See where your device project has gaps before development, in about three minutes.
- A readiness scoreOne number for the whole project, and a score for each of 11 areas.
- Your three biggest gapsEach one with a concrete action for next week.
- Where to read moreThe chapter of Hardware Bible that covers each gap.
The short answer
A device project is ready for development when the basics are written down and checked: intended use and users, who pays, the FDA route, requirements, risks, budget, team, manufacturing and timeline, plus a prototype tested against written questions. This check scores 15 yes, partly or no questions from Hardware Bible, and 75% or more counts as ready to develop.
How it works
- Answer 15 questionsYes, partly or no, on users, payment, regulation, engineering, budget, team and timeline.
- We score each areaYes is worth 2 points, partly 1 and no 0, for each area and for the whole project.
- You get three actionsYour lowest answers, each with what to do next week and the chapter that covers it.
What the check asks, and where the book covers it
| Area | Questions in the check | Chapter in Hardware Bible |
|---|---|---|
| Intended use and users | 1. Intended use written down; 2. Users and setting known from watching them | Chapter 2, The regulatory map; Chapter 4, Finding clinical needs worth solving |
| Who pays | 3. Payer and budget named; 4. Billing codes checked | Chapter 3, Who pays: reimbursement from day one |
| Regulatory route and evidence | 5. FDA class and route checked; 6. Predicate chosen; 7. Clinical study needed or not | Chapter 2, The regulatory map; Chapter 16, Clinical evidence and clinical trials |
| Requirements | 8. Testable written requirements | Chapter 11, Quality systems and design controls |
| Risk analysis | 9. Risk plan and hazard analysis | Chapter 12, Risk management: finding the dragons |
| Patents and IP | 10. IP position written | Chapter 5, Turning needs into concepts |
| Prototype | 11. Prototype tested against written questions | Chapter 7, Prototyping that answers real questions |
| Budget and cash runway | 12. Budget built from the real route, cash past launch | Chapter 1, The medical device market behind the numbers; Chapter 2, The regulatory map; Chapter 21, Distribution and hospital sales |
| Quality and regulatory team | 13. Experienced quality and regulatory owner | Chapter 2, The regulatory map |
| Manufacturing plan | 14. Manufacturer, volume, cost, design review | Chapter 8, Design that survives manufacturing |
| Timeline | 15. Phase-by-phase timeline with real FDA times | Chapter 1, The medical device market behind the numbers |
The check scores your own answers. It does not read your documents, decide your FDA class or stand in for a regulatory specialist, and the points and the 40% and 75% lines are our simple rule, not an FDA or ISO standard. The book says little about patents, so the patents question asks only whether your IP position is part of your written strategy, not whether anyone has checked your freedom to operate.
What OVA does here, and where our responsibility ends
We design the electronics, firmware and mechanics of medical devices and take them from concept to design for manufacturing. We are not a regulatory consultancy and not a contract manufacturer: the regulatory strategy and the submission stay with you or your regulatory consultant.
The result is an orientation from your own answers, not an audit or a regulatory opinion. Confirm the pathway with a regulatory specialist or through a Pre-Submission (Q-Sub) with FDA. The tool runs in your browser. Your answers are not sent to us; with your cookie consent, Google Analytics records only that the tool was used and the category of the result.
Questions
Will my 510(k) need a clinical study?
Often not: many 510(k) devices reach the market without a new study. FDA’s usual triggers for clinical data are new indications, new technology, a comparison bench tests can’t settle and a new risk with the predicate. A required trial adds years and millions, so decide what evidence you need before the design is frozen.
How long does medical device development take?
Founders usually tell Lisa 12 to 18 months. In the book the phases add up to about three years for a simple device with no clinical study, and about ten for one that needs a large trial. Plan a 510(k) review at about five months of calendar time, not FDA’s 90-day goal.
When should I write the intended use statement?
Before your first prototype. The words you choose decide the device class, and the class sets your timeline, your budget and the evidence you need.
Does FDA clearance mean someone will pay for my device?
No. Clearance lets you sell a device but says nothing about whether anyone will pay for it. Lisa has seen more good devices die of a missing billing code than of a failed test.
How is the score calculated?
Each yes is worth 2 points, partly 1 and no 0, so 30 points in all. Under 40% reads as early, 40 to 74% as partly ready and 75% or more as ready to develop. Your three biggest gaps are your lowest answers, every no before any partly, with ties in question order.
Related pages
Sources
Based on Hardware Bible, revised edition 2026. By Lisa Voronkova, CEO of OVA Solutions. Updated on October 22, 2026.