Last Minute Save of a Major New Product Introduction


I was hired to manufacture the company’s newest product line, which was saddled with the most technically challenging aseptic process in the company’s history. The launch date was late and no one could say why or how long they expected it to last. Meanwhile, the company was waiting to use the sales from this product line as evidence of growth to their stock holders, who were growing increasing concerned about expiring legacy patents. There was also a confidential effort underway to sell the company, the value of which could be leveraged by sales of this new product.

Action Plan:

  • Prioritize the ‘To Do’ list and attack the ‘A’ items needed for launch. Prepare a timeline for all issues noted. Update the President daily.
  • Assemble task groups and assign team members to complete specific action items. Identify facility needs and complete the buildout for the three designated production rooms. Complete the new in-house Aseptic Validation requirement that tests 100% of sample parts for sterility testing, and allows zero failures.
  • Prove the integrity of the finished production process by successfully completing three production lots, manufactured in a row, with zero failures per the validation document.


Four months after I arrived, the first production order was released to ship. Under my direction, the production team went on to complete 18 months of consecutive builds with zero sterility failures – something no other current or prior product line had ever achieved. In the midst of this unprecedented achievement the company was sold, but the product line continued to grow. Within 5 years it had grown to over $50 million in sales, more than offsetting the legacy market shares lost through expiration of older patents.