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Articles from 2014 In November

What to Expect When Implementing UDI

                     UDI label

Although September marked the first unique device identification (UDI) compliance deadline—for Class III devices—many manufacturers are still in preparation mode. And, unsurprisingly, as industry has soldiered forth with implementation, a number of complex issues have come to light, according to Jay Crowley, a former senior advisor for patient safety and UDI architect at FDA who now serves as vice president of UDI services and solutions at USDM Life Sciences

In the early days of UDI development, Crowley recalls, stakeholders assumed that the primary challenges with implementation would be centered on enumeration of devices and similar issues. But the more significant stumbling blocks—so far, at least—have actually centered on process, organizational, and business challenges, he says.

The rollout of UDI in the United States has caused some confusion—and perhaps a bit of tension—between medical device manufacturers and contract manufacturers, for example. Determining which party is responsible for performing which UDI-related tasks, assigning the UDI to the product, applying it, verifying the bar code, collecting the data, and submitting the data is a massive undertaking, Crowley notes. 

"It often requires a lot of individual conversations," he says. "Any one company probably doesn't want to do it 52 different ways because they have twenty some-odd private label activities and twenty some-odd contract manufacturing activities. But they may end up having to do it 52 different ways." Although there are efforts to develop systemic solutions to this sizable obstacle on the path to implementation, there's simply not a one-size-fits-all solution.

Nor is there an easy pathway for large manufacturers that have actively acquired an array of companies and product lines over time. Wildly disparate data systems and SOPs, in addition to a lack of visibility into such basic information as how to identify products, the number of levels of packaging a device has, or a device's product code, present a daunting organizational challenge, according to Crowley.

"One of the first things we do with a new client is to ask them a question that, on paper, appears to be a relatively straightforward question: 'How many medical devices do you make that you think will be subject to UDI.' And they have no idea," Crowley comments. "They've got systems that were never designed to provide information in this way. Just wrapping their heads around how many finished medical devices they actually make subject to UDI that are distributed in the United States is an enormous task."

Once companies have a handle on their basic product portfolio, iron out UDI responsibilities with contractors, and have implementation underway, they must contend with the GUDID submission. This critical component of UDI prompts a plethora of questions related to location of data, who actually owns the data, and change controls. 

"Getting that data together in one place, figuring out how you're going to store that data, managing that data, submiting that data, and managing this [process] going forward is an enormous challenge, and one that most organizations aren't ready for," Crowley states.

To steadily navigate these unfamiliar waters, it's imperative that companies—particularly large organizations—have a multidisciplinary team leading the UDI charge. "Make sure you've got everyone this might touch, at least that's tangentially involved," Crowley advises. "There's a huge void in terms of people just knowing what [UDI] is and what's going on. If you get the right team on board, then you can understand your product portfolio and what that looks like. It's a lot easier then to move this along."

Critical team members include a strong senior champion and project manager in addition to stakeholders from regulatory affairs, quality, IT, and labeling. Product managers or other experts on the company's product portfolio are also essential.

"[UDI implementation] isn't a very sexy thing; it's a brute-force effort," Crowley says. "I think, ultimately, it's going to be very useful and a very positive experience. But its going to take us a while to get there…and it's going to be a little painful in the process."

Focused on UDI, labeling, or medical packaging? Visit the Medical Packaging Community for relevant information and peer-to-peer engagement.

 —Shana Leonard, group editorial director, medical content

10 Medical Hazards to Steer Clear of in 2015

1. Alarm Hazards: Faulty Alarm ConfigurationsFor many healthcare professionals and caregivers, having reliable medical device alarms to inform them of any changes in a patient’s status can make all the difference in providing adequate care. When the warning system fails, patients can find themselves in potentially dangerous situations that can result in serious injury or death.One of the major focuses is on alarm fatigue, a condition that often leads to missed alarms as caregivers are overwhelmed, and ultimately desensitized by the number of alarms that are active. Missed alarms, or unrecognized alarm conditions can often be traced to inappropriate alarm configuration practices, which include determining which alarms should be enabled, selecting appropriate alarm limits, and establishing default alarm priority levels. Selections are typically based on specific patient needs. This is something that should be constantly examined and evaluated to ensure all alarm configuration settings are appropriately tuned.For now, experts are adamant that establishing policies for care-area specific alarm configuration practices is crucial to limiting the risks involved with alarm fatigue. Ensuring healthcare professionals and caregivers are apprised of these policies will limit the risks involved with alarm fatigue, and improve overall patient care.Image from Flickr user Ishikawa Ken.

