A key issue in the election is the US healthcare reform (The Patient Protection and Affordable Care Act), which most Republicans would like to see repealed. Part of the reform is the medical device tax, a 2.3% excise tax on medical devices. The tax will impact not only US companies but also other companies selling medical devices to US end users. The upcoming election therefore will have a significant impact not only on the medical device industry in the United States, but also on the industry globally.

In the video below, Richard Park, Editor in Chief of IVD Technology, discusses the project. The video is available on YouTube.

This implantable medical sensor can be powered by music.

At the IEEE MEMS conference in Paris this week, Purdue researchers introduced an implantable sensor that can be powered by exposure to music, according to a Purdue press release.

Music within 200-500 Hz causes a cantilever in the device to vibrate.  Strong bass, common in rap music, is especially suitable because of its low frequency sound. When the frequency falls below 200 Hz, the cantilever stops vibrating and electrical charge is transferred to the sensor.

The cantilever beam is made from lead zirconate titanate, or PZT, which is piezoelectric. Traditionally, medical implants are powered by batteries or receive power from coils and an external transmitter. The disadvantages of these methods are that batteries need to be replaced, and powering implants by inductance is difficult because the coils and the external receiver must be lined up and only about a centimeter apart.

The technology is suitable for medical sensors for blood pressure or urine pressure. The measurements can be made quickly and only a few minutes of music each hour would be required for the monitoring.

From the wire:

LAL chromogenic, turbidimetric, and gel clot analyses were performed by an independent ISO-9001 laboratory registered with US FDA and the Drug Enforcement Agency. Multiple lots from three extrusion lines passed each method of testing.

Pyrogens are readily detected by LAL testing systems. The test was accepted by US FDA in 1983 as a standard test for endotoxins, and it later established guidelines for LAL testing of pharmaceuticals and medical devices in 1987. The LAL method is effective for measuring endotoxin levels in production processes, product releases and water systems.

“For many manufacturers, independent testing of vendor tubing is required,” says Andre Noronha, Director, Medical Extrusion, Interface Catheter Solutions. “Our customers count on us for endotoxin-free tubing, which is why we conduct our own rigorous outside testing.”

The implants have a coating that has been linked to a cancer-causing toxin in previous studies, reports the Daily Mail. The implants were approved by a German notified body and launched on the European market in 2004. In 2003, MHRA recommended against introducing the Silimed implants on the market because of the possible carcinogenic risk.

The UK MHRA previously recommended that surgeons don’t use the Silimed implants, but later revised its recommendations, saying that they could be used as long as patients are informed of the risks. The MHRA is now saying that the risk of cancer from the implants is “small,” according to the Daily Mail.

Worries about the Silimed implants, in addition to the Pip implant scandal, could affect the revision of the EU medical devices directive, to be released this spring. NHS Medical Director Bruce Keogh said to the Daily Mail: “If a product has been given a CE mark in another European country, it can be legally sold and used in this country. This is an important issue and that’s why we are feeding into the ongoing review of the EU Medical Devices Directive.”

EPflex’s nitinol-based guidewire systems are designed to provide high flexibility and stability, which enable safer treatment of difficult-to-reach lesions. DSM’s ComfortCoat coating technology is said to improve the performance of the systems by reducing the amount of force needed to pass through stenoses and lesions. Benefits include excellent gliding properties, an extremely soft tip, a torsion stable core and and high flexural strength, according to the company.

Common application areas for the guidewires are urology, cardiology, radiology and gastrology.

Many researchers still frown upon the sharing of results from scientific studies before the publication in a peer-reviewed journal. The publication of a study in one of these journals is still a major milestone and a source of academic credibility and success. I don’t think the peer review process is going away anytime soon—there is not yet a better option to provide vetting and quality control before publication.

However, it is inevitable that scientific journals will see a similar evolution to other media outlets—publishing more content and finding new avenues and revenue models online, incorporating new ways for readers to participate in the process by commenting and contributing and offering a greater variety of options, including different types of subscription models. The comments on the New York Times article offer some creative ideas for new models that can maintain a rigid quality control system in place, while providing greater and faster access to research.

Blog: State of the Union Address Hits Home for Medical Device Manufacturers (MPMN)

Don’t Believe the Hype: Boston Sci Isn’t the Only One Experiencing Shrinkage (Medtech Pulse)

Working Towards Sustainability (PMPNews)

Why 3D Printing Isn’t Like Virtual Reality (Technology Review)

Medical devices: 5 tips for commercialization in China (MedCity News)

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.

