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Laser Ablation Machine Handles Surfaces with Arbitrary Geometry

Russia Plans to Release New Medical Device Regulations

Impending new medical device regulations in Russia are expected to make the regulatory system more streamlined. The regulations are expected to be released in the next few weeks. A blog post on medtechinsider details the expected changes in more detail.

One of the reasons Russia is changing its regulatory system is to make it easier for medtech manufacturers to export their products, said Sergey Tsyb, head of Department of Chemical Industries and Bioengineering Technologies within Russia’s Ministry of Industry and Trade, in an interview with EMDT Editor in Chief Norbert Sparrow last November. Medical device registration in Russia is challenging, especially for foreign companies, and you can't easily get answers by picking up the phone. According to the Emergo Group, representatives for the Federal Service for Control over Healthcare and Social Development, which oversees medical devices, prefer to do business in person and in Russian.

Camilla Andersson

Is 2.3% Sales Tax Really Too Much Headwind for US Medtech? Observations from Across the Pond

NIck Woods, Hill Woods Medical Media
Nick Woods was a founding partner of Atlantech Medical Devices Ltd, until recently CEO of Tissuemed Ltd and now director of Hill Woods Medical Media Ltd and Editor of European Medical Device News Site, medlatest.com.

I’ve admired the U.S. medical device industry for 26 years now, from the perspective of being part of it and being an observer of it. I’ve attended congresses and marvelled at the sheer scale of the thing. I mean look at it... AAOS next month will again be a gigantic showcase of everything orthopaedic and goodness knows how many thousands of orthopods and industry staff will be there... 26,000, 27,000?

And then there’s the innovation. Whether from universities, the minds of medical professionals, or company R&D staff, ideas turn to reality with breathtaking frequency compared with the rest of the world. Why so? Well, again it’s scale: The market size and willingness to embrace the latest and greatest (market forces and all that), making ideas that wouldn’t stand a chance in for example UK, appealing to an investor community seeking the next big thing.

The result: expensive sales teams getting paid more than their overseas counterparts for selling more devices than their overseas counterparts in what looks to some like a land of milk and honey. It’s all about one word: “incentive.” And until recently, incentive has been big enough for companies to do all this stuff and even make it worthwhile to embark on the painful FDA approval process because of the promise approval brings.

But now, things seem to be changing. I witnessed Bill Clinton’s speech at Advamed 2009, during which he referred to the U.S. healthcare system as being an “unsustainable drag on the US economy.”

Leap forward two years and we have the embodiment of what he was warning us about... 2074 pages of PPACA, summarised for medtech as a number—2.3%—the sales tax on medical devices.

And industry is on a mission to have the act repealed, because it appears to be the cause of all its ills. Tell me if I’m wrong, but medtech’s position looks something like this: Why penalise a successful industry to this extent? The result will be 43,000 lost jobs, less innovation, and higher priced goods.

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 that might be right... this could be good old fashioned Darwinism at work, industry’s gripe being that the comet that hit the earth was self-inflicted this time around.

From over the pond, messages appear to be getting mixed up. One minute it’s: “U.S. companies are going overseas because of the 2.3% levy” (not that company location is going to make a difference to the levy... if you sell in the U.S. you’re “in”, whether your stuff is made in Birmingham Alabama or Birmingham UK).

The first reason for locating overseas seems to be that many big companies are openly stating that U.S. sales growth is slower than elsewhere and downward price pressure is exacerbating the effect. Why, if an overseas government offers you an inducement to build a shiny new factory right where your new market growth is projected to come from, wouldn’t you take it?

Reason number 2: FDA. Another barrier to US domestic progress and explanation for sales coming increasingly from non-U.S. markets is the burdensome, expensive, and slow FDA process, meaning you can start to generate revenue from your new widget more quickly overseas than you can in USA.  

The levy will adversely affect already weak investor sentiment.

So, there we have it. Two reasons to expatriate at least some of your company and neither of them are directly related to a year-away provision of a tax.

