Challenge
You are the Director of Quality Assurance at SomeCompany, Inc., which is on the verge of acquiring approval for a new innovative product. Your company is in head to head competition with SomeOtherCompany, Inc., who has a similar product that is scheduled to enter the market in about one year. You and other SomeCompany employees are under enormous pressure from company officers (who are, by the way, in control of your fate as an employee) to get the product out to market first. Your product release decision will have significant financial impact on stockholders and employees company-wide since the launching of this new product has been anticipated for several years. Availability of the product also will potentially cut in half the fatality rate of premature babies that currently must use an older generation, but similar, product.
The night before you submit your approval for release of the product, you encounter a dilemma. The lead engineer has approached you with puzzling results from the latest experiment. According to the data, out of one thousand male lab rats that were implanted with DEHP catheter tubing, two became infertile during testing. The engineer believes that this is due to an undesirable by-product released from poly-vinyl chloride (PVC), which is the material of choice for the new product.
PVC is commonly used as a constituent in medical devices such as catheters and tubing. Your company’s new product is a smaller catheter than what is available on the market, and combines PVC with DEHP, a plasticizer to create more flexible and less invasive tubing that can be used in neonatal oxygen delivery. Twelve percent of babies in the United States are born prematurely every year. Of this percentage, 10 out of 1000 babies die. The new product can potentially cut the fatality rate in half. The lead engineer believes that the addition of DEHP to the product has triggered the detrimental effects to the rats’ reproductive systems.
As the Director of Quality Assurance, you must decide if this information is compelling enough to delay the decision for product approval. Further testing could reveal more explicit information on the cause of the infertility, but will cause a schedule delay that potentially will put you behind your rivals at SomeOtherCompany, Inc. You must keep in mind the consequences of your decision not only on the company, but also on the stockholders and the consumers who could benefit from the product.
Continue to #2 'Generate Ideas'
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