10 Medical Hazards to Steer Clear of in 2015

Medical errors are the third leading cause of death in the United States, killing more people than everything but cancer and heart disease. The reasons behind those errors include everything from drug-delivery mix-ups to ignored medical device alarms.

While human error plays a large part in such mistakes, technology also plays a role in many of them. On that note, the healthcare research organization ECRI Institute rounds up an annual list of the Top 10 Health Technology Hazards. Here, we have summarized the most recent list, providing information specifically related to medical device development.

Image modified from Flickr art.

How Nanotech Could Improve Imaging Tech

Rutgers cancer imaging
Image courtesy of Rutgers

A new potentially lifesaving imaging technique developed at Rutgers University uses nanotechnology to reveal small cancerous tumors and cardiovascular lesions deep inside the body, according to a report in Qmed's sister media site European Medical Device Technology. 

The researchers utilized dyes made out of nanocrystals from rare earth elements. The nanocrystals react to shortwave infrared light with fluorescence. Past fluorescent dyes that react to this kind of light have either been too toxic to use safely or could not deliver sharp images.

Read the full EMDT story here.

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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4-D Printing Could Come Sooner Rather Than Later

The arrival of 4-D printing--what Skylar Tibbits at MIT calls "programmable materials that build themselves"--could be sooner than one might think, medtech industry analysts tell European Medical Device Technology

Related Slideshow: Coolest Technologies of 2014

Coolest Technologies

For example, 4-D printed neurovascular coils could soon reach the prototype stage, says Venkat Rajan, an analyst for Frost & Sullivan. "Recently, advances with the coils involve having them covered with bioreactive coatings that can expand after implanted and create a better seal," Rajan said.

Also watch out next year for prosthetic device prototypes with 4-D printing capabilities, according to Pete Basiliere, an analyst for Gartner.

Read the full EMDT story here.

Another example involves shape-shifting thiolene/acrylates that could enable self-coiling cochlear implants inside the ear, electrodes that coil around a nerve, and a host of cardiovascular implants, Walter E. Voit, assistant professor of bioengineering at the University of Texas at Dallas, explained in October at MD&M Minneapolis.

Meanwhile, 3-D printing equipment maker Stratasys has demonstrated enough interest in the concept that it has formed a partnership with Tibbits for 4-D printing research.
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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Coronary Stent Market To Be Worth $5.61B By 2020

Coronary Stent Market To Be Worth $5.61B By 2020

The coronary stent market - both for bare metal and drug eluting stents - is expected to grow to $5.61 billion by 2020, according to a new report.

The report issued by GlobalData finds that the latter category (DES) dominates the global stent market, which itself has a few major players - Abbott Vascular, Boston Scientific and Medtronic, and followed by Biosensors International and Terumo, according to the report.

Other companies in the space include French startups like Stentys as well as firms like San Diego-based Reva Medical and Germany-based Translumina. 

The advances made in minimally invasive technology as well as in interventional cardiology has broadened and expanded the number of therapeutic applications of such stents. Coronary stents are used to open up blocked arteries for patients suffering from coronary artery disease. It's the most common type of heart disease and kills 380,000 Americans annually, according to the Centers for Disesae Control and Prevention. 

The growth in the market will also come from advances in bioabsorbable stents that disintegrate in the body over a period of time. 

In the European Union, however, between 2011 and 2020, the market is actually declining. Like in the U.S., the drug eluting stent use is much more prevalent than bare metal stents. The report projects that in the future growth will be slower there because if improved outcomes and less need for repeat intervention.

