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2015 MDEA Finalists: EPIQ Ultrasound Platform

EPIQ Ultrasound Platform 

The EPIQ ultrasound platform, manufactured by Philips North America (United States), achieves a 76% increase in penetration and 213% increase in temporal resolution compared with conventional premium ultrasound systems and offers benefits such as ergonomic design and portability. .

Supply/design credits: Philips Design, NIC Global, Altek, Southco, BCM Advanced Research, Sanmina, Fimi Barco

          

2015 MDEA Finalists: Cologuard

Cologuard 

 

Cologuard, manufactured by Exact Sciences Corp. (United States), is a noninvasive screening test for colorectal cancer designed to help increase rates of screening compliance.

Supply/design credits: Mayo Clinic, Phillips-Medisize Corp., Exact Sciences Corp.  

          

2015 MDEA Finalists: BacterioScan 216R Laser Microbial Growth Monitor

The BacterioScan 216R Laser Microbial Growth Monitor, manufactured by BacterioScan, Inc. (United States), delivers accurate detection of urinary tract infections from patient specimens within 90 minutes, reducing lab time-to-result by more than 90% for the vast majority of patients.

Supply/design credit: Metaphase Design Group Inc. 

          

2015 MDEA Finalists: AngelMed Guardian

The AngelMed Guardian, manufactured by Angel Medical Systems (United States), is an implantable cardiac monitor that can alert patients about a potential acute myocardial infarction; demand ischemia; and high, low, and irregular heart rhythms. 

          

2015 MDEA Finalists: Woundhub II

Woundhub II

 

The Woundhub II, manufactured by Wondermed Ltd. (South Africa), provides all aspects of advanced wound treatment—cleaning, debriding, irrigating, drying, applying creams, and massaging—in a single machine. 

Supply/design credit: Kevin Boyd Design 

          

2015 MDEA Finalists: SERVO-U and SERVO-n ICU Ventilators

The SERVO-U and SERVO-n ICU Ventilators, manufactured by Maquet Critical Care (Sweden), provide a modern user experience and an intuitive interface to help improve quality of life for patients, families, and caregivers..

Supply/design credit: Veryday  

          

Is Healthcare Going to See an Uber? These 3 Things Should Give You Pause

Deepak Prakash

Some experts think healthcare is ripe for an Uber- or Airbnb-type disruption. But Deepak Prakash at Vancive Medical Technologies is more of a realist.

Chris Newmarker

Talk to someone in fields such as medical sensors and wearables, and odds are you'll hear a lot of words such as "revolutionary," "disruptive," and "game changing." (Qmed/MPMN has repeated plenty of those words itself.)

In reality, people may have to wait 20 to 30 years for healthcare to truly change, says Deepak Prakash, global director of digital health at contract manufacturer Vancive Medical Technologies.

"It's a different beast. Things don't change very rapidly in healthcare," says Prakash, who is based out of Chicago for Vancive, which is part of Avery Dennison Corp. (Glendale, CA).  (See Prakash discuss, "Leveraging Emerging Healthcare Sensor and Remote Technologies," at MD&M East, June 9-11 in New York City.)

In charge of marketing and commercial activities for Vancive's Digital Health business, Prakash has a great deal of hope that health sensors and wearables will eventually improve healthcare. "It's probably one of the most promising technologies," Prakash says.

But he is more skeptical when it comes to the prospects of changing such a complicated and entrenched industry.

Contrast Prakash's views Stuart Karten, the founder and principal of Karten Design (Los Angeles). Karten thinks Uber-like medical companies will emerge in the next decade:

"We are also seeing a transformation of the man-machine relationship--we are starting to wear computers, and soon, we will be implanting them into our bodies to connect with our communication systems, cars, and homes. As artificial intelligence improves, it will help us interact with increasingly smart environments. In healthcare, highly evolved sensors and powerful algorithms will give us proactive, personalized care. By 2035, the majority of our treatments will occur at home. Our home will be watching us and helping us track our health."

Prakash gives it a little more time, especially because healthcare is not a transaction between two people such as buying a car ride (Uber) or staying in someone's home (Airbnb). There are doctors, other health providers, health insurers, employers, government agencies, and more factors to consider.

Here are three things Prakash thinks will have to be overcome to disrupt healthcare:

1. Getting Beyond the Concept Stage to Mainstream

Prakash suspects that health wearables are about where electronic cars were 20 years ago: really neat gizmos but not yet proven technology.

To go mainstream, wearables will have to accurately provide the data that doctors and other health providers actually need, Prakash says.

Take smartphone-based ECGs such as AliveCor as an example. They are able to provide plenty of useful data. But for more complex heart conditions, a Holter monitor is still needed, according to Prakash.

When it comes to many type of wearables, not everything about a person's condition is being taken care of, Prakash says. "Technology hasn't gotten there yet."

2. Operational Hurdles

A tremendous amount of investment is still needed to create the data systems, cloud-based platforms, and analytics to effectively handle the health data wearables could potentially produce.

Health providers need to change their entire operational frameworks, and public and private health insurers have yet to set up the systems to pay for it.

