Title: Biosensor Commercialization Strategies

Biography:

Doug Sparks has been involved in the commercialization, product development, and operations of MEMS and microfluidic sensors, He has worked at large MEMS IDMs, start-ups and MEMS foundries. Doug is the VP Asia-Pacific for MANCEF (Micro And Nano Commercialization Educational Foundation) and the CTO of Hanking Electronics which built the first 200mm pure MEMS fab in China. He also founded a microsensor packaging company called NanoGetters, was the EVP at Integrated Sensing Systems where he launched nine microfluidic sensor products, including an FDA approved MEMS drug infusion device. Doug holds a PhD in materials engineering from Purdue University has published more than 120 technical papers and has 68 issued patents.

Abstract

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.