Improving manufacturing process for biomedical products: a case study

Bimal Nepal (Department of Engineering Technology and Industrial Distribution, Texas A&M University, College Station, Texas, USA)
Malini Natarajarathinam (Department of Engineering Technology and Industrial Distribution, Texas A&M University, College Station, Texas, USA)
Krishna Balla (Department of Mechanical and Industrial Engineering Technology, Purdue University‐Fort Wayne, Fort Wayne, Indiana, USA)

Journal of Manufacturing Technology Management

ISSN: 1741-038X

Publication date: 3 May 2011

Abstract

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.

Keywords

Citation

Nepal, B., Natarajarathinam, M. and Balla, K. (2011), "Improving manufacturing process for biomedical products: a case study", Journal of Manufacturing Technology Management, Vol. 22 No. 4, pp. 527-540. https://doi.org/10.1108/17410381111126436

Download as .RIS

Publisher

:

Emerald Group Publishing Limited

Copyright © 2011, Emerald Group Publishing Limited

Please note you might not have access to this content

You may be able to access this content by login via Shibboleth, Open Athens or with your Emerald account.
If you would like to contact us about accessing this content, click the button and fill out the form.
To rent this content from Deepdyve, please click the button.