TY  - JOUR
AB  - Purpose– The purpose of this paper is to design and implement a new manufacturing process for biomedical products by removing an electro‐polishing (EP) operation. The research was performed in a major North American orthopedic industry.Design/methodology/approach– Value stream mapping is used to analyze and identify the waste in the current manufacturing process of bone screw. Upon formulation of new (to‐be) 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 non‐EP process.Findings– The 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/implications– Scope of the pilot study was limited to stainless steel screw. In future, the company plans to perform similar studies on other material types.Practical implications– The 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/value– Biomedical 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.
VL  - 22
IS  - 4
SN  - 1741-038X
DO  - 10.1108/17410381111126436
UR  - https://doi.org/10.1108/17410381111126436
AU  - Nepal Bimal
AU  - Natarajarathinam Malini
AU  - Balla Krishna
PY  - 2011
Y1  - 2011/01/01
TI  - Improving manufacturing process for biomedical products: a case study
T2  - Journal of Manufacturing Technology Management
PB  - Emerald Group Publishing Limited
SP  - 527
EP  - 540
Y2  - 2024/04/24
ER  -