New data presented by Mauna Kea at DDW showed that needle-based optical biopsies could assist physicians in the diagnosis of pancreatic cystic tumors and help patients with benign cysts avoid unnecessary surgery. “Current imaging and sampling techniques make it difficult to accurately rule out malignant or premalignant pancreatic cystic tumors, so certain patients have to undergo surgery before a diagnosis can be confirmed,” said Marc Giovannini, MD, head of the endoscopy unit at Paoli-Calmettes Institute in Marseille, France. “This can have dramatic implications for these patients, especially when we find out the cyst was benign. This new data show that needle-based optical biopsies may provide the missing information needed to separate high- and low-risk cysts.”

At the event, the company also displayed its AQ-Flex 19 miniprobe, reportedly the first microscope small enough to fit into a 19-gauge needle. The device was cleared by US FDA in April 2013 for real-time optical biopsies during endoscopic ultrasound-guided fine needle aspiration procedures in the digestive tract.

DDW was held in Orlando, FL, USA, from 18 to 21 May. It is described as the largest international gathering of physicians, researchers and academics in gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

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“We have seen evidence that routine exposure to salt water reduces the number of lung infections in CF patients and leads to fewer hospital admissions, but the challenge was to develop an optimal delivery system,” says Dr. Richard Boucher, co-founder and chairman of Parion. “We enlisted Cambridge Consultants to design the system, given its track record of creating world firsts in drug-delivery device development, and the results have exceeded our expectations,” says Boucher, who is quoted in a press release issued by Cambridge Consultants.

Studies have shown that the inhalation of a hypertonic saltwater solution improves the condition of sufferers by rehydrating the layer of mucus film that lines their lungs. Cambridge Consultants conducted human-factor studies and applied its expertise in fluid dynamics to develop a system that could deliver an aerosol mist through the nose continuously for eight hours.

“We immediately recognized the potential of this project to transform the lives of CF patients,” said Matthew Allen, program director at Cambridge Consultants. “The challenge was to build an aerosol nebulizer system that could be comfortably used by patients overnight, with the saline mist travelling down a long cannula to the sleeping patient without forming the large droplets that often occur in a standard nebulizer system. The size of the saline droplets is crucial to the success of the treatment, as they need to be small enough to penetrate deep into the lungs.”

The tPAD (trans-nasal pulmonary aerosol delivery) device has been assessed in a clinical trial, where it greatly exceeded its predicted performance. Additional devices have been requested to support further clinical trials. The aim is to provide an easy and effective treatment system for CF patients that is suitable even for young children and allows the disease to be treated at the earliest possible stages.

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Bio-patch, developed by researchers at KTH in Stockholm and Tampere University of Technology, Finland

Focusing on comfort is important when designing next-generation medical devices, says Yang the press release, adding that the device is designed to be flexible, easy to attach to the skin and comfortable. The battery in the patch is as thin as a sheet of paper. The sensors on the patch are inexpensive so that a patient can throw away the patch after using it, says Yang.

A patient can track his or her own health by transferring the information to a smart phone. The data can also be transferred to the hospital so that a physician can analyse it further.

Wireless technologies was the centre of the conversation at the Wireless Connectivity in Medical Devices conference, taking place in Munich this week. The conference was organised by UBM Canon. Those who were not able to attend the conference can purchase conference presentations online at http://bit.ly/14Ncigo.

By: Camilla Andersson

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 Nanocircuits Flex Tech Muscle

Frugal engineering entered the popular lexicon a few years back after Carlos Ghosn, the head of Renault and Nissan, described it as “achieving more with fewer resources.” Rather than stripping down technologies imported from western economies to make them affordable in the developing world, the idea is to design products that serve the needs of a specific population while avoiding needless costs. The Nano car from Tata Motors is one example. GE Healthcare has been a poster child for this movement in the healthcare space since it launched a low-cost portable electrocardiogram in 2008. Its R&D centre in India plans to roll out 20 new healthcare products this year, according to the Financial Times. In the process, GE Healthcare also discovered a ready market for these low-cost innovations in advanced economies, where healthcare budgets are going under the knife.

