BIRMINGHAM, UK — The debate and lobbying pressures were so intense over single-use medical devices (SUDs) that, in the end, "the European Parliament chickened out," said Mika Reinikainen of AbNovo (Weybridge, UK).

The decision, he said, has been put off until 2010.

Dario Pirovano, who is with the regulatory affairs department at Eucomed (Brussels, Belgium), acknowledged that there was "strong pressure from reprocessors that resulted in a stalemate," though during a session updating manufacturers on the Medical Device Directive at MedTec UK, held here last week, it became clear that the industry trade association was happy to have played to a draw its opponents in favor of reprocessing or, as a stalemate is called in Brussels, an "annulation."

Pirovano worked a pro-SUD tandem during the session with Peter Schroeer, who heads up regulatory affairs for Ethicon Endosurgery (Cincinnati), a business of Johnson & Johnson (New Brunswick, New Jersey).

Schroeer spent so much time seconded to Eucomed during the battle in Brussels that Pirovano said they had to remind him that he worked for J&J.

In his presentation, Schroeer said the pro-reprocessing lobby was successful in blocking a total ban by the European Union, thereby winning a continued tolerance, or reprocessing by omission in national regulations.

But the pro-SUD lobby knocked down a requirement that manufacturers offer proof that a product made for single use cannot be designed as a multiple-use product.

The vote in Parliament on the draft Medical Device Directive reflects how Europe is divided over SUDs — ranging from a total prohibition in France to what Pirovano called "quasi-approval" in Germany, where a subcontracting industry has sprung up.

Germany's regulation of reprocessing was promoted as a potential template for European-wide adoption, but Schroeer attacked this proposition, saying there is no regulation of reprocessors in Germany, only guidelines.

German reprocessors are required to be registered, but audits of the companies are not mandatory. Reuse of devices is tolerated, but design differences between single-use and multiple-use devices, which are manipulated and sometimes reconfigured during reprocessing, are ignored, and there is no design validation, he said.

He compared this with the U.S., where reprocessors are legally viewed as manufacturers and a 2006 guidance requires devices to be relabeled with the reprocessor's name and not the original manufacturer.

Schroeer said the U.S. also is struggling with implementation of validation of reprocessed devices and the market is uncertain at the moment. There have been recalls of products that indicate improved vigilance processes in the U.S., not an uptick in bad products.

Reprocessing is estimated to be an $87 million industry in the U.S., "and not billions," he said, citing what he called the only available statistic coming from a 2004 report filed during the acquisition of a reprocessor.

Ascent Healthcare Solutions (Phoenix) holds a 72% share of this market, he said, with SterilMed (Minneapolis) holding 25%.

Half of the presentation was a replay of the pro-SUD "scare campaign" against the dangers of broken blades, filthy instruments, false financial information and a total transfer of liability under European law to individual patients who are poorly informed of the risks.

A silence followed Schroeer's conclusion and session chairman David Purnell of Total Quality Matters delivered a perfect British understatement, saying, "Well, that is certainly frightening."

Some participants were disappointed the pro-SUD lobby avoids the environmental issues of disposable medical devices, leaving the med-tech industry swimming upstream against the public current toward greater sensitivity.

Key trends: usability, evidence-based design

"If I had to choose, I would say the biggest product trend is a consumerization of medical technology," said Amy Dumas of Kinneir Dufort (Sunderland, UK), a leading medical device design firm.

"It used to be that we listen to what clinicians needed for the design brief," she said. "Now more and more it is coming down to what the users need, and we spend more time with user research, and this is paying enormous returns. We are making products today that look less medical and more consumer-oriented."

The challenge becomes in preserving the integrity of these design requirement through ramp-up of manufacturing processes, Dumas said.

Robert Woolston, managing director of DCA Design International (Warwick, UK), agreed, saying that his 50-year-old company is spending more and more time researching "how users will use a product, and how they may abuse the product."

And he put the accent on evidence-based design as the development most critical for new projects.

The demand is more and more for design robustness, meaning that the product meets its stated intent, but also considers the risks in how the product was developed and conducting a failure mode-and-effects analysis.

"These products are strategically complex for companies and often can represent their profits five years out," he said.

Woolston showed as an example the line of SoloSTAR insulin pens created by DCA for Sanofi-Aventis (Paris).

SoloSTAR was developed following a challenge by Novo Nordisk (Copenhagen, Denmark) for a patent violation for Sanofi's OptiClik line of insulin pens in 2005.

"This is the first time we are allowed to show this," he said, adding that it emerged from a strong evidence-based design process with an emphasis on user usability for regime assurance and regime assistance.

He said med-tech currently accounts for 50% of DCA project revenues.