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Drones Could Give Heart Patients Fast Access to Defibrillators in Remote Areas

In the future, aerial drones could be used to deliver defibrillators and other medical devices to patients in remote areas, according to Definetz, a German non-profit organization. The group is developing a medical drone called Defikopter. After being launched by a specialized smartphone app, the drone can fly a defibrillator to a heart attack victim, allowing for fast treatment.

Aerial drones could provide a new means of delivering medical devices like defibrillators. Image credit: Height Tech

When an individual launches the Defikopter app, the app sends the GPS coordinates of the victim over a cellular data connection. Based on these coordinates, a drone will be dispatched to a person's location. A drone can fly approximately 40 miles per hour. A single drone could traverse an area with a radius measuring six miles; it could potentially reach a patient anywhere in that area in 4.5 minutes or less.

While the invention has received praise from medical services in Germany, the system is still under development. As of now, Definetz and its partner Height Tech haven't issued further information about the release of the device.

"We'll have to see how much these drones can help," notes one representative for the German emergency services union. According to one German news site, the system will carry a price tag of $26,000.

For now, using the device could be a problem. Since all unmanned flying vehicles in Germany must be supervised, an automated aerial drone would not be legal under existing laws.

 

Under-the-Skin ICDs Fare Well in Limited Study

According to a new study published in Circulation: Journal of the American Heart Association, subcutaneous implantable cardioverter-defibrillators (ICD) are safe and effective.

In the study, researchers noted that the S-ICD was able to meet both its trial and primary endpoints. Over the course of six months, complications associated with the device were approximately 1%. In addition, the device achieved acute ventricular fibrillation conversion in 100% of trial participants.

Based on these results, researchers conclude that subcutaneous ICDs are a viable alternative to traditional transvenous systems. These systems hold potential for patients who aren't in need of pacing therapy for ventricular tachycardia, bradycardia or heart failure.

"The results of the present study indicate that the subcutaneous ICD is a viable alternative to transvenous systems among patients who do not require pacing therapy for heart failure, bradycardia, or ventricular tachycardia," noted researchers.

While results are considered positive, there has been criticism of the available evidence over endpoint termination of induced verus spontaneous ventricular fibrillation. In addition, the six-month followup period was criticized for being too short.

"Although these data are reassuring and comparable to transvenous ICD success rates, the overall number of treated episodes is incredibly small in comparison with the data on transvenous defibrillator therapies delivered outside the hospital, over the life of the device, that are available for analysis in tens of thousands of patients," notes Dr. Leslie Saxon in an editorial that accompanied the published results.

Millions of Manufacturing Jobs Could Return to United States

By 2020, the United States manufacturing sector could add up to five million jobs, according to the Boston Consulting Group. The report, released on Tuesday, states that outsourcing will change to "resourcing." This represents a migration of manufacturing jobs from China and other BRICs back to the United States.

In total, the report notes that the total number of manufacturing jobs added by 2020 could range from 2.5 million to 5 million. If the 5 million jobs figure holds true, this could represent a 2% to 3% drop in unemployment in the United States.

A recent article in Design News comes to a similar conclusion, arguing that new technologies such as "three-dimensional vision, offline programming, and force-sensing technology being used in robotic automation systems" are reducing the need to offshore production; they are in fact, leading to an increase in domestic jobs.
Over the past two decades, the manufacturing sector in the United States has lost approximately 5 million jobs. As of now, approximately 12 million people in the United States are employed in manufacturing.

While the 2007-2009 recession affected many different parts of the United States economy, one result was stagnant labor costs. On top of this, the United States experienced a significant increase in energy production. These factors have both contributed towards an increase in domestic manufacturing. With low energy costs and low labor costs, the United States may experience a resurgence in manufacturing.

Another report by the Manufacturing Alliance for Productivity and Innovation stated that the trade gap of $227 billion during the first half of this year is equal to the trade gap during the first half of 2012. This could indicate that the trade gap is leveling off.

Still, the reshoring phenomenon may be overhyped--at least in the medical device industry, where the hurdles to commercialize medical devices have become especially challenging in recent years.

Covidien, for instance, has been steadily increasing its level of offshoring over the years. In 2008, 10% of its manufacturing was performed in low-cost nation. It was 14% last year.

