Advanced Imaging

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Advanced Imaging Magazine

Updated: July 8th, 2008 05:26 PM CDT

Rules of the Game

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By Kristin Lewotsky

If you want to succeed in high tech, you need the best technology, right? But that alone isn’t enough. It is an exquisite irony that often the most challenging part of being in a high tech business isn’t the technology — it’s the regulatory environment in which companies must operate.

In the pharmaceutical industry, for example, U.S. drug manufacturers must comply with 21 CFR, a Food and Drug Administration regulation that requires complete, unchangeable traceability of all processes. If they put in a machine vision system for marking or inspection, that system needs to be traceable as well. That requires hardware validation and the development and execution of a software validation master plan, according to David Wyatt, president of Midwest Integration (Mishawaka, Ind.). “It can cost as much to validate as it does to produce the product and install it,” he said. “It can double the price, depending on the master plan of the pharmaceutical company.”

Get the Lead Out

On the first of July, the European Union will institute a directive on the restriction of certain hazardous substances in electrical and electronic equipment (RoHS). No new products can be sold that contain more than the specified low levels of six banned substances, including lead. For the electronics industry, which uses tin lead solder, the implications are profound. The replacement solders not only cost more but have higher melting points, meaning that reflow processes, for example, need to be hotter. RoHS is changing industry operations — and their cost basis. And it most likely represents only the tip of the banned substances iceberg.

“There are two different levels of compliance that we’re seeing,” said Eric Karov, senior research analyst at AMR Research (Boston). “One is a ‘year one’ compliance — do whatever we have to do to get compliant. It probably is not the best long term solution but let’s at least get a baseline level.” The “year two” and beyond approach is to prepare for both RoHS as it currently stands and future regulations, which ultimately means visibility across the entire supply chain. “But doing that is really difficult and a lot of people are tripping over it,” said Karov. “So that’s why they’re defaulting back to ‘Let’s just do what we can to get compliant for this specific regulation.’”

That short term approach will likely be costly in the long run. California has enacted a RoHS type law that goes into effect in January 2007, and both China and Korea are developing legislation. “As additional laws are enacted in other countries, there’s going to be more work,” said Stefanie Breyer, RoHS Program Manager at National Instruments (Austin, Texas). “I think companies are seeing that there’s definitely an ongoing impact.” In addition to RoHS, the EU has passed a directive on waste electrical and electronic equipment (WEEE) that requires manufacturers to take responsibility for the ultimate recycling and disposal of their products.

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