An Introduction To Competitive Regulatory Strategy
Most medical device companies have some form of regulatory strategy in place, but few have designed their regulatory strategy to give them a true competitive advantage in the marketplace. What is a “competitive regulatory strategy”? What does it look like? And how can a device maker go about developing one? Our guest, Michael Drues, Ph.D., will help answer these and other important questions about leveraging regulatory pathways to your competitive advantage. Drues is president of Vascular Sciences, an education, training, and consulting company serving the medical device, pharmaceutical, and biotechnology industries. He has a long history of working both for and with the FDA and other international regulators, and he has helped companies ranging in size from start-ups to Fortune 100s navigate many different regulatory pathways.