1. Introduction to medical device requirements -- 2. Preventing recalls during specification writing -- 3. Risk assessment and risk management -- 4. Preventing recalls during early design -- 5. Preventing recalls during the detail design phase -- 6. Designing for prognostics to protect patients...

With the diffusion of new technologies, technical errors may pass down to subsequent inventions and create negative externalities. Using predicate lists in the 510(k) premarket notification program, we track the knowledge flows in medical devices that claim the equivalence between existing...

Introduction -- 1 The dynamics of the global medtech industry -- 2 Formation of medtech big business -- 3 The lasting competitive advantage of US firms -- 4 Japan: From electronics to medical technology -- 5 Germany: Between Siemens and specialized medtech firms -- 6 Orthopedics SMEs and...

When firms span related product categories, spillovers across categories become central to firm strategy and industrial policy, due to their potential to foreclose competition and affect innovation incentives. We exploit major new product innovations in one medical device category, and detailed...