"Growing cost concerns among [medical device] OEMs is driving more production to Central America and Asia," explained Phillips-Medisize CEO Matt Jennings at MD&M West in Anaheim this year (as quoted in Pastic News).

The August 2013 Layoff List

While the summer months may be coming to an end, companies and their workforces are always in a constant flux. In August, a significant number of medtech companies have announced restructuring initiatives.
 

  1. Mela Sciences stated that it would lay off 25% of its staff following a disastrous second quarter. In addition, the company announced that it would restructure its existing operations. Mela Sciences manufactures a skin cancer detection device, dubbed MelaFind. In part, the company believes that its poor second quarter was due to an over-saturated sales force.
     
  2. Volcano Corp. also announced layoffs earlier this month. Starting this September, the company will terminate 39 positions. In March of 2013, Volcano Corp reported a workforce of 280 employees in its Rancho Cordova facilities. Over the past few years, the company's workforce has been on the decline. In 2011, the company had a workforce of 570 employees. One year before that, Volcano had a workforce of 685 employees.

    The company manufactures a variety of devices for the treatment of vascular diseases. Volcano's product lines include catheters and intravascular guidance technologies. In addition, the company manufactures ultrasound consoles and disposable imaging catheters for use in ultrasound labs. These systems are designed to diagnose the severity of cardiovascular disease. Volcano also manufactures pressure guidewires, flow guide wires and functional management consoles.
     
  3. Thermo Fisher Scientific. On August 8th, Qmed reported that Thermo Fisher Scientific (Waltham, MA) laid of 150 of its employees in lab products, 80 positions in analytic techonlogies and 110 employees in speciality diagnostics. Combined, these cuts represent $12.8 million in severance costs. This comprises more than half of the company's $21.5 million in restructuring charges, first disclosed in Q2.

    Thermo Fisher branded the latest layoffs as a "headcount reduction and facility consolidations." While restructuring has played a prominent role at Thermo Fisher over the past year, the company is looking towards the future. In early 2014, the company plans to complete the acquisition of Life Technologies. However, that acquisition will take some financial maneuvering. To do this, the company has raised $2.2 billion in a stock sale. In addition, the company will use $4 billion in equity financing and $10 billion in debt / cash to cover the deal.
     
  4. CareFusion also announced a restructuring initiative. While CareFusion's initiative has resulted in some divisional staff reductions, the net impact has been an increase in jobs.
     

For more on recent layoffs:

Covidien Invests $21M to Open New R&D, Training Center in South Korea

Covidien Invests $21M to Open New R&D, Training Center in South Korea

Covidien announced Tuesday that the company is opening its first research and development, and training center in South Korea.

Called the Covidien Center of Innovation Korea, the nearly 20,000-square foot facility will cost $21 million over three years. It will incorporate surgical labs with 11 operating stations, an intensive care unit lab and state-of-the-art technology to help train physicians who will learn more about Covidien's devices and technologies.

Physicians affiliated with Korean Surgical Society and the Korean Society for Thoracic & Cardiovascular Surgery will start training there as part of memorandum of agreements that Covidien signed earlier this year with the two groups.

“Korea is a key market in our global strategy, and this investment is a reflection of our commitment to partnering with Korean healthcare professionals," said Mr. Brian King, Covidien's president of Emerging Markets.

The opening of the Korea facility comes a little over a year after Covidien announced the official opening the $45 million China Technology Center, a R&D facility in Shanghai. 

But Covidien is not the only medical technology company that is keen to capitalize on emerging markets and focus on local R&D, amidst a challenging U.S. market environment.

Last August, Medtronic also announced the opening of an R&D center in Shanghai. In March 2011, St. Jude Medical opened a technology training center in Beijing. In June 2011, Boston Scientific announced a five-year, $150 million investment in China that included the development of a training center.

[Photo Credit: iStockphoto.com user ssiltane]

-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com
 

Four IVD Devices Influenced by Consumerization

The design of IVD devices, especially those intended for use at the point of care or at home, is getting sleeker, more compact, and more intuitive: just like that of their consumer-electronic cousins. Occupying a footprint smaller than the proverbial bread box and requiring little, if any, expert knowledge to operate, the IVD devices of today and tomorrow will cause you to draw unavoidable comparisons between them and your personal, handheld electronic devices.

