Structured Design Process

The current process for new drug development and commercialization is very long. The industry claims this process can take 12 to 15 years. This time line is shocking when you think of the opportunity lost and opportunity cost. The industry and the government have identified front-end work as the major opportunity phase in the drug development life cycle. The front-end process is defined as the tasks that include new product concept and definition, technology and technical approach selection, requirements definition, and market positioning. This phase of the process requires involvement of many people from different functional areas with very different perspectives. During the process, collaboration, open communication, and solid team dynamics are critical for success.


The drug industry realized that during this phase there is quite a bit of unstructured activity. The SDP approach was applied to improve the front-end component of the drug life cycle process. The benefits of using the SDP are reducing the work that normally takes weeks to just several days. Moreover, the SDP enables better quality products and faster termination of bad products, reducing the size of wasted assets.

The SDP in this case maintained a triggering question which in essence kept the various teams focused on maximizing profits and reducing time to market. Some of the specific benefits that resulted from the application of the SDP were:

130 well defined requirements

Affinity patterns were identified between requirements

114 options identified to help realize the options.

I think a really good application for the SDP is in the development of new products and systems in the wireless industry. One example that comes to mind for me is business process design for new business support systems. These systems are very complex and can include CRM, call and data rating, billing, invoicing, and a bunch of other stuff. When carriers migrate or attempt to migrate from their legacy BSS systems to the new BSS, major process redesign is likely. Getting alignment on which processes to retire, converge, or modified is critical and must be completed before implementation. Completing this phase can in many cases delay the project and seriously impact the schedule. The SDP process can potentially reduce the time to get through the business process design faster, with better alignment, and higher quality work.