Research and Experience Driven Reports

Assessment of your device, creating a custom program study to get you

a comprehensive landscape analysis of your project from all angles.

$899

$3,599

$8,599

The Zewski

Report

Milestone 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.

Next Step Consult

Post report next step consults are based on where you are and what report you have ordered but are designed to help you lay out a plan for moving forward with your idea in terms of connections, design and funding options.

The Advisor

Report

Milestone 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.

Next Step Consult

Post report next step consults are based on where you are and what report you have ordered but are designed to help you lay out a plan for moving forward with your idea in terms of connections, design and funding options.

IP Landscape Study

Our IP landscape study is a partnership with our partnering institution technology transfer department. Team will look at the patent, market and research landscape, providing an overview of technological space your idea sits with in. This study does not replace the need for a legal expert on your project, but aids in laying out the necessary information they will need to do their job in creating solid IP protection for you. IP legal fees can cost in excess of 30k. This study gives you a bird's eye view of the landscape before investing that money.

Reg. Landscape Study

Our regulatory landscape study is a partnership with our regulatory advisor who assists us in analyzing the FDA product database landscape for products that may be acceptable predicates for your devices. This study does not replace the need for a regulatory expert on your but aids in laying out the necessary information they will need to do their job in creating a regulatory strategy for you. A regulatory strategy alone can cost in excess of 8,000.00. This study gives you a bird's eye view of the landscape before investing that money.

Resource List

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.

Vendor Introductions

Following up on the resource list, we will either introduce you to qualified resources or find them for you. These introductions will be a valuable start in generating a set of resources needed to move forward. Although they may change through the process, this step will give you a leg up and much needed free support, as many supplier resources are able to give guidance at no cost in hopes of winning the project in the future.

Advisor Board Review

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.

ROI Report

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.

Opportunity Analysis

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.

Next Step Consult

Post report next step consults at this level, are more serious and may involve members of the advisory board to help you lay out a plan for moving forward with your idea in terms of making larger steps forward.

The Executive

Report

Milestone 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.

Next Step Consult

Post report next step consults are based on where you are and what report you have ordered but are designed to help you lay out a plan for moving forward with your idea in terms of connections, design and funding options.

IP Landscape Study

Our IP landscape study is a partnership with our partnering institution technology transfer department. Team will look at the patent, market and research landscape, providing an overview of technological space your idea sits with in. This study does not replace the need for a legal expert on your project, but aids in laying out the necessary information they will need to do their job in creating solid IP protection for you. IP legal fees can cost in excess of 30k. This study gives you a bird's eye view of the landscape before investing that money.

Reg. Landscape Study

Our regulatory landscape study is a partnership with our regulatory advisor who assists us in analyzing the FDA product database landscape for products that may be acceptable predicates for your devices. This study does not replace the need for a regulatory expert on your but aids in laying out the necessary information they will need to do their job in creating a regulatory strategy for you. A regulatory strategy alone can cost in excess of 8,000.00. This study gives you a bird's eye view of the landscape before investing that money.

Resource List

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.

Vendor Introductions

Following up on the resource list, we will either introduce you to qualified resources or find them for you. These introductions will be a valuable start in generating a set of resources needed to move forward. Although they may change through the process, this step will give you a leg up and much needed free support, as many supplier resources are able to give guidance at no cost in hopes of winning the project in the future.

Advisor Board Review

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.

ROI Report

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.

Opportunity Analysis

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.

Next Step Consult

Post report next step consults at this level, are more serious and may involve members of the advisory board to help you lay out a plan for moving forward with your idea in terms of making larger steps forward.

Clinical Survey

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.

Market Landscape Study

This study dives deeper into the IP and Regulatory studies, looking at the products identified in those studies and looking at how they are performing in the market, costs, sales and users. This data is then used to outline the strongest position for your innovation. This data can be used as a guide when choosing a Clinical Research Organization for a more indepth and exhaustive study. 

Funding Landscape Study

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Gantt Timeline Planning

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.

Proof of Concept Proposals

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.

Bi-weekly Planning Calls

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. These calls alone have a value of over $4000.

Advisor Board Call

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.

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.