Technology Factors Review
1. Technology & Solution Assessment
Now it's time to get deep into the innovation you've developed. Please articulate:
- Overview: What is your technology/solution and why it is unique?
- Feasibility: How do you prove feasibility of your technology? (e.g. similar technology, bench studies, animal or human tests)
- Relative Advantage: Compared to the current standard, what is your degree of innovation?
- Compatibility: Can this product be used with existing protocols or fit in easily without significantly disrupting workflows?
- Ease of Use: How easily can this technology be used? Is there a learning curve, and if so, how intensive is it?
- Observable Results: Can this technology achieve readily identifiable results such as patient survival or improved health?
- Development Costs: How much specialized engineering do you need to build a commercial-ready product? What costs do you anticipate?
2. IP Landscape
We are particularly interested in innovations with the potential for strong IP. Please review and document:
- What existing IP is relevant to this project?
- Are there any potential IP conflicts?
- What is the IP potential for this project?
- What is the estimated cost for protecting your innovation?
3. Regulatory Pathway
Before you market or launch your product, you must receive approval from the regulatory body of the country in which you intend to launch (in the U.S. that is the Federal Drug Administration, or FDA). Please seek expert guidance to inform and articulate your most likely regulatory pathway.
You should be able to answer:
- Are you a device, drug, or combination product?
- What evidence will the FDA require to support your submission?
- What studies will you need to complete to amass that plan? What is the estimated cost of those studies?
- What market trends are the current regulatory guidelines or recommendations driving?
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