Remember back in the fall of 2011 when GE committed $1 billion to cancer research and development? A new video put out by the GE Global Research Center commemorating National Cancer Research Month gives a glimpse into some of the work the multidisciplinary research team is doing along several points in the continuum of care for cancer, from diagnosis to remission.

Much of the technology discussed is imaging-focused, but among other interesting developments is molecular pathology technology that would look at more than 60 disease markers in a patient’s tumor and help physicians gauge the aggressiveness of a tumor and what kind of treatments the patient might respond to.

On the treatment side, researcher Reginald Smith says a team is developing new tools for the implementation of emerging targeted, cellular therapies in cancer. Last year, GE opened a new cell science lab in Wales and told Outsourcing-pharma.com that it was working on technologies for multiplying cells and determining the toxicity of drug candidates.

There’s one point noticeably missing from the GE’s “continuum of cancer treatment,” and that’s prevention. But over the past few years, the healthcare side of the company has been making a modest effort there with its annual #GetFit campaign. It’s a social media-driven public awareness campaign created to promote healthy habits that can reduce the likelihood of developing cancer.

[Screen cap and video from CE GRC]

Researchers from Brigham and Women’s Hospital made the discovery that the clay known as synthetic silicate nanoplatelets could be induce stem cells to become bone cells without the addition of other materials was published in Advanced Materials this week. Akhilesh Gaharwar of the BWH division of Biomedical Engineering, the study’s first author, said it could be used to develop therapeutics for bioengineering and eventually speed up recovery times.

The National Institutes of Health, U.S. Army Engineer Research and Development Center, Institute for Soldier Nanotechnologies, and the National Science Foundation. funded the research, according to the Harvard Gazette.

With more baby boomers reaching retirement age and beyond there’s a need for a new generation of devices and therapeutics that can improve recovery times from fractures. Having an organic source of bone, albeit in the very early stages of development could also be appealing to the medical device industry which has been plagued by lawsuits over problems with metal hip implants.

Another bone related innovation occurred earlier this year, when a a skull implant developed by Oxford Performance Materials with the help of 3-D printing was used to replace 75 percent of a man’s skull. The OsteoFab Patient Specific Cranial Device is made from a high performance polymer that’s biocompatible and mechanically similar to bone.

[Photo credit BigStock Photo surface cracked clay]

Here are some industry insiders who offer a wide variety of perspectives on genetic testing and genome analysis from professors and public health directors to scientists and entrepreneurs.

Misha Angrist (@MishaAngrist) is an assistant professor with the Duke Institute for Genome Sciences & Policy.

Daniel MacArthur (@dgmacarthur) heads a lab at Massachusetts General Hospital and the Broad Institute @broadinstitute to extract information from human DNA sequence data.

Justin H. Johnson (@BioInfo) is director of bioinformatics at @EdgeBio and tweets about genomics, biotech and science as a service.

Dr. Muin Khoury (@DrKhouryCDC) is the director of the Centers for Disease Control and Prevention’s Office of Public Genomics.

Kenna Shaw (@kennamshaw) is the director of The Cancer Genome Atlas program. Set up by the National Institutes of Health, it’s a collection of multidimensional maps of genomic changes in major and subtypes of cancer, and serves as a resource for researchers to develop better ways to diagnose, treat and prevent these cancers. It’s jointly led by the National Cancer Institute and the National Human Genome Research Institute.

Deanna Church (@deannachurch) is a staff scientist at the National Center for Biotechnology Information at the National Institutes of Health with a focus on genetics and genomics.

Saskia Sanderson (@SCSanderson) is an adjunct assistant professor at @IcahnInstitute and @MountSinaiNYC who does research on the psychological impact of personal genomics.

Dr. Michael Pellini (@MichaelPellini) is the CEO of Foundation Medicine, a cancer diagnostics company bringing comprehensive cancer genomic analysis to routine clinical care.

