New laws for medical devices examined at Medical Device & Technology Expo 2011

The continually changing European Union regulations governing medical devices were the focus of two days of workshops offered by leading industry experts at the inaugural Medical Device & Technology Test Expo held in Cologne, Germany, this week.

Dr Rosy Eloy, Medical Director for Europe of BIOMATECH – NAMSA, focused on the changes to the new 2007/47 Medical Device Directive in her workshop.

As of March 2010, medical device manufacturers are required to beef up the evaluations of the safety and performance of their products. Dr Eloy underscored the new provision that manufacturers produce clinical data on the safety and performance of all medical devices, regardless of the classification of the device. Also new is the requirement that manufacturers back up their data with an analysis of the related risks and benefits.

Looking ahead, two workshops focused on how manufacturers of electronic medical devices can comply with changes to the regulations due to come into force from June 2012 in Europe and in Canada, and from June 2013 in the United States.

A team from Underwriters Laboratories (UL) led an interactive workshop on how manufacturers can get their products certified according to the 3rd edition of the IEC 60601-1, the internationally harmonized standard for the safety of electrical medical devices.

Dr Terenzio Facchinetti, UL’s Business Development Manager for Life & Health Sciences, said manufacturers could avoid the frustrations and cost of redesign of products if they consider the regulatory and certification requirements at the early stage of product development.

In a separate workshop, two experts from DEKRA Certification B.V. (formerly KEMA Quality), gave a practical demonstration on how manufacturers must incorporate risk analysis—a new provision in the law—into the safety testing of their products.

The workshops were a key feature of the Medical Device & Technology Test Expo 2011, the world’s first-ever business to business trade fair to focus exclusively on testing at each stage of product development. The three-day Medical Device & Technology Test Expo, held at Koelnmesse, closes today.

Check the Medical Device & Techology Test Expo website for pdf versions of the workshop and forum presentations: www.medicaldevicetestexpo.com. They will be made available by the end of February 2011.

Medical Device & Technology Test Expo 2011

After much anticipation, the medical device testing community was given an event to remember at HuLST Expo 2011.

Walter+Bei enjoyed a productive show, with many interested visitors stopping by the stand

The inaugural Medical Device & Technology Test Expo offered many visitors their first chance to see a number of industry products, such as Mark-10’s Series 5 digital force gauge and the Falcon video measuring solution from Vision Engineering.

Mark 10's Series 5 digital force gauge.

Mark-10 believes the Series 5 gauge is perfect for a broad range of industries, including medical device. Available in capacities from 0.12lb to 500lb (0.5N to 2,500N) and boasting ±0.1% accuracy, the gauge is overload protected to 150% of capacity. An analog load bar tells users when such an overload is imminent.

Many visitors saw Vision Engineering's Falcon measurement machine for the first time

Falcon has been designed with 3-axis measurement of precision machined component parts in mind, according to its creator, Vision Engineering. The technology works with a touchscreen display that shows accurate measurement results in microns.

Medical Device & Technology Test Expo 2011 also played host to Bose Corporation’s ElectroForce Series 7 software, which works with the company’s range of test equipment. Operating on the Windows 7 platform, the software allows users to alter testing protocols, and change loading profiles based on specimen response.

Other product debuts came courtesy of Mecmesin, with the MultiTest-xt, and Lloyd Instruments, manufacturers of the LS1

The big news from the Lloyd Instruments stand was the breakthroughs being made in materials testing. Such advances have been made possible due to the LS1, a 1kN testing machine, that made its debut at the show. The LS1 features a wider crosshead speed range and improved measurement accuracy for evaluating the mechanical properties and performance of medical devices.

Visitors were keen to talk to industry heavyweights Instron and Marposs about their latest developments and products for the medical device market

Other stands of great interest were Instron’s, which featured a range of test equipment including the 5900 series and the latest ElectroPuls instruments and Marposs’, which featured the first public outing Orthoflex, the company’s latest optical vision system. Over at Mecmesin, all the talk was about MultiTest-xt, a touchscreen force measurement system that is specifically designed for conducting quality control assessments.