What does seem to make sense to me at least, is the argument that the levy will adversely affect already weak investor sentiment. If the tax really equates to a 15% tax on profit, then the time to gain a return on investment is no doubt extended. If I was lobbying, this would be my starting point, especially when I listen to the State of the Union Address and hear so much about encouraging innovation (and no mention of this act at all).  

My business, in fact my passion, lies in trying to help medical technology to find its way into non-U.S. markets. It’s my conviction that U.S. medtech is, as a rule, generally under-communicative with its medical professional target audience outside USA, to the extent that it’s no real wonder that  the UK NHS is known as the western world’s slowest adopter of new technology. That just sounds like an underexploited opportunity to me that might need to jump up the priority list if you’re really to deal with this domestic headwind. Come and have some of ours. But believe me when I say you still would not prefer the situation over here. DRG systems in some of our biggest markets like Germany do not favour healthcare economic arguments, reps being met every day by; “a new product must replace something else, be better und cheaper!” In UK it’s usually a matter of “no new products” embargoes, which may sound utterly crazy, but is the budget holder’s first response when faced with your shiny new widget.  

Back to U.S. medtech’s plight then. Are there better, more targeted ways of saving $20 million over ten years? I notice measures like the additional levy on elective cosmetic surgery procedures, and think that seems like a smart move. But it has already been rescinded in New Jersey. And someone’s going to have to get creative about a hit list much bigger than that.
Alternatively, now that there is an incentive to pay executives and reps less or trim your distributors’ margins, why not do it? Surely that’s a better idea than mass redundancies, yet I’ve not seen it mooted anywhere. 

Even after everything we’ve considered here about why U.S. may be a better place to be than UK on many counts, even in today’s straitened times and with the tough prevailing investment landscape and even in the face of a 2.3% sales tax levy. Where would I, given the choice, pitch my medtech newco tent? It might not be as rosy as it once was, but it’s not exactly Hades.

—Nick Woods
 

Opening Up Innovation in Medtech

light bulb
Image from Flickr user Matthew Wynn

“But the concept of open innovation had not really hit the life sciences or medtech industries until recently,” says Peter von Dyck, chairman and CEO of E-Zassi. “Now, open innovation is a big deal, and everyone wants to embrace it as a better way to find new products,” he says. “Obviously, no one company, no matter how big it is, can innovate everything in their area of expertise. So it really makes sense to look outside.”

Many medical device companies—especially large ones—have embraced this thinking and have acknowledged the need to either attract outside ideas or actively seek them out. Internal product development can be risky and costly.

Peter von Dyck

Despite cuts made to many companies’ R&D budgets during the recession, there is, of course, still a lot of groundbreaking research of interest to medical device companies. “We have the NIH funding tons of research in the United States and a lot of other foreign countries are doing the same,” von Dyck explains. “You have universities and hospitals and doctors around the world innovating constantly. And so there is a lot of innovation flow that can offset medtech companies’ R&D costs,” he adds. “Companies should find ideas that are synergistic with their portfolio and areas of focus.”

In many cases, it is much more economical to introduce new product ideas that have been developed to a certain degree of maturity by other parties. “This way, you can get going much faster and can defer a lot of costs.”

NDAs Impact on Medtech R&D

For medical device companies that largely rely on developing new product ideas in house, non-disclosure agreements (NDAs) are fairly straightforward. “In this case, you don’t have an issue because your intellectual property is coming from your employees, von Dyck says. “That’s already captured and you already own it by virtue of their employment agreements.”

“Obviously, no one company, no matter how big it is, can innovate everything in their area of expertise. So it really makes sense to look outside.”

But if a company is obtaining new product ideas from the outside—that is, if the firm is embracing an open innovation methodology—disclosure and over-disclosure are especially important. “They are a big deal for both parties—the one that has the idea and the one who wants the idea. The U.S. patent system is now based on the fact that, when you have a new idea, now you have to be the first to file a patent on that idea,” von Dyck says. “And you cannot disclose it to any outside party without a non-disclosure agreement. If you do, you could lose your ability to gain patent protection on that idea ever again.”