Dr. Stefan Gruenwald (@sgruenwald) is a co-founder and chief technology officer for Diagnomics, a genome-sequencing service provider.

Telecomm giant Qualcomm Technologies Inc. is no stranger to the world of connected health, but its interest in healthcare actually reaches much further than that.

Today, Qualcomm CTO Matt Grob was a panelist on the first in a series of science and tech-focused Google+ Hangouts organized by the Obama administration called “We the Geeks.” He shared why the company is taking part in the $100 million BRAIN Initiative unveiled by the White House in April.

Hailed as the country’s next Grand Challenge, similar to the Human Genome Project, the initiative will link and fund public and private projects to deepen researchers’ understanding of how the brain works.

“It turns out, a number of the fundamentals of communication theory and information theory that we are familiar with at Qualcomm intersect with certain branches of neuroscience, and it’s actually a quite good match,” Grob said.

In fact, Qualcomm has quietly been working in neuroscience for at least a few years through one of its portfolio companies, Brain Corp. The company is creating what Grob called “neuromorphic hardware,” or processors designed with inspiration from the biology of the brain. Ultimately, it wants to create smart consumer products powered by these “artificial nervous systems.”

“While we do that [...] we create a set of tools and simulation capabilities and authoring tools that we think will be useful to (those in) the community that are participating in BRAIN initiative,” Grob added.

Of course, this isn’t the only Grand Challenge that Qualcomm is getting in on. It’s also paired up with the X Prize Foundation to host the $10 million Tricorder XPRIZE.

Meanwhile, it’s also continuing a push into connected health with its acquisition of HealthyCircles earlier this month, to boost its cloud-based data hub for remote monitoring devices called 2net. “There’s a lot of very innovative startups out there and small companies that are producing medical sensors of all kinds, and it’s always a challenge for them to then connect their device wirelessly,” Grob said. “We’re trying to make that a lot easier for them.”

[Photo from FreeDigitalPhotos user samuiblue]

The discussions about a potential sale of the Roche unit are still in their early stages and a deal may not materialize, one of the people said.

Earlier this year, the Centers for Medicare & Medicaid Services announced it was cutting the reimbursement for diabetes test supplies by up to 72 percent. That would make it more difficult for companies to be profitable in this space, said another of the sources.

The change takes effect July 1.

It could not be learned how much the Roche unit was worth. All the sources wished to remain anonymous because the matter is not public. A Roche spokesman declined to comment.

Last year, Bayer AG, Germany's biggest drugmaker, attempted to sell its blood glucose meter business for around $1.5 billion, only to pull the plug on the sale early this year after failing to find sufficient buyer interest.

There are only a handful of companies that sell blood glucose meters, including Medtronic Inc and Johnson & Johnson, that would make logical buyers, two of the people said. (Reporting By Jessica Toonkel, Editing by Soyoung Kim)

Angeline Jolie’s disclosure of her double mastectomy has drawn the mainstream media’s attention to genetic testing, a recent medical advancement with huge, albeit challenging, implications.

Many experts predict that genetic testing is on its way to becoming a routine part of clinical care. Already, genomic tests have been developed for more than 2,200 diseases — many of them rare genetic disorders. But a growing number are being developed to look for mutations in numerous genes that may affect a person’s risk for cancer.

Despite the fact that most cases of cancer are not inherited, this has been a likely place for commercial activity because cancer is so prevalent and there’s already so much research going on. The National Cancer Institute, for example, launched the Cancer Genetic Markers of Susceptibility project in 2005 to identifying common inherited genetic variations associated with various types of cancer.

Commercial applications started in women’s cancers, with tests for mutations in BCRA1 or BCRA2 associated with breast and ovarian cancers, but now span a few other kinds that are overlooked. It’s important to remember, though, that there are still many questions around the actual value of these pricey tests.

Colon cancer – Several genes have been linked to increased risk of developing two kinds of colon cancer: familial adenomatous polyposis and Lynch Syndrome. But still, genetic mutations likely account for only 5 to 6 percent of colorectal cancer cases overall, according to the NCI. Some patients with these genes may opt to have preventive surgery, which involves removal of some or all of the bowel.