It’s about time for this conceptual shift, says Bagla. The notion that you can solve healthcare problems in emerging economies by “stripping down so-called perfect western products to good-enough products is a primitive way of dealing with the needs [of those populations]. Breakthrough innovators in the medical device sector need to think of how to address the needs of 4 billion people rather than the top 1 billion or so by income. This often requires revolutionary design, manufacturing, use models and distribution processes. What could be more exciting and fertile ground for a true innovator?” asks Bagla.

Bagla cites the Lullaby Warmer developed at GE Healthcare’s Bangalore facility as one recent made-in-India success story that transcends national borders. The neonatal bed with an overhead heater “was conceived and manufactured to respond to conditions in India,” says Bagla. “But the device has turned out to be quite popular in modern European hospitals.” The device is not available—tellingly?—in the United States.

Where telemedicine fulfills its promise

In countries such as India with challenging geographies and an underdeveloped healthcare infrastructure, telemedicine may find it easier to gain traction than in the western world. “Inventors in the United States are often stifled by concerns of legal liabilty and restrictions on the practice of medicine across state or national boundaries,” notes Bagla. “But knowledge knows no boundaries and today telemedicine is being embraced in emerging economies.” The technology allows the government to leapfrog the hugely expensive option of building hospitals or having practitioners spend days travelling by allowing healthcare providers to connect with patients remotely. “Eventually, some of the innovations [pioneered in emerging economies] will make it past the thicket of lawyers, regulations and third party processes,” says Bagla.

Access to affordable healthcare is not just a life-or-death issue in emerging economies. As Gopi Katragadda, Managing Director, GE India Technology Center, writes on the Forbes India blog:

“I spent quality time in the recent weeks with a small working group developing an understanding of affordable healthcare. I was surprised to learn that affordable healthcare is a significant problem not only in emerging economies but in the western world, as well. In the United States, as an example, 27% of the population has serious problems paying their medical bills.”

The time is ripe—some might say urgent—to rethink the parameters of medtech innovation. In some respects, we might start by asking, what would India do?

MD&M East in Philadelphia will feature an overview of the global medical technology landscape in terms of compliance and commercialisation as part of its conference programme. Bagla will be among the featured speakers at the session on 19 June 2013. The MD&M East conference runs from 17 to 20 June; the exhibition starts a day later on 18 June.

 Norbert Sparrow

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In the YouTube video below, Lance Nanek demos MedRef, but also says that the team will continue to develop the hack, making it more advanced.

Facial recognition is not officially part of Google Glass right now (Google’s API doesn’t allow it, Technology Review reports), but at the Google I/O, Google encouraged developers to hack Glass by hosting a workshop on how to do so (hacking Google Glass can void the warranty of the glasses). Google Glass hacks are experimental apps that are not officially approved for Google Glass. (Google Glass users trying out facial recognition apps have to consider local privacy laws, and physicians using Google Glass in their work will need to comply with electronic health records laws.)

Google Glass was not at the center of the Google I/O conference this year, although the company announced seven new apps for the device. But Google made several health-related announcements at Google I/O:
- Google Glass CEO Larry Page announced that he is suffering from left vocal cord paralysis, a nerve condition that is affecting his voice. Page also announced he will fund a research program at the Voice Health Institute that will aim to find treatments for vocal cord paralysis.
- Page also discussed the failure of Google Health and said that the resistance from the health insurance industry was one reason Google Health was not successful
- Page said that Google’s future advancements in healthcare will be made in areas with “technological levers” such as DNA sequencing, CNET reported
- CNET spotted Google employees wearing Google Glass devices with prescription frames

By: Camilla Andersson

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Threats from animal activists are so common they might lead to some research shutting down or being moved to countries outside of the European Union, say researchers quoted in the article.

The threats are underreported because scientists fear that discussing the situation will only make it worse. Instead, some researchers say that local police have asked them not to discuss it, and they in turn have asked newspapers not to write about it. Pharmaceutical company Astrazeneca has been a common target, but many other research institutes, including Karolinska Institutet, have also reported threats by phone, mail and in person by activists appearing at their homes.

