CASE STUDY

Case Study

Case Study

Answer of Question No. 1

D.U. Singer Hospital Products Corp. has done sufficient new product development at the research and development level to estimate a high likelihood of technical success for a product of assured commercial success: A long-term antiseptic. Management has instructed Singer's Antiseptic Division to make a market entry at the earliest possible time; they have requested a complete plan up to the startup of production. Project responsibility is assigned to the division's research and development group; Mike Richards, the project scientist who developed the product is assigned responsibility for project management. Assistance will be required from other parts of the company: Packaging task force, R&D group, corporate engineering, and corporate purchasing.

Mike was concerned about the scope of the project. He knew from his own experience that a final formula had yet to be developed, although such development was really a “routine” function. The remaining questions had to do with color, odor, and consistency additives rather than any performance-related modification. Fortunately, the major regulatory issues had been resolved and he believed that submission of regulatory documentation would be followed by rapid approval as they already had a letter of approval contingent on final documentation.

Mike was concerned about defining the project unambiguously. To that end, he obtained an interview with S. L. Mander, the group vice-president. When he asked Mander where his responsibility should end, the executive turned the question back to him. Mike had been prepared for this and said that he would like to regard his part of the project as done when the production process could be turned over to manufacturing. They agreed that according to Singer practice, this would be when the manufacturing operation could produce a 95% yield of product (fully packaged) at a level of 80% of the full production goal of 10 million liters per year.

“But I want you to remember,” said Mander, “that you must meet all current FDA, EPA, and OSHA regulations and you must be in compliance with our internal specification - the one I have got is dated September and is RD78/965. And you know that manufacturing now - quite rightly, I feel - insists on fully documented procedures.”

After this discussion, Mike felt that he had enough information about this aspect to start to pin down what had to be done to achieve these results. His first step in this effort was to meet with P. H. Docent, the director of research.

Yes, but while you are working on the product specifications you can get going on the regulatory documentation (d). Full internal specifications are not required for that work, but you can't start those documents until the formula is complete.” “Yes, and I find it hard to believe that we can push through both preparation of documents and getting approval in 3 weeks, but Environmental swears it can be done.”

“Oh, it can be done in this case because of the preparatory work. Of course, I won't say that this estimate of 3 ...