Myriad Genetics offers a test called Colaris and Genomic Health Inc. markets Oncotype DX Colon Cancer to look for gene mutations associated with Lynch syndrome. A company called Ambry Genetics has also developed a next-generation sequencing panel that looks for mutations in 14 genes associated with colon cancer.

Prostate cancer – About 5 to 10 percent of cases are believed to be due to inherited genetic factors. Some experts think genetic testing could be especially helpful in prostate cancer, which is often associated with over diagnosis and overtreatment.

The first test on the market was Prolaris by Myriad Genetics Inc. Last week, a new test from Genomic Health, designed to gauge the aggressiveness of prostate cancer, made headlines when it hit the market. Both reportedly cost more than $3,000.

[Photo from Flickr user dancentury]

South Carolina is joining the ranks of Massachusetts and New York in formalizing a partnership that could benefit local biomedical and health IT companies by allowing them to tap into scientific innovation happening in Israel, a nation rich with promising technology startups.

Under the partnership, research entities in the state and the nation will support joint R&D projects between Israeli and South Carolina companies and universities. The S.C. Research Authority and MATIMOP, the Israeli Industry Center for R&D , have both reportedly set aside $1 million to invest in high-tech collaborations in six industries where both regions excel: biomedical, sustainable systems, transportation, health and insurance IT, defense and homeland security, and advanced materials.

“These are things we already have expertise in, and we found a lot of companies there that were a really great fit with some of the things we were already working on,” said Micki MacNaughton, spokeswoman for SCRA.

As another example of the burgeoning relationship, SCRA’s technology venture arm announced a first-round investment in Israeli company NeuroQuest, which is developing blood-based immune biomarkers to enable earlier detection and treatment of Alzheimer’s disease and Lou Gehrig’s disease. According to SCRA, the company is preparing for a clinical study of its diagnostic test with the Harvard Clinical Research Institute and other U.S. research centers.

MacNaughton said the investment in NeuroQuest wasn’t directly tied to the new partnership, but is an example of the continued collaboration with Israel.  She declined to disclose the amount of the investment, as it was just approved at SCRA Technology Ventures’ SC Launch program’s board meeting last week and was still being finalized.

Following other recent investments from U.S.  investors including InterTech Group and the Maryland/Israel Trendlines Fund, NeuroQuest is also establishing a clinical development facility in Charleston.

Tom Glaser, president of the American-Israel Chamber of Commerce, Southeast Region, which works to boost relationships and business opportunities between Israel and southeastern U.S. states, noted that Vaya Pharma is another medical company that established a U.S. headquarters in the state.

“For South Carolina, this (partnership) means a pipeline of really exciting technologies from Israel and companies that all want to expand into the U.S. market but need to have a foothold somewhere,” Glaser said. “South Carolina companies are engaging in R&D with Israeli companies, they’re engaging in partnerships of all kinds, they’re investing in Israeli companies. On the other side, Israeli companies are partnering and looking for clinical relationships — thought leadership, advisory boards and connections to the big players.”

[Herzliya, Israel photo courtesy of Flickr user RonAlmog]

PARIS (Reuters) - France's Carmat has won approval to proceed with the first human implantations of its artificial heart in four countries, the company said on Tuesday, sending its shares up 25 percent.

The approval were given by the four international cardiac surgery centers in Belgium, Poland, Saudi Arabia and Slovenia, where the tests will be carried out, but not in France, where Carmat's artificial heart is still to gain approval from the drug safety agency, ANSM.

Shares of Carmat rose 24.56 percent at 12.12 GMT to 129.5 euros, valuing the company at 535 million euros ($694.56 million).

Among Carmat's competitors are privately-held SynCardia Systems and Abiomed Inc., both of the United States.

