The aim of the treaty is to support “sustainable growth, employment, competitiveness and social cohesion” in Europe through budgetary rules. Only countries that have ratified the treaty will be able to receive funds from the European Stability Mechanism, a new rescue fund. Supporters say that a yes vote will encourage businesses to continue to invest in Ireland.

The medtech sector in Ireland employs 25,000 people. About half of the med-tech companies in Ireland are indigenous. Executives at several medical technology companies have expressed their support for the treaty. In an IMDA press release, both Donal Balfe, Vice President of Covidien, and John O’Dea, founder and CEO of Crospon, speak out in support of the treaty.

“The medical technology sector is playing a vital role in Ireland’s export-led recovery and creating jobs in the process,” says O’Dea. “While major challenges remain, it is crucial that we build on this success. It is important that we don’t jeopardise the progress already made by isolating ourselves in Europe.”

“We operate in a global environment where there is enormous competition for future research and development investments,” says Balfe. “Financial stability in Ireland is critical for companies to be able to plan for future innovation in the country.”

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.

CMDM: Can you tell me under what circumstances the collaboration was initiated, and why your university selected SIC as your partner in China?

Dr. J. Zhou: The cooperation in research on biomaterials was initiated in September 2008 during the China Medical Technology Tour, headed by Dr J.W.A. van Dijk, former Vice Governor of the Netherland’s South Holland province, and Prof. J.T. Fokkema, former Rector-Magnificus of TU Delft. The main reason for choosing SIC as our partner is quite simple: complementary expertise.

The Biomaterials and Tissue Engineering Research Center of CIS, led by Prof. Jiang Chang, is particularly strong in developing bioactive ceramics and ceramic-matrix biocomposites. In addition, it has expertise in understanding cell-biomaterials interactions (including the effect of biomaterials on cell adhesion, proliferation, differentiation and gene expression) and is capable of characterising the physical and chemical properties of biomaterials. Its research covers the fields of bioactive materials, tissue engineering scaffolds, nano-biomaterials for controlled drug release, biolabelling, diagnostics, inorganic bioactive coatings for medical implants, and fibre-optic materials for medical devices.

The Biomaterials Technology Group of TU Delft is particularly strong in developing biometals and metal-matrix biocomposites and adding multiple biomedical functionalities to the surfaces of these biomaterials. Its unique expertise lies in metallic and composite biomaterials processing and surface biofunctionalisation. It is equipped with a full range of facilities, including a bio-safe lab, for biomaterials processing, characterisation and surface biofunctionalisation. This research covers the whole chain of biomaterials research for advanced multifunctional combination devices and instruments.

CMDM: The updated MoU will contribute to a joint research project with ZonMw (The Netherlands Organisation for Health Research and Development) and CIS. Can you tell us more about this?

Dr J. Zhou: We strongly believe that the MoU contributed to the approval of a four-year joint research project titled, “Bioactive and biodegradable composites for new-generation bone fixation devices.”

Our joint proposal was submitted in April 2011 in response to a call for proposals under the China-Netherlands Joint Scientific Thematic Research Program 2011 (JSTP) with a thematic focus on “Medical Devices for an Ageing Society.” It was assessed by three international experts appointed by the JSTP assessment committee. (Sino-Dutch cooperation was one of the four criteria for the assessment.) It was then assessed in China.

The Chinese-Dutch Assessment Committee ranked our proposal as one of the six top proposals out of 29 applications and approved funding for our project in November 2011.

In its first term (2009-2011), the MoU provided a formal framework under which many joint research efforts were conducted and a joint research proposal was rewritten.

Satisfied with the outcome of the collaboration, both institutions agreed to a renewal of the MoU for five years (2012-2016). The execution of the approved joint research project will certainly be part of the new MoU.

CMDM: What are the goals for the project mentioned above? Specifically, how might this benefit the medical technology industry?

Dr. J. Zhou: The project intends to make the best use of the expertise of the individual institutions in biomaterials research. It aims to develop composite materials for new-generation bone fixation devices that are both biodegradable and bioactive. Their clinical applications will eliminate the medical problems of current bone fixation devices, which are left permanently in the body after the bones have healed. These problems include stress shielding, physical irritation and [the devices'] inability to adapt to changes in the human body, and, thus, the need for a second surgical procedure to remove them.

