Generates instant ballpark results based on non- proprietary information.

These questions help us evaluate the use of the product you are developing and how it compares to known data.

Our review discusses in detail, the impact of the state of your technology; development challenges (which are items that bring greater development uncertainty); And other associated information related to the engineering, regulatory and manufacturing challenges of device development.

Our report evaluates the data and provide feedback on potential FDA classification; providing you a start point for research. 

The Feasibility Score provides an assessment of your project’s path to market, with higher values indicating lower complexity and fewer anticipated obstacles.

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 expenses including prototype and pre-production tooling.

Graphs the total development costs and 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); Feasibility Score; Est. Compliance Service Fees; Graphed Compliance Costs; Graphed Engineering Costs; 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.