Revising Directive’s Time-of-Use Clause May Cause Reclassification of Devices

Medical device manufacturers are required to comply with Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC by 21 March 2010. Despite having made every effort to meet the essential requirements, companies may be surprised to learn that the classification of some of their devices may be challenged, writes René Clément, co-chairman of Medimark Europe, in an article in the forthcoming Consultants Corner electronic newsletter. Specifically, Annex IX of the Directive places a special emphasis on a new definition of a device’s time of use. The implications of this shift for manufacturers were discussed during a recent meeting with French competent authority Afssaps. Read more…

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Seeing through Opaque Materials

Knowing enough about the way light is scattered through materials would allow physicists to see through opaque substances, such as the sugar cube on the right. In addition, physicists could use information characterizing an opaque material to put it to work as a high quality optical component, comparable to the glass lens show on the left. Image courtesy of American Physical Society

From the Wire: Biological tissue and other opaque materials are opaque because the light that passes through them is scattered in complicated and seemingly random ways. A recent experiment conducted by researchers at ESPCI has shown that it’s possible to focus light through opaque materials and detect objects hidden behind them, provided you know enough about the material. The experiment is reported in the current issue of Physical Review Letters, and is the subject of Viewpoint in APS Physics by Elbert van Putten and Allard Moskof the University of Twente.

To demonstrate their approach to characterise opaque substances, the researchers first passed light through a layer of zinc oxide. By studying the way the light beam changed as it encountered the material, they were able to produce a numerical model called a transmission matrix, which included over 65 000 numbers describing the way that the zinc oxide layer affected light. Read more…

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Materials Testing Lab Offers Video Extensometer Technology

Smithers Rapra has announced the purchase of a video extensometer for its physical testing laboratory in Shawbury, UK. The noncontact video-based instrument, which can measure 3-D displacement and strain on materials, components and structures, is an alternative to traditional contacting extensometers. Many material tests are being replaced by these next-generation video extensometers, according to Smithers Rapra. Read more…

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Post Consolidation, Rexam Healthcare Looks Ahead to Bright Future

Rexam did not have a good year in 2009. The supplier of cans to Coca Cola and Pepsi announced a pretax loss of £59 million in the year to 31 December after exceptional costs. While its speciality cans operations will continue to face a tough economic environment, the group’s healthcare packaging division is more upbeat. At least that was my impression a couple of weeks ago when I ventured to the other side of Paris’s Boulevard Périphérique to visit Rexam’s offices in Suresnes for an interview with Global Marketing Director Patrice Lewko.

Consolidation of the company’s three healthcare packaging businesses—Rexam Pharma, Primary Packaging and Prescription—and the establishment of technical centres in Europe, the United States and, most recently, India are milestones that bode well for the company, according to Lewko. Read more…

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Artificial Bee Silk a Step Closer to Reality

Honeybee larvae produce silk to reinforce the wax cells in which they pupate and now CSIRO scientists have produced this silk artificially. Image courtesy of CSIRO.

From the Wire: CSIRO scientist Dr Tara Sutherland and a research team have hand-drawn fine threads of honeybee silk from a ‘soup’ of silk proteins that they had produced transgenically. As strong as threads drawn from the honeybee silk gland, the fibres represent a significant step towards the development of coiled silk biomaterials, according to the researchers.

“It means that we can now seriously consider the uses of these biomimetic materials,” Dr Sutherland says. “We used recombinant cells of bacterium E. coli to produce the silk proteins which, under the right conditions, self-assembled into similar structures to those in honeybee silk,” she adds. “We already knew that honeybee silk fibres could be hand-drawn from the contents of the silk gland so used this knowledge to hand-draw fibres from a sufficiently concentrated and viscous mixture of the recombinant silk proteins. In fact, we had to draw them twice to produce a translucent stable fibre.”

Sutherland says numerous efforts have been made to express other invertebrate silks in transgenic systems but the complicated structure of the silk genes in other organisms means that producing silk outside silk glands is difficult. Read more…

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Specialty Coating Systems Announces 2010 Parylene Seminars

Specialty Coating Systems (SCS) has announced its spring 2010 parylene seminar schedule. The complimentary one-day seminars will discuss the applications of parylene polymers for the medical device, electronics, automotive and aerospace industries. A technical specialist from SCS will lead the events, which will detail the use of parylene conformal coatings for a variety of material, component and device challenges.

Read more…

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More to See at MedTech Museum

If you have not yet paid a visit to Eucomed’s MedTech Museum, here’s one more reason to stop procrastinating. The online museum, which medtechinsider previewed in October, has added a wing on eye disorders. Information on eye conditions, treatment options and historical perspectives is presented in an attractive and entertaining 3-D environment. Read more…

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New Metrology Systems for Orthopaedic Applications Have the Right Stuff

The Mechanical Taper Gauge achieves a six-second cycle time and 1-µ accuracy.

A developer of bespoke metrology systems for the orthopaedics industry has introduced two new products: a taper measurement gauge to ensure that tolerances are met and a part identification gauge to verify that the correct parts have been packaged together.

Tapers on implants are stringently controlled with tolerances as low as 10 microns. Coordinate measuring machines (CMMs) and air gauges are traditionally used to verify dimensions, but both techniques have drawbacks, according to Trac Measurement Systems Ltd. Read more…

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Biosensor Enables Human Arm to Be Used as Touch Screen

From the Wire: Researchers at Carnegie Mellon University and Microsoft have developed an acoustic biosensor that turns an arm into a crude touch screen, writes Kristina Grifantini on the Technology Review blog.

An armband, worn around the bicep, detects minute sound waves that travel through skin when it is tapped. The researchers designed a software program that can distinguish the origin of the acoustic sounds—which vary due to slight differences in underlying bone density, mass and tissue. The system then translates these locations into button commands. A pico projector embedded in the armband projects a display—a game of Tetris or button controllers—onto a user’s palm or arm. Read more…

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The Home Is the Place to Do Good Business

The European intravenous (IV) therapy and enteral nutrition devices market currently offers med-tech companies a highly lucrative environment, according to new analysis from Frost & Sullivan (F&S). The market is expected to grow to US$2981.2 million in 2012, up from US$2423.0 million in 2008. This is being driven by the increasing number of drug therapies that can employ IV devices and the now proven ability that IV therapy can be administered safely and effectively in the home. In addition, the ability to administer IV therapy safely and effectively in the home has been proven, and European hospital now are focused on downsizing and reducing the time spent by patients in hospitals, which has raised the value of homecare in Europe. Read more...

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Multivac Introduces Revamped Website

Multivac has announced the launch of its new corporate website. The revamped site includes a sign-up area where registered users can view a selection of Multivac package animations from around the world. The interactive 3-D animations allow users to control movements and viewing angles with the click of a mouse.

The site highlights Multivac’s packaging expertise across all the sectors it serves including the medical device and pharmaceutical industries. A number of brochures on sector-specific packaging applications and related products can be downloaded.

Headquartered in Germany, Multivac manufactures thermoform-fill-seal rollstock packaging technologies, chamber vacuum pouch sealers, tray sealers, shrink tanks, and cross-web and inline labellers.

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Aseptic Surgery Forum Addresses Development of Antimicrobial Coatings for Implants

The first Aseptic Surgery Forum, which is scheduled later this month at the Cité des Sciences in Paris, France, will include a session devoted to innovative antimicrobial implant coatings that may be of interest to medtech engineers and manufacturers. The session titled Antimicrobial Coatings: Prospects will be held on 26 March, the first day of the two-day event, and will be chaired by Thomas Bauer, surgeon at Hôpital Ambroise Paré in Boulogne-Billancourt, France. Read more…

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