Learning New Devices

As a company looking to hire FCE Source to support your clinical trial, you may be wondering how it would be possible for us to become “experts” in your medical device quickly. Rest assured that over the last 10 years, we have developed the experience required to know what to focus on and how to learn new products, procedures, and protocols quickly and thoroughly.

We have broken down our learning process into three phases. The first phase is pre-reading, where we learn the background on your company and disease state that your new product is designed to address. The second phase is an in-person training put on by your company and attended by our FCEs with the goal of gaining hands-on experience and establishing relationships. The third and final phase of our learning is post-training review, where we consolidate our knowledge and put it into practice.

Pre-Reading

The goal of the pre-reading phase is to gain an understanding of the current state of the disease and your company. Our first step of pre-reading is going through all of the publicly available information on your company, the disease state and current treatment options, the trial if it has begun, and how your company’s solution fits in. After this, we’ll ask you for any relevant journal publications as well as the study protocol, device IFU, and any other training materials to start absorbing that information before the in-person training.

In-Person Training

In-person training is almost always beneficial, either in conjunction with virtual training or stand-alone. We strongly suggest that client companies focus the in-person training on topics that are not suited for virtual training sessions. Generally the in-person training begins with a presentation that goes over critical parts of the protocol and device IFU. This gives us an understanding of what the procedure normally looks like, how your device fits into it, and what you anticipate the most challenging steps to be. We recommend factoring in ample time for our FCEs to ask questions about the device and documentation to make sure our role in this trial is fully understood.

A live demonstration of the device is one of the most crucial steps of learning a new product. We generally believe in the “see one, do one, teach one” approach for learning how to demonstrate a new product to a new user.  As such, we suggest that our clients plan for more time than they may think is necessary for hands-on training, since our FCEs will want to learn your device inside out. By the time we leave the in-person training we would like to have such a thorough understanding that we are able to walk someone through the procedure and device.

In-person training also brings the benefit of meeting face to face the people we will be working with directly. It allows us to build relationships with clinical managers and the product development team. These relationships give us the confidence to go on site knowing who we can contact should any questions arise that we don’t know the answers to.

Post-Training

Following the in-person training, our team at FCE Source likes to focus on what we call the “3 P’s.” The 3 P’s are procedure, product, and protocol. We make it a priority to know the protocol and its required steps, as well as the flow of the general procedure and how this particular product fits in, and how this may deviate from the typical procedure.

At this point in our training, we direct our attention to the procedure and any study visits that involve an FCE. We make sure we know what is required at each visit and any documentation that goes along with it. We also like to make sure to know the inclusion and exclusion criteria and other key protocol requirements so that if any questions come up on site we can answer them quickly.

If the trial has not yet begun, it can be helpful to set up regular virtual meetings with your team to do mock procedures and walkthroughs. As cases start to happen, these meetings can be helpful to share tips and tricks we have picked up as well as parts of the protocol and procedure we are noticing to be most difficult.

If the trial is already underway, the main focus of the Post-Training phase is to shadow people who have already participated in cases to see our role in action, gradually taking on more responsibility in each case until we are ready to be solo. This is a great way to build our confidence in the project as well as your confidence in us, so that you know we will represent you well.

At FCE Source we have developed a system that works and allows us to represent a new product confidently and efficiently. If you are uncertain about a training plan for new FCEs, we can help you create and execute one. Contact us at info@fcesource.com to learn more.