DECEMBER - FEBRUARY8In My OpinionNPD ­ new product development, is the framework that engulfs all the functions involved in the development of new products. Marketing will initiate the process while driving to approve the project that will be chosen to be developed based on many factors such as market research, platform menu, business strategy, and competition. Next, a project manager will be assigned to drive the core team, consisting of leaders from all departments. The next steps within the life cycle of the NPD will be ­ design inputs, research, design and development, design freeze, transfer to production, clinical trial, and regulatory submission. To accomplish the design, development, and clearance of a new IVD product, strong R&D leadership is invaluable. Now, the question is, what is R&D's role within this long process that typically takes three years? The way I see this, the pathway to success must rely on strong R&D leadership. The R&D leader's role covers all aspects of the NPD life cycle and must be a strong communicator that can establish productive work relationships within the company. The obvious goal is to develop a high-quality diagnostic device that can successfully pass a clinical trial and regulatory scrutiny and is reproducible and easy to manufacture. In those three years, R&D needs to drive most of the processes. Communication is key for healthy processes and open, collaborative discussions. For example, identify gaps in the clinical plan and collaborate with the clinical team Dan Dror Siman-Tov, Senior Director of R&D, Meridian BioscienceByR&D'S LEADERSHIP ROLE WITHIN THE NEW PRODUCT DEVELOPMENT LIFE CYCLETo summarize, R&D's strong leadership includes working well with others and having a strong voice when other functions need to be challenged or recognized
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