection Patent pending One patent granted Multiple patents granted Extensive IP portfolio 15. What is the scope of the IP protection? No current protection One country Multiple countries Worldwide protection 16. Are there existing patents related to the technology? No existing patents One existing patent Several existing patents Many existing patents 17. Are there any patent litigation concerns? No litigation concerns Possible litigation concerns Pending ownership concerns Regulatory Questions The answers to these questions help estimate a medical device's compliance needs. 18. Does the device have clinical and/or institutional support? No clinical or institutional support Institutional support only Clinical support only Both clinical and institutional support 19. What is the risk classification and regulatory pathway of the device? Class I (low risk, design controls exemption) Class I (sterile) Class II (510k exemption) Class II (510k requirement) Class II (De Novo pathway) Unsure 20. Is the device reusable or disposable? Disposable Reusable with minimal cleaning Reusable with extensive cleaning Reusable with sterilization Reusable with advanced sterilization 21. Is the device used inside or outside the body? No patient contact Skin contact only Superficial invasive Moderately invasive Deeply invasive or short-term implant 22. What is the highest level of testing planned before seeking final approval? Basic benchtop and limited user feedback Verification and validation Verification, validation, and clinical evaluation Verification, validation, and clinical trial 23. Will the device need customization for different markets or user groups? No customization needed Minor customization for specific markets Significant customization for multiple markets 24. How unique is the functionality compared to existing devices? Not unique Slightly unique Moderately unique Highly unique Groundbreaking uniqueness Submit Copyright © 2026 The Zewski Report LLC.  All rights reserved. [Home](https://thezewskireport.com?hsLang=en)   |   [Team](https://thezewskireport.com/ourteam?hsLang=en)   |   [Zewski Corporation](https://www.zewskicorp.com)  |  [Try a Ballpark Report](https://thezewskireport.com/ballparkquestionnairex)