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.

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.

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.

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.

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

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

Graphs the total development costs and Time broken into 5 phases.

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. 

Every project requires a team of resources. Even a simple ET tube requires molders, material suppliers, toxicology labs, engineers, regulatory experts, etc. But what kind of engineers, what kind of test labs? Based on the design and regulatory requirements of your projects, we will help you identify those resources and generate a list of necessary team members.

Our advisory bord has combined experience of nearly 200 years in device development in: packaging, kitting, sterilization, assembly, molding, regulatory, distribution/sales; bioengineering and hospital administration. With four members owning their own device companies in the development space. Our board will review critical aspects associated with your project based on their specific experience and expertise.

With your market data, we can estimate the cost of goods, capital investments, ROI and potential sale price. If you did not edit the market data, these values will be inaccurate.

With your market data, we can estimate the cost of production tooling, manufacturing and automation expenses.

The ROI report focuses specifically on the options for moving the project forward in terms of funding and return on investment. We will look at your overall project outline, landscape and regulatory studies and look at outline level scenarios if you create a standalone company, create a shell company with offsite manufacturing or make a license deal.

This segment of work focuses on what information would be valuable to an investor or manufacturing company interested in licensing or partnering on your technology. Then we break out this data into a standalone report for presenting to interested parties.

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.

During this process we will be gathering large amounts of data and need to communicate with you regarding our progress and questions. With the Executive plan we will schedule regular calls over the 90 days we are gathering the data and support you for 6 months assisting in Q&As; Vendor calls; and Developemnt Questions. 

Our report includes all items available in The Zewski Report and Advisor Reports

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; Resource List; Detailed ROI Report; Technology Landscape Study; Regulatory Landscape Study.

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. 

Our team looks at your device and puts together a clinical nonproprietary survey to receive clinical responses to the need and value of an idea like yours. We can do this without exposing your idea yet ask questions about how they current process is handled and the positive and negative experiences with it. The survey is limited to 30 clinicians, and we will follow-up with 5 in person interviews. The combined data can be very valuable in understanding how to move forward with the project.

Every project at some point needs a planning tool. These tools are often int the form of Gantt charts that map out timelines and costs for a project. We will create a Gantt chart for your project in out online program software and give you read access for generating more accurate outlines as we add more research to your program. This online tool can be used for communicating with potential investors and partnering institutions or your administration for up to 12 months without additional fees. We will maintain the data for free during the 90 days' time we are preparing your reports. Note write access to platform for the client comes with 100.00/mo. fee and 6-month minimum increments.

We will reach out to engineering teams on your behalf and get you proposals on a proof of concept for your device. This is a valuable asset to you in two folds. First, we are well versed in the engineering space and understand who can and can't get the job done. Second, it's something else you don't have to worry about. We'll get the proposals and set up interviews for you with the vendors.

Calls with members of our advisory board are rare and valuable. Our board members bring decades of experience and the Executive Report service gains limited access to the members that can most benefit your program. Towards the end of the work, we will schedule a call with the key members that can help your project and leverage our connections through them as well as get valuable information from them about the next steps.

During this process we will be gathering large amounts of data and need to communicate with you regarding our progress and questions. With the Executive plan we will schedule regular calls over the 120 days we are gathering the data and support you for 12 months assisting in Q&As; Vendor calls; and Developemnt Questions. 

With the advisor report service, at your request, we will review your program for potential licensing partnerships where Larry personally champions your program on his own to help you find a license deal in exchange for a small royalty agreement.