Ravi Shankar is the founder of FCE Source, a boutique CRO that serves as a strategic partner to medical device companies looking for field clinical engineering support.
FCE, which stands for Field Clinical Engineer, is a specialized role that specifically serves medical device trials.
FCE is a medical device expert who knows exactly how the medical product needs to be used in the medical setting. In many ways, an FCE is a right hand to the physician.
In this interview, Ravi does a fantastic job of sharing with us the roles and responsibilities of the FCE, what to expect from an FCE, how to get hired as an FCE and the skills needed to become a great FCE, common mistakes and challenges faced by FCEs, and much more.
Please join me in welcoming Ravi to the Clinical Trial Podcast.
[02:00] FCE provides in-person product expertise in a medical device trial setting (medical device boots on the ground for a clinical trial)
[03:20] Difference between Field Clinical Engineer (FCE) and Clinical Research Associate (CRA)
[08:00] Can/ should sales representatives serve as FCE on a clinical study?
[10:20] History of FCE role and how it all got started in Cardiac Rythm Management (CRM) and pacemaker space
[13:20] Education qualifications such as biomedical engineering needed to become an FCE
[16:15] FCE training involves observing in the operating room. You may react a certain way when watching a surgical procedure
[16:28] You need to work and learn independently as an FCE
[22:00] Studies are not designed keeping in mind the execution. You need to incorporate scientific, marketing, statistical and research coordinator perspective when designing trials
[28:50] How do you find out about job opening for FCE role
[30:35] FCE should not sell. They need to focus on research.
[47:40] Visual tools in the operating room (OR), study guide summarizing the protocol, and inclusion/ exclusion cards are helpful
[51:00] Sponsors need to think of any additional ask as a trade-off with enrollment. Qualify your asks as minor, moderate, or significant
[55:10] FCE training would include observing cases, speaking up during cases, developing soft skills, experience with active implantable devices, direct patient interaction, and working in an operating room environment
[58:10] Not all FCEs are engineers
[58:57] FCE is not practicing medicine. FCE is a coach to physicians and other medical professionals
[1:00:00] FCE needs to be balance action versus learning
[1:00:05] Salary for FCE is similar to entry-level engineering roles
Essential Neuromodulation by Jeffrey Arle and Jay L. Shils
There are many books on pacemaker defibrillator medical products
A Clinical Trials Manual From The Duke Clinical Research Institute: Lessons from a Horse Named Jim 2nd Edition by Margaret Liu (Author), Kate Davis (Author)
Mike Pollan books
Michael Lewis books