"All of this has to be taken care of for it to be mainstream," Prakash says.

3. Embracing Consumer Engagement

Used to doing online research about just about everything, people are ready to engage more with their doctors and other health providers.

But many doctors simply aren't ready. They're still stuck in the old model, in which patients followed doctors' orders. In addition, many doctors remain skeptical whether all this new wearables data is really useful, Prakash says.

Prakash suspects a generational shift will have to take place before doctors and other health providers truly embrace "consumer engagement."

"In about 10 to 15 years, you'll see that some digital technology has replaced the old way of doing things." 

See Prakash discuss, "Leveraging Emerging Healthcare Sensor and Remote Technologies," at MD&M East, June 9-11 in New York City.

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

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Industry’s Unofficial Training Ground

Industry’s Unofficial Training Ground

CDRH claims to be losing talented employees to industry; patient advocates believe this is evidence of a too-close relationship between the center and businesses.

Jim Dickinson

It was over in less than a minute, at the midway point in the Senate Health, Education, Labor, and Pensions (HELP) committee’s April 28 hearing on the future of U.S. medical innovation leadership—CDRH director Jeffrey Shuren let slip FDA’s dirty little secret: it is, and has long been, industry’s unofficial training ground.

The admission came during casual questioning by ranking member Patty Murray (D–WA), harking back to a conversation she’d had with outgoing commissioner Margaret Hamburg about how difficult it has been for CDRH to attract and keep top-notch staff. Uncompetitive salaries make this a general problem across government.

But in CDRH’s case, Shuren blurted out: “We are the training ground for industry. Once trained, they become more marketable and they leave for salaries twice as high as they are making at the agency. A high workload combined with less pay makes it hard to get people and this also leads to high turnover.”

That, in turn perversely “hurts companies because in the middle of a review and your lead reviewer or medical officer leaves and I don’t have a deep bench in my Center.”

Murray: “So industry steals your employees but they need you?”

“That is exactly right,” Shuren answered, “and we have to change that because it best serves not just industry, it ultimately serves patients and that is what this is all about.”

Murray then turned to a previous FDA witness, Center for Drug Evaluation and Research director Janet Woodcock, asking “I assume you see the same thing?”

Woodcock: “Absolutely. Our scientists need to go toe to toe with the best industry scientists. And yet when my people leave either to academia or to industry they typically double their salaries.”

Then it was over. The hearing moved on to other topics.

The senators, their staffs, and their witnesses took it all in stride, seemingly unaware that FDA’s unplanned and undesired service as a “training ground for industry” isn’t widely known outside the Beltway, where patient activists are increasingly unhappy with CDRH.

“This is a blatant admission to how closely aligned the CDRH is with industry,” stormed heart surgeon Hooman Noorchashm, who is campaigning for a power morcellators-motivated CDRH makeover that puts patients first, instead of industry. He was venting in an email to his extensive list of activists, FDA leaders, lawmakers, and their staffs.

“Where is the patient’s voice?” he demanded. “Where is the public voice? Where are the real representatives of the harmed? ‘A training ground for industry’???!!! Mission corruption, indeed! The CDRH and its leadership have strayed far away from their public health mission.”

Seemingly not suspecting that his words might evoke such a response beyond the Beltway, Shuren actually built upon the “service to industry” theme that Noorchashm and others find so offensive, in his 33 page prepared testimony to the HELP committee.

“In the early part of this decade,” his testimony reads, “many policymakers and FDA stakeholders called for reform of FDA’s device program, arguing that FDA regulation was driving companies to relocate overseas or market their devices abroad before introducing them in the United States.”

These complaints were backed up by surveys of device manufacturers, an influential and sobering Pew Charitable Trusts research report on FDA staffing in 2012, and even FDA’s own data. These all led to programmatic and policy changes at CDRH, as well as to increased funding by Congress that has now “significantly improved” the Center’s performance, Shuren’s testimony says, before plunging into two-and-a-half pages of improvement details across every type of product submission.

“Our experience also suggests that there is marked improvement in the medical device industry’s perception of FDA,” the testimony says. “In 2014 CDRH made providing excellent customer service a strategic priority and launched an effort to improve customer service that included staff training, surveys to assess interaction with customer and measure customer satisfaction, and, based on feedback from customers, actions to improve the quality of CDRH actions and services. CDRH’s 2014 results show 86 percent satisfaction.”

There was a time, not too long ago, when official use of the word “customers” to describe regulated industry was decried as unseemly by the general run of FDA employees. It evoked a well-known and popular catch-phrase in commerce: “The customer is always right”—even when he’s wrong.

Accordingly, most FDA leaders adopted the more neutral term “stakeholders”—until Shuren’s prepared, and presumably vetted, HELP testimony.

Shuren’s happiness with the new industry happiness with CDRH was shared by former FDA Office of Chief Counsel medical device specialist Nathan Brown, now with Akin Gump Strauss Hauer & Feld, in an interview published in Metropolitan Corporate Counsel.

