Improving manufacturing process for biomedical products: a case study
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PurposeThe purpose of this paper is to design and implement a new manufacturing process for biomedical products by removing an electropolishing (EP) operation. The research was performed in a major North American orthopedic industry.Design/methodology/approachValue stream mapping is used to analyze and identify the waste in the current manufacturing process of bone screw. Upon formulation of new (tobe) process, it has been validated to meet the regulatory requirements for the products through autoclave, endotoxin level, and biomechanical tests. Statistical tests are performed to compare the EP versus nonEP process.FindingsThe study has shown that the EP operation was not only redundant to bone screw manufacturing but also created other problems such as quality and production delays. The overall production lead time of the screws has been reduced from 17 to 4.5 days.Research limitations/implicationsScope of the pilot study was limited to stainless steel screw. In future, the company plans to perform similar studies on other material types.Practical implicationsThe EP operation is very common in the orthopedic industry. However, as found in this paper, it is not required for every component. The bone screw case study presented in the paper offers a huge saving for the company by eliminating a wasteful activity from the manufacturing process.Originality/valueBiomedical products pose unique challenges to the process optimization efforts because of their stringent government and industry requirements. This paper provides an original case study of design, validation, and testing of an improved manufacturing process for a biomedical product.
