Michael Drues

About Michael Drues

I am President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including (but not limited to): stimulating & innovative educational programing, brain-storming sessions, prototype design, product development, benchtop & animal testing, regulatory strategy & clinical trial design, FDA presentation preparation & defense, reimbursement, clinical acceptance, business development & technology assessment.I received my B.S, M.S, & Ph.D. degrees in Biomedical Engineering from Iowa State University. I have worked for & consulted with leading medical device, pharmaceutical & biotechnology companies ranging in size from start-ups to Fortune 100 companies. I also work on a regular basis for the U.S. Food & Drug Administration (FDA), Health Canada, the US & European Patent Offices, the Centers for Medicare & Medicaid Services (CMS) & other regulatory & governmental agencies around the world.As an internationally recognized expert & featured keynote speaker, I present frequently on cutting-edge medical technologies & regulatory affairs. I conduct seminars & short-courses for medical device, pharmaceutical & biotechnology companies, FDA, Health Canada, US & European Patent Offices, CMS & other regulatory & governmental agencies around the world.Finally, as an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology, I regularly teach graduate courses in Regulatory Affairs & Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs & Product Development, Combination Products, Pathophysiology, Medical Technology & Biotechnology at several universities & medical schools on-ground & on-line.Specialties:Combination Products, Medical Devices, Biotechnology, Pharmaceuticals, Animal Studies, Pathophysiology, Clinical Trial Design, Regulatory Strategy, Pharmacogenomics/Personalized Medicine, R&D, Testing & Evaluation and Bus. Dev.

Experience

1. Course Director

   The Center For Professional Innovation & Education Cfpie

   Aug 2015 — Present

   Current Courses Taught:Introduction to Medical Combination Products (3 days)Introduction to Medical Device Submissions (2 days)see:

Education

• Iowa State University

  M.S., Biomedical Engineering

  1985 — 1987

• Iowa State University

  B.S., Engineering Mechanics & Materials and Pre-Medicine

  1982 — 1987

• Iowa State University

  Ph.D., Biomedical Engineering

  1987 — 1992

Skills

• Pharmaceutical Industry
• Fda
• Technical Advisory
• Life Sciences
• Regulatory Affairs
• Nanotechnology
• Lifesciences
• Design Control
• Personalized Medicine
• Biologics
• Trainer
• Pharmacogenomics
• Keynote Speaker
• Medical Devices
• Clinical Research
• Clinical Trials
• Companion Diagnostics
• Drug Development
• Gcp
• Start-Ups
• Pathophysiology
• Pharmaceuticals
• Technology Assessment
• Business Development
• Testing and Evaluation
• Molecular Diagnostics
• Animal Testing
• U.s. Food and Drug Administration (Fda)
• Medical Diagnostics
• Tissue Engineering
• Clinical Trial Design
• Research
• Consulting
• Consultant
• Combination Products
• Training
• Medical Device R&D
• Product Development
• Technology Transfer
• Commercialization