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Articles from 2014 In December

Challenges Facing Medical Packaging in 2015

Maintaining high standards amid cost pressures and the need for sterile barrier system makers to become involved early in the development process are among the emerging challenges facing the medical packaging industry in coming years, David Harding, director general of the United Kingdom-based Sterile Barrier Association, writes in European Medical Device Technology.

"A common and understandable approach is to seek lower-cost alternative products. In the case of sterile barriers, however, it is imperative that any replacement or alternative is fit for purpose and meets all of the quality requirements necessary to help protect patients and users from infection," Harding writes.

"Risks are high if alternatives come from unknown sources--especially for products that are not intended or designed for medical applications."

Read the full EMDT story here.

Refresh your medical device industry knowledge at MD&M West, in Anaheim, CA, February 10-12, 2015.

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

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5 Top Medtech Trends for 2015

3-D Printing Gives Injection Molding a Run for its Money3-D printing has a long way to go to become mainstream in the medical device industry, but the technology is quickly gaining traction. Helping to fuel the trend in 2015 will be the greater use of 3-D scanning technology, which will make it easier to scan and print replicas of physical objects.3-D printing stands to be both a threat and powerful supplementary technology to injection molding. Already, 3D Systems is confident that 3-D printing technology could soon be faster than injection molding.In the medical device industry, rapid-prototyping will likely be the most promising application of 3-D printing for some time to come. Although talk about 3-D printed organs is interesting, don’t bet on it to go mainstream in the near future.[Related: 7 3-D Printing Breakthroughs That Matter for Medtech]The use of 3-D printing and injection molding in a hybrid process is also poised to take off in the next few years, as it can be used to create a wider variety of parts than 3-D printing alone. The 3-D injection molding process, developed out of collaboration between 3-D printing firm Stratasys and Worrell Design, drastically cuts the costs and timelines traditionally associated with creating molds. The so-called 3D IM process leverages 3-D printing to quickly produce molds using a heat-resistant polymer from Stratasys known as digital ABS.Shown above is a polycarbonate medical device component made using 3-D printed injection molds.3-D printed electronics are also becoming more of a reality, which should open up still more applications for the technology.Of course, 4-D printing technology—what Skylar Tibbits at MIT calls "programmable materials that build themselves"—is another technology to keep an eye on as well.Continue >>

5 Top Medtech Trends for 2015

Here at Qmed, we are discovering new medical device trends and technologies all the time. Here are five top trends that we bet will gain momentum in 2015.

Continue >>

When Smart May Also Mean Vulnerable

When Smart May Also Mean Vulnerable

We may agree that political assassination of a demented and despotic world leader as a premise for a movie represents inanity and arrogance at its worst.

We may even have little sympathy for the powers at be at Sony.

However, cybersecurity should be on top of mind of everyone given the bold hack that the movie company suffered apparently at the behest of North Korea.

In fact moving into 2015 and beyond, when smart devices will increasingly proliferate our world and more attempts are made to integrate device data in the electronic medical record, cybersecurity of healthcare information should be top priority. 

I interviewed a very interesting startup called Geneva Healthcare recently. The company is aiming to integrate implantable cardiac device data from pacemakers and defibrillators and create a dashboard viewable from the EMR that a emergency room physician will be able to see and understand. The company has nine hospital customers currently.

Currently, if a patient with such a device comes to the ER, and complains of being inappropriately shocked, hospitals have to identify the make of the device and then call the device makers' sales rep to come and interrogate the device and interpret the data from it.

Having a software tool that can automatically bring this data from the cloud to the EMR and interpret it for busy ER physicians is a boon for them and has the potential to vastly improve care for patients and make it efficient. No more waiting hours for reps to be contacted and for them to show up.

While this is the direction that smart devices and intuitive software should lead us, this also means that more vital data will now begin to reside in the EMR. This makes it incumbent for hospitals and EMR providers to have an unflinching focus on cybersecurity.

And yet ironically, John Halamka, chief information officer and dean of technology for Harvard Medical School, tells MIT Technology Review that compared with other industries, the healthcare industry spends very little on IT.

In fact, the number one security prediction for 2015 from Websense, a cybersecurity and data theft prevention company, is this:


The report says that 43 percent of major data breaches reported in 2013 were healthcare related and predicted that in 2015, healthcare will witness a "significant increase" in data theft attack campaigns.

"The healthcare industry is a prime target for cybercriminals. With millions of patient records now in digital form, healthcare’s biggest security challenge in 2015 will be keeping personally identifiable information from falling through security cracks and into the hands of hackers,” said Carl Leonard, principal security analyst, Websense Security Labs, in the report.

Perhaps its time for the industry to wake up and make cybersecurity a priority. 

Otherwise, it would be really like watching a bad movie play out endlessly. 