The approval is "good news" that allows the French medical devices maker "to make progress on the subject of human implantation despite the growing demands of the ASNM," Portzamparc analysts wrote in a note.

The French regulator has asked Carmat to test the device on animals before it can allow implantation in humans.

"The patient selection process and the training of the clinical teams are ongoing in these four countries (...) Implantations could start shortly following the completion of the training," Carmat said in a press release.

Developed by a team of engineers from Airbus parent company EADS, the Carmat devices - expected to cost 150,000 euros ($193,600) each - mimic heart muscle contractions with two micro pumps, one for each ventricle or heart chamber.

"Carmat expects to receive additional approvals in a near future, potentially in France and in other countries," Chief Executive Marcello Conviti said in the press statement.

Last October, Carmat had said it expected to seek approval for its artificial heart from French authorities by the end of the year, enabling it to carry out its first implant in early 2013.

($1 = 0.7703 euros)

(Reporting by Alice Cannet; editing by James Jukwey)

Mike Dunkley

The reality, however, is that most of these new technologies fall by the wayside before they get to market. That’s because the way they are designed has not kept up with the times in order to meet the market’s demands for fast time-to-result, ease of use, and high degree of reliability.

Mark West

A researcher’s primary objective may be to advance scientific understanding or to perfect the assay performance, while engineers may be pre-occupied with automation and regulatory compliance. The knowledge-gap between the two groups may simply be too big for one group to anticipate or question the requirements of the other and the lack of alignment of goals may not steer the development effectively. In order to get scientists and engineers working towards a common objective, it is necessary to bring in a third discipline – design – to establish the vision for the ideal product early in the process.

At Continuum, we call that ideal user experience the “lighthouse” — and make it the ultimate goal when we develop a diagnostic tool for a clinical setting. It’s important to define the long-term goal so you can think through the implications of your decisions early on in the process of development of the technology—ideally after you establish ‘proof of principle’ in the lab, but before you lock in any key architectural decisions. As the scientists in the lab meet the key forks in the road where they must make decisions on how to implement their assay, they can take into account the ideal experience of users in a clinical setting.

That development requires an understanding of several key factors, including where device will be used, the skill of the users, the time necessary for results, and the cost of the test. At the same time, the ideal experience represented by the “lighthouse” must be balanced by what is technically feasible. Depending on these factors, there must be a creative give-and-take that might sacrifice accuracy, portability, or up-front cost depending on the most successful solution for usability.

For example, when we worked with Daktari to create an HIV test for use primarily in rural sub-Saharan Africa, it was clear that fluorescent detection of CD4 cells was not suitable. Sensitive optics would never be rugged enough to survive transport in a backpack to remote villages. Instead, Daktari needed a solution that could be used at point of care by a relatively inexperienced clinician in sometimes difficult environments with high heat and humidity. Daktari understood that electrical detection of CD4 cells had the inherent robustness required for its intended application. Continuum engineers and designers used this robustness “lighthouse” to make smart architectural decisions for the device early on in the development of the assay – the result was a simple hand-held instrument with a unique disposable cartridge.

A similar process took place with the OraQuick rapid HIV test, which was approved for home use last year. To create a test that could be used quickly and easily in home by unskilled users, the parent company OraSure Technologies sacrificed some technical performance. It got to market because it successfully convinced the FDA that this solution was better than the “gold standard” because it would be used by people who would ordinarily not get tested at all, therefore increasing the number of people who could be diagnosed and treated, leading to a greater benefit to public health as a whole.

On the opposite end of the spectrum, we worked with Raindance Technologies to develop the RainDrop digital PCR (polymerase chain reaction) system for use in cancer research, knowing that sensitivity at one-in-a-million levels of detection would be paramount. In this case our “lighthouse” was to produce a dramatically simpler and more reliable instrument without sacrificing performance. R&D and product development teams collaborated to simplify complex flow controls by putting more technological features into the consumable cartridge that contained the sample. This eliminated pipetting robots and tubes, creating a streamlined bench-top device that could be more accessible to cancer research labs worldwide.

