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Articles from 2014 In October

Why Google Wants to Put Nanoparticles in Your Body

Google has infiltrated so much of our lives; now it wants to get inside our bodies, via disease-detecting nanoparticles.

The tech giant has announced its ambitious project to develop nanoparticles that would be coated with a disease-detecting substance and possibly packed into a pill, according to a report in the Wall Street Journal. 

5 Ways Google Could Transform Medtech, and Maybe Cheat Death

Google Glass surgery Philips

Google's cofounders may have once downplayed that they're interested in turning the tech giant into a healthcare company. But their company sure hasn't been acting that way lately. Here are five recent Google efforts worth keeping an eye on.

The nanoparticles, which would be one-thousandth the size of a red blood cell, would circulate throughout the body, hunting for and attaching themselves to cells, protein particles, or other molecules that indicate the presence of a disease, such as cancer. Google is also working on a wearable device that would magnetically attract and count the particles.

Dr. Andrew Conrad, who leads the Life Sciences team at the Google X research lab, announced the project at The Wall Street Journal's WSJD Live conference.

Google X has drawn 100 employees from its astrophysics, chemistry, and electrical engineering staff to work on the nanoparticle project, and predicted the disease-seeking probes would be available within five years, according to the Journal report.

The nanoparticle project is the latest in a series of health-related initiatives that Google has announced in recent months. One would measure the blood sugar levels of diabetics through a contact lens.

Qmed has also reported that Google has been working with Alcon, a branch of Novartis, on developing contact lenses to help people living with presbyopia to read without glasses.

Surgeons have also begun to use Google Glass to assist in surgery.

Conrad predicted that Google X's nanoparticle project would allow patients to skip medical office visits for testing.

If pulled off, it could be a pretty disruptive innovation.

Contact lenses are one thing, worn atop the eye, and removable by the user. Small armies of magnetized nanoparticles circulating inside the body are quite another.

The project has raised several sets of eyebrows about the challenges behind such an endeavor. They include the number of nanoparticles that would be needed; how to develop a viable coating that would attach itself to different types of cells; a potentially difficult and lengthy regulatory process, particularly if it involves pills; the size of the wearable device; its unobtrusiveness; and need for recharging, the Journal reported.

And that doesn't even cover the privacy issues around such a project.

Refresh your medical device industry knowledge at BIOMEDevice San Jose, December 3-4, 2014.

Nancy Crotti is a contributor to Qmed and MPMN.

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3 Questions You Should Ask about Surface Coatings

Biocoat Inc. (Horsham, PA) plays an important role in the medical device industry with its Hydak-brand immobilized hyaluronan coatings technology, which can be applied on most commonly used polymers and metals using a relatively simple process using conventional coating equipment and curing ovens. 

Keith Edwards Biocoat
Biocoat president and CEO Keith Edwards during his Wednesday presentation at MD&M Minneapolis

"We are strictly there for those clients that want lubricity, and they want to be able to pull in and out. They want to go into the femoral artery, snatch out an embolism and pull it right out," Biocoat president and CEO Keith Edwards said after a Wednesday talk at MD&M Minneapolis

When that is the need, there are generally two types of coatings to turn to: polyvinylpyrrolidone (PVP) and hyaluronic acid (HA).

Edwards has explained to Qmed before that most medical device coatings available today are based on PVP, a well-known biocompatible material with a long, established history as a blood substitute and blood thinner. Moreover, it's known to be biocompatible. PVP's chemistry makes it behave somewhat like soap.

HA-based coatings, on the other hand, form more of a hydrogel-type surface. This material is a long-chain polysaccharide that traps water and hence makes a very durable, pliable coating offering advantages in certain cases.

Here are three things Edwards thinks device designers should consider when deciding between the two coatings:

1. What do you need the coating to do?

Edwards says it is important to put into design inputs all of the parameters around what you want to see out of a coating, including lubricity and durability to hold up over whatever number of passes are needed with the device.

"Simple lubricity can be accomplished by both; more demanding applications may indicate a hydrogel is appropriate," Edwards says.

2. What is the pH of your test media?

"Buffered Saline is ideal as it mimics blood," Edwards says. "If you have DI water as a test media the pH is important as either too acid or basic solutions will give false readings for HA based coating performance."

3. What kind of sterilization are you using?

"Most coatings do not survive gamma or e-beam," Edwards says. "If you choose this method of sterilization, specify a coating that can demonstrate performance following sterilization."