As a result, companies will soon stop conducting animal experiments on primates in Europe and moving them to other countries, which could mean that the animals will face worse conditions due to less strict local regulations, says Anatomy Professor Brun Ulfhake to Life Science Sweden.

Animal research will continue to be a hotly debated topic until more alternatives evolve. Some recent advances include:

•  Fraunhofer researchers recently reported advances in sensor nanoparticles that could be used to test how cells are affected by different chemicals.
• As tissue engineering advances and engineered tissue becomes more similar to human tissue, it will be more useful for research purposes.
• In vitro irritation and sensitisation testing
• Using zebrafish embryos to screen for toxicity

Have you experienced threats due to your or your company’s involvement in animal testing? Do you think that threats will lead to animal testing being moved outside of Europe? Share your thoughts in the comment field below.

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Phasing out the Lab Rat

As part of his initiative, Abe announced that he intends to launch a Japanese version of the US National Institutes of Health (NIH) to help create advanced medical devices and drugs. A growth strategy, which includes the NIH plan, may be announced as soon as June.

Growth was a theme at this year’s MEDTEC Japan, as well. Held at the Tokyo International Exhibition Centre, the event welcomed 383 exhibitors, of which 167 were newcomers. Exhibitor numbers were up 27% from 2012. More than 13,200 attendees, compared with 10,500 last year, clogged the aisles.

“I can feel that more and more people are interested in expanding their business in the medtech industry,” said Isao Shimosaki, president of Blast Inc., a maker of thermal glass and related products. “I met more potential customers than expected.”

Since its launch in 2009, MEDTEC Japan has shown consistent year-on-year growth, according to show organisers. Smart health, biomedical technology and medical packaging were among six new pavilions introduced this year, bringing a grand total of 10 specialised shows within a show.

Attendees also swarmed the conference sessions and technical forums that addressed such topics as international markets, advances in smart health and biomedical trends.

To accommodate surging exhibitor interest, MEDTEC Japan will extend the show to three days and offer more exhibition space next year. Scheduled for 9 to 11 April 2014 at the same venue, organisers project approximately 500 exhibitors and 16,000 visitors. MEDTEC Japan is produced by UBM Canon, which also maintains this blog.

Japan’s medical technology market, which is valued at approximately €21.5 billion, represents roughly 10% of the global market. It is the third largest medical device market in the world after the United States and the European Union. During the past 25 years, the size of Japan’s medtech market has doubled. While the market share of domestically made devices has been largely flat, imports have soared, creating a medical device trade deficit of €4.6 billion.

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The other winners, who were announced on 15 May at Eurexpo in Lyon, are:

• Centre Technique de la Plasturgie et des Composites (PEP; Belignat, France) for a preloaded injection device used in intraocular implant procedures. Judges praised the the elimination of a process step and improved repeatability. STAAR Surgical (Nidau, Switzerland) expects to bring the device to market in 2014.
• Mecaplast (Monaco) and Comesat (Ustaritz, France), who tied for third place. Mecaplast has developed a single-use urological device that combines “ease of use, patient comfort, reliability and cost effectiveness,” according to the judges. Comesat was singled out for a telemedicine valise. The Futura NG1 adapts aerospace technology to a telemedicine product that integrates multiple medical sensors capable of performing instantaneous diagnostics in remote locations.

Read the complete press release in French. Le communiqué de presse est disponible en français.

MEDTEC France was held at the Eurexpo convention centre in Lyon on 15 and 16 May 2013.

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To get the lay of the land, we spoke with Mike Kreuzer, Executive Director for technical and regulatory matters at UK industry association ABHI and chair of the Eucomed group on UDI; Jeff Secunda, Vice President, Technology and Regulatory Affairs, at US device association AdvaMed; and Dutch lawyer Erik Vollebregt, who opines on all matters medtech on www.medicaldeviceslegal.com.