For that reason, disclosure and over-disclosure are a big concern for the medtech innovator in particular and for parties that employ innovators such as research hospitals and small companies. NDAs are a big deal for larger firms as well because, as an established entity, they attract lots of outside ideas. “Larger companies are usually pursued by people with ideas. Now if that larger company looks at ideas and looks at confidential matter, they could have legal exposure,” von Dyck says. “And if they sign a non-disclosure agreement in order to look at the outside idea, it could limit their freedom to operate. That means if they sign, say, 10, 20, or 30 non-disclosure agreements in an area they focus on, let’s say respiratory, they are going to limiting their freedom to operate in those areas where they agreed not to compete or not to share information, et cetera,” he explains. “So this disclosure issue is a big deal for both parties—the innovator and for the company looking to secure the next big idea.” 

—Brian Buntz

Related Content:

Nano Loudspeakers May Enable Compact, Patient-Friendly MRIs

A collaborative project between physicists from the Joint Quantum Institute (JQI; College Park, MD), the Neils Bohr Institute (Copenhagen, Denmark) and Harvard University (Cambridge, MA) has yielded a theoretical nanosized speaker-like technology capable of detecting weak electrical signals. These nano loudspeakers, if realized, could someday enable more patient-friendly MRI machines.

NIST Nano Loudspeaker
Researchers have developed a theoretical nano loudspeaker that could lead to improved MRI machines. Image: Taylor/NIST

"We envision coupling a nanomechanical membrane to an electrical circuit so that an electrical signal, even if exceedingly faint, will cause the membrane to quiver slightly as a function of the strength of that signal," explains Jake Taylor, a JQI physicist. "We can then bounce photons from a laser off that membrane and read the signal by measuring the modulation of the reflected light as it is shifted by the motion of the membrane. This leads to a change in the wavelength of the light."

This ability to amplify weak electrical signals using nano loudspeakers could ultimately contribute to the development of more-compact MRI machines that are less intimidating to patients than current models. "MRI machines are so big because they are stuffed with really powerful superconducting magnets. But if we can reduce the strength of the signals we need for a reading, we can reduce the strength--and the size--of the magnets," Taylor says. "This may mean that one could get an MRI while sitting quietly in a room and forgo the tube."

In addition to detecting faint electrical signals, the nano loudspeakers will also feature the ability to cool electrical circuits. The researchers believe that the task of translating the mechanical motion of the nanomechanical membrane into photons will result in the transport of a significant amount of heat out of the system. This cooling capability, they note, will reduce noise in the system and enhance signal detection.

While the theoretical tiny speaker has a lot of potential, the researchers must first prove that their theory is viable through experiments.

Accuracy Apples and Accuracy Peaches—What Does that Vendor Quote Really Mean?

Accuracy Apples and Accuracy Peaches—What Does that Vendor Quote Really Mean?


Image courtesy of Flickr user ultramega.

Sounds good, doesn’t it?  But you have to know that what you are being quoted is the accuracy of the transducer and not the accuracy of the entire leak test system. A transducer is simply taking an electrical signal and processing that signal from analog to digital and a clear value that we humans can look at. In any analog-to-digital conversion there are always noise factors that come into play. The speed at which you are testing, cycle times and the time you allow for stabilization also comes to bear on your ultimate measurement accuracy.

You can have the most sensitive and accurate transducer in the world but still come up with questionable accuracies in your measurements because of these inherent noise factors. Some leak test instruments with less thoughtful design have PC board layouts that tend to amplify noise—or rather, mitigate against your ability to control it. If tests are then also configured with inadequate fill and stabilization times that very fine sensor your leak test instrumentation uses won’t matter much.

There’s the accuracy of a sensor—let’s call that the accuracy apple. Then there’s the accuracy of the entire test system—let’s call that the accuracy peach. If you try to mix up the two the laws of physics will correct you every time.   