As these examples show, while it may be expedient to treat R&D and product development as sequential steps, superior products can result from a collaborative approach guided by a clear view of market needs. The solutions that win are those where the technology is a good fit to the eventual application. That means establishing a “lighthouse” early in the process to guide researchers, designers and engineers toward a common vision of the ideal product.

Mark West is a principal at Continuum, a global innovation and design consultancy, where he specializes in electro-mechanical product design and development with specific expertise in robotics, precision machine design, clinical diagnostics and life-science instrumentation.

Mike Dunkley is vice president of program development for Continuum Advanced Systems, where he is responsible for building successful client engagements in the design and development of medical devices, connected health applications, clinical diagnostics and life sciences instrumentation.

The illegal payments allegedly took the form of grants, rebates, conference fees, marketing assistance and free medical equipment that Bard provided between 1998 and 2006 to customers who used its brachytherapy seeds to treat prostate cancer, DOJ said Monday.

Hospitals submitted bills for the seeds to the Medicare program for the elderly, in violation of the False Claims Act, DOJ said.

A Bard spokesman did not immediately return a phone call seeking comment.

The civil settlement resolves a lawsuit filed in U.S. District Court for the Northern District of Georgia by whistleblower Julie Darity, a former Bard manager.

Darity will receive about $10.1 million as her share of the civil settlement, DOJ said.

Bard has agreed to pay an additional $2.2 million to the government and to take remedial steps to improve its compliance program as part of a non-prosecution agreement, DOJ said.

(Reporting by Susan Kelly in Chicago; editing by Andrew Hay)

Lately, the U.S. Food and Drug Administration seems to be doing a bit of re-branding: A new Patient Network site is anchoring a push for more patient engagement in the agency’s decision-making duties. There’s a good reason for that move, and it’s not just because everybody else is doing it.

“There’s this transition in thinking of the agency from a purely regulatory agency to embracing the public health mission of the agency,” said James Valentine, program manager with the FDA’s Office of Health and Constituent Affairs.

Since the 1990s, the FDA has recruited patient advocates to serve on advisory committees and as consultants to divisions that review new drugs and medical devices for approval. But Valentine said that over the past few years, patient engagement has become increasingly important.

Part of that has been driven by legislation: the Food and Drug Administration Safety and Innovation Act enacted last summer calls for expanded use of patients as consultants of review teams, and part of the Prescription Drug User Fee encourages patient-focused drug development practices.

But really, those are things that should be happening anyway. Traditional practices engage patient advocates when a drug or medical device reaches and advisory committee for evaluation. But the FDA sees an opportunity in bringing the patient voice into the conversation earlier, when they can provide input around the actual design of clinical trials. Patient input on unmet medical needs in a certain disease area, for example, could help determine what the most important clinical outcomes would be for a new drug being studied.

Then, once that scientific data is available, the agency needs patients to help interpret what a drug or medical device could, or could not do, for a certain disease community. Of course there are certain scientific requirements for a new drug or device, namely well-controlled clinical studies that demonstrate safety and efficacy, but Valentine said it has become more accepted that the benefit-risk judgment of a drug is truly that — a judgment.

“Are you at a point in a disease where you have no treatment and you just want anything, or is it something like in HIV/AIDS, where now the disease is manageable and you’re looking for a cure?” he said.  “When it comes down to final decision, we want input on what risk patients are willing to tolerate to get the benefits.”

In addition to boosting the patient representative program, the FDA also hopes its efforts will help it reach more of the less engaged patient population. Using the Patient Network site as a vehicle, it wants to do a better job of providing clinical trial information, FAQs and live interaction with FDA representatives to those who just have questions or are frustrated with their current treatments, so they can better understand the regulatory process and what their options are. (The site’s  next virtual town hall meeting happens next Tuesday at 3 p.m.)

“The next steps are to keep our ears to the patient community and see where there are areas that (the site) could be further developed as we hear from patients in areas where they want more information,” Valentine said.