Away from the exhibition floor, there was a full program of presentations and workshops, giving audiences the chance to find out about industry developments and trends that could have an impact on the way they operate. Kicking off proceedings was Kathleen Johnson, president and founder of Medical Device Approvals, who talked about the implementation of FDA requirements into the new product design process.
There were also presentations from key organisations in the industry including Sterigenics, Intertek, SpineServ, LMS International and Underwriters Laboratories.

Pharma & Biotech Test Expo

One of the pharmaceutical industry's leading authorities on drug substances that could harm our DNA kicked off the workshops at the inaugural Pharma & Biotech Test Expo, now being held in Cologne, Germany.

Dr Andrew Teasdale, chair of AstraZeneca's Genotoxic Impurities Advisory Group, conducted the workshop, "Evaluating the risk of genotoxic impurities", at Koelnmesse on Tuesday, February 8, the opening day of the three-day Pharma & Biotech Test Expo 2011.

Drug manufacturers work continually to ensure their products are free of these toxins.

"Most if not all arise through the synthetic process used to manufacture drugs," said Dr Teasdale, whose groundbreaking book on the subject, Genotoxic Impurities: Strategies for Identification and Control, is due to be published later this month by Wiley.

Regulatory authorities' increasing concern with the potential presence of impurities that are genotoxic in drug products led to the publication of the European Medicines Authority guideline, effective from January 1, 2007, Dr Teasdale said.

The US Federal Drug Administration followed suit with a draft guideline, published in December 2008, but there remain many unanswered questions for regulators and industry.

"The biggest problem area we have is to get a common system," said Dr Teasdale, who gave the example of a drug AstraZeneca produced which the regulators of four different countries queried on 10 issues related to genotoxic impurities. Proof that there is no agreement among the regulators was evidenced by the fact that each highlighted a different area of concern, requiring the company to re-test the drug to answer each of the 10 queries. All tests came back negative, but the major headaches the company endured were unavoidable.

Industry and regulatory authorities will have to work together to achieve a common regulatory approach, he said, though progress is being made, particularly in Europe.

Dr Teasdale is actively involved in the work of the International Committee for Harmonisation to develop a common standard for testing of genotoxic impurities, a process that may take several years.

For the latest news on Pharma Test Expo 2011, visit the website: www.pharmatestexpo.com.

Note: Dr Teasdale's presentation at the Pharma Test Expo 2011 is available to download as a pdf file: 
http://www.hulst-expo.com/downloads/evaluating-gi-risk-pharm-test-expo-workshop.pdf (929kb).

Promising start to HuLST Expo

The human life science test community has gathered in Cologne to participate at the inaugural HuLST Expo, which is running in the German city from 8 to 10th February 2011.

Cologne played host to the inagural Hulst Expo

With more than 110 exhibiting companies covering four events – Medical Device & Technology Test Expo, Pharma Test Expo, Biotech Test Expo and Food & Beverage Test Expo – HuLST has been hailed as the only fully focussed exhibition that meets the specific needs of the human life science test industry.

HuLST Expo provided a great opportunity to meet potential future customers and suppliers

Featuring major industry names such as BOSE GmbH, PANalytical GmBH, HBM, PerkinElmer and Fraunhofer ITEM, HuLST Expo 2011 has proved popular with visitors and exhibitors alike. The show has provided an excellent platform for many products to be launched into the marketplace, such as the Series 5 digital force gauge from Mark-10, and the LS1 materials measurement system from Lloyd Instruments.

The forums held throughout the hall proved popular with delegates and exhibitors

Meanwhile, the latest industry developments have been be presented in the free-to-attend forums and workshops running alongside the main exhibition.

With more than 110 exhibitors, there was plenty of technology to be seen by visitors to HuLST Expo

David Stradling, marketing director at Total World Media, organisers of the show, was also satisfied with the first day. “We have seen plenty of activity on the stands, with exhibitors talking to potential and existing customers about doing business together,” he said.

Visitors came to Germany from Europe, North America and Asia.

“With two more days still to go, we believe that exhibitors will be delighted with the quality of visitors and leads that they depart Cologne with,” added Stradling.

For more information on the event, go to www.hulst-expo.com or contact John Challen at j.challen@hulst-expo.com