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Optimizing Device Development & Training Initiatives through Simulation

MDI lifecycle use case focusing on how Mentice solutions are used by one of the world’s most influential device manufacturers.

May 18, 2023
In this article, we dive into the user experience of Chris Hughes, Medical Educational Manager, Endovascular, at Cordis. Chris has worked at Cordis for twelve years and has extensive experience in sales and marketing before going into clinical education.
Cordis is a global leader in breakthrough cardiovascular and endovascular solutions, and the company has connected and collaborated across the industry for over half a century to invent better ways to serve clinicians and their collaborators. Since the start, Cordis has been at the forefront of developing guide catheters and tools for endovascular procedures and developed the first drug-eluting stent in the early 2000s.
Five years ago, Cordis implemented virtual simulation into their device lifecycle strategy (R&D, professional education, and device adoption) as they purchased their first Mentice VIST® simulator. A year ago, the company expanded its use of simulation also to include physiological flow systems, the radial-to-peripheral customized SIM Core model. Mentice and Cordis have developed the customized a flow model for Cordis’ interventional cardiology and lower extremity peripheral arterial solutions to support training initiatives along the product lifecycle. The Mentice platform additionally supports Cordis with strategic case planning and therapy development. Cordis owns five SIM Core models with various anatomy and morphology configurations and three VIST® virtual simulators.
Mentice had the opportunity to ask Chris Hughes a few questions about his experience using simulation and implementing the radial-to-peripheral flow model into the product lifecycle strategy.

A radial-to-peripheral customized flow model supporting device development and training initiatives

What is the radial-to-peripheral flow model used for, and how does it help solve your clinical challenges?

In my opinion, the physiological model is what has been missing in simulation. One of the great benefits of the flow systems is that we can use real devices, which I believe creates a more engaging training environment and improves the understanding of the device. There are many flow models on the market; however, most are rudimental and lack complexity.

Together with Mentice and our partner physicians, we have been able to devise, and design the radial-to-peripheral models so that they are challenging and spark clinical inquiry and discussion. We can use these flow models for various interventional applications such as coronary, peripheral or carotid applications etc. I believe this platform checks many boxes for Cordis, and we are excited about the many ways we can use it, from sales training to physician, fellow, and cathlab nurse training. We can use these models in different scenarios and create a great user experience. That was my priority and what convinced me.  

The design of your physical flow model supplies a tactical feel and motion of how the catheter moves and track. In addition, there is vessel tortuosity and very realistic disease morphology. I believe this type of physiological simulator plays an essential role in the form of a clinical hands-on tactile model that previously did not exist.  

At Cordis, we are excited about the future and the development of new products. We plan to introduce new therapy-driven technologies that have not been in the market before, and this is where the flow models will enable us to shine and help our products succeed.

The radial-to-peripheral flow model will serve as a platform for these new products and will be incorporated and used for product launches, conferences, physician education programs, sales training, etc.  

We currently use the flow model in our “Center of Excellence*,  physician and fellowship programs, for sales training and promotion, and at conferences for hands-on application. Since we acquired the flow models in July/ August, we have been using them continuously.

What challenges did you experience prior to using simulation that led to the implementation of simulation?

We have had difficulties replicating the true clinical experience before using the Mentice flow model simulation. I found models and other teaching tools we have utilized unrealistic, lacking educational value, and not indicative of the procedure being performed. I set out to find a hands-on model that was anatomically correct, utilizing physiologically relevant anatomy, that incorporated tortuosity and morphology, and could be used repeatedly. All our needs and requirements were met with the Mentice flow models.

Having implemented simulation, what has been the main impact?

The main impact has been in three areas.

  1. Conference and Centers of Excellence Education. The Mentice flow models have allowed us to engage and train physicians at a much higher level than we could previously. The level of realism is notably unique and it has elevated and expanded the engagement and training for all our physicians.
  2. Voice of Customer Activity. The flow model has enabled us to collaborate and discuss future technologies and product iterations with our physician consultants in a more clinical and realistic scenario. With this improved collaboration, we can iterate and make future product decisions on a much faster timeline and more meaningful way.
  3. Internal Sales Training. These models have provided such realism to our training activities. We can now truly simulate clinical scenarios and situations experienced with our products like never before. This improvement has elevated our curriculum and the field sales team’s understanding and confidence when they leave training.
The “Center of Excellence” is a facility that has exceptionally high expertise centered on a particular therapy or procedure. These centers have esteemed faculty that are current thought leaders in their clinical specialty and provide in-depth knowledge and experience. These programs typically train and educate physicians on best practices, clinical outcomes, procedure steps, and and techniques, along with other relevant topics.

Cordis SIM Core
In addition to sales, marketing, and education, might the radial-to peripheral flow model also be useful in other departments?

When it comes to prototype testing and development, our R&D team was used to working with quite rudimentary models which they created themselves. However, there has been a great interest in utilizing flow models for additional validation. We now use the flow models in a product development activity we call Voice of Customer, which is invaluable. We have had Voice of Customer activities at every conference.

We have a separate room with the flow model set up for the Voice of Customer activity. Physicians sign a non-disclosure agreement, and we present them with a device we are evaluating/ developing. The physicians can compare it side by side with the device they currently use to provide feedback on the new device. We also do blind tests and present, e.g., product one, two, and three. Many devices, such as catheters, wires, and sheaths, have been tested this way. In this scenario, the flow model offers a real-world clinical environment with realistic anatomy and performance, allowing for strategic input from the physicians.

This activity helps us understand whether the proposed device will meet or exceed expectations. Few models can give that side-by-side comparison, which is an important feature. The fact that they have many different applications is a testament to the benefits of the Mentice flow models. The Mentice flow model is not just a simple model.

It has that dynamic capability and true anatomical features. The Voice of Customer provides us with clinical differentiation of performance and the understanding – will we meet the standard? Or are we going to be below or above the standard? If the product is not performing where it needs to, we do not launch. We bring the device back to R&D and develop it further. Then the device again gets tested and validated. It is essential to validate that the device can perform consistently and correctly. The Voice of Customer activity provides a level of validation that can help ensure that we have a good product in development.

In your opinion, what is the best use case for simulation in the future?

For Cordis, we are expanding and moving very quickly into new products and technologies. The Mentice flow models have allowed us to create a simulation foundation that will carry us into the future. With new products and technology on the horizon, flow simulation will allow us to adapt and use these models for nearly any clinical scenario. From coronary, peripheral, radial to peripheral or below-knee interventions, we will be able to utilize, adapt and, educate using these models. The Mentice flow model has elevated clinical simulation to an all-new level, and we are excited to continue to partner with Mentice and develop for our future.

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