Bioactive, biodegradable bone-fixation devices that are being developed in this project will be welcome additions to existing orthopaedic devices and further drive market growth in Europe and China. The research will generate know how and intellectual property and provide the medical device industry with an opportunity to develop innovative products.

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.

While the review found that the MHRA acted reasonably, it also calls for several improvements to the agency. MHRA needs to improve its procedures for gathering evidence related to device safety and analysing reported problems, according to the report. It also needs to find better ways of communicating with the public. In addition, the report calls for changes to the European regulatory system, stating that EU countries must work more closely together and become better at sharing information on medical devices.

However, the report rejects the need for a premarket authorisation system, something the European Parliament called for in its Pip resolution. “Nothing about this case provides evidence to suggest the system for regulating medical devices is fundamentally unsound and that there needs to be a shift to a system like that used to regulate pharmaceuticals in the EU, or the system used to regulate higher risk devices in the United States…Putting in place even the most exhaustive testing regime before market authorisation would not have prevented this deliberate fraud taking place once the product was on the market,” the report says.

Chomerics Europe uses advanced manufacturing techniques to achieve a combination of shielding effectiveness, optical transmission and mechanical and environmental performance, notes the company in a press release announcing the completion of the new specialist cell. The Grantham facility has been producing optical windows for more than 10 years, during which time the company has developed expertise in the design and manufacture of these specialised products.

Commenting on the commissioning of the new cast window production cell, Billy Sheedy, General Manager, Parker Chomerics Division Europe, said: “With an increasing demand for equipment to be designed for portability and use in uncontrolled environments, along with more stringent regulations in terms of EMC, we are seeing greater demand for the shielded optical products designed and manufactured at our facility in Grantham. The establishment of an advanced, dedicated cell for cast windows will enable us to further advance the quality of our products for this important market.”

Last week, US FDA approved the first surgical device that can be assembled and disassembled inside a patient. However, Ethicon Endo-Surgery, the manufacturer of the device, might never launch the product, MedCity News says.
A look (kind of) at the first ever, FDA-approved surgical device that can be assembled inside a patient’s body (MedCity News)

Open access publishing often shifts the cost from subscribers to authors because of processing fees. Universities should encourage the growth of journals that don’t charge readers or authors, two UK professors argue in this blog post from The Guardian.
Open access publishing should not favour those with deep pockets (The Guardian)

In this video, device inventor Thomas Fogarty discusses how medical device companies can overcome hurdles such as difficulties getting funding and regulatory challenges.
Thomas Fogarty, MD on Overcoming Barriers to Innovation in Medtech (MD+DI)

The global minimally invasive surgical market will see an estimated annual growth rate of 8% during the next five years, according to a report by global market research and consulting company MarketsandMarkets.
Minimally Invasive Device Market Poised for Continued Growth (Medtech Pulse)

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.”

As the European Commission drafts its proposal for the revision of the Medical Device Directives, the controversy is likely to impact the outcome. The Pip resolution, which was passed in April, already included references to the controversy, using it as an example of the failure of the European regulatory system. The resolution is not binding and only expresses the views of the European Parliament, but it demonstrates the prevailing view in the Parliament that Europe’s medtech regulations are not strict enough to prevent similar incidents (see this medtechinsider post for more information and for Eucomed’s response to this argument).

With an x-ray voltage range from 10 to 160 kV, the new X25 CT-system provides an overall maximum system resolution of <0.5 µm and a geometric magnification of up to 4000x. Its maximum scan travel is 228 mm vertical and 152 mm horizontal, with a z-axis (source to detector) of 1003 mm and a rotation of 360º continuous. Each axis is independently joystick controlled. Tailored to the specific task, the high-resolution system combines nano-focus, micro-focus, open or sealed, and transmission x-ray tubes with flat panel (DDA) or linear diode array (LDA) digital x-ray detectors. Features of the cabinet include cable access port with cover, interior lighting, powered sliding access doors, leaded glass viewing window, safety light curtains and touch screen functionality. The steel/lead/steel construction meets or exceeds all Federal and State radiation safety regulations (21 CFR 1020.40) and several other standards. The system is CE mark compliant.

