Companies large and small are coming to Cleveland Clinic to leverage world class expertise, validate early-stage technologies, and conduct educational hands-on training.
For eleven years, Cleveland Clinic Innovations’ Preclinical R&D Facility has been busy proving a theory: Combining top-notch minds with state-of-the-art resources will create an alchemy of innovation.
The lab was opened on Cleveland Clinic’s campus in 2006 to provide state-of-the-art surgical and interventional resources for testing the next generation of medical devices and procedures. Since its opening, the suite has hosted a steady stream of studies in a variety of fields and for large and small companies. According to Marwane Berrada-Sounni, Sr. Director, Product Development and Business Development Director of the Preclinical R&D Facility, it has experienced a bit of a boom in the last 18 months, and it may have something to do with its home.
“It’s no secret that we are located steps away from the world’s top clinicians,” said Berrada. “In this new era of value-based care and outcomes focus, companies are realizing that it’s more important than ever to get direct feedback from the end-users as early in the product development process as possible. Cleveland Clinic physicians, as our clients have learned, are not only world-class clinicians, but they truly enjoy the innovation process.”
Oussama Wazni, MD, of the Cleveland Clinic Heart & Vascular Institute is one such physician. Dr. Wazni is the section head of electrophysiology and has been a valuable resource to a number of clients that are not only looking to get key opinion leader input on the design of their products, but also to provide training to their customers in the safe and effective use of the products. Dr. Wazni provides both.
“As any company knows, physician input is critical to the success of a new technology adoption, and I take enormous pride in assisting with that process for the benefit of patients everywhere,” says Wazni. “When a company comes to Cleveland and to our facility, the overall partnership engagement is heightened. I can adjust my schedule, my fellows can join me, and I can be easily reached if a question arises.”
The Preclinical R&D Facility is also outfitted with state-of-the-art imaging, surgical, monitoring and recording equipment, similar to that which is used in the hospital’s operating and procedure rooms. For example, structural heart or electrophysiology product evaluations can utilize the latest in 3D echocardiography and mapping systems to guide and assess the procedures. Featuring two large procedure suites, the facility can accommodate both acute and chronic studies along with conscious testing and telemetry monitoring capabilities for on-site extended follow-up. The two large procedure rooms are complemented by a separate surgical preparation room, a conference room, and videoconferencing capability for observing procedures remotely. In addition, four additional smaller surgical stations are available for conducting studies with microscope observation capabilities.. Whether it is for conducting new disruptive research or clinical training, the facility is a prime location meeting everyone’s needs in a confidential and comfortable environment.
“We work hard to keep the resources state-of-the-art, and we’re proud of what the suites can offer our clients,” says Berrada. “But at the same time, we realize the power of this facility is outside these walls. It lies in the expert guidance from Cleveland Clinic staff and the success stories of our clients.”
Clients over the years have included some of the biggest players in the device industry and a variety of start-ups seeking to introduce disruptive new technologies. Some of the commercial technologies that have been evaluated and developed through the facility include a left atrial appendage (LAA) closure device, an LAA occlusion system, a 3-D cardiac mapping device, and a transcatheter mitral valve replacement system. A variety of procedures have been tested, including hernia repair and wound healing. And physician training programs have included image-guided procedures and robotic surgery.
The facility is overseen by Cleveland Clinic Innovations (CCI), the commercialization arm of Cleveland Clinic. CCI employees have decades of combined experience in developing and marketing a vast array of biotech and medtech technologies at companies of various sizes and stages. The office leverages this experience to wed the practical challenges of product development with the Cleveland Clinic “patients first” mantra.
“Truly impactful technologies can’t be developed without relationships, and many times you just need a venue to foster those meaningful connections,” says Berrada. “The Preclinical R&D Facility will always be one of those places.”