Algorithmic Driven Data

Assessment of FDA approved device similar to your innovation and 

new technologies available for license or sale.

For a quick glance of what your program costs and time might look like.

Curious

Create a Feasibility Study | ~15min.

Feasibility Score

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.

Compliance Score

Like the Feasibility Score, the compliance score runs between 1 and 100.  However, the compliance score only looks at the difficulty of the of FDA approval. 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, will have a lower feasibility score than compliance score. 

Partial Compliance Review

Our compliance 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.

The FREE partial compliance review only highlights some of these items. A full review comes with every paid option.

Partial Q&A Assessment

During the questionnaire, you will answer about 9 questions associated to use and the state of your idea. The Q&A Assessment give detailed responses to each answer and how it impacts the development of the device. 

The FREE partial Q&A assessment covers 4 of the most impactful answers. A full Q&A assessment comes with the Ballpark Assessment comes and the Ballpark Limited.

All custom programs have much more extensive detailed analysis.

Data Recorded

As long as you leave your name and email address, we will record your data in case you choose to order a report off your original answers in the future. We just need your name, email and the day of your entries (if you took the questionnaire more than once).

We do not sell data, but we do collect the answers for research, and may reach out if we have parties interested in investing in the technology space you are working.

Research

Ballpark Report | Instant

Feasibility Score

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.

Compliance Score

Like the Feasibility Score, the compliance score runs between 1 and 100.  However, the compliance score only looks at the difficulty of the of FDA approval. 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, will have a lower feasibility score than compliance score. 

Full Compliance Review

Our compliance 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.

The FREE partial compliance review only highlights some of these items. A full review comes with every paid option.

Full Q&A Assessment

During the questionnaire, you will answer about 9 questions associated to use and the state of your idea. The Q&A Assessment give detailed responses to each answer and how it impacts the development of the device. 

The FREE partial Q&A assessment covers 4 of the most impactful answers. A full Q&A assessment comes with the Ballpark Assessment comes and the Ballpark Limited.

All custom programs have much more extensive detailed analysis.

Data Recorded

As long as you leave your name and email address, we will record your data in case you choose to order a report off your original answers in the future. We just need your name, email and the day of your entries (if you took the questionnaire more than once).

We do not sell data, but we do collect the answers for research, and may reach out if we have parties interested in investing in the technology space you are working.

Cost by Phase

The cost by phase chart is just as it sounds, a cost breakdown by phases in the project. All our assessments are based on a 5-phase program and a post development manufacturing readiness step. In cost by phase, the 6 steps are divided based on the costs that will occur during them.

 

Time by Phase

The time by phase chart is just as it sounds, a time breakdown by phases in the project. All our assessments are based on a 5-phase program and a post development manufacturing readiness step. In time by phase, the phases are divided based on the time it will take to get through that phase.  Unlike the cost by phase, time by phase does not estimate manufacturing readiness.

For License

Zewski Report | Instant

Ballpark Report

Cost and time milestone analysis creates a list of most critical items that will impact time and cost on a macro level. Breaking the project activities into approximately 50 items over 5 phases, depending on the project there may be less or more items identified.

Manufacturing Study

The manufacturing study is an expert assessment of the technology needed in order to bring your product idea to fruition. Through research and experience, we will lay out a likely path from your products production methods and the fields of expertise that will need to be involved to make it happen.

Financial Assessment

Our financial assessment will include scenarios of cast based on location of Manufactuing, type of manufacturing and the necessary quality level needed for each aspect of your project. It will also look at low and high-volume scenarios of the project, labor and automation if needed to assess where your costs are likely to lie.

Licensee Information

Report includes information to contact the licensee of the technology to request a meeting. The Zewski Report can act as a catalyst for this activity for our standard consulting fee.

Most start-ups look back in wonder at the project path they took.

We provide a pragmatic method of looking forward so you can anticipate costs, processes, and risks to make confident decisions.