Four such products—three already on the market here in the United States and one recently developed by a venture-capital-backed start-up company—are the iBGStar blood glucose monitoring system by Sanofi, the OraQuick In-Home HIV Test by OraSure Technologies, the Alere INRatio2, and Bio-Meme’s smartphone-based PCR device, respectively.

iBGStar by Sanofi
iBGStar by Sanofi

1. The iBGStar blood glucose monitoring system consists of the iBGStar blood glucose meter and iBGStar Diabetes Manager app and was made commercially available in the United States last summer. Sanofi says the device is the first FDA-cleared blood glucose meter that directly connects to a smartphone and iPod touch. 

Shiv Gaglani, editor of Medgadget, curator of The Smartphone Physical, co-founder of medical-education-technology start-up Osmosis, and speaker on consumer-driven design concepts and developments at the upcoming MD&M Chicago tradeshow and conference says of the iBGStar, “By nature of bringing blood glucose monitoring to the smartphone, it is highly consumerized. Many IVD devices are complicated or relatively inconvenient to use, which is why the smartphone provides a unique opportunity and has led to the mobileization of many of these devices.”

2. OraSure Technologies’ OraQuick In-Home HIV Test is the first over-the-counter home-use rapid HIV test kit to detect the presence of antibodies to human

OraQuick In-Home HIV Test
OraQuick In-Home HIV Test

immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). It is designed to allow individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, then place that sample into a developer vial and obtain test results within 20 to 40 minutes.

OraSure developed a flip-up laptop design for this test, reminiscent of a notebook or laptop computer. By building the test stand into the actual box, the design “allowed for a more robust testing platform and enabled users to flip through step-by-step instructions as they conducted the test,” write Lucy Sheldon, Karen Unterman, and Mick Withers in an MD+DI article on home-use IVDs. Another change implemented was the modification of the developer vial cap. “This was altered to add thumb indentations to the cap, making it easier for the consumer to open the vial without spilling the solution,” Sheldon, Unterman, and Withers add.

3. After Medicare approved home PT/INR use in 2009, new consumerized versions of PT/INR meters were designed to

INRatio2 by Alere
INRatio2 by Alere

transmit data wirelessly to computers and, ultimately, physicians. The resultant Alere INRatio2 device for anticoagulation management is small, unintimidating, and reminiscent of an iPod in its user interface. A fingerstick sample is placed on a test strip that performs both the test and the quality controls, and results are provided in about one minute.

(Alere also just this month received FDA approval to market its Determine HIV 1/2 Ag/Ab Combo for the detection of HIV-1 p24 antigen and antibodies to HIV-1/HIV-2.  The lateral-flow test is the first and only FDA-approved rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear days after infection and prior to HIV-1/2 antibodies.)

4. On the horizon, and possibly representing the future of molecular diagnostics, is an IVD device currently in development that acts as a smartphone-based PCR machine for point-of-care diagnostics. The device, by start-up Biomeme and brought to my attention by Gaglani, “turns your smartphone into a

Biomeme's smartphone-based PCR machine
Biomeme's smartphone-based PCR device

convenient, low-cost lab for quick DNA diagnostics and on-site disease tracking,” according to Biomeme’s website. Among its many potential benefits touted on the site are mobility, professional-caliber DNA lab diagnostics at low cost, connectivity, accuracy via qPCR, and ease of use.

Writer Chris Velazco of TechCrunch.com describes the operation of the device this way:

“Once you’ve connected your smartphone over Bluetooth, you slot it into the mobile PCR machine. Then you crack open a test kit that’s designed to detect different diseases (sold separately, think of it as health-conscious twist on the old razor-and-blade model) and do a bit of pipetting. After a bit of sample test prep — co-founder and bizdev lead Max Perelman says ‘even VCs’ have been unable to screw up the process—you load the sample into the top of the machine and wait for your results.”

