Douglas Coveney

- Drove the R&D and go-to-market strategy of a new diagnostic detection technology increasing reagent revenues by 10% - Initiated and launched open platform software opening research markets and increasing instrument sales and reagent revenue - Attained business plan approval for software and assay development activities - Developed the company molecular probe commercial strategy establishing multimillion revenue for the North American market - Developed and implemented FDA regulatory strategies in relation to the Class I, II and III devices, including Pre-IDE and 513g submissions - Managed clinical studies for class I and class III diagnostic assays - Implemented quantitative and qualitative market research to manage innovation pipeline of diagnostic tests

- Lead the development of and launched the first DNA molecular diagnostic assay on a immuno platform device - Managed a cross functional team of scientists and engineers (8 staff) to automate diagnostic assays - Co-authored De-Novo 510K and Pre-Market Applications - Developed and implemented risk management for product development - Lead verification, validation and clinical trial activities

- Developed a novel in vitro 3 dimensional model of organ development - Defined in situ gene expression profiling of the novel and first testicular cancer susceptibility gene, Dnd1 - Co-Authored two successful NIH grants and three personal fellowships totaling $1+ M USD - Authored five peer reviewed articles and presented at four international conferences

Microeconomics Financial accounting Business analytics