Refresh your medical device industry knowledge at BIOMEDevice San Jose, December 3-4, 2014.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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Small Device Maker Fights FDA on ‘Grandfather’ Claim

Small Device Maker Fights FDA on ‘Grandfather’ Claim

By Jim Dickinson

Is there such a thing as a “grandfathered” medical device? The term means a device that was on the market before the 1976 Medical Device Amendments and therefore presumptively exempt from that law’s approval or clearance requirements.

FDA holds, as it has successfully done in the case of “grandfathered” (pre-1962) drugs, that there is no such thing.

Now, in contradiction comes Newark, NJ-based Pharmaceutical Innovations Inc. (PI), manufacturer of FDA-unapproved accessory gels for use with ultrasound and other devices. By pure coincidence, perhaps, New Jersey was the main legal battleground on which FDA won its victories against purportedly “grandfathered” generic drugs in the 1980s.

In October, PI announced that it is contesting an FDA complaint for permanent injunction in New Jersey federal court, arguing that its unapproved, uncleared, pre-1976 gel products are “grandfathered” and thus largely out of FDA’s regulatory reach.

In a brief press statement, PI complained that for more than two years FDA has refused to provide documents it needs to fully investigate and respond to agency allegations about PI gels that, after an unexplained two-month FDA delay, were seized by U.S. marshals for alleged contamination.

FDA said at the time that its lab analyses had found Pseudomonas aeruginosa and Klebsiella oxytoca in the gels after receiving a report that 16 surgical patients had been infected at a Michigan hospital. PI recalled four lots of the affected gel.

PI’s statement said that this incident was “the only report about contamination to date” after more than 40 years of manufacturing and safe use both domestically and internationally, and that it came from Beaumont Hospital in Royal Oak, “where its hospital personnel misused the PI Other Sonic nonsterile topical gel during procedures in which patient sterility was essential. Even though PI gels are not intended for internal use, the PI Sterile Ultra Phonic gel was also available, and there has NEVER been any report of any contamination of PI sterile gels.”

While PI acknowledges that it has not obtained PMA approval for its gels because they are grandfathered, it does say it has maintained registration and listing since entering the market.

FDA’s complaint, however, asserts that the gels are not grandfathered because PI has “failed to demonstrate that these exact devices were introduced into interstate commerce prior to May 28, 1976, or that these devices have not been significantly changed or modified from” devices PI distributed before that date.

The complaint gives four examples of PI devices that FDA says were changed or modified in ways that “could significantly affect the safety and effectiveness of the devices.”

The complaint also cites four FDA inspections at PI since 2011, including a five-page warning letter from July 29, 2011, that describes nine alleged CGMP violations found by investigators and calls company responses to all of them “not adequate.” According to legal counsel Larry R. Pilot, all these issues remain unresolved.

PI’s press statement says it “regrets the conduct of the government and its employees. It disagrees with the various allegations by the government, which it believes to be unsupportable and reckless. PI will answer the allegations to the complaint, and it intends to support its innocence through the judicial process.”

Jim Dickinson is MD+DI's contributing editor. 

[image courtesy of TOA55/FREEDIGITALPHOTOS.NET]

Medtronic-Covidien Deal to Close in Early 2015 As New Details Emerge

Medtronic-Covidien Deal to Close in Early 2015 As New Details Emerge

Medtronic's purchase of Ireland-based Covidien will now be completed in early 2015, according to new documents filed with the Securities & Exchange Commission. That updates a timeline that previously put the range at later this year to early next.

In a message to employees, Medtronic CEO Omar Ishrak, also highlighted how the company's businesses will be structured into four businesses and four regions.

The four businesses include Medtronic's existing three businesses - Cardiac and Vascular Group, valued at $8.8 billion; Restorative Therapies Group worth %6.5 billion and Diabetes Group, $1.7 billion - and the Covidien Group, valued at $10.4 billion. They will be led by the Medtronic group presidents heading them currently and Covidien's Bryan Hanson respectively.

After the close of the transaction, the Covidien Group will function as before with the exception of its Peripheral and Neurovascular businesses. The peripheral vascular business will be integrated into Medtronic's Aortic and Peripherals business, under the broader Cardiac and Vascular Group. 

And Covidien's Neurovascular business will function as an independent business under the umbrella of Medtronic's Restorative Therapies Group.

Ishrak also announced four geographic regions around which the combined company will operate - Asia Pacific, the Americas, EMEA and Greater China - down from Medtronic's seven regions currently.

