| Client: A Medical Products Manufacturer |
Client Success Stories
Charles Brooks Associates, Inc
| BACKGROUND: The company manufactured custom-fit medical products for their customers. Each item was individually designed based on a series of patient measurements. The Design process required a large number of calculations and adjustments to the patient’s measurements to allow for material and usage variations. This was a long and tedious process, and required the Designers to memorize or reference many pages of Design tables. It took at least a year to train a new Designer to accurately account for all the product variations and consistently design a product that would pass FDA audits. ASSESSMENT by CBA: An analysis of the operation revealed the following: There were over 1,100 pages in the Job Instruction manuals that detailed how to design the various products based on the age, size and symptom severity of the patient and the materials the products could be made from. Except for some of the most common products, even the experienced Designers had to reference the design tables and Job Instructions prior to designing an order. Most of the calculations were simple arithmetic done on a desktop calculator. Once the X and Y coordinate calculations had been made, the final Design step was simply to connect the dots on the design sheet. The Designers already had to enter customer information and measurements into a software program to generate the work order and tracking paperwork. ACTIONS: CBA reviewed the Design process and created a series of decision trees to isolate the major variables and group similar stages. CBA developed several simple Excel spreadsheets to illustrate how sections of the Design process could be driven by the customer measurement data already being entered. CBA created a prototype report that combined a printout of the calculated design dimensions with the existing work order and tracking paperwork. CBA worked with the company’s management and MIS staff to design and develop the computer program to adapt to all product and customer variables into a single Design Calculation Worksheet. CBA helped the R&D group produce a series of plastic drawing templates for common, but variable size, components to eliminate the need to calculate and plot these elements. CBA work with department management to teach the existing Designers how to use the new program and developed the training process to teach new employees how to design the products. RESULTS: The typical Design cycle time was reduced by 30%. Errors caused by selecting the wrong design table were eliminated. The plastic drawing templates eliminated a further 13% of the normal design errors. New employees were trained and qualified in 20 weeks instead of a full year. |
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