The need for medical innovation is driven by the infinite variety of unsolved or poorly-solved therapeutic and diagnostic problems. Such innovation is supported by the rigorous pace of medical and biotechnological research, by evolutions in clinical practice, and by the strong economic incentives at play: the emergence of new geographic markets and the fierce competition for existing consumers.
At the same time, an increasing awareness of the role that medical devices play in patient safety has led to a rise of regulations, all aimed at reducing risk and defining responsibility.
These needs have had a polarizing effect on the industry. Within large organizations, R&D departments struggle to innovate under the stifling influence of their own quality systems. Start-ups and spin-offs have taken on an increasingly important role as the source of innovation, while Fortune 500 multinationals provide the sheer bureaucratic horsepower to drive products through the regulatory quagmire and out onto the market.
Based on our experience supporting innovation processes in this environment, we believe a more enlightened approach to harmonizing innovation and control can reduce this polarization and provide significant benefits to any organization developing new medical devices.
Innovation is one of the most over-used words in business. Its true meaning is surprisingly simple: “the act or process of introducing new methods, ideas, or products.” In common use, however, we expect an innovation to be not just new, but new and better – or at least, in our culture of ubiquitous reinvention, newer than usual. We can clarify this fuzzy definition by distinguishing between two categories of innovation: technical innovation (introduction of new technical enablers for a given customer benefit) and customer innovation (delivery of new customer benefits). Both are continuous variables that can be mapped to a matrix, as shown in Figure 1.
A project that uses less than state-of-the-art technology to deliver less than best-in-class customer benefit can be considered a pure development project and does not represent an innovation – though that doesn’t mean it’s always easy. But more often than not, design projects mix elements of pure development with hardcore R&D. Managing this mix is a key challenge of innovation processes.