Competitive Advantage: Core Competencies

The medical device industry is one of the most competitive industries in the world. If the institute is to be successful, it must offer federal research organizations such as the NIH and corporate customers a significant competitive advantage.

In other words, why would companies and government research agencies choose the Cardiovascular Innovation Institute as a partner for testing and enhancing next-generation bio-adaptive heart innovations?

• The vast surgical expertise of Gray, Dowling and their team of cardiac surgeons includes years of experience in the utilization of HeartMate, Thoratec and Novacor VADs; ABIOMED’s BVS 5000; the AbioCor Implantable Replacement Heart; and the MicroMed DeBakey continuous-flow pump. Few institutions in the country have this depth and breadth of successful clinical experience with heart assist devices.
• The institute will be one of the premier large-animal surgery sites in the nation with the ability to accommodate 15 acute procedures per week and 12 simultaneous chronic cases.
• The institute will operate under the most stringent Good Laboratory Practices, which require routine calibration of equipment and standards for data acquisition and quality assurance. Good Laboratory Practices are essential for FDA market approval of devices.
• The institute can offer reduced time between the first pre-clinical studies and the first use of the device in a patient because Jewish Hospital cares for a large population of heart patients and can provide the most suitable patient for each type of device.
• The institute will employ clinical engineers, cardiovascular physiologists and bioengineers with extensive experience supporting surgical implantation and postoperative care of patients receiving heart assist devices. These bioengineers will collaborate with bioengineers at the Speed School of Engineering, researchers at other universities, industry engineers and the National Institutes of Health in evaluating and refining bio-adaptive heart innovations.
• The institute will offer corporations the opportunity to collaborate by having their researchers on site and by using the institute for training physicians and technicians on the first use of new technologies. In addition, the institute will operate under a user-friendly set of business and intellectual property practices, consistent with the University of Louisville’s policies.
• An annual symposium will bring together the best investigators in the world working on bio-adaptive heart innovations. They will discuss advances at the institute and identify future opportunities for improvement and collaboration. The symposium will provide participants with a powerful “window” into the future of bio-adaptive heart innovations.