Brown told the publication that the medical device industry is emerging from a period of significant frustration with FDA and entering into an improved regulatory environment following the injection of more resources and “more formalized procedures.”

“There are still refinements to be made to the premarket review process,” Brown told his interviewer, citing the de novo program as an example. It’s “very challenging legally because it requires creation of a brand new classification; these reviews tend to take longer and, so far, the de novo process hasn’t been subject to the types of negotiated performance goals that other submission types have.”

In his prepared testimony to the HELP committee, Shuren hailed a final decision time reduction for de novo requests from 992 days in FY 2010 to 300 days in FY 2014. And over the past five years, the decision time for 510(k)s has fallen from 116 days to 105 days while PMA decision times have come down during this period from 320 days to 236 days.

Shuren’s happiness and industry’s happiness are reciprocal benefits of an intensely close relationship that has strong economic and political foundations since the advent of user fees.

The strident unhappiness of certain patient constituencies such as morcellator, duodenoscope, dental amalgam, and LASIK victims, owes much to the absence of a comparable relationship with CDRH.

Meanwhile, as Brown observes in his online interview, later this year user fee negotiations will resume, leading to a 2017 reauthorization that he expects will help continue the focus on how to accommodate new technology from the medical device industry. 

Stay on top of the latest trends in medtech by attending the MD&M East Conference, June 9–11, 2015, in New York City.


Jim Dickinson is MD+DI's contributing editor. 

[Image courtesy of BOIANS CHO JOO YOUNG/FREEDIGITALPHOTOS.NET]

Varian Medical Unveils New Linear Accelerator

Varian Medical Unveils New Linear Accelerator

Varian Medical Systems presents its newest linear accelerator, the VitalBeam, and discusses its potential as a “cost competitive option.”

Marie Thibault

The VitalBeam linear accelerator is the newest addition to Varian Medical Systems' product portfolio.

Varian Medical Systems, the largest player in the linear accelerator (linac) market, has added another system to its lineup. During the European Society for Radiotherapy and Oncology (ESTRO) annual meeting, held recently in Barcelona, the company presented its VitalBeam linac. The system, which is awaiting CE Mark and FDA 510(k) clearance, is expected to be targeted at centers in the emerging markets.

Linacs, a major part of the radiation oncology market, are used to deliver radiation to kill cancer cells. Varian has 60% global market share and as the United States and other developed markets have reached saturation in linacs, the company and its competitors have increased their focus on the emerging markets.

Hospitals in the emerging markets often have more limited budgets, so companies usually offer more basic linacs at more attractive prices. Varian has long sold its most basic linac, the Unique system, into these developing countries. The VitalBeam is targeting a customer population somewhere between the Unique system and the company’s high-end TrueBeam system.

According to a Seeking Alpha transcript, Dow Wilson, Varian’s president and chief executive officer, explained the new system’s future position in the product portfolio on a April 29 earnings call with analysts: “we see this [VitalBeam] as really kind of between Unique and TrueBeam, and fulfilling a space where we can be more competitive. I think it's going to give us better price support, TrueBeam, and it's not going to compete with the Unique at all.”

The company's press release announcing the VitalBeam describes the system as being upgradable from its foundational offering, which includes "an 80-leaf collimator for intensity-modulated radiation therapy (IMRT), low-dose megavoltage (MV) imaging using the accelerator beam for image guidance, and respiratory gating for motion management." Hospitals can choose to upgrade the system with other Varian offerings like faster RapidArc radiotherapy, a 120-leaf collimator, and cone-beam CT imaging capabilities, according to the release. 

Tim Clark, head of European marketing for Oncology Systems, said in the release, "Customers can configure the system they way that they want it. They can choose to start with one configuration and add capabilities over time, at a pace that suits them. It is distinct from our versatile TrueBeam radiotherapy and radiosurgery platform in that VitalBeam is optimized for advanced radiotherapy while TrueBeam systems were designed to handle both." 

"VitalBeam is a scalable and upgradeable system that affordably meets the clinical needs of hospitals today and as they grow in the future...Customer interest at ESTRO was very high and we plan to make it available to customers in Europe first, while seeking clearances around the rest of the world," Wilson said on the earnings call, adding that the system has not yet attained CE Mark or FDA 510(k) clearance.  

Stay on top of the latest trends in medtech by attending the MD&M East Conference, June 9–11, 2015, in New York City.

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie

[Image courtesy of Varian Medical Systems Inc. All rights reserved.]

10 of the Most Profitable Medtech Companies

10 of the Most Profitable Medtech CompaniesWe looked at the most recent annual financial data for medical device companies and rounded up 10 that had some of the highest profit margins.Check out the first company...Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6–7, 2015, or MD&M East in New York City, June 9-11, 2015.Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarkerLike what you’re reading? Subscribe to our daily e-newsletter.Image from Flickr

10 of the Most Profitable Medtech Companies

We looked at the most recent annual financial data for medical device companies and rounded up 10 that had some of the highest profit margins.

Check out the first company...

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6–7, 2015, or MD&M East in New York City, June 9-11, 2015.

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

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Image from Flickr