Medical Device R&D

Consulting for Structural

Heart Devices, Delivery Systems,

and Biomechanics-Driven

Innovation

NovaBioMech Consulting helps medical device companies transform complex clinical and engineering concepts into robust, verifiable, and development-ready products

  • Led by Fabien Lombardi, former Vice President of R&D and senior product development leader, the consultancy supports medtech innovators in product strategy, device development, design verification, risk management, manufacturing transfer, and technical due diligence.

  • NovaBioMech Consulting provides strategic and hands-on support for medical device companies developing complex implantable and catheter-based technologies.

  • • Medical device startups and scale-ups

    • Structural heart and cardiovascular device companies

    • Catheter, delivery system and implant developers

    • R&D teams preparing for V&V, design transfer or regulatory submission

    • Investors and strategics evaluating technologies

    • Companies needing senior R&D leadership on a fractional or project basis