[Photo Credit: user KyKyPy3HuK]

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

Uroplasty Charts New Course with Acquisition, Name Change

Urinary-incontinence device manufacturer Uroplasty hopes to turn a money-losing proposition into a winner.

The Minnetonka, MN-based manufacturer of minimally invasive treatments of urinary dysfunctions and pelvic disorders has announced it will merge with Vision-Sciences, which has struggled financially since its inception.

Under terms of the agreement, each outstanding share of Uroplasty's common stock will be exchanged for 3.6331 shares of Vision-Sciences' common stock. Upon news of the proposed merger, Uroplasty's share price increased 4.68% to $2.46 per share as of 12:54 p.m. Eastern Time. Vision-Sciences' stock fell 13% to $0.878 per share.

The deal is expected to close during the first half of 2015, per a shareholder vote and other customary closing conditions. The combined company will be called Cogentix Medical,

The combined company, to be called Cogentix Medical, will be headquartered in Minnetonka and headed by Uroplasty CEO Rob Kill. The companies expect Cogentix to generate revenue of approximately $50 million for the fiscal year beginning April 1, 2015. That is about double the sales that Uroplasty brought in during its most recent fiscal year.

Cogentix will market Vision-Sciences' flexible endoscopy device to Uroplasty's existing customers. Vision-Sciences' EndoSheath Endoscopy combines an endoscope with a sterile, disposable covering that reduces cross-contamination between patient and endoscope, according to the company.

Vision-Sciences (Orangeburg, NY) has received FDA clearance to market EndoSheath in laryngoscopy, cystoscopy, sigmoidoscopy, colonoscopy, gastroscopy, bronchoscopy, and esophagoscopy, the company's website says.

Vision-Sciences said in a November 13 SEC filing that it "has incurred substantial operating losses" since its founding in 1987 and expected to continue doing so through the end of the 2015 fiscal year. It cited "continued investment in a direct sales force for the U.S. market, spending for marketing, revitalizing a research and development pipeline, and general business operations" as reasons for the losses ($3.5 million for the six months ended Sept. 30).

"There can be no assurance that we will ever achieve or sustain a profitable level of operations in the future," the company said in the 10-Q report.

Uroplasty products include Urgent PC, a neuromodulation system for percutaneous tibial nerve stimulation. It treats overactive bladder and associated symptoms of urinary urgency, urinary frequency and urge incontinence on an outpatient basis.

Its Macroplastique line offers soft-tissue augmentation for the endoscopic treatment of stress urinary incontinence (approved for women only in the U.S.; for men and women outside the U.S.), and an implantation system for non-endoscopic treatment of female urinary incontinence (not approved in the U.S.)

Upon completion of the merger, Uroplasty shareholders will own 62.5% of the shares of the combined company on a fully diluted basis, and Vision-Sciences shareholders will own 37.5%.

Refresh your medical device industry knowledge at MD&M West, in Anaheim, CA, February 10-12, 2015.

Nancy Crotti is a contributor to Qmed and MPMN.

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A Remarkably Thin Material for Medical Imaging

A material that is hailed as the "thinnest-ever imaging platform" by Rice University (Houston, TX) could be integrated with electronics to create tiny imaging devices to monitor medical conditions in real-time.

The platform is based on an atomically thin layer of copper indium selenide (CIS) that is extremely sensitive to light--the new material is thought to be 10 times more efficient than the best alternative material currently available. The material also has the benefit of having a broad spectral response range. Synthesized in this research by Sidong Lei, a Rice graduate student, the 2-D material is comprised of a single-layer matrix of copper, indium, and selenium atoms.

To prove the material's ability to capture images, Lei integrated it into a three-pixel charge-coupled device (CCD). The small size of the device opens up an array of biological imaging applications, Lei says. "In the past, if you wanted to take an image of biological tissues, you would have to use a microscope or another complex imaging system with lenses that tended to be very bulky," he explains. "With the CIS device, you can just put the sensor on top of whatever you want to take an image of. You can just get rid of the bulky systems that were used in the past," Lei says.

Rice imaging electronics
Rice grad student Sidong Lei holds a 2-D material made from copper indium selenide that could be used for imaging devices that are one atom thick. Image from Jeff Fitlow/Rice University.

Traditional silicon-based CCDs are thick and rigid, making it difficult to integrate with an atomically thick material. But the CIS-based CCD has the advantage of not only being superthin but also transparent and flexible.

The flexibility of CIS enables devices to be developed in which a user can adjust the curvature of the material to conform to the focal surface of the optical system, thus correcting for optical aberration. "If you have a good system, maybe you can even do that actively in real time," says Robert Vajtai, a senior faculty fellow at Rice and a colleague of Lei's.

The device works by trapping electrons that are formed when light hits the material and holds them until they are released for storage. CIS pixels are so sensitive to light because the trapped electrons dissipate extremely slowly.