 
Putska (pictured on the left) is a medical device leak testing technical support manager for Uson, which first developed high accuracy leak testing methods for NASA, and since 1963 has specialized in leak detection, leak testing, and non-destructive testing for the medical device and medical packaging industries, among others. Putska works with medical device companies throughout North and Central America and has worked with Uson in various technical capacities since 1980.
 

 Image derived from Flickr user opensourceway

Medical Design Excellence Awards Extended

Medical Design Excellence Awards Extended

Medical Design Excellence Awards 15th AnniversaryThe Medical Design Excellence Awards (MDEA) program is extending the deadline until February 8, 2012.
 
Our goal is to reward the highest caliber medical devices on the market today. You can find out more about our criteria for submission at http://www.mdea.com
 
The MDEA is the only design completion that considers clinical excellence on par with design and usability. It is unique among its class. Winners of the MDEAs demonstrate benefits to patients, and to the overall healthcare system, in addition to employing state-of-the-art design technology, human factors.
 
After the jury selects finalists, winners are announced at a ceremony in conjunction with MD&M East mdmeast.com.
 
We sincerely hope that you will submit your company’s products to the MDEA competition, and help us continue the program’s record of excellence in recognizing groundbreaking innovations in the fields of medical device and diagnostic products.
 

I appreciate the innovation and creativity that is frequently seen in the submissions to the MDEA. Seeing advancements, clever designs that are both functional and elegant, even for simple, but very important applications is reassuring and encouraging for the medical devices and the industry that produces these devices.”

—Craig M. Jackson, PhD, 2012 MDEA Jury Member
For additional information go to www.mdea.com
Or email us at [email protected]
 
 

Past and Present Jurors on the Importance of MDEA

“The MDEA represents a team of dedicated professionals who in an unbiased fashion attempt to reward the beauty, utility, and relevance of a broad swath of technologies designed to support humankind. I appreciate partnering with a team and an organization that makes an effort to reward organizations for developing technologies that truly impact society. Ranging from innovative toothbrushes to the most complex surgical instruments, the participating companies showcase the very best that they have to offer, and we are genuinely the award winners, because at the end of the day, we are also the end users of these impactful technologies.”
Eliot Lazar, MD, ElCon Medical, Jury Member 2013
 
“One thing that's special about the MEDA is that the jury contains clinicians, which means users of the products, and technical folks who can intelligently evaluate the entries from a technical point of view. This contrasts with the product design awards in the industrial design world. The value of the MDEA approach was brought home to me the year I was on both IDSA's IDEA Jury and the MDEA Jury. We gave a gold award to a particular product in the medical category for the IDEA awards and when it came up in MDEA, all the clinicians starting laughing because it didn't actually work properly (ouch).”
Stephen B. Wilcox, PhD, FIDSA Design Science Consulting Inc., MDEA Jury Chair, 2012.
 
“The MDEAs bring welcome recognition to those within the medical device industry who aspire to design excellence; excellence measure in ways that goes well beyond styling and focuses on functionality, usability, and practicality. It is enjoyable to watch designers and engineers receive their awards at UBM Canon's MD&M East tradeshow. You can see the sense of fulfillment on their faces as they accept an award that after 15 annual competitions has considerable gravitas. You have to assume that the award will further motivate them and their employers to pursue excellence in their future development efforts as well. Of course, the ultimate beneficiary is the public and healthcare professionals who benefit from the introduction of high-quality devices to the marketplace.”
Michael E. Wiklund, PE, CHFP, Wiklund Research & Design, MDEA Jury Chair, 2007.
 
