Medical Devices Assembly / Lean Manufacturing Assembly

Medical Device Manufacturers Slowly Go Lean

February 1, 2013
/ Print / Reprints /
ShareMore
/ Text Size+

Compared with the automotive industry, medical device manufacturers are in the early stages of applying lean manufacturing principles. Manufacturers of advanced imaging equipment and surgical devices tend to be further ahead of companies that produce high-volume, low-cost devices.

“Generally speaking, the medical device industry has just begun its lean journey,” claims Don Penkala, president of Granite Bay Global, a lean manufacturing consulting firm. “Of course, there are exceptions. [Some] medical device plants [rank among] the leanest I've seen.”
Automotive companies have used some form of lean for several decades with varying degrees of success. Consumer products manufacturers embarked on their lean journey in the mid-1990s.

“The adoption of lean initiatives in the medical device industry accelerated with the economic downturn, as manufacturers had to find new methods for reducing costs and sustaining quality in increasingly regulatory and price-sensitive markets,” says Penkala.

“The reluctance of some [medical device players] to adopt lean is a result of the intense regulatory environment in which they operate,” Penkala points out. “It is not as easy to experiment with cell creation, team modifications, test runs [and other initiatives] with the level of documentation and reporting requirements inherent in medical device manufacturing.”

Medical device manufacturers have used many of the same excuses, delaying the widescale adoption of lean manufacturing. “Besides the typical justification that ‘lean is for automotive manufacturers’ or ‘lean only works for Toyota,’ the most common excuse against using lean concepts is [the misnomer that it can’t] work in a highly regulated environment,” says Sammy Obara, president of Honsha Associates, an alumni association of former Toyota Motor Corp. engineers and managers.

“One company I ended up teaching lean to for several years gave me an early push back claiming that continuous improvement would make them ‘too bureaucratic,’” recalls Obara, who spent three years studying lean manufacturing principles in Toyota City, Japan, and another 10 years applying it at Toyota plants in North and South America. “They explained that for every tiny change in their process they would have to create lots of documents to obtain FDA approval and that could take a long time.”

“Aside from the typical challenges with lean implementation, such as gaining commitment and understanding and applying the principles to a specific environment, the medical device industry faces rapid technological change,” adds Penkala. “[Manufacturers typically] need to incorporate automation where precision in required. [There’s] a reluctance to adopt change because of regulations; component and product traceability; and increased reporting and documentation requirements.”
 

Did you enjoy this article? Click here to subscribe to Assembly Magazine.

Recent Articles by Austin Weber

You must login or register in order to post a comment.

Multimedia

Videos

Image Galleries

Behind the Scenes at Ford's Michigan Assembly Plant

People are the heart and soul of the 2012 Assembly Plant of the Year. This slideshow shows some of the men and women who build three different types of electrified vehicles alongside traditional gas-powered cars on the auto industry’s most flexible assembly line—Ford’s Michigan Assembly Plant in Wayne, MI. Photos courtesy Ford Motor Co.

Podcasts

Anyone even thinking about advanced power tools needs to pick the brain of Eric Dees. He’s the Global Lean Business Process Leader for Ingersoll Rand Power Tools and Category Manager for their Assembly Tools Business.

More Podcasts

Assembly Magazine

october 2014 assembly

2014 October

The 2014 October Assembly includes our Assembly Plant of the Year winner plus much more. Check it out today!
Table Of Contents Subscribe

Assembly Plant Age

How Old Is Your Assembly Plant?
View Results Poll Archive

THE ASSEMBLY MAGAZINE STORE

welding.gif
Welding: Principles & Practices

This text introduces students to a solid background in the basic principles and practices of welding.

More Products

Clear Seas Research

Clear Seas ResearchWith access to over one million professionals and more than 60 industry-specific publications,Clear Seas Research offers relevant insights from those who know your industry best. Let us customize a market research solution that exceeds your marketing goals.

STAY CONNECTED

facebook_40px twitter_40px  youtube_40pxlinkedin_40pxgoogle plus  

Assembly Showrooms

ASSEMBLY Showrooms