Another benefit to Lei's material is that it is transparent, allowing for a CIS-based scanner to use light from one side to illuminate an image on the other side for capture.

The research on the 2-D materials used in this technology is an outgrowth of the discovery of graphene in 2004. Following that breakthrough, a wave of additional 2-D materials have been developed, paving the way for an array of electronic breakthroughs such as atomically layered field effect transistors and photodetectors.

The research on materials like CIS is noteworthy in that its is comprised of three elements; most research on 2-D materials in the past decade has been focused on materials comprised of one or two elements. Multielemental materials like CIS offer scientists more freedom for fine tuning their physical properties, owing to stoichiometric variation.

In addition, the Rice researchers report that, until recently, the use of 2-D materials in an optoelectronic memory for image sensing had not been demonstrated.

The researchers were hesitant to estimate how long it might be before such technology could be commercialized.

Refresh your medical device industry knowledge at MD&M West, in Anaheim, CA, February 10-12, 2015.

Kristopher Sturgis is a contributor to Qmed and MPMN.

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What You Need to Know About the DuPont Tyvek Transition

In 2011, DuPont announced its intention to transition Tyvek 1073B and 1059B medical-grade materials to the company's latest flash-spinning technology with the stated objective of ensuring greater continuity and flexibility of future supply.

"Although this is being managed and dealt with very comprehensively by DuPont, there will still be an element of validation work necessary at each packaging manufacturer and medical device manufacturer," according to Tony Paolino, president of SteriPack USA, which provides sterile packaging solutions and contract manufacturing services to the medical device industry. "It's the single biggest change in the industry for years."

To minimize the amount of testing that medical device manufacturers must perform for requalification as a result of the transition, however, DuPont's Medical Packaging Transition Project (MPTP) aims to prove that the transition protocol material is functionally equivalent to current Tyvek materials. 

In a recent Medical Packaging Community Webinar titled, "The Results Are In--But What Can I Do With Them?" DuPont global technical director Bruce Yost presented pre- and poststerilization data for the transition protocol material. The effects of sterilization and one-year accelerated aging on the transition material demonstrated puncture strength that was approximately 10 to 15% better than current Tyvek while tensile strength was shown to be equivalent to or better than current Tyvek. Microbial barrier performance of the transition material was also improved, according to Yost.

Although DuPont is striving to minimize additional work by medical device manufacturers, there are still some tasks for medtech companies to do in order to prepare for the transition. During the Webinar, Leslie Love, MDM specialist for DuPont Protection Technologies, identified four key action items on manufacturers' to do lists:

  1. Complete change management and risk assessments
  2. Perform supply-chain assessment and documentation
  3. Implement risk assessment testing, if necessary
  4. Engage regulatory teams, as necessary

It's also important for manufacturers to accept the concept of interchangeability between the transition material and current Tyvek, according to Love. She noted that, for devices currently on the market, interchangeability allows the medical device manufacturer to use either current Tyvek or the transition material, if:

  • The medical device manufacturer has considered this in its change control, risk management, and regulatory submission process
  • The specifications for the device package do no restrict the use of current Tyvek or transition protocol materials
  • There were no changes to the packaging or sterilization process conditions
  • Any required regulatory submissions for the transition are structured and approved to allow both products to be used, if applicable

New device qualifications, Love added, can either employ current Tyvek, use the transition material via the controlled sales program, or use both current and transition Tyvek materials.

DuPont expects FDA affirmation of functional equivalence in Q3 of 2015. The company further stated during the Webinar that if everything goes as planned, full commercialization of the transition protocol material would begin September 2015. The complete transition will likely take between 12 and 18 months.

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

Will Acquisition By Philips Save Volcano Corp.?

Will Acquisition By Philips Save Volcano Corp.?

By Tom Salemi

In late September, a group of Volcano Corp. shareholders castigated the company’s management and demanded Volcano bring its financials in-line by reigniting growth, streamlining costs, and bringing the business closer to profitability. The message must have gotten through loud and clear, as Volcano’s management may be positioned to accomplish all three goals by selling the company to Royal Philips for $1.2 billion.

Indeed, in the eyes of some, Volcano management may have taken the company’s intravascular ultrasound (IVUS) and Fractional Flow Reserve (FFR) systems as far as it could as an independent entity. In 2013, Volcano recorded $393.7 million in sales, up only 3.1% over 2012, when sales were 11.2% higher than in 2011.)

But in recent quarterly calls the Volcano team outlined an aggressive plan to reinvigorate the business. Simultaneously, it invited bids from larger companies, securing what some see as too generous a deal from Philips, which will pay $18 per share.

Founded in 2000, Volcano has successfully placed more than 7000 systems using the pitch that improvements in interventional vascular procedures could improve outcomes. The company projects the $1 billion market for the imaging tools could climb to $1.7 billion by 2017, and many other suppliers, including Boston Scientific Corp. and St. Jude Medical Inc., have grabbed share in the market.