Kreuzer and Secunda are cautiously optimistic about the prospects for a harmonised US-EU approach to UDI. “There are a number of loose ends, but given the scope of this project, we are relatively satisfied with progress made thus far,” says Kreuzer. Secunda concurs, with the caveat that it’s all theoretical at this stage. “It doesn’t become a reality until the United States and Europe have a regulation on UDI, and then you can really see if harmonisation is successful,” says Secunda. While US FDA has made significant progress on UDI, Europe is a bit of a laggard. The biggest obstacle, at this stage, is the absence of an appropriate database.

Blogging from a conference in Berlin in February 2013, where UDI was a featured topic, Vollebregt colorfully compared the protracted construction of the Eudamed database to Gaudi’s Sagrada Familia cathedral, which is scheduled for completion in 2026, just 144 years after ground was broken.

“There is no UDI component to the current Eudamed database,” says Secunda, and without a functioning database, it’s hard to see how a harmonised form of UDI can work. “The old version of Eudamed is no good,” says Kreuzer. “Even the European Commission will admit to that. They have to develop a new database, and they are not exactly getting on with it.”

In the absence of a functioning pan-European database, it would not be surprising if member states decided to take matters into their own hands. That would be a nightmare, says Vollebregt. To preempt this, the European Commission issued a recommendation last month instructing member states to hew to guidance published by IMDRF should they decide to draft a national UDI system. “By and large, the recommendation is very good,” says Kreuzer, “but it has a shortcoming: the Commisson cannot tell member states not to develop their own UDI or database, because a recommendation is not a law.” The danger is that a member state loses patience and develops its own database, which would lead to fragmentation, the opposite of harmonisation, he adds.

On the ground, countries have to press on, says Vollebregt, so they may develop policy that is supposed to align with IMDRF. The problem, he adds, is that IMDRF has produced little more than a sketchy roadmap that produces more questions than answers.

A proper database with a UDI component must be built, agrees Secunda, but then the issue becomes resources. “Who will maintain it?” he asks. The answer is not simple in times of austerity.

“There is talk of a great database in the cloud,” says Secunda, but that’s a bit of a red herring. “What matters more than where the data resides is how people enter and access the data. It’s more important to ensure that the data is entered identically, whether it’s being done in Germany or France, and that all regulators have the same method of access and can aggregate data appropriately.”

By and large, industry and regulators alike recognise the value of a harmonised UDI system. Kreuzer sees the Transatlantic Trade and Investment Partnership (TTIP) between the European Union and United States as an opportunity to prove its mettle. The EU and US medtech industry, represented by AdvaMed, COCIR, Eucomed, EDMA and MITA, has urged officials to include medtech regulatory convergence, and notably a single UDI process with interoperable databases, in the TTIP negotiations. “UDI would be a big win,” says Kreuzer, within the framework of what would be the single largest free trade agreement in history.

To escape a regionalised, fragmented nightmare, all you have to do is dream big.

Want to know more? UDI and traceability is the theme of a daylong track on 18 June at MD&M East in Philadelphia. Secunda will be among several industry experts addressing US FDA’s proposed UDI rule and its ramifications for industry along with attendant labelling and packaging issues. The MD&M East exhibition and conference celebrates its 30th anniversary at the Pennsylvania Convention Center from 17 to 20 June 2013.

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— Norbert Sparrow

The survey is good news for an industry that has feared that the Pip implant scandal would have the same dramatic effect on the public’s perception of the industry as it had on influencing the new medical device regulations (75% of the people surveyed were from Europe, reports Eucomed.) Early in 2012, French medical association Snitem even issued a press release cautioning that the Pip implant scandal should not be used to tarnish the reputation of the whole industry.

Although the medtech industry’s reputation as a whole improved last year, it did decline in certain areas. Respondents found that companies are showing less integrity, less transparency and less ability to manage negative product news. The full report, which is available for a fee, also details rankings of 30 medtech companies. Coloplast is the most reputable medical device company from a patient perspective, the report found.

PatientView is a UK-based research, publishing and consultancy group created to support the patient movement and emphasise the importance of patient views in healthcare decisions.

By: Camilla Andersson

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