—Heather Thompson

User Fees Debate Heats Up as Democrats Request Hearings on Surgical Mesh, Lap-Band

Several House Democrats have taken off their gloves in the escalating partisan fight over reauthorization of the Medical Device User Fees Act (MDUFA). Democratic representatives Henry A. Waxman (CA), Diana DeGette (CO), and John D. Dingell (MI) sent a letter recently requesting hearings to examine dangerous medical devices to Republican leaders Fred Upton, Cliff Stearns, and Joseph Pitts, chairmen of the Committee on Energy and Commerce, Subcommittee on Health, and the Subcommittee on Oversight and Investigations, respectively. Although the hearing request singles out surgical mesh for pelvic prolapse and the weight-loss Lap-Band device, it represents a larger divide on Capitol Hill regarding conflicting views of the current medical device regulatory approval process and environment.

Following on the heels of a similar request in October for hearings on controversial brain stents and metal-on-metal hip implants, this letter questions the efficacy of existing medical device regulation and whether FDA has sufficiently ensured patient safety. "The Committee has failed to schedule the hearing we requested in our October 12 letter, and we remain concerned that the Committee's previous hearings on medical devices have presented a skewed and inaccurate picture of the importance of appropriate medical device regulation," the letter states. "We hope you will reconsider your approach so that the Committee can have a fuller understanding of these critical issues as we prepare to reauthorize the Medical Device User Fees Act."

A fuller understanding, according to the authors, can be gained through such information as the safety of medical devices currently on the market, marketing tactics employed for these devices, and the relation between these marketing strategies and increased risk. "The Committee's reauthorization of the Medical Device User Fee Act is an important opportunity to improve the efficiency of the FDA's review process while, at the same time, strengthening assurances of safety and efficacy," the letter concludes. "Obtaining information about devices like the Lap-Band and intravaginal mesh will be critical to informing members of the Committee on an issue that has this far been absent from the Committee's record."

The current MDUFA II expires on September 30.

AdvaMed 2012: Do you have a Panel Topic?

AdvaMed 2012: The MedTech Conference has opened the call for program panel proposals for its event held at the Boston Convention & Exhibition Center in Boston, Mass., October 1-3, 2012.

The AdvaMed 2012 conference will feature an expanded eHealth and Health IT track, extended company presentations, a CEOs Unplugged Super Session on the exhibit hall floor, and a special “Salute to Massachusetts” closing reception. The educational program will consist of 11 tracks containing a series of 75-minute panels addressing industry advancements and challenges. Program track topics include: In Vitro Diagnostics, Key Health Policies, Business Development & Finance, Compliance Best Practices, Emerging Growth Company Issues, Executive Workshops, eHealth & Health IT, Legal, Quality,


AdvaMed 2012 encourages prospective organizers to submit panels that are novel, timely, relevant and valuable in educational content, impart helpful lessons learned, or share proven best practices and have a global appeal. All panel proposals should include a working title and a suggested list of senior global industry and policy experts as panelists. Executive Workshop submissions should feature interactivity and may be tutorial in nature.

The application deadline is March 16, 2012.
 

European Commission Publishes Guidance on Stand-Alone Medical Software

The much-anticipated (and unbelievably wordy) "MEDDEV 2.1/6: Guidelines on the Qualification and Classification of Stand-Alone Software Used in Healthcare within the Regulatory Framework of Medical Devices" has just been published. Guidance has been sorely needed by industry, as stand-alone software plays an increasingly important role for clinical purposes. As Erik Vollebregt, a Dutch lawyer specialising in the life sciences, remarks: "There is an app for everything these days." How this software meshes with EU medical device regulations that were drafted with embedded or pre-installed software in mind has been a dilemma for manufacturers. This document, although not legally binding, will set some parameters that are expected to be followed within the member states of the European Union.

In a blog post on medtechinsider, Vollebregt takes a first stab at dissecting the document, which is written in that curious eurospeak that sometimes defies comprehension. His overall impression? "It basically provides a frame of reference for stand-alone software under the three medical device directives, which is important for compliance purposes. Many companies don’t know how to comply because they are coming from a software background and are new to medical device regulations."

If that describes you and you market products in the European Union, make it a point to read "MEDDEV Guidelines on Stand-Alone Medical Software."

Norbert Sparrow