"While we will move to four regions in the future — versus the seven regions represented in the Medtronic structure today — this is in no way intended to reflect a diminished importance or focus on those markets that previously served as regions, nor will I remain any less focused on seeing that these markets reach their potential and objectives," Ishrak assured. "Rather, this approach will ensure we have the appropriate leadership involvement in these markets on a daily basis as we grow our overall scale and complexity."

The Asia Pacific region will comprise India, Australia/New Zealand, Korea and Southeast Asia. This region will be organized under Bob White, who currently leads Covidien’s Emerging Markets business. White's new title upon close of the deal will be , senior vice president and president of Medtronic Asia Pacific.

Canada, Latin America and the United States make up the new Americas region, which will be led by Mike Genau, Medtronic's current SVP and President of its U.S. region, Genau will become senior vice president and president of the Americas Region upon close.

As the name suggests, EMEA will be made up of Europe, the Middle East and Africa. This region will largely remain the same as Medtronic’s existing structure, with the exception of Canada moving to the Americas region. Rob ten Hoedt, our current EMEAC leader, will serve as Executive Vice President and President of EMEA upon close.

Recognizing the immense growth potential that China promises, as well as the incredible complexity and its size, Medtronc will continue to maintain the based on the Greater China region as a standalone region. Chris Lee, current president of Medtronic Greater China, will become senior vice president and president of the combined Greater China region upon close. 

 [Photo Credit: user Cimmerian]

-- By Arundhati Parmar, Senior Editor, MD+DI

How a Prevalidated Rigid Packaging System May Cut Costs, Save Time

The BargerVPAK is a prevalidated, off-the-shelf packaging solution.

After kicking around the notion of launching an off-the-shelf rigid packaging system for some time, Elkhart, IN-based Barger, which specializes in custom medical packaging solutions, finally pulled the trigger. Upon custom-designing the sterile packaging system for a client, Barger realized its broader potential as a prevalidated stock system for spinal and extremities implants. And the BargerVPAK was born.

"In our market, the fact that it's a rigid system that's ready to go is uncommon," Mike Nielsen, national sales manager for Barger, said during an interview at MD&M Minneapolis this week. 

Validated to ISO 11607 standards, the double sterile barrier stock packaging system consists of inner and outer rigid thermoformed PETG trays. The system also features inner and outer die-cut lids, a primary carton, and the company's BargerGard-branded protective liner. BargerGard is a puncture- and abrasion-resistant polyurethane material that is die-cut into a liner to protect the sterile barrier and medical devices contained in the packaging system.

Ultimately, the sterile, rigid, off-the-shelf packaging system is designed to reduce the time, money, and risk associated with getting new medical products to market, according to Nielsen. He noted that between getting validated and building tooling, developing a custom packaging solution in six months is not uncommon; the BargerVPAK can dramatically reduce that burden, however.

"In Europe, because of regulations, more product is being sold sterile than ever before," Nielsen said. "There are also a lot of startups that don't have the know-how in terms of packaging engineering talent or the capital to buy six different tools that this project required. So, with this product, they can get to market without a lot of help or capital."

Shana Leonard is group editorial director, medical content, at UBM Canon.

For additional information on and conversation about novel packaging solutions, visit the Medical Packaging Community.

Microsoft Band Beats Apple Watch to Market—and It's Cheaper Too

Microsoft Band Beats Apple Watch to Market—and It's Cheaper Too

Microsoft Band is smaller, cheaper, and more interoperable than the Apple Watch, and consumers will be able to get their hands on the device, which launched today in the United States, at least two months earlier. 

Microsoft Band packs 10 sensors into an 18.5-mm band that—although it does tell time—looks less like a traditional timepiece than competing smartwatches and more like fitness trackers such as the Nike+ Fuelband SE and Samsung Gear Fit. Available for $199, the device costs around $150 less than the Apple Watch will when it makes its debut early next year, and it can also work with Windows Phone devices as well as those running iOS and Android operating systems, something the Apple Watch can't do.

In addition to providing productivity tools such as e-mail, text, and calendar alerts, the wrist-worn device can monitor heart rate continuously as well as track calories burned, sleep quality, and steps, plus provide GPS runmapping.