Maureen Kingsley

See Shiv Gaglani's talk on consumerization in medical technology live and in person; register for MDM Chicago Exposition & Conference here

Graphene Nanocomposite Is Hundreds of Times Stronger than Metal

An international team of researchers have developed a nanocomposite of graphene and copper that is 500 times stronger than pure metal. A related material, which fuses graphene and nickel, is 180 times stronger. The scientists, most of them hailing from Korea Advanced Institute of Science & Technology (KAIST; Daejeon, Korea) created the material by layering the metal with monolayer graphene. To accomplish that, they used chemical vapor deposition to create what is reportedly the first metal-graphene multilayer composite. If the material succeeds in being commercialized, it could enable the production of components with an unprecedented strength-to-weight ratio.

The researchers tested the materials using micro-compression tests with transmission electronic microscopes and molecular dynamics simulation.

As the researchers explain in an abstract:

Graphene is a single-atomic-layer material with excellent mechanical properties and has the potential to enhance the strength of composites. Its two-dimensional geometry, high intrinsic strength and modulus can effectively constrain dislocation motion, resulting in the significant strengthening of metals. Here we demonstrate a new material design in the form of a nanolayered composite consisting of alternating layers of metal (copper or nickel) and monolayer graphene that has ultra-high strengths of 1.5 and 4.0 GPa for copper-graphene with 70-nm repeat layer spacing and nickel-graphene with 100-nm repeat layer spacing, respectively. The ultra-high strengths of these metal-graphene nanolayered structures indicate the effectiveness of graphene in blocking dislocation propagation across the metal-graphene interface. Ex situ and in situ transmission electron microscopy compression tests and molecular dynamics simulations confirm a build-up of dislocations at the graphene interface.

Previous research to create similar composites of graphene and metal have not been as successful as the KAIST's researchers.

With a tensile strength 200 times stronger than steel, graphene is itself the strongest material known to man. So strong, in fact that a sheet of the material as thick as plastic wrap could withstand an elephant standing on it. As Columbia University professor James Hone has explained, such a sheet would not break unless the elephant's weight was concentrated to an area the size of the tip of a pencil.

In a separate research project, Columbia professors James Hone and Jeffrey Kysar showed that crystalline graphene threads could be stitched together to for structures nearly as strong as pure crystalline graphene.

Why Abbott Shelled Out $310 Million for IDEV

Abbott Lab's vascular products represent an important part of the company's business, but the company's traditional stent portfolio has been less than stellar recently. That may change in the future as the company is working to stay on the cutting-edge of technology and has emerged as an innovator in the bioresorbable stent space, for instance. The company is also setting its sights on a new target: metal-based stents that differ dramatically from conventional stents produced from thin tubes. The company recently acquired stent technology developed by IDEV Technologies Inc. (Webster, TX), which is made using a braided-wire manufacturing technique. As a result, the stent is able to offer both high strength with flexibility. The latter characteristic enables the stent to be used in arteries that are subject to substantial flexion, such as in the superficial femoral artery in the thigh or the proximal popliteal artery, which gives blood to the knee joint and leg muscles.

Recently, Abbott closed a deal to acquire the company for $310 million as they see a bright future for IDEV's Super Veritas stent, which has passed regulatory muster in Europe for treating blood vessels blocked by peripheral artery disease. The company is undergoing pre-market approval review in the United States, where the device is now cleared only for the treatment of biliary strictures.

With the conventional stent market having matured, the treatment of peripheral artery disease may be a significant opportunity for Abbott. There are, according to the Lancet, 200 million people internationally with PAD, which is frequently treated with medication. "Peripheral artery disease is a significant and growing health concern around the world, raising the need for new and effective treatment options," explained Chuck Foltz, senior vice president, vascular, Abbott in a statement.

The Supera may be such a new effective treatment option. A recent clinical study found that primary patency in a clinical trial involving the Supera was 87.7% at 12 months. The stent's proprietary design makes use of nitinol, but unlike currently available self-expanding nitinol stents, the Supera Veritas offers sufficient strength to support blood flow while simultaneously providing flexibility and resistance to kinking fracturing. According to the company, the Supera is the first in a new line of stents dubbed vascular mimetic stents.

