The Clinical Products Division of Eastman Kodak was in the process of introducing an innovative product aimed at analyzing blood samples using a unique process. No water or centrifugation was required to perform the 15 tests scheduled for global markets: only a minimal blood sample was required. The challenge lay in the product itself. It was highly sensitive to time and /or temperature variation—the sensitized product had to remain frozen throughout the supply chain until processed in the analyzer device to ensure totally accurate readings. The analyzer itself had to be calibrated based on variables unique to demographics, diet, climate, etc.
We tackled the frozen product in our project as the company elected to work internally on the equipment component. Our team was challenged to provide an alternative to existing client operations as they were not prepared to handle frozen product. They were equally unprepared to deal with the stringent FDA requirements for global tracking and tracing of this type of product due to the possibility of recall or misdiagnosis.
We undertook a new world approach for this particular client—outsourcing. We met frequently with senior management to establish the credibility of our proposal which was foreign to their internal controls and history.
After much research regarding cost, time and quality requirements and potential channels, we implemented a triad alliance for operations. We formed an alliance of previously unfamiliar supply chain partners between the manufacturer, a frozen food distributor and Federal Express for operations in Memphis, TN, Strasbourg, France and Tokyo, Japan. We added a fourth dimension by implementing an add-on component to their ERP, focused specifically on FDA tracking requirements. Finally, we held a series of educational seminars for both internal and external customers directed at the critical importance of control in warehousing, in transit and—equally important—at the user site.
Product launch was announced and our network was tested repeatedly for issues. We shared the pride of a very successful launch, with the added attraction of reducing the total estimated unit cost of making this product by close to 40%, or $470K per million units produced and distributed.
This product line is still among the leaders in diagnostics and is currently a division of J&J Medical Devices.