Generates instant results once you have selected an FDA approved device as a baseline for your project.

These questions help us evaluate the use of the product you are developing and how it differs from the FDA approved device.

Our calculator gives you the option to enter the engineering rate and market data that applies to you and your program.

Our report provides the FDA classification information for the baseline product you selected; providing you a start point for research. 

Your device Cost, Time and Feasibility vs other device classifications.

The Feasibility Score, or Zewski Score, is a number between 1-100 that identifies how difficult of a program your project is to initiate and maintain a plan and budget for.  The higher risk the project, the lower the score. Average projects fall between 40-60, with projects above 75 being generally predictable and projects below 25 being, complex and high risk.

The questions in the questionnaire, help us determine where you project lies within that range.

Like the Feasibility Score, the compliance score runs between 1 and 100.  However, the compliance score only looks at the thoroughness of the of FDA reviewal process for the device. Its values are more focused on patient risk and testing challenges, vs over all business feasibility.  Your compliance score may be higher or lower depending on the overall project details. 

For example, a project with a small market, but little risk, may have a lower feasibility score than compliance score. 

Our review discusses in detail, the impact of the state of your technology; special conditions (which are items that bring greater development uncertainty); Fees associated with the FDA and regulatory experts that may work on your project.

Estimates for general guidance, submission and FDA fees.

Estimates for FDA recognized compliance tests; consultant fees; FDA fees; and Design Control Costs.

Estimates engineering fees and capital expenses, pro production prototype tooling.

If you entered market data, we can estimate the cost of good, ROI and potential sale price. If you did not edit the market data, these values will be inaccurate.

Explanation of special conditions having a serious impact of the development time and cost of your program.

Graphs the total development costs broken into 5 phases.

Graphs the total development time broken into 5 phases.

Our report is created using FDA regulation and use data for similar devices.

Our mathematical algorithm applies risk scores to specific inputs, then applies those formulas to pre-generated case studies on 'like' devices using our costing calculator. The result is a real-world based evaluation taking into account risk, and modern development applications, and inflation.

Our lead engineer hand writes a development assessment for each device application, briefly describing the factors involved in costing.

For proprietary reports, this work is paid for by the client and these reports are not available to the general public.

The license-investor research and assessment are paid for by the licensee interested in finding investors or licensors for their technology. This can include various items including a market review, detailed regulatory assessment or an intellectual property and landscape study. 

Some license reports are made available to the general public.

We refer to the IP data to generate an overview of the technology to make the product real. Using a patent as a guide, we can identify may necessary methods of development and manufacturing that can be used to feed our calculators.

Our report includes all items available in the blind studies including:

FDA Product Classification (where applicable); Comparision Graph; Feasibility Score; Compliance Score; Use Assessment (specifically for the device listed); Est. Compliance Service Fees; Graphed Compliance Costs; Graphed Engineering Costs; Special Conditions; Total Development Costs by Phase; and Total Developemnt Time by Phase. 

A personal assessment written by a senior engineering staff member of the construction and manufacturing methods employed in the device manufacturing.

A personal assessment written by a senior engineering staff member of the potential manufacturing path for the device selected.

Clients can opt-in to have market research conducted on the problem they are solving, either through social media or direct contact. We partner with educational institutions to support this early-stage research activity, which saves innovators precious cash at the beginning. 

Clients can op-in to conduct a bird’s eye view of the technical landscape of a particular area. It is different from a targeted prior art search which compares a distinct invention to published references. It is possible that prior art could interfere with the ability to obtain a patent from outside of the related technology area. This is not an exhaustive list of references. If a portion of this search report is of particular interest to the client, then a refined, in-depth search can be conducted to understand that space; This report is not legal advice, and it doesn’t provide an assessment of patentability and/or freedom to operate in a given technology space.

Clients can op-in to conduct a bird’s eye view of the regulatory landscape of a particular area. This targets projects of similar indications and risk as viewed by the FDA. This helps determine early budgetary estimates of the program from a compliance perspective. When the client decides to proceed or receives funding, they can move to the more formal and required design control item the Regulatory Strategy from a qualified regulatory support firm.