Do you sign NDAs?

Ballpark services available through the questionnaire do not ask proprietary questions.  If necessary, we sign NDAs for the following report services: Advisor Report, Executive Report, and Knock-Out + Provisional. Since these services include either a senior consultant or advisory board review; however, we always recommend having a filed provisional patent for The Zewski Report services. Our knock-out-provisional service can assist you in getting what you need to file a well-structured provisional patent, which in many cases can be done on your own with a small USPTO fee.

What is the Knock-Out + Provisional option?

Our Knock-Out service covers research into existing patents and applications, so you can position your invention to surpass similar ideas by highlighting its novelty. If the report finds technology exactly like yours, there are two options from which to choose: (1) get a 50% refund of the report purchase or (2) redefine your idea to make it more unique.

Do I have to enter any proprietary information?

No. We do not ask any questions that disclose the details of your invention.

How can you calculate without the product's intent?

All service providers have to make guesses in order to quote R&D and development projects. They do this using the laws of averages. Although the space we work in may be complex in the number of activities to complete a project, the fact it is very repetitive and predictable. The expected classification of a device will identify much about what has to be done to bring it to market. For example, in manufacturing, there are common processes and costs associated with certain sizes and shapes. Also, by presenting FDA approved products and known intended uses and potential predicates, we are able to identify may costs associated with development, testing and design controls. With experience in development of over 30 years and an advisory board with over 300 years of experience, there's little we haven't accounted for in our calculations.  

The largest unpredictable factor will be the level of service providers you use for the services. Typically, you will be using Tier 1, 2 or 3 providers. Each brings a different talent to the table. Tier 3 providers are usually smaller yet still qualified firms, more nimble but less available. Thier fees may run 1/3rd that of a Tier 1 provider who will offer more inhouse capabilities and a faster timeline.  

Depending on your financial capacity, you may start with Tier 3 providers, and move to Tier 1 as you get more funding through grants or investors. Our service is designed to help you know when to make those moves and who is the best match for providing the services for your project at any given time.

Are there limitations to The Zewski Report?

The following device categories are beyond our expertise and not suitable for The Zewski Report services:

  • Biological or pharmaceutical
  • Implantable
  • Life-sustaining or supporting
  • FDA Class III
  • Software only Devices
How do your calculations work?

Although our calculators are proprietary, what is important is that the specifics of how your device works, particularly when using a combination of existing technologies, will generally have a small effect on the end time and cost. In most cases, how your product will be made and where it is used have the biggest impact, and those items can be determined without disclosing details about your device.  However, we do recommend having report completed that is reviewed by our advisory board in order to both fine tune the numbers as well as open up channel to additional resources.

When does the Advisory Board review data?

Purchase of the Advisor Report or Executive Report includes an advisory board review.

What knowledge is the data based on?

Our calculations came from data acquired over 6 years on over 100 projects considering over 35,000 engineering data points from NRE, Expenses, Capital cost and Regulatory Costs.  In reality, the actual dollar and time values will vary depending on what suppliers the innovator uses to do the work for each area of work.  However, values in the standard report are based on Tier 2 engineering services ranging from 140-250.00 per hour and an average team experience of 5-8 years in medical devices.  If the innovator uses Tier 1 firms, the cost will go up, but the time may go down; adversely, if they use Tier 3 firms, the cost will go down, but the time may go up.  Our reports are based on averages and only to act as a start point for investor discussions where there is limited information available.

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.