“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

• On Today's Episode: 

 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 

• 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: 

• • Lisa Ferrara, PhD on LinkedIn 
  • Website: OrthoKinetic Technologies  
  • Email: [email protected]