Is CE Mark “Good Enough?” LinkedIn Members Weigh In

Over the years, a growing number of medical device companies in the United States have decided to obtain the CE mark for new products before attempting to approve products through FDA. While FDA is not monolithic, many in the industry view the European system as generally more consistent, transparent, and often easier to deal with than FDA’s Office of Device Approvals. And the reason for that thinking is easy to understand: products generally obtain the CE mark much earlier than they do FDA approval.

In late 2010, a somewhat controversial survey titled “FDA Impact on U.S. Medical Technology Innovation” sought to quantify the feeling of medical device professionals in the United States who had experience with product approvals in the United States and Europe. In terms of “overall experience,” the survey found that 75% of respondents rated their regulatory experience in the European Union as “excellent” or “very good.” Only 16% held FDA in such high esteem.

The report was later criticised by Gregory Curfman, MD, executive editor of the New England Journal of Medicine as well as by Howard Bauchner, MD, editor in chief of JAMA.

But the fact remains that many people active in the industry had the opinion that the European regulatory framework was, in a word, better than the US version. In early 2011, Jeffrey Shuren, MD, director of FDA’s CDRH division came to the defense of the US regulatory system, stating that, in the EU, patients are treated as “guinea pigs.”

His remark was widely attacked at the time. But, more recently, there has been growing disapproval of the EU system as a result of the PIP breast implant scandal.

Over on the Medical Devices Group, I asked if a CE mark was ”good enough,” and 67 responses came pouring in within two weeks. I wrote:

As you know, medical devices sold in America require FDA clearance. Is gaining FDA clearance more stringent than obtaining a CE mark?

And a question for regulatory experts in our group: Is it defensible for your sales reps to say to a prospect, “Well, our device has FDA clearance and the competitor only has a CE mark.” The clear inference is that FDA clearance is better, so you should buy my product instead.

See the answers

Posted in medtechinsider | Add Comment 

Why Is the United States Upset Over the Device Levy?

Nick Woods, Director of Hill Woods Medical Media Ltd, has written an editorial for MD+DI. In it, Woods explains that US manufacturers aren’t really arguing the right way to get the device tax repealed.

“The only problem is, chaps, that the legislature is either not listening or it doesn’t believe you. Lobby all you like, but the belief that you’ll get through it with typical American guts and ingenuity will prevail.”

And even if American guts and ingenuity don’t work, he says, getting medical device companies on the market in the United States is still more lucrative than it is in the United Kingdom.

In the United States, we tend to get a little insular. It’s sort of refreshing to get some perspective from the dudes across the pond. (And I’m only calling them dudes because Nick Woods called us chaps. Quid pro quo, Nick)

Heather Thompson

Posted in Regulation | 1 Comment 

Medisiams and World Medtech Forum Lucerne Join Forces

Medisiams, the supplier trade fair from West Switzerland, is going to be integrated into the World Medtech Forum Lucerne held from 25 to 27 September 2012 in Lucerne, Switzerland. This decision was made by the Medical Cluster, Medtech Switzerland, Siams SA and Messe Luzern AG to establish Switzerland as a vital hub for the research, development and production of medtech products. “It is extremely challenging to bring the Swiss medtech industry and, especially, its suppliers to international attention. The resources in the SME-dominated supplier industry are limited,” says Francis Koller, President of Siams SA. By joining the only two Swiss trade fairs that focus solely on medtech, resources can be channeled to create a powerful platform where the entire Swiss supplier industry can present itself to international manufacturers. Read more…

Posted in Trade Shows | Add Comment 

Nano Tech Japan Highlights Life Science Applications

After celebrating its 10th anniversary last year, nano tech 2012 – The 11th International Nanotechnology Exhibition & Conference will take place 15 to 17 February 2012 at the International Exhibition Center Tokyo Big Sight in Japan. After highlighting “green nanotechnologies” in previous years, life science applications of nanotechnology will be added as a new focus of the exhibition. Under the topic of “Life & Green Nanotechnology 10-9 INNOVATION”, nano tech 2012 will especially highlight products and technologies for the medical field, without leaving popular green technologies aside. A special symposium “Life Nanotechnology – Cutting Edge Technology for Health Innovation in an Aging Society” will pick up main developments in this field. Read more…

Posted in Nanotechnology and Microtechnology | 1 Comment 

Russia to Release New Medical Device Regulations

Russia is expected to release new medical device regulations within the next few weeks, writes Stewart Eisenhart, an editor covering regulatory affairs for Emergo Group, in a blog post on the Massdevice website. Eisenhart expects the regulations to be clearer and have more specific requirements than current regulations, for example by providing reporting timelines and requirements for post-approval reporting. One part of the new regulations is expected to cover the clinical trial process, with components such as requirements for ethics committee reviews and patient agreements, Eisenhart writes. Read more…

Posted in Regulation | Add Comment 

Nano Loudspeaker Could Improve MRI Technology

If a theory about detecting extremely faint electrical signals by means of a nanomechanical loudspeaker can be shown to work in experiments, it could result in much simpler MRI procedures, reports Nanowerk News.

