Strategic Management Journal
How do new ventures strategically position their products to accelerate regulatory clearance? We investigate this question in the medical device industry, where regulatory clearance is a prerequisite for market entry. We examine 239 new firms’ 510(k) device clearances by the FDA between 2001 and 2019. Our approach combines quantitative analysis of firms’ claims of similarity with extensive field research. We find that strategic positioning significantly impacts time to clearance, and that effective strategies evolve over time.
Mike Howard is the Hilsinger-Janson Professor and a professor of management and entrepreneurship at the Ivy College of Business. His paper is published in the Strategic Management Journal.