In recent years, biomedical engineers have started to learn how to grow replacement body parts from living cells.

Now, Princeton University engineers have pushed the concept further, with a project that evokes the old Bionic Woman TV show.

They created an ear, shaped like a human's, with an antenna woven into the cartilage, which would let the user tune in to radio stations or even a cellphone.

The ear was created with a 3-D printer -- an increasingly common device that fashions objects by squirting out layer upon layer of material.

The project was not grafted onto anyone and was more a proof of concept than anything else, said research director Michael McAlpine, an assistant professor of mechanical and aerospace engineering. After all, it is unlikely that someone with a functioning ear would want to replace it just to have electronic capability.

"It seems kind of a little crazy," McAlpine said.

Still, a similar ear, minus the electronics, could be used by plastic surgeons on patients who need reconstructive surgery. And the bionic version gives a hint of what might be possible if we think of the human body as just a starting point, McAlpine said.

Previously, his lab has developed electronic "tattoos" that can be printed on teeth or skin to detect certain bacteria or biomarkers for cancer. He also envisions implanting patients with piezoelectric materials -- substances that can convert mechanical to electrical energy. So, for example, you might have a pacemaker that was partly powered by the rise and fall of your diaphragm muscle.

McAlpine and colleagues described their ear this month in the journal Nano Letters. The lead author was Ph.D. student Manu S. Mannoor. Other authors were from Johns Hopkins University and a high school: the Peddie School in Hightstown, N.J.

Ziwen "Jacky" Jiang, a native of Hangzhou, China, is in 11th grade at the private school, which has a special program enabling students to work in university labs. Jiang started working with the Princeton team last summer, designing the ear using computer-aided design software. "He's a very talented kid," McAlpine said.

The ear was printed with a combination of materials. The antenna was made from silicone and silver nanoparticles. The fleshy part of the ear was printed with a mixture of starch molecules and calf cells called chondrocytes. (An ear for an actual person would use cells taken from the patient.)

The cells were kept alive in a growth medium for several weeks. The starchy molecules were just a temporary scaffold. They dissolved and were replaced by collagen and other proteins secreted by the calf cells, giving the tissue a composition similar to animal cartilage.

Though the ear was not attached to a person, the team proved that the antenna worked -- testing it with a recording of Beethoven's F?r Elise. McAlpine said the electrodes could theoretically be attached to a patient's nerve cells, much like a cochlear implant.

"You and your wife could be sitting next to each other on a couch watching TV, but picking up different signals," McAlpine said.

--

Contact Tom Avril at 215-854-2430 or tavril@phillynews.com ___

Penn’s department of physics and astronomy are also collaborating on the project, funded by an $80,000 grant from the Kaleidoscope of Hope Foundation for ovarian cancer.

Research has shown that trained detection dogs and electronic devices can detect minute quantities of odorants that signal the presence of ovarian cancer, even before the cancer can be detected by current methods, according to a statement from Penn.

Tissue and blood samples collected by Penn Medicine will be used by the working dog center for training and analysis. The initial study will assess the ability of dogs and other sensors to detect the total odorant signatures that distinguish disease from healthy samples.

Cynthia Otto, director of the Working Dog Center and associate professor of Critical Care at Penn Veterinary school said: “By utilizing the acute sense of smell in detection dogs in conjunction with chemical and nanotechnology methods, we hope to develop a new system of screening for ovarian cancer using analysis of odorants to facilitate early detection and help decrease future cancer deaths.”

Ovarian cancer is the fifth leading cause of death among women. If caught early the survival rate is 90 percent but it usually is not diagnosed until it has progressed to later stages when it becomes more difficult to treat.

Although dogs are currently only detecting samples, the idea is that future studies will determine the most suitable tissue for evaluation and will measure odor differences among various tumor grades, according to the statement.

In addition to the ovarian cancer research at Penn, dogs are being trained to detect breast cancer and prostate cancer.