Microsoft Band is backed by the new Microsoft Health security-enhanced cloud platform—the company’s answer to Apple’s HealthKit and Google Fit. The open platform can store and analyze data from disparate health and fitness devices, such as UP by Jawbone, and services including MapMyFitness, MyFitnessPal, and RunKeeper. It can also “learn” from the metrics it captures to suggest custom workout plans. Examples of insights Microsoft Health can provide include fitness performance relative to work schedule and which exercises burned the most calories during a workout, according to the company. 

Soon, Microsoft hopes to enable data from Microsoft Health to be shared with healthcare providers via its HealthVault online health data portal.

“We plan to have a regular cadence of Microsoft Health announcements including additional device and service partnerships, SDK availability, and additional cross-platform applications and services,” Microsoft corporate vice president Todd Holmdahl wrote in a blog on the company’s Web site.

Joe Belfiore, corporate vice president of Microsoft's operating systems group, tweeted that the Microsoft Band is not yet open to third-party developers but that the company is working on that for the future, although he said he didn’t know when it might happen. 

Reaction to the device has so far been largely positive.

Though PCWorld senior editor March Hachman wrote that the device looks "as much like a hospital bracelet as anything else" and has similar features to other fitness bands and smartwatches, he also noted that it promises up to 48 hours of battery life (less if you're running GPS), comes in three sizes to fitt different wrists, and is available now.

On the Web site Reddit, user AgentBole commented that the Microsoft Band is a departure from other smartwatches.

“Everybody else is just trying to make it basically like a watch with social and internet features. But this thing went light on that a bit, but instead doubled down on fitness sensors and capabilities. Its also gives up on big screen for more battery power, and its completely multiplatform,” the user wrote. “I'm still not completely sold on this thing, but props for innovation and attempting something else then the rest of the pack.”

Twitter user Eric Lamy (@ewlamy), a self-described fitness geek and quantified-selfer, was more enthusiastic, tweeting, "The biggest draw of the @Microsoft #MSBand is that it looks exactly like what I had hoped the #AppleWatch would be... " 

Jamie Hartford, managing editor, MD+DI

How a Shape Memory Polymer Could Drive Medical Device Innovation

Shape-shifting thiolene/acrylates could open the door for a whole new host of applications in medtech, according to Walter E. Voit, assistant professor of bioengineering at the University of Texas at Dallas. 

Walter Voit
Walter E. Voit

Speaking Thursday at MD&M Minneapolis, Voit said 3M Co. undertook research on thiol-type polymers in the late 1970s, but shelf life issues and small commercial markets prevented their adoption.. But it was only in recent years that Voit and fellow researchers at UT Dallas latched on to it for its ability to soften and change shape under human body temperatures.

So far, it has been tested on animals, but Voit said Defense Advanced Research Projects Agency is "really pushing to get some of these devices into people in the next half decade."  Devices could include implantable nerve tags that could read electrical signals in an arm stump to power a robotic prosthetic such as Machester, NH-based DEKA's Luke Arm.

Voit and his team have a whole host of partnerships with companies seeking to develop devices with the substance. Not only can it be engineered to change shape in a specific way inside the body, but it has great adhesion with metals such as gold--which makes it a highly useful flexible electronics material, Voit says.

"We get orders of magnitude better adhesion," Voit said.

There are also processing advantages compared to other polymers such as PEEK, according to Voit. It remains smooth up to temperatures above 200 degrees Celsius. And aging tests have shown that it can hold up for at least 10 years.

The substance could enable self-coiling cochlear implants inside the ear, electrodes that coil around a nerve, and a host of cardiovascular implants. Chris Bowman from the University of Colorado-Boulder has been engaged in pioneering work on dental applications with thiol-based polymers. 

Walter E. Voit, assistant professor of the University of Texas at Dallas, holds semiconductor electronics embedded inside a thiol-based polymer film. The matrix-addressed transistor arrays used to stimulate nerves in a rats brain.

Refresh your medical device industry knowledge at BIOMEDevice San Jose, December 3-4, 2014.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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Regulatory Expert: 510(K) Not Appropriate Pathway For 3-D Printing

Regulatory Expert: 510(K) Not Appropriate Pathway For 3-D Printing

Oxford Peformance Materials has received two 510(k) clearances for its novel and groundbreaking 3-D printed facial and cranial implants in the last 20 months.

But a regulatory expert who is also a consultant for the FDA declared that he believes that the 510(k) pathway is not appropriate for meddical devices made using 3-D printing because they are so unique.

