To best serve medical device manufacturers’ training and demonstration needs, simulated use models must be a collaboration between training staff and simulation designers. Combining product- and procedure-specific knowledge with biomedical engineering and materials science expertise results in accurate simulations that demonstrate your unique value. While BDC Laboratories works on many custom simulated use models, here are two use cases from one American medical technology company we’ve partnered with over the last five years:
When valves in the heart become narrow or leaky, they can be replaced via minimally invasive valve replacement. During this procedure, a delivery system is advanced to the heart, and a prosthetic valve is deployed. Indirect visualization and multimodal coordination make positioning the prosthetic valve a delicate task, and it can be more challenging depending on the patient’s condition.
While this medical technology company uses a combination of low-, middle-, and high-fidelity models for physician training, the team decided on dry bench models for economically feasible hands-on training. For teaching purposes, the team needed a pulmonic model that could demonstrate their device, a delivery system designed to guide a new valve into position inside the right ventricular outflow tract (RVOT).
After using glass models in the past, the team was looking for something more polished and robust. They wanted a single model with multiple anatomies for hands-on procedural planning, and the model needed to maintain relevance without using water, which can add unwanted complexity to a training set-up. It also needed to be sturdy enough to withstand the force required for the procedure.
With certain teaching points in mind, the medical technology company and BDC Laboratories dedicated time for brainstorming and design iteration. The final model, made of rigid support structures and silicone, featured two compatible anatomies, so trainers could tailor the model to the next day’s cases. It featured BDC Laboratories’ proprietary SLIC friction reduction coating to achieve clinically relevant surface friction without water. While the model has been adapted over time, the same models are still being shipped all over the world for demonstrations 5 years later.
Congenital structural heart procedures address heart structure problems present at birth, including narrowed heart valves or holes in the heart that alter blood flow. Some heart structure problems are more common than others, and treatments vary based on the type of defect and the patient’s symptoms. Noticing an underserved patient population, the same medical technology company wanted a simulated use model for an uncommon congenital structural heart procedure.
Simulated use models for congenital conditions must be as small as the patients themselves, presenting inherent engineering challenges. With a non-standard device delivery path, and fewer physicians with procedural experience, the model needed a realistic feel for meaningful training.
The medical technology company collaborated with BDC Laboratories to create the simulation. Between the medical technology company’s procedural and device expertise, and BDC Laboratories engineering and materials expertise, the team was able to design a clinically relevant model for use in fellow courses. Today, the model allows physicians to practice a niche, high-stress procedure with a sense of realism.
With decades of experience in testing for Class II and Class III medical devices and a deep understanding of industry standards, we approach custom simulated use models from a medical device engineering perspective. Starting with patient scans or our optimized catalog of anatomies, BDC Laboratories consults with your team to customize attributes, including: