Irish Medical Devices Association Supports EU Stability Treaty

The Irish Medical Devices Association (IMDA) last week announced its support for the EU stability treaty, saying that it’s necessary to help Ireland’s exporters continue driving economic growth. Ireland will vote to ratify the treaty, officially titled the “Treaty on Stability, Cooperation and Governance in the Economic and Monetary Union,” on 31 May 2012. IMDA Chairman Paraic Curtis said that “a no vote would be a dangerous step into the unknown that would damage confidence and set back the recovery.” Read more…

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TU Delft, Shanghai Institute of Ceramics Collaborate on Development of Next-Generation Bone Fixation Devices

A Memorandum of Understanding (MoU) between TU Delft in the Netherlands and the Shanghai Institute of Ceramics (SIC), Chinese Academy of Sciences (CAS), was recently renewed for five years. Scientists from both universities will collaboratively pursue research on the development of composite materials for biodegradable and bioactive orthopaedic devices, a process that began under the initial MoU signed in September 2008.

To learn more about the objectives of the renewed MoU, which was signed on 26 April 2012, Helen Zhang, Associate Editor of China Medical Device Manufacturer (CMDM), spoke with Dr. J. Zhou, Associate Professor, Department of Biomechanical Engineering and Faculty of Mechanical, Maritime & Materials Engineering at TU Delft. Read more…

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UK Pip Implant Report Calls for Improvements to MHRA, EU Device Regulations

The UK Health Minister Lord Howe has published a report looking into the actions of the Medicines and Healthcare Products Regulatory Authority (MHRA) relating to the Poly Implant Prothèse (Pip) implant scandal.

The report found that the agency started to receive reports related to the Pip implant scandal as early as 2002. In 2006, surgeons contacted the agency, concerned that the implants were breaking more frequently than other brands. MHRA brought these concerns to the attention of the notified body TUV Rheinland, which was responsible for assessing the implants, and continued to analyse Pip incident data afterwards. Ultimately, the blame “lies squarely with the fraudulent manufacturer”, the report found. Read more…

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Chomerics Europe Inaugurates Advanced Production Cell for Shielded Cast Windows

Demand for shielded cast windows continues to rise in terms of quantity and quality. To satisfy demand on both fronts for these products, which reduce radio-frequency and other electrical interference and help manufacturers achieve electromagnetic compliance (EMC), Chomerics Europe, a division of Parker Hannifin, has established a new manufacturing cell at its facility in Grantham, UK. The windows are used in medical devices and a host of other products that integrate electronics. Read more…

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Medtech Week Recap: Robot Identifies and Records Neurons

Researchers at MIT and Georgia Institute of Technology used a robotic arm and a computer algorithm to identify and record neurons in a mouse brain. The method automates an extremely complicated task and could help uncover how diseased cells are different from normal cells. Read more…

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BMJ Editor Defends Hip Implant Article

An article about metal-on-metal (MoM) hip implants that was published in the British Medical Journal (BMJ) in February continues to stir controversy. The article has resulted in a heated debate between BMJ and DePuy. DePuy claims that the article was “unnecessarily alarmist” and included several incorrect facts, while omitting other essential information. BMJ defended the article in a detailed response to the criticism.

Last week, the author of the article, BMJ Investigations Editor Deborah Cohen, responded to DePuy’s comments, accusing DePuy of sidestepping the issue of metal hip safety. Cohen claims that the article “provided a necessarily alarming portrait of the state of medical device regulation today.” Cohen also said that the main point of her article was to point out “the laxity of medical device regulation in Europe as a whole and some aspects of the US system.” Read more…

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Control 2012: Compact Digital X-Ray and CT System Looks At Small and Medium Objects

