The medical device industry strives to develop high quality and innovative products that will contribute to the improvement of patients’ lives Today’s guest is Bruce Gingles, one of my first bosses and mentors as a medical device professional. He taught me about medical device product development and patients. Currently, Bruce is vice president of Global Technology Assessment and Healthcare Policy at Cook Medical. He’s also the co-author of Medical Innovation: Concept to Commercialization. Some of the highlights of the show include: ● Barriers to Business: Bruce’s role is identifying and breaking down barriers to connect with customers and put products on the market that make a difference. ● Bruce presents a cross-functionality of understanding the market, clinical, and patient needs to effectively communicate with sales, marketing, and other areas. ● Bruce expresses appreciation for the impact I had on Cook’s quality engineering and design control process. ● Shift in Healthcare Technology: Who better to solve clinical and healthcare problems than doctors and nurses? Now, it’s a conflict of time and commitment. ● Passion vs. Profit: Separating the inventor/doctor from the evaluation of the early product impedes manufacturer’s ability to be true to that person’s vision. ● People making buying decisions for hospitals are removed from the practice of medicine. Decisions were based on clinical outcomes, but now also control costs. ● Current trend is a reduction in new ideas that relate to therapy, and more ideas for diagnosis. They’re not keeping pace with the number of solutions to problems. ● Solution: Insist that inventor is the operator during prototype evaluations, and assign objective chaperone to validate patients and accuracy of records of cases.