Biosensor Commercialization Strategies

This talk will discuss how to commercialize new biosensor products. Launching medical devices and microfluidic diagnostic sensors will be addressed.  Biosensors must be biocompatible if used to test bodily fluids or to be implanted. Material selection impacts issues like sterilization, hemolysis, cytotoxicity, osmotic fragility, Partial Prothromboplastin Time (PTT) and Prothrombin Time (PT)  - clotting time. Regulatory approval concerns for new products must also be considered when launching a biosensor. These biospecific issues must be laid on top of traditional business development tasks such as fund raising, manufacturing, reliability, quality, packaging and documentation.  A systematic, stage-gate approach to commercializing biosensor products will be presented along with examples of prior sensor manufacturing technologies such as MEMS & additive manufacturing as well as, drug infusion, diagnostic and implant devices.

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