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Biodesign by Paul Yock, Josh Makower, Stefanos Zenios

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5.9 Competitive Advantage and Business Strategy

Introduction
As overwhelming as it may sound, figuring out an approach to intellectual property (IP), R&D, quality, clinical trials, regulatory approval, reimbursement, marketing, and sales is not enough. An innovator must also think about how all of these factors come together to create a compelling competitive advantage and, ultimately, a business strategy. Without an explicit point of view on how a company and its technology will be differentiated from the competition in the complex and dynamic medtech field, a product may never achieve or sustain its market potential.
Fundamentally, a company has a competitive advantage if its competitors cannot replicate its offering in some material way. ...

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