Strategic positioning and accelerating regulatory clearance for new ventures

Deskripsi

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 offirms' claims of similarity with extensive field research. We find that strategic positioning significantly impacts time to clearance, and that effective strategies evolve over time. For first products, firms accelerate clearanceby citing fewer reference products while strategically positioning relative to same category products and tocategory exemplars; for second products, firms acceler-ate clearance by referencing their own products. These findings extend positioning theory into regulatory contexts and reveal how a firm's optimal strategic position-ing changes across successive products.