Medical implants like catheters and pacemakers can be a hotspot for bacteria, which grow in hard-to-treat films on the surface of such devices. Scientists and engineers are taking different approaches to changing the surface of implants so bacteria can't take hold. For example, some groups are developing polymer films with structures that prevent bacterial growth (see “Pillowy Antibacterial Polymers”), while others are developing coatings that slowly release antibiotic compounds over time (see “Safer Joint Replacements” and “Innovators Under 35, 2007: Christopher Loose”). And recently, researchers from Clemson University in South Carolina and the University of Southern Mississippi have described how a layer of bacteria-killing viruses could help prevent bacterial infections.

In a study published in Biomacromolecules, the investigators describe a new method for attaching bacteria-busting viruses, also known as bacteriophages, to plastic and Teflon-type materials. When a bacterium gets too close to these enemy-coated surfaces, a tethered bacteriophage can grab on and inject its genetic material into the bacterial cell where it is copied and turned into many more bacteriophage. Eventually, these virus copies burst open the bacteria, killing it. Each newly freed bacteriophage can then go on to infect more bacteria (the authors note that this “amplification effect” could make it hard to control the population size of the bacteria killers).

The researchers show that E. coli and the species of bacteria that causes staph infections can both be killed by tethered bacteriophages. The team writes that their method could work with most any surface and add that beyond fighting infections, their idea could also be used as a “technological platform for the development of bacteria sensing and detecting devices.”

NEW YORK (Reuters Health) - Publicly reported statistics about how patients fare after a common heart procedure often are inaccurate, says a new study that suggests publishing the poor quality numbers may do more harm than good.

The proportion of patients who die within 30 days of a medical procedure is sometimes used to gauge the effectiveness of the treatment, or of the hospital or doctor administering it.

After analyzing thousands of patient records at one U.S. hospital, researchers found that less than half of the deaths following percutaneous coronary intervention (PCI) - also known as coronary angioplasty - were related to the procedure.

That's far fewer than the number of deaths usually attributed to the surgery, which involves clearing a narrowed artery then inserting a mesh tube called a stent to prop the vessel open.

"I think what this really points out is that (with) the clinical complexity of medicine (it) can be tough to get a policy that's sort of one size fits all," said Dr. Karen Joynt, a cardiologist at Brigham and Women's Hospital in Boston.

Joynt, who was not involved with the new study but has done similar research, said there are a number of factors that determine whether or not a person dies after PCI - many of them unrelated to the actual procedure.

About 500,000 angioplasties are performed in the U.S. every year. It's often used in emergency situations, for instance to stop heart attacks caused by blocked blood vessels.

New York State first reported the number of people who died after PCI in its hospitals in 1991. Since then, Massachusetts and Pennsylvania started to report that figure as well.

According to the new study's authors, the U.S. Centers for Medicare and Medicaid Services have also proposed using the number as a quality measure, in the hope of improving patient care.

For the new study, researchers led by the Cleveland Clinic's Dr. Mehdi Shishehbor used patients' medical records to see whether deaths following PCI could be blamed on the procedure.

Out of 4,078 PCIs performed between January 2009 and April 2011 at one U.S. hospital, they found 81 deaths within 30 days of the surgery, representing 2 percent of patients who had the procedure.

Forty-seven, or about 60 percent, of those 81 patients died of a heart-related problem, but only 34, or 42 percent, of the deaths resulted from a complication of the procedure itself.

Previous research has attributed up to 60 percent of deaths following PCI to the procedure, but those figures were often based on causes of death listed on death certificates, which are frequently inaccurate, according to Shishehbor and his colleagues.

In the current study, based on close reading of every patient's chart, many of the deaths were among patients who were very sick when they got to the hospital and might have died with or without PCI, the researchers report in the Journal of the American College of Cardiology.

Fifty eight percent of the patients who died arrived in cardiac arrest, cardiogenic shock or with the most lethal type of heart attack, the authors point out.

