The first phase represents what the development experts have traditionally performed to understand the functional requirements. The experts must take a moment to ask, "What function must the health care product perform?" without jumping to a solution. Using a total knee system as an example, what is the range of femurs the system addresses? Obtain the necessary criteria that will be utilized to assess the possible solutions, technical needs, marketing desires, and budget-friendly costs.

Develop several different scenarios regarding the rationale and reason for various numbers of sizes. Is each change in size uniform; for example, is it a fixed 4-mm change/size? Or is the change in size progressive and relative to the increasing size of the implant? What other possible change in size alternatives can you brainstorm? Each method could potentially lead to a different number of sizes to address the orthopedic application.

The selected alternative solutions from the Analysis Phase would be further developed to ensure a more robust appraisal can be performed. For example, total knee system A has 10 different sizes, while total knee system B has seven. This difference impacts the number of tibial trays, tibial inserts, and instruments required for each system. The cost should not be viewed as only the manufacturing expense for each femoral component or the total inventory cost, but more as the total cost to service the account. In other words, consider what would be used to evaluate the performance of the system post-launch.

As the pressures from rising healthcare costs continue, the requirements for the development expert to innovate, create new products, and optimize the commercial aspects of those products will continue to become more daunting. The development engineer will have to examine projects with a broader lens as to the needs of what a successful product is and their influence upon it. Greater support from the healthcare product marketing company will be required to simulate the various configurations to gain greater insight into the impact of the design considerations and alternatives on the short- and long-term viability of the product over its anticipated 20-plus-year lifecycle. A valuable healthcare company helps your healthcare product stand ahead of the crowd.