The benefits of improved imaging may seem intuitive, but Raj Denjoy, senior equities research analyst at investment banking firm Jefferies, says IVUS and FFR have enjoyed lukewarm support from insurers and medical associations. FFR is a unique challenge in that is uses a catheter to measure how badly a blockage is impeding the flow of blood. The test may sometimes advise against the insertion of a stent or use of angioplasty, advice that sometimes runs counter to accepted treatment guidelines.

Those headwinds slowed Volcano’s growth, and the company’s attempt to diversify by acquiring treatment devices—such as the $130 million paid out in April for peripheral vascular device company AtheroMed—often didn’t sit well with investors. Shareholder pressures more largely stemmed from Volcano executives’ seemingly chronic inability to properly guide investor expectations. Volcano shareholders watched the company’s year-to-year sales growth drop from the teens to the low single digits in just a few years. Shareholders’ strong response to the Volcano performance earned the company a spot on MD+DI’s roster of medtech losers in 2014.

Boston Scientific currently competes only in IVUS, but the company is reportedly planning to release an FFR system to match Volcano’s and St. Jude Medical’s offerings. St. Jude already sells an FFR system but doesn’t offer IVUS, though its optical coherence tomography (OCT) performs a similar function. (In Japan, Volcano competes against Terumo Corp., which sells both IVUS and OCT systems.) Volcano is also poised to release an adenosine-free Instant Wave-Free Ratio FFR, or iFR, which would free patients entirely from the potential side affects associated with adenosine.

The sale to Philips could help foster a faster turnaround for Volcano. Michael Matson, senior research analyst for Needham & Co., says Philips’s angiography business gives the company a strong presence in catheter labs. Matson wasn’t certain of the overlap, but he anticipated a Philips’ sales force—likely including some of the Volcano team—could use that foot in the door to sell additional systems. Ultimately, Volcano’s IVUS and FFR capabilities could be incorporated in Philips own system easily enough, putting the company in position to retake market share from Boston Scientific or St. Jude Medical.

In a note on the deal, Danielle Antalffy, director of medical supplies and devices at Leerink, says the acquisition makes sense for Philips. “As the global market leader in medical imaging, Philips has the scale and breadth to help execute growth reacceleration of VOLC's key IVUS and FFR product offerings,” the report states. “Image-guided therapy remains a $5 [billion worldwide] market, and the transaction augments Philips[’s] already strong breadth and scale to drive market share in this category around the world.”

Volcano management recently told analysts that they hoped to get Volcano’s growth back to 6% to 8%. The acquisition by Philips may help make that a more likely outcome.

Tom Salemi is a freelance contributor to MD+DI.


What Are The Top Issues and Trends For Life Sciences in 2015?

What Are The Top Issues and Trends For Life Sciences in 2015?

A nifty infographic from Deloitte's Center for Health Solutions captures both market size and trends outlook for the life sciences sector in the future.

The top four trends are:

  • Searching for innovation and growth through collaboration and partnership
  • Adapting to a changing global regulatory and risk environment
  • Preserving and building shareholder value amidst pricing pressure and increasing costs.
  • Preparing for the "next wave" as life science companies have to contend with new demands from  different stakeholders and look for new opportunities

lifesciences outlook, 2015 outlook

[Photo Credit: user Oez]

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

Best Practices for Product Lifecycle Management

Best Practices for Product Lifecycle Management

A new MD+DI ebook sponsored by Sparton provides tips for managing medical devices from the cradle to the grave.  

The key to success in the medtech industry is managing every aspect of your product from beginning to end. But while product lifecycle management is easy in theory, it's actually much more difficult in execution.

Medical device OEMs have to consider everything from design and compliance to manufacture in order to manage a product's lifecycle effectively. The process involves parties as diverse as designers, regulatory affairs professionals, and production staff—all of which bring their own goals, expertise, and bias to the table.

To help medical device OEMs navigate this complex landscape, MD+DI presents Technology Roundup: Product Lifecycle Management, an ebook sponsored by contract design and manufacturing firm Sparton.

This collection of articles covers key topics such as product design and development, design to manufacturing transfer, and complex device manufacturing services to help OEMs better manage their products from the cradle to the grave. It includes tips to fast-track medical device development, design for regulatory compliance, smooth the transition from design to manufacturing, and establish stratetic outsourcing partnerships. 

If you're looking to brush up on best practices for product lifecycle management, be sure to check it out.

10 Most Popular Medtech Features of the Year

7 Medical Device Failures Catching FDA's EyeAn article from March explains why several recalled medical devices failed. The list cites everything from rust to flaking guidewire coatings.Continue >>

10 Most Popular Medtech Features of the Year

We’ve rounded up the content that received the most pageviews since the beginning of 2014.

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