Development of global go-to-market and regulatory strategies for new hemostatic products, managing all product development projects, clinical/pre-clinical research, and submissions to FDA, resulting in successful 510(k) clearance. Executive leadership: managing Board of Directors, employees, contractors. Raising millions of dollars in institutional and private investor capital. Strategic partnerships, M&A, business planning, finance, accounting, sales/marketing, HR. Implementation and internal customization of strategic tool kits across teams, including Traction (EOS) & 4DX (Franklin Covey) Project Management Systems, N&I Innovation, Sandler Sales, Consiliso Quality Systems, A3 Thinking. Invention, product design, and product development from inception through patenting, management of R&D scientists, contract manufacturing, packaging design and validation, and establishment of clinical protocols and release criteria. Quality System planning and implementation, including the development of Management Review procedures, complaint handling, risk management, and process validation.