A team of physicists from the Joint Quantum Institute and Harvard University in the United States and the Neils Bohr Institute in Denmark has described coupling a nanomechanical membrane to an electrical circuit so that even a very faint electrical signal will cause the membrane to quiver slightly. The signal is then read by bouncing photons off the membrane and measuring the modulation of the reflected light. If the theory holds, it could lead to a significant reduction in the strength and size of MRI magnets.

A paper on the theory is published in Physical Review Letters.

Posted in Nanotechnology and Microtechnology, Research, medtechinsider | Add Comment 

Medilink Launches Medtech Funding Resource

Tony Davis, Chair, Medilink UK

UK medtech business support organisation Medilink has launched a funding and finance leads service for companies operating in the life sciences sector. The service provides subscribing companies with access to a regularly updated database compiling sources that are willing to fund innovation.

“Many firms in the [UK health technology] sector are SMEs, which are finding it incredibly difficult to access funding and loans that are essential to enable innovation and investment,” explains Medilink UK Chair Tony Davis. “The economic reality and failure of banks to lend to entrepreneurial firms, as well as withdrawal of government-funded business support, is making it harder than ever for companies to succeed.” This programme, adds Davis, connects manufacturers with specialist support to increase sales and stimulate innovation.

In addition to the funding tool, Medilink has also developed a complimentary tender and sales leads service.

Posted in Business News, R&D funding, medtechinsider | Add Comment 

MEDDEV Guidelines on Stand-Alone Medical Software Published

The MEDDEV guidelines on stand-alone software have just been published, prompting the question: What does it all mean? We asked lawyer and blogger Erik Vollebregt. He had the answers (and a few more questions). Vollebregt is a partner at Amsterdam-based life sciences boutique law firm Axon Lawyers and maintains the medicaldeviceslegal blog.

Erik Vollebregt

medtechinsider: Can you give us some background on the genesis of this document and why it is needed?

Vollebregt: This MEDDEV basically came about as a result of the movement started by the now-famous report from the Swedish Competent Authority Lakemedelsverket: the “Proposal for guidelines regarding classification of software-based information systems used in health care.” This very useful document published in 2009 addressed issues involving both the classification of software as a medical device and risk management of software in a clinical environment. The report also contained a useful set of examples. COCIR later developed a flow chart that could be used for qualification under the medical device directives.

The current MEDDEV is a version of these two documents drafted by the Medical Device Expert Group minus the part on risk management of software and IT implementation in clinical settings from the Swedish report.

The guidance is needed because stand-alone software is playing an increasingly important role for clinical purposes: there is an app for everything these days. However, the current medical device rules in the European Union were drafted with embedded or pre-installed software in mind. For that reason, it is incredibly important to have guidance on how to deal with this for regulatory purposes. Read more…

Posted in medtechinsider | Add Comment 

UK Spin-Out Company Markets Biomedical Carbon with Unique Properties

Mast Carbon, a manufacturer of synthetic carbon–based specialty materials based in Basingstoke, UK, has established a spin-out company to commercialise biomedical carbon in a joint venture with Second Mile. Named Acesco Health, the spin-out is developing a proprietary range of activated carbon bead products that combine the usual benefits of activated carbon with some specific advantages. Read more…

Posted in Materials, Nanotechnology and Microtechnology, medtechinsider | 1 Comment 

Japan’s Regulatory Agency Goes Back to School

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has entered into a collaboration with Gifu University to promote education and research involving medical technology. Under the agreement, students at Gifu University’s United Graduate School of Drug Discovery and Medical Information Sciences can attend classes taught by PMDA staff and have an opportunity to spend time working at PMDA headquarters and getting an in vivo view of the medical device review process. Read more…

Posted in Industry News, Japan, Medtech World News: Update from Japan, Regulation | Add Comment 

Terahertz Transmitter Developed at TU Darmstadt Shows Promise for Medical Applications

A tiny terahertz (THz) transmitter developed at the Technische Universität Darmstadt Institute for Microwave Technology and Photonics achieves the highest frequency on record for a device of this kind and can operate at room temperature.

Typically used to nondestructively inspect materials, THz transmitters have found limited adoption because of their cost and size. However, researchers at TU Darmstadt have built a resonance tunnel diode that can generate THz electromagnetic radiation using relatively conventional semiconductor manufacturing technologies in a size of less than 1 sq mm. The device has numerous potential applications, including in vivo detection of diseased tissue, according to the researchers.

To learn more about the technology, read the post about the tiny transmitter on the Medtech Pulse blog.

Posted in Electronics, medtechinsider | Add Comment 

T-Ray Imaging Technology Could Lead to Real Version of Star Trek Tricoder Device

The Consumer Electronics Show, taking place in Las Vegas each year, is primarily a showcase of products about to hit the market, but this year Qualcomm made news when it announced a US$10 million competition for the development of a device similar to the Tricoder in Star Trek. The hand-held scanner is used on the show to diagnose medical conditions.

Now researchers from the United Kingdom and Singapore say they have developed a new technology that could result in such a device. The scientists from Imperial College London in the United Kingdom and the Institute of Materials Research and Engineering (IMRE), a research institute of the Agency for Science, Technology and Research (A*STAR) in Singapore, developed a technique that increases the strength and efficiency of T-rays. Read more…

Posted in Imaging, medtechinsider | Add Comment