Featured Episode
Breakthrough Devices Program (BDP) versus Safer Technology Program (STeP)
There are two powerful tools that can make interactive communications with FDA more efficient if your device is eligible. These are: Breakthrough Devices Program (BDP) or Safer Technology Program (STeP)
About the Host
Linda Braddon, Ph.D., CEO and founder of Secure BioMed Evaluations (SecureBME / SBME), works with both emerging and established companies to provide regulatory, quality and technical support to both the medical device and biologics industry. Dr. Braddon holds a bachelor of science in engineering from Mercer University, School of Engineering along with a master of science and a Ph.D. in mechanical engineering with a specialization in bioengineering from Georgia Institute of Technology.
I have been working in the medical device and biologics industry for over 25 years. I wanted to do a podcast that highlights the common conversations that I have had over the past two decades with both medical device companies and young engineering and science professionals who are trying to make their mark. For the start-up medical device companies, the regulatory process can be quite daunting for new companies but there are some simple things companies can do to increase their likelihood of success. From the perspective of young medical device professionals, I wish I had known all the opportunities that awaited me while I was in school. Understanding how the process works and how the decision makers think can make the difference between success and failure. Whether it is a new medical device company or a new college graduate looking for a career in medical devices, I hope my experience can shorten someone else’s runway to success.