Projects / Challenges / Results
ILE’s will always work for the best interest of clients. We will highlight 3-5 different projects on this page and provide information about the methods, tools, services we that help clients succeed. Additionally, we will not shy away from case studies that highlight projects that aren’t ready to move forward. By doing so, we will demonstrate our value to all life science entities with which we engage in discussion.
United States Department of Commerce
ILE was recently recognized by the U.S. Department of Commerce for contributing to the 2014 Intellectual Property Protection: Technology Commercialization Program in July 2014. This program is part of the Department’s SABIT Program, which is a division of the Department of Commerce Global Markets unit. We’re proud to contribute to such programs and welcome opportunities to share our expertise with a goal of helping more life science businesses grow and gain access to U.S. and global markets. View the letter we received here.
Bringing Diagnostic Product to Market
This product is approved for use in the country in which it was developed. The U.S. market, however, represents a significant opportunity to A) gain broader use; B) raise awareness; C) increase North American market share; D) build a platform for global markets. Setting up clinical trials with the FDA clearance process in mind is the main challenge and objective.
ILE, within three months, has helped this client to:
- Set up U.S. testing to validate the diagnostic process
- Establish the clinical testing protocols needed for FDA clearance
- And once the FDA clearance process is underway, ILE will consult with the client to help them determine if they can adequately develop the remaining portion of their U.S. business and marketing plan. If not, ILE will develop manufacturing and distribution strategies (considering the best location(s) for manufacturing and assembly), overall U.S. business strategies, handle various regulatory matters, develop a funding plan and build initial sales/marketing programs, etc.
Go or No Go Market Analysis
The client, being early stage, needed help to understand whether they A) have a U.S. market opportunity; B) can raise sufficient funds to complete development and testing; C) have a financially viable product around which a business can be built. The overriding challenge (and question) revolved around whether this client has a product that can be made ready for market — now or ever.
ILE’s always start a client relationship by doing an upfront business and/or market analysis. Depending on the complexities of the product or service, the depth or level of analysis will be determined. (Whether a deep dive or quick analysis, the objective is to help the client understand their options through a comprehensive set of recommendations and potential strategies.)
- The results of this client’s analysis determined they were not ready to enter the U.S. market — and may never be.
- The funding required to get to market was deemed to be significantly more than would expected to make through sales
The result of working with ILE resulted in the client disengaging with ILE and returning to their R&D and core/foundational business strategy to determine if A) they can make appropriate changes; B) deploy remaining capital more appropriately; C) confer with their investors (who appreciate the effort to protect their investment); D) understand how and when to again make attempts to move forward in the U.S.