The Zewski Report is an educational planning tool for early-stage medical device innovators. It uses information about your device concept to create a personalized planning report covering areas such as development complexity, estimated cost and timeline ranges, regulatory considerations, testing and validation, prototyping, manufacturing, team needs, and potential project risks.

The report is designed to help you understand what your concept may require and prepare for more informed conversations with development firms, regulatory professionals, manufacturers, potential partners, and other qualified advisors. It is not a professional assessment or a substitute for device-specific expert guidance.

The Zewski Report is designed for early-stage medical device innovators, including inventors, clinicians, patent holders, founders, and university or innovation teams exploring a device concept.

It is most useful when you need an initial view of the work your concept may require but don’t yet have a complete development plan. You don’t need to be an engineer or regulatory professional to use the report.

The report provides a planning snapshot of your device concept, including:

• A summary of the concept and its development profile
• Development complexity and feasibility considerations
• Estimated cost and timeline ranges
• Lean and full development program comparisons
• Phase-based development activities
• Regulatory pathway considerations
• Testing and standards considerations
• Prototype and manufacturing assumptions
• Potential team and resource needs
• Key risks, dependencies, and planning considerations

The report’s dashboard also lets you compare how selected development scenarios may affect planning assumptions, tables, and timelines. The contents are educational estimates based on the information provided—not a formal development proposal or device-specific professional assessment.

The report uses your questionnaire responses and device description to identify development characteristics that may affect project scope, complexity, cost, and timing. These inputs are evaluated within a structured planning model and used to generate estimated ranges, phase assumptions, and development scenarios.

The estimates are directional planning ranges, not quotations or guaranteed outcomes. Actual costs and schedules can vary based on the final product requirements, development approach, regulatory strategy, testing needs, design changes, supplier availability, team structure, and other device-specific factors.

The dashboard lets you explore how different planning assumptions may affect the development program. You can compare scenarios involving execution strategy, regulatory region, clinical evidence, and funding conditions.

Your selections recalculate applicable planning tables and timeline views throughout the report. They are intended to help you compare possible approaches—not recommend a particular strategy or predict the actual cost, schedule, regulatory pathway, clinical requirements, or funding available for your device.

You’ll answer a series of questions about your device concept, including what it is designed to do, its main functions and materials, where it will be used, how it interacts with the patient, whether it includes electronics, its current stage of development, the number of versions planned, and your current regulatory and sterility assumptions.

You can also upload a document describing the device—such as a patent, specification, grant, or design notes—or enter a project description directly. Closest-fit answers are appropriate, and you don’t need to have every technical or regulatory detail resolved.

Choose the closest answer based on what you currently know. Some questions include additional guidance to help you interpret the available options, and you don’t need to have every technical or regulatory detail resolved.

The report reflects the information and assumptions you provide, so uncertain answers should be treated as planning assumptions that may need to be revisited as the device develops.

Only provide information you’re comfortable submitting through the service. You don’t need to disclose every technical detail for the report to be useful, and you should avoid including trade secrets, highly sensitive personal information, or information you don’t have permission to share.

Submitting information does not create a nondisclosure agreement or confidential relationship with Zewski Corporation. If your concept requires confidentiality protection, consider consulting a qualified advisor before uploading or entering sensitive materials.

During the current beta, you can preview your report and then enter your email address to unlock the full report at no charge. We’ll send you a private link that provides access to the report for 30 days.

Keep the link for your records and avoid sharing it publicly. After the 30-day access period ends, the link may no longer open the report.

The Zewski Report is currently available at no charge during beta in exchange for an email address and feedback about your experience.

Beta access and pricing may change as the product develops. Any applicable price or access requirements will be shown before you choose to unlock the full report.

We may retain your report and the information used to generate it for up to 180 days to support report administration, troubleshooting, feedback, and product improvement.

Your private report link is available for 30 days during the current beta. The access period and retention period are different: after the link expires, the report may remain stored but will no longer be accessible through that link. After the retention period, it may be deleted and may not be recoverable.

You may share your report with development firms, regulatory professionals, manufacturers, potential partners, and other advisors involved in evaluating your device concept.

Your private access link is intended for you and shouldn’t be posted publicly. If you choose to share the report or its contents, consider whether they include confidential, proprietary, or personally identifiable information. The Zewski Report doesn’t provide an NDA or control how recipients use information you share.

Review the information and assumptions you provided, since they influence the report’s estimates and planning considerations. If an answer was incomplete or inaccurate, you can generate another report using revised information.

During beta, we also encourage you to submit feedback about unclear, incomplete, or unexpected results. Feedback helps us evaluate report quality and identify areas for improvement.

The report’s usefulness depends partly on the completeness and accuracy of the information you provide. It applies a structured planning model to those inputs to produce directional estimates, assumptions, and considerations for early-stage planning.

Because many product requirements and development decisions may still be unresolved, the report can’t predict actual costs, timelines, testing requirements, regulatory outcomes, or commercial results. Its estimates should be treated as a starting point that can be refined as the device concept and supporting evidence develop.

No. The report may identify regulatory considerations and a potential pathway based on the information you provide, but it doesn’t determine your device’s FDA classification, product code, or applicable submission pathway.

Those conclusions depend on the device’s intended use, indications for use, technological characteristics, claims, risk profile, and other device-specific details. Consult a qualified regulatory professional and current FDA resources before making regulatory decisions.

No. The Zewski Report is an educational planning tool and doesn’t provide legal, regulatory, clinical, engineering, investment, or other professional advice.

The report can help you identify questions, assumptions, and potential areas of work to discuss with qualified professionals. Any decisions about your device’s design, development, testing, regulatory strategy, manufacturing, funding, or commercialization should be based on device-specific evaluation and appropriate professional guidance.