[Photo Credit: useranzlyldrm]  

Tuesday, March 05, 2013 12:49 PM -- By Arundhati Parmar, Senior Editor, MD+DI

Europe Seeks Answers to Ebola Outbreak in Africa

A number of universities and startups in Europe are stepping up to the challenge of combatting the Ebola outbreak in Africa, according to a recent report on Qmed's sister media site European Medical Device Technology.

The goal is devices that provide faster and more effective diagnosis. Examples include work at the University of Westminster (United Kingdom) on a small handheld diagnostic device, the French company Vedalab's commercialization of its rapid 'Ebola eZYSCREEN' test, and the British company PrimerDesign's Ebola test kit.

Read the full EMDT story.

Related Slideshow: 10 Ebola-Fighting Technologies


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.

Like what you're reading? Subscribe to our daily e-newsletter.

Coolest Technologies of 2014

Coolest Technologies of 2014There are technology breakthroughs, and then there are jaw-droppingly amazing technology breakthroughs.We at Qmed have seen plenty of incredible technologies come across our radar this year. Here are 10 that especially impressed us:Image derived from Radiohead stage-lighting photo on Wikimedia Commons.

Coolest Technologies of 2014

There are technology breakthroughs, and then there are jaw-droppingly amazing technology breakthroughs.

We at Qmed have seen plenty of incredible technologies come across our radar this year. Here are 10 that especially impressed us:

Image derived from Radiohead stage-lighting photo on Wikimedia Commons.

New Zealand Sensor Startup Aims To Help Measure Body Metrics

New Zealand Sensor Startup Aims To Help Measure Body Metrics

StretchSense makes sensors that can be used to assess how sports injuries are healing

Executives from StretchSense, an Auckland, New Zealand-based sensor company, were in Chicago in October to attend AdvaMed'a annual conference and make some headway into the U.S. medical device industry.

The company aims to bring what it believes is an advances sensor technology to device manufacturers but wants to skirt the arduous regulatory process. In other words, it wants to work with device makers interested to use its sensors to develop a custom medical device, but will not be involved in getting FDA approval if required.

"We are focused on being a sensor company and where our technology is good, is measuring soft structures," said Todd Gisby, chief technology in an interview in Chicago. "Our sensors are made up of tiny polymers that have a soft effect."

In fact that he believes that is the chief differentiation between StretchSense and better-known U.S. startups like MC10 that are also developing flexible and stretchable electronics and have companies like Medtronic as investors. 

"Probably the simply way to define what we do is that we make rubber bands with bluetooth on them," he said.

Gisby said the most obvious application of the company's technology would be in the rehab and sports injury space where data on how a person's body is moving is required. 

"We are making that more objective by putting numbers to it, whereas before this was evaluated very subjectively," Gisby said.

The first product, which will be in the healthcare industry is expected to debut in 2015, Gisby said. But the company, which currently has 11 employees is looking at non-medical applications of the technology too. Still, Gisby declared that the medtech market is an attractive one.

"It's a more difficult market to enter, but it has much higher margins," Gisby said. 

Here is a video with more details:


[Photo courtesy of StretchSense website] 

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

FDA Recommends More Morcellator Restrictions

To reduce the risk of spreading undetected cancer, the FDA has issued stricter guidance on the use of power morcellators in certain gynecological surgeries.

The guidance, which follows a similar warning in April, goes into effect immediately. It advises physicians not to use power morcellators to remove the uterus (hysterectomy) or uterine fibroids (myomectomy) from patients who are peri- or post-menopausal, or are candidates for removing tissue intact through the vagina or a minilaparotomy incision.

Morcellation is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites by dividing it into smaller pieces or fragments. The problem with the procedure is that cutting a tumor into fragments can make it difficult to remove all of the tumor tissue. In addition, small tumor fragments can be seeded throughout the body, leaving the patient in many cases with multiple tumors.

To avoid such outcomes, FDA also advised against using the devices in gynecologic surgery on known or suspected malignant tissue. Physicians should also advise their patients on the risks of power morcellation, according to the FDA.

