D.U. Singer Hospital Products Corp.

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. Marketing and other plans following startup of production are to be prepared separately after this plan has been completed.

Project responsibility is assigned to the division’s Research and Development Group: Mike Richards, the project scientist who developed the product, is assigned responsibiliy for project management. Assistance will be required from other parts of the company: Packaging Task Force, R & D Group: Corporate Engineering: Corporate Purchasing: Hospital Products Manufacturing Group: Packaged Products Manufacturing Group.

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 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.

But there were also issues in packaging that had to be resolved: development of the packaging design was one of his primary concerns at this time. Ultimately, there will have to be manufacturing procedures in accordance with corporate policies and standards: capital equipment selection and procurement, installation of this equipment and startup.

Mike was concerned about defining the project unambiguously. To that end, he obtained and 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 for 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 percent yield of product (fully packaged) at a level of 80 percent 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, OSHA regulations and you must be in compliance with our internal specification—the one I’ve got is dated September and is RD78/965.