At Control taking place this week in Stuttgart, Germany, North Star Imaging is presenting its newly developed compact digital x-ray and computed tomography (CT) system designed for submicron resolution imaging and ultra-high accuracy scanning. The international trade show for quality assurance runs 8 to 11 May 2012 at the Stuttgart Exhibition Centre. The system is dedicated to the inspection of small to medium sized objects in the electronics, medical devices and other sophisticated industries. It houses a precise five-axis manipulator with vibration isolation system and provides a spacious 228 x 228 mm scanning envelope and a rotational stage capable of handling up to 11 kg. These features make it suitable for x-ray and CT applications ranging from 3-D metrology to failure analysis both in industrial quality control and R&D laboratories. Read more…

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Cloud-Based Healthcare Device Will Improve Patient Outcomes and Reduce Costs, Says Isansys Lifecare CEO

Isansys Lifecare CEO and co-founder Keith Errey

Isansys Lifecare CEO Keith Errey may have his head in the cloud, but his feet are planted firmly on solid business ground. Isansys has developed the LifeTouch Patient Surveillance System, which is touted as the first cloud-ready product to be certified as a Class IIa medical device under the terms of the Medical Devices Directive. The CE-marked system can now be used clinically within the European Union along with other countries that recognise the CE mark. Given that the system promises to improve patient safety and clinical outcomes while reducing healthcare costs, the potential uptake is enormous.

Comprising a body-worn wireless sensor and associated Patient Gateway, the LifeTouch system is defined by Errey as a “vitals-as-a-service” clinical solution. “In the general ward of a hospital, patients are monitored, at best, every couple of hours,” says Errey. If something happens and they need attention, “that requires an emergency response, which is a high-cost intervention,” he explains. By contrast, the LifeTouch system provides continuous real-time monitoring of a patient’s key vitals in the hospital, at another care facility or in the patient’s home. Read more…

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Radiation-Free Technique Detects Breast Tumours with the Use of Ultrasound and Photoacoustics

An imaging device developed by researchers in Netherlands combines photoacoustics (light-induced sound) with ultrasound to detect breast tumours, according to a press release from The Optical Society (OSA).

The device, Twente Photoacoustic Mammoscope (PAM), was recently used in clinical testings. Preliminary results were reported yesterday in the open-access journal Optics Express.
Read more…

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ISA France Invests in Dimensional Integrity

ISA France has added a Keyence image dimension measurement system to its array of quality control instruments. Because the company specialises in the fabrication of micromoulded components for the medical device industry, it is imperative that best-in-class quality systems are in place to ensure dimensional integrity. The IM 6500 system performs this task reliably and rapidly, according to ISA France.

The IM 6500 can measure up to 99 features almost immediately. The data is obtained using the sort of image processing technology that is found in digital microscopes, but in a system designed for factory automation environments. The data is automatically stored and can be processed later to produce a range of statistical reports. The instrument’s capabilities mesh well with the needs of ISA France, which works routinely with small parts destined for integration with medical devices, watches and connectors.

ISA France provides R&D services to customers in the medical technology sector, and is equipped with state-of-the-art high-speed stamping and electric micromoulding systems.

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Metal-Free Hip Implant Incorporates New Combination of Materials to Provide High Durability

A European Commission-funded project titled ENDURE focuses on developing a new type of hip implant that is metal-free and provides bone-like elasticity.

An international team of ten partners, which include companies, research organisations and universities, collaborated to develop a hip implant that demonstrated good wear resistance in initial tests. During the tests, a robot simulated various movements while wearing a prototype of the implant, according to a press release from Fraunhofer Institute for Manufacturing Engineering and Automation IPA. Read more…

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Medtech Week Recap: DSM Expands Biomedical Division with Acquisition of Kensey Nash

Last week, DSM, the Dutch plastics giant, announced it will acquire Kensey Nash, which develops devices based on resorbable materials such as collagen, synthetic polymers and extracellular matrices. The acquisition gives DSM access to Kensey Nash’s US custom base, which includes many major OEMs. It also continues a trend of the company focusing more on specialties instead of commodities. Read more…

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