In an interview with MPMN last year, IDEV's president and CEO explained how the stent is developed:

Supera is designed from six wires that are woven around a mandrel to create a stent structure. This stent structure exhibits both strength and flexibility. Because of this feature, it has the ability to adapt to and mimic vessel anatomy. In contrast, nearly all other stents in the marketplace start from a stiff hollow tube. Those stents are laser cut from the tube, and the final design does not enable the device to exhibit a high level of both strength and flexibility. Thus, if you want more strength, you have to leave metal in, but you then lose flexibility. And if you want more flexibility, you have to take metal out, but you then lose strength.

HIPAA vs. The NSA: Who Wins When Medical Devices Are Concerned?

In light of the IRS, NSA, and Justice Department Scandals, the efficacy of the privacy protections contained in the Health Insurance Portability and Accountability Act (HIPAA) has been called into question, wrote blogger Westby G. Fisher, MD, FACC in June. Fisher goes on to point out that the U.S. Department of Health and Human Services is enforcing privacy restrictions contained within the new Health Information Technology for Economic and Clinical Health (HITECH) Act, pointing to the case of Blue Cross Blue Shield of Tennessee, which paid HHS $1,500,000 for a data breach. He goes on to argue that the government is using such settlements as "a funding tool for our government health care administration disguised as a beneficent effort to protect the health care data of our populace." (For the record, the IRS is facing a lawsuit alleging that it wrongly seized 60 million personal medical records.)

Fisher's claim that HIPAA fails in offering solid privacy protections seems well warranted, however. HIPAA, which was first enacted in 1996 by President Bill Clinton and the United States Congress, was designed to protect workers' health insurance coverage when they change or lose employment. HIPAA also requires national privacy standards for electronic healthcare transactions.

Under HIPAA, protected health information (PHI) may only be transmitted without a patient's express written authorization to facilitate payment, treatment or healthcare operations. Other disclosures of PHI require written authorization.

While the Privacy Rule does protect patient health records in most cases, private information can be disclosed under certain terms. For instance, HIPAA does not protect a patient's medical records from the National Security Agency and other law enforcement entities. The department of Health and Human Services explains that note that patient health information can be transmitted "to federal officials authorized to conduct intelligence, counter-intelligence, and other national security activities under the National Security Act (45 CFR 164.512(k)(2)) or to provide protective services to the President and others and conduct related investigations (45 CFR 164.512(k)(3))."

Perhaps more relevant is the growing connectivity between medical devices and consumer devices like smartphones and tablets. As Smarthphone Physical Shiv Gaglani curator has explained, "I don't see wearable technologies working without synching to a phone. And because of the recent news with Snowden and NSA, there could be a growing backlash to having devices that interface with implantable or external health tracking devices. "I think 90 to 95% of the population thinks that convenience outweighs privacy concerns," Gaglani says.

FDA Clears PSI Shoulder System by Zimmer

Zimmer (Warsaw, IN) received clearance from FDA regulators for its Patient Specific Instruments (PSI) Shoulder system. The system uses a 3D visualization tool with the Trabecular Metal Reverse Shoulder implant to create an operational plan for surgeries. According to the company, the new device can make device placement easier.

Zimmer's PSI Shoulder entered the European market in May of this year. The company's Trabecular shoulder implant has been available for approximately two years. The Trabecular Shoulder implant uses the same technology found in hip and knee implants. As a porous bone implant, Zimmer's Trabecular Metal technology can promote biologic ingrowth. At the same time, the system promotes optimal function and overall stability.

"Reverse Shoulder Arthroplasty has helped restore function and alleviate pain for thousands of patients each year," noted Roberto Munoz, vice president of Zimmer Extremities. "But the primary challenges remain on the glenoid. With PSI Shoulder, we present our surgeon customers with a powerful new tool to plan the glenoid side of the surgery with the patient's unique anatomy in full view and functional needs in mind..."

When used with the company's planning software and patient-specific instrument guides, the PSI system is designed to match patients' specific anatomy, while providing the appropriate level of porosity and a friction to support ingrowth into the the glenoid bone.

In the first half of the year, Zimmer reported net sales of $1.7 billion. This represents a 4% increase over the first half of 2012. However, the company faces a $228 million one-time payout following the loss of a patent lawsuit against Stryker. The lawsuit alleges that Zimmer's Pulsavac Plus infringes on Stryker's intellectual property.