"In my opinion, that's the totally wrong direction for a whole bunch of reasons," said Michael Drues, at MD&M Minneapolis, a conference and tradeshow, on Wednesday. "It simply doesn't make sense to apply our current regulatory structure - 510(k), PMA, de novo, HDE, whatever it is to personalized medicine for drugs and personalized medicine for medical devices."

He noted that the today's regulatory model has been designed for the "blockbuster approach" because when millions of medical devices and drugs are being made, it is entirely appropriate to test a portion of them.

"But when you are printing a  medical device for one patient or you are printing one pill for one patient - the intended patient population is one - what does a clinical trial even look like?" Drues, president at Vascular Sciences, a consulting firm offering business development, education and training among other services, contended.

The answer, Drues believes, lies in what medtech engineers do everyday - validation.

"One way is to validate a product and that's the way clinical trials are done today, but the other way is we can validate the process, and that's the solution to the clinical trial dilemma here," he declared. "The closest thing that we have to a suitable regulatory pathway for personalized medicine of medical devices is the custom device exemption - or CDE."

Drues believe that the CDE will emerge to be the most commonly used regulatory pathway in the future.

However, while that may work now when 3-D printing is in its infancy and is being used in small production scenarios, the regulatory challenge is steeper when the technology is able to scale and is used in mass manufacturing

Meanwhile, the FDA is trying to manage these new questions as it designs a comprehensive policy toward 3-D printing. Earlier this month, the agency held a two-day workshop on 3-D printing. Details and a webcast of that meeting are available here

 [Photo Credit: user mailfor]

-- By Arundhati Parmar, Senior Editor, MD+DI

MD&M Minneapolis 2014 Highlights

Mark Domyahn of St. Jude Medical discusses healthcare economics and reimbursement at MD&M Minneapolis.

MD&M Minneapolis
Midwestern medtech professionals are returning to the Twin Cities this week for the MD&M Minneapolis conference and expo. In this gallery, MPMN provides a continuously updated slideshow capturing highlights from the conference sessions and show floor.

The Top Medical Technologies of 2015 according to the Cleveland Clinic

Today the Cleveland Clinic announced its annual list of top medical innovations that are most likely to have a major impact on patient care in 2015. Among the various breakthrough technologies is a mobile stroke ambulance, a new quick and painless blood-testing method, and the world's first dengue fever vaccine.

The list of emerging technologies and drug therapies was put together by a panel of 110 Cleveland Clinic physicians and scientists, and was announced at this year's 2014 Medical Innovation Summit.

mobile stroke unit
Image of the Mobile Stroke Unit

1. Coming in at number one was the Mobile Stroke Unit, a high-tech ambulance that brings in-hospital neurologists to the scene of a stroke to interpret symptoms via a broadband internet link. The mobile unit also travels with an onboard paramedic, nurse, and CT technologist who all assist in neurological evaluations and administer fast, effective treatment.

2. Pulling in at a close number two is the new dengue fever vaccine, the world's first approved vaccination for the disease. Dengue fever is tropical disease that is spread through mosquitoes, and has become endemic in more than 110 countries worldwide. The vaccine has been developed and tested, and is expected to be submitted to regulatory groups in 2015, with commercialization expected by the end of next year.

3. Rounding out the top three is a new groundbreaking, painless, and cost-effective new blood testing method. Rather than the laborious act of applying a tourniquet and drawing multiple vials of blood with a needle, the new art of blood collection simply involves a virtually painless prick of the fingertip. The results are also available in a matter of hours and can cost just a fraction of the current cost of today's traditional methods.

The rest of the top 10 can be found on the Cleveland Clinic website, and includes many other fascinating technologies ranging from inhibitors for cholesterol reduction that could lead to lower LDL cholesterol levels than ever before, to a vitamin-size leadless cardiac pacemaker that can be implanted directly into the heart without surgery. This was Cleveland Clinic's ninth annual list for breakthrough medical innovations, all of which are expected to have a significant impact on patients by next year.

While this list contains many impressive revolutionary ideas, it isn't the only recent gathering of innovation. Recently the finalists were announced for the Nokia Sensing XCHALLENGE, a competition designed to develop breakthrough medical sensing technologies that can improve diagnostic processes and make health care monitoring more efficient.

While many of the technologies announced on Cleveland Clinic's list still have some final boxes to be checked, all are expected to have an impact on patient care in the next year. While some technologies will further enhance current diagnostic processes, others will establish all new treatments for various diseases and medical conditions, rendering 2015 as a potential landmark year for innovative medical discovery.