Team

Max Lerman, PhD

Associate Director, Solutions Engineering

Max brings nearly 15 years of experience spanning academic research, medical device development, FDA combination product review, and combination product consulting. His career arc gives him a grounded perspective at every stage of the product lifecycle and allows him to operate fluidly across bench research, product development, regulatory science, and strategic advisory. He holds a PhD in Materials Science and Engineering from the University of Maryland, College Park.
Prior to joining Suttons Creek, Max developed and maintained complex electrocautery and energy-delivery platforms at Medtronic and was a member of FDA’s infusion devices team, where he helped develop and standardize review practices for infusion systems, life-critical drug delivery devices, and electroporation technologies. During his FDA tenure, he also participated in AAMI’s ID and IP infusion pump committees, contributing to the standards infrastructure that governs the devices he now advises on.
At Suttons Creek, Max combines strategic consulting with project development and delivery execution across complex combination product programs. He offers a perspective that is equal parts technical, regulatory, and strategic, and is a committed advocate for a well-informed and effective combination product ecosystem.
Academic & Professional Qualifications:

  • Bachelors of Science in Biomedical Engineering, Boston University College of Engineering

  • Masters of Science and Doctor of Philosophy in Materials Science and Engineering, University of Maryland College Park

  • Author of 11 peer-reviewed publications, 17 conference presentations, and 3 patent submissions  (to date)

Training, Quality Systems, & Specialties:
  • GMP Requirements & Industry Practices
  • UK Responsible Person FDA Quality Systems Regulations
  • Design Controls
  • Process Validation, Design Validation, Design Transfer
  • Stage-Gate Product Development Process
  • Combination Product Regulations
  • Combination Product Design & Development
  • Medical Device Design & Development
  • Global & Multi-site Program Management
  • Design For Manufacturing & Assembly
  • Disposables & Systems Development
  • Low & High Volume Disposable Devices
  • PMA & 510(k)
  • Computer-Aided Design