ABSTRACT
Figure 3.1 The four A’s. It is thus essential that the Marketing manager works with folks in Regulatory and Reimbursement to assess times and rates of approval and build good assumptions around rate of adoption and awareness to arrive at robust forecasts. The importance of this cannot be overemphasized as there is no bigger embarrassment than to have forecasted a wrong approval date and be sitting on valuable inventory when other parts of the world have shortages. 3.5 New Product Approval Dates
Finally, Regulatory Affairs also has an important responsibility to provide timely feedback to Marketing and Supply Chain so that they can plan the launch effectively and not waste resources by planning to early or miss revenue opportunity by not being prepared when the product approval comes through. Working together of Regulatory Affairs, Marketing, and Supply Chain in a seamless fashion that identifies delays early and responds to problems proactively, thus minimizing the time to market, can be a key source of competitive advantage for a medical device company (Fig. 3.2). It is not easy but is worth all the time and money spent in making it happen.
