Annie Lutz

Senior Director, Medical Device & Digital Innovation

Professional Experience
20+ years’ experience in product development, 510(k) documentation, supplemental submissions to PMA, international submission documentation, post market surveillance and technical lead on interactions with the FDA. Extensive experience in Human Factors medical device, combination product and Software as a Medical Device. Project leadership experience in medical device design controls, medical device software development, product support and product outsourcing.

  • Director, Medical Device & Digital Innovation, Innovenn
  • Director, Medical Device & Digital Innovation, Improvita
  • Disease Management Technology Manager, Innovenn
  • Medical Device Consultant, Innovenn Life Sciences
  • Molecular Support Scientist, Hologic
  • Scientist, Research and Development, Hologic


  • Lean Champion
  • Six Sigma Green Belt


Bachelor of Science in Wildlife Biology from The University of Wisconsin-Madison