Michael Olmsted, an experienced VP of field services for medical device companies, taught me I was comparing apples and oranges. “As a US-based manufacturer, we didn’t compare CE and the FDA but whether your equipment was UL (Underwriters Laboratory) certified and then CE approved to be sold into Europe.” Ben Vonk added, “CE is not a mark (like the UL mark) but rather a marking. So it is better to talk about CE marking a product.”

Medical Device Regulatory Affairs Expert Michael Santalucia squarely answered my question. He opined, “I wouldn’t necessarily state that FDA is better than the EU process – rather it is different based on law and other requirements … As to the question of a marketing use to compare approvals between jurisdictions … it may not be the best practice to state having authorization to market in one or multiple countries is an indicator of quality or performance.” Click to enlarge Michael Santalucia’s opinion:

Leslie Gestautas, an EU notified body, sides with Michael. “Comparing the two systems in an apples-to-apples or which-is-better scenario is a fast road to frustration (this is true outside of MDD and IVD as well – CE doesn’t compare directly to UL for other types of manufacturers, for example). I’m not aware that a marketing claim like the one you came across could get you into “trouble” per se, but as a former entrepreneur myself I think it’s a weak marketing stance, and at worst it broadcasts a clear misunderstanding of the two types of clearance (FDA and CE). I’d want a lot more for my marketing dollar than that! Sounds to me like their regulatory dept. was doing a good job by nixing that approach.”

Uffe Kemnitz promotes high-end ophthalmology products. Uffe wrote, “I have worked with medical devices for many years. My experience is that the FDA at any time will rank higher than the CE marking. Although within the EU must not use the FDA as a standard, many doctors [ask] ‘What does FDA say for this device?’ What I think is ludicrous is you can not agree on creating a common labeling and thus a common set of rules for approval of products for both the EU and the U.S.. It is tremendously expensive to pay for studies at one and the other to the Atlantic. EMEA and FDA on the medical side Santander are often unaware of each other’s results so companies to get access to one or the other market are forced to spend much money on documentation to satisfy the bureaucrats in both institutions. It would be worthwhile to work towards a common label.”

Jean Bigoney prepares 510(k) submissions and HCPCS coding requests for a variety of medical devices. She wrote, “FDA clearance is indeed far more cumbersome than getting the CE mark. I’ve run into several medical device manufacturers and startups in Europe blindsided by the requirements for a 510(k) but also baffled as to how our system works … they usually do not understand the FDA is reactive and not proactive, and only responds to issues pertaining to specific products. So to use the FDA approval process as a marketing argument in Europe could be difficult – your audience may have no idea what the approval process entails.” Jean continued: “Having said that, there may be an opportunity to use the current breast implant scandal to play up the positive side of FDA regulatory authority. Make no mistake, someone determined to substitute inexpensive non-approved materials for costlier approved ones could get away with it in the US, at least for a limited period of time. However I like to think that sooner or later, they would be on the FDA radar. As a matter of fact, in the case of PIP, the FDA inspected the manufacturing site way back in 2000 in connection with a different type of breast implant and as a result sent PIP this warning letter. If the FDA knew way back in 2000 that PIP had GMP manufacturing issues, why didn’t the EU regulatory system pick up on it?

Norbert Sparrow, EMDT Editor-in-Chief, added, “I do believe that the European regulatory system will become stricter, partly to respond to public concerns of device safety in the aftermath of the PIP implants scandal as well as other perceived shortcomings of the “new approach” directives … Will the “Europe first” strategy that many medical device manufacturers have embraced be a casualty?”

The LinkedIn conversation is robust, ongoing, and larger than is practical to summarize here. Click over to the discussion and add your voice.

Special thanks to UBM Canon editor-at-large Brian Buntz for his help with this article.

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Joe Hage is the owner of the largest Medical Devices Group on LinkedIn. His LinkedIn goal is to create the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders. As CEO of Medical Marcom, a medical device marketing consultancy, Joe helps companies become more approachable and engaging so they can generate more qualified leads.

“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

The four partners Medical Cluster, Medtech Switzerland, Siams SA and Messe Luzern AG want to establish the World Medtech Forum Lucerne (WMTF) as an essential gathering of the global medical technology industry. “With the trade fair, congress and meetings concept, we are creating formats that will appeal to visitors from home and abroad and establish the WMTF as an indispensable platform for the industry,” says Peter Biedermann, CEO of Medical Cluster and member of the project development team.

The WMTF concept also supports the objectives of Medtech Switzerland as an export platform. According to the CEO of Medtech Switzerland Patrick Dümmler, Swiss medical technology enjoys a first-rate reputation across the globe. The three-day forum offers Medtech Switzerland an excellent opportunity to invite foreign delegations to Switzerland and connect them with potential customers from all over Switzerland.