But Joynt said doing PCI on these patients may have given them a better chance of survival, even though they ultimately died.

"That's the kind of overuse (of PCI) that we're probably willing to accept in many cases," she said.

However, Joynt's own research has suggested that hospitals avoid doing PCI in the sickest patients when their states start reporting the number of 30-day deaths.

In 2012, her study found that hospitals in Massachusetts, New York and Pennsylvania performed fewer PCIs - especially among the sickest patients who could possibly have benefited the most.

"Public reporting is a good thing and needs to be done, but when done incorrectly there are a lot of downstream consequences, such as denying patients treatment," said Dr. Duane Pinto, head of interventional cardiology at Boston's Beth Israel Deaconess Medical Center, who wrote an editorial accompanying the new study.

"We have to recognize and adapt to the unintended consequences of public reporting and fix them when we identify them," Pinto said.

SOURCE: http://bit.ly/10L9DPz Journal of the American College of Cardiology, online May 7, 2013.

BALTIMORE - A Linthicum, Md., firm is among several orthotics and prosthetics companies that will offer victims of the Boston Marathon bombing artificial limbs at no charge if their insurance doesn't cover all or some of the costs of the devices.

Dankmeyer Inc., founded by an amputee who lost a leg in a childhood skating accident, joined with other firms late last month in announcing the Coalition to Walk and Run Again. The companies have agreed not to charge victims who provide a doctor's note proving they don't have insurance to cover the devices, which cost $8,000 to $60,000.

Manufacturers of prosthetic components agreed to provide knee, foot and other parts to enhance the use of basic prosthetics. Some components will enable the amputees to run again.

"We hope this gives the victims peace of mind to know they will be able to have prosthetics - and not have to worry about if their insurance will cover it - so they can get back to their previous lifestyle," said Charles Dankmeyer, whose father started the company.

Erika Brannock, a 29-year-old teacher at a Towson, Md., preschool, is among those Dankmeyer hopes to help. Brannock had her left leg amputated, family members told The Baltimore Sun. She was at the race cheering on her mother when the explosion occurred.

Dankmeyer CEO Mark Hopkins said he has been in contact with friends of Brannock's about helping her with any costs. Hopkins said amputees can generally be fitted with a prosthetic a month after surgery to remove the limb.

Members of the coalition said it is too early to know how many people they will be able to help. The bombing killed three people, injured at least 264 and took the limbs of 14, according to The Boston Globe.

Dankmeyer and the other firms will cover the cost of the prosthetic but not doctor and physical therapy fees.

Advocacy groups say insurance doesn't always cover the cost of prosthetics. Some companies put a $1,000 cap on how much they will pay while others cover one device in a lifetime, according to the American Orthotic & Prosthetic Association. Prosthetics must be replaced every five to seven years.

In Maryland, the General Assembly passed a prosthetic parity bill in 2009 that removed caps and exemptions that made the devices costly for patients. Prosthetic parity legislation at the federal level has seen little movement in Congress.

The announcement by the orthotics and prosthetics companies comes as others have pledged to help the victims as well. Country star Kenny Chesney started the Spread the Love fund to help those who lost limbs. Proceeds from the sales of a single by that name will be used to help buy prosthetics and provide other care to amputees.

Each panelist named a clinical area ripe for innovation during a session at the Medtech Investing conference in Minneapolis on Wednesday.

Dr. Richard Migliori, chief of medical affairs for UnitedHealth Group, and Jim Epple, former chief operating officer of Blue Cross Blue Shield Minnesota, both said orthopedics.

“We have a continual need for improvements in that area and I would love to see more effective and more efficient options,” Migliori said.

As the only provider on the panel, Ken Paulus of Allina Health said he is looking for anything that will lower labor costs or lower the readmission rate.

Dr. Edmund Pezalla, the national medical director of pharmacy policy and strategy at Aetna, wants solutions for treatment of long-term, complex diseases that require people to be