Overview:
A yet2 client is seeking antimicrobial solutions for wound care applications that can be categorized as a CE Class IIb medical device by EU regulations.
Background:
To conform with regulation changes in the EU, there is a need to develop antimicrobial solutions for wound care applications that are categorized as CE Class IIb medical devices. To meet this regulation, solutions must reduce the bioburden by a passive mode of action, thus nothing will be secreted into the wound and no biological modulation of the wound, surrounding tissue or any physiological fluids as well as microorganisms is to occur. In addition, the solutions must not alter the wound physiology, biochemistry or immunology in any way.
Constraints:
Technology will:
- Meet CE Class IIb requirements, by EU regulations.
- Demonstrate suitable scientific evidence to substantiate antimicrobial claims.
- Completed clinical trials are not a requirement.
- Have a Technology Readiness Level that would enable development to commercialization within the next five years.
- Offer reason to believe that a developed, commercial product is likely to be cost-competitive.
Possible Solution Areas:
Anything with a physical antimicrobial mode of action.
Desired Outcome of the Solution:
Our client seeks to acquire a successful solution and develop the technology in-house towards commercialization within the next 5 years.
Field of Use and Intended Applications:
Wound care applications such as medical dressings
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