How FCEs Provide Value

At FCE Source, we are often asked the question: “what does a Field Clinical Engineer do?” Many within the medical device industry are still learning the value of adding FCEs to a trial. In discussions with potential clients (who later hired us) we’ve been told “we think we need FCEs, but we’re not really sure what they do.”

Let’s try to shed light on the FCE role by considering the case of a new medical product ready for human testing. The sponsor company selects sites to participate in a clinical trial, conducts initiation visits to train site personnel, ships the investigational product, and periodically checks in with coordinators and investigators as data starts coming in.

Is this a recipe for success? If the product is a new drug, this may be more than adequate. Even for the next generation of an existing device, this could be a reasonable plan. But for a novel medical device, there are many additional aspects to take into consideration. For example:

Do we know if the device is being properly placed/administered during surgery?

What if the product requires specific sterile preparation – are the scrub technicians performing this according to the instructions for use?

If it’s an active implantable medical device– who is programming the device parameters for optimal results?

What if there are deficiencies in product's usability that may not have safety or efficacy implications but could significantly hinder its eventual adoption – is this feedback being conveyed to the sponsor?

Any of these aspects being sub-optimal could result in a trial failing to meet its endpoint(s). That’s conceivably tens of millions of dollars wasted, not to mention years of lost opportunity.

Now consider the alternative:

The sponsor company has an FCE present at each surgery making sure that the device is properly prepared, deployed, and positioned; that any programmable settings are optimized; that data is collected and the Protocol is followed; and that actionable feedback is quickly incorporated into the research and development process. The site’s questions are answered in real-time, and errors in product usage and data collection are identified and corrected early on. With investigators and coordinators feeling supported rather than uncertain, they in turn enroll more subjects into the study. The trial reaches completion within a reasonable time frame, with high-quality data. Most importantly, patients receive the maximum benefit from their devices based on the knowledgeable, in-person support provided by FCEs.

Adding a team of FCEs – as with any other knowledge-based job function – has its cost, but one that’s worth the spend based on the risks of not supporting a trial adequately. For companies running several trials simultaneously, building a group of full-time employee FCEs may make the most sense. For others, a team of contract field clinical engineers such as FCE Source could be a cost-effective, high-quality option.

To learn more about how FCE Source may be able to help your company with its clinical trial, contact us at info@fcesource.com.