Medical Device Innovation Handbook

The Medical Device Innovation Handbook is a resource for those innovators who want to learn and follow a medical device innovation process. Its development is sponsored by the Medical Devices Center at the University of Minnesota. 


Download the free PDF (about 48 Mb) or purchase a bound version (about $4/copy). 

Current edition is 7.0

List of Chapters

  • Innovation
  • Medical Device Product Development Process
  • Understanding the Opportunity
  • Secondary Market Research
  • Human Anatomy and Physiology
  • Discovering Needs
  • Generating and Screening Ideas
  • Preclinical Testing
  • Clinical Trials
  • Reliability Considerations
  • Product Security
  • Innovation Notebooks
  • Patent Basics
  • Intellectual Property Strategy
  • Regulatory
  • Regulatory Case Study
  • Reimbursement Basics
  • Funding Your Idea
  • Business Models
  • Business Plans
  • Pitching Your Idea