The agency also advised manufacturers to add warnings about the dangers of using power morcellators in most hysterectomy and myomectomy patients, including the two contraindications for the devices, according to its statement. It also advised physicians to share the boxed warnings with patients. The guidance is available online

Some younger women who want to have children or wish to keep their uterus intact after being informed of the risks may be candidates for power morcellation, the FDA added.

Other surgical treatment options available for women with symptomatic uterine fibroids include traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, and laparotomy using a smaller incision (minilaparotomy).

The FDA estimates that 1 in 350 women undergoing either procedure to treat fibroids has an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. There is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma, the agency said.

"If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient's long-term survival," the FDA statement said. "While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood."

The new guidance applies to currently marketed and new laparoscopic power morcellators for general and specific gynecological indications.

In April, Johnson & Johnson announced a sales suspension that included the Gynecare Morcellex Tissue Morcellator, Morcellex Sigma Tissue Morcellator System and the Gynecare X-tract Tissue Morcellator. Three months later, the company's Ethicon subsidiary pulled all of its power morcellators from the market.

The issues surrounding the morcellators have not only effected the companies that make them, such as Ethicon, but also companies such as Intuitive Surgical, which makes surgical robots for the early stages of hysterectomies, before morcellation takes place.

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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How 3-D Printing Could Help Medtech Right Now

The potential applications of 3-D printing are vast, and include everything from making synthetic tissue and organs to custom medical devices--but such innovations could be years if not decades away.

For now, medtech industry insiders need to identify how 3-D printing can help them meet their most pressing need: developing innovative medical devices in a manner that helps them save time and money, and reduce the risk inherent in new product development.

Mike Patton
Michael Patton, MD says the greatest current application of 3-D printing for the medical device industry is rapid prototyping.

"Where we see the biggest opportunity with medical devices is to use 3-D printing for rapid prototyping," says Michael Patton, MD, who is the CEO of Medical Innovation Labs (Austin, TX), an organization designed to help drive medical device development. 3-D printing, when used for rapid prototyping, can be used to de-risk new product designs early on and ultimately get more promising medical devices on the market, Patton says.

Already, 3-D printing for rapid prototyping has been shown to be effective at reducing risk in product development--in the medical device and other industries. By printing several product iterations at the proof of concept stage and testing them thoroughly, problematic product ideas can be weeded out early on, while promising ones can be refined.

This process can save considerable sums of money down the road, while helping startups create prototypes that can help them win funding.

There are plenty of increased incentives when it comes to avoiding costly mistakes down the road. That's because most of the medtech R&D operations in the U.S have tightened their budgets. "And rapid prototyping can certainly be a way to reduce costs to get products on the market," Patton says.

Medical Innovation Labs itself makes extensive use of rapid prototyping and collaborates with Joe Beaman, PhD, the inventor of selective laser sintering (SLS) 3-D printing technology who is a professor at the University of Texas, Austin.

Rapid prototyping could also help break an innovation logjam that's been caused by a variety of factors, including increased regulatory barriers, a dearth of cash for medical device startups, and the new challenge of designing not just for doctors or patients but for group purchasing organizations and hospitals. Thanks to these factors, too few truly innovative medical devices are making it to the market despite growing demand for new technology that can not only improve outcomes but also play a role in making healthcare more efficient, according to Patton.

"It is amazing when you go through top hospitals at leading universities, and you don't see as much innovation; you don't see many products being developed that could really improve healthcare," Patton says.

Rapid prototyping, in conjunction with an effort to break down the silos in healthcare to spur collaboration, is the path forward, Patton says. "We understand the importance of secrecy and we don't want everyone having their ideas stolen," Patton says. But collaboration--matched with a good dose of due diligence in evaluating new medical device ideas--can be powerful.

While the potential of 3-D printing to be used in the future for, say, bioengineering is an exciting possibility, that technology is years away from commercialization. "For instance, I think 3-D printed organs are exciting, but we are years away from that," Patton says. "The biggest challenge there is going to be vasculature."

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

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.