“We are moving at light speeds with respect to smart technologies, incorporating that, and that’s everything from smart software in feedback and telemetrics systems but, also moving towards artificial intelligence, augmented reality. All of this is starting to come to fruition within the device industry, having these smart implants, being able to use your iPhone to track its performance or if there are problems.” -Lisa Ferrara, PhD

Lisa discusses the challenges with the FDA approval process for new Smart Technologies. She explains that each Smart Technology will be very unique and customized, so we have to work as a team to asses, evaluate, and test these new technologies. She stresses that you must put together the appropriate evaluation strategy, identify the risks, and make a plan to mitigate these risks. Lisa also shares insight into healthcare’s move to non-invasive and minimally invasive treatments.

“What I’m seeing is the FDA wants to work with us, as a team because it is going to take a very large team effort to really solve certain issues and concerns. For instance, how do we test these, how do we evaluate the particular smart technology?” -Lisa Ferrara, PhD

Listen using the embedded player on this page or click to listen on your favorite podcast app icons.

Today’s Podcast Topics:

  • Lisa informs our audience on the key technologies she believes will have a profound impact in Med Tech
  • Dr. Ferrara explains what biomechanical research should an early stage Medical device address prior to FDA submission.
  • How has the FDA Med Device approval process changed during her career?
  • What financial “headwinds” should be avoided in research?
  • What is the Future of Healthcare?
  • Finally, Lisa’s perspective to people who are newly entering the Med Tech Industry?

Links and Resources Mentioned in this Podcast:


Did you enjoy this episode? Click here to Leave a Review. Each review helps us grow the Avenu Community and bring more guests to you! Thank you.


About the Host:

Jon has more than 25 years of experience in the medical device industry with progressive senior level experience with both public and private medical device companies.  Prior to Spineway USA, Inc., he was EVP of Prosidyan, Inc., focused on synthetic bone graft materials for optimal healing, exclusive rights were acquired by DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies in June, 2018.  Jon has successful commercialization and revenue generation with Zimmer Spine, Centinel Spine and Wenzel Spine.  Jon received a BS from Ball State University and is an active Board Member (Advisory) at ZygoFix, Ltd.

Connect with me directly on LinkedIn or subscribe to “Avenu Podcast” via our Website News Letter.