As with all NSI x-ray/CT systems, the X25 comes standard with NSI’s efX-DR and efX-CT software, both featuring comprehensive data acquisition, processing and archival routines, high performance image processing and measurement functions, and an intuitive user-friendly interface.

You can find North Star Imaging Inc at stand 1522.

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.

“The system collects data continuously,” stresses Errey. “This is the key to being able to accurately determine the future trajectory of a patient’s status, what clinicians call early warning scores. It’s all about intervening when a patient starts to deteriorate—if we can extend that view [into the patient's condition] and intervene earlier, the situation can be dealt with by a much simpler, less traumatic and lower cost intervention such as providing a little more fluid, in some cases, or adjusting drug dosage.” The cost savings can be huge, he says.

Despite its promise, wireless telemetry in healthcare has not achieved anything approaching its potential, and Errey has been wondering why for some time. The reason, he concludes, is its complexity. “It’s too complicated for many clinical people to use,” he explains. “It’s not that they are technically inept—they just don’t have the time. That’s why making the technology available as a service makes so much sense. We can screen our clinical users from things like technological obsolescence,” says Errey.

The LifeTouch body-worn sensor.

“Hospitals investing in wireless monitoring systems look at purchasing cycles of five, and often 10 years,” notes Errey. That is unrealistic given the pace of technological change, and Isansys Lifecare’s business model enables upgrades within a timeframe that is more like what we are used to in consumer electronics. What’s more, the “vitals-as-a-service” model, which underpins the LifeTouch system, makes the technology relevant to hospitals in Barcelona or Bangalore, according to Errey. In fact, India is a target market. The affordability of the technology allows healthcare providers to leapfrog expensive conventional monitoring systems and meet the demands of India’s growing middle class, which is woefully underserved in healthcare. On the other end of the economic spectrum, the US healthcare system also has something to gain from LifeTouch, says Errey.

“There is a lot of interest in the United States, especially regarding the system’s ability to resolve patient-safety issues and, in light of changes to US reimbursement policies, provide a high level of patient surveillance once patients have been discharged from the hospital. This is critically important during the first month after discharge,” says Errey. He estimates that hospital-acquired infections, medical errors, avoidable patient deteriorations and resulting litigation end up costing the US healthcare system in the neighbourhood of US$50 billion per year. The LifeTouch system can make a real dent in minimising these events by offering a means of continuously monitoring patients who have been released from the hospital, analysing the data in real time, merging it with a patient’s electronic health record and securely delivering it to authorised personnel anytime and anywhere.

Data protection is not an issue with this technology, Errey adds, because of the system’s scalable architecture. “We are not seeking to own the data. Some prospective customers have told us that the patient data belongs to them, and that’s fine,” says Errey. “We can establish the service in the hospital and make the cloud a little smaller. Or we can make the cloud larger and incorporate several hospitals.” The possibilities are practically endless.

LifeTouch may well be the first CE-marked medical device living in the cloud, but if the system lives up to its promise, it is going to have a lot of company up there real soon.

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

The technique could provide an alternative to conventional X-ray mammography, a procedure that has been a controversial topic lately. Health experts disagree on when the benefits of routine mammography outweigh the risks, including the radiation from the scan, false positive results and unnecessary treatments such as surgery or chemotherapy.

The device developed by researchers from Netherlands’ University of Twente and Medisch Spectrum Twente Hospital in Oldenzaal does not use ionising radiation. Instead, the technique improves the established technology of photoacoustics (optical mammography), which uses red and infrared light to image tissue and detect tumours. Until now, it has been difficult to target the specific area to be imaged with optical mammography. By combining the technique with ultrasound, researchers were able to achieve better targeting ability.

The PAM device is built into a hospital bed. Laser light scans the patient’s breast. The malignant tissue absorbs more light and the temperature therefore increases, causing a pressure wave that is detected by an ultrasound detector. The photoacoustic signals are processed by the system and reconstructed into images revealing areas of high intensity, indicating tumour tissue.

Further research is needed to develop the device and determine if it could offer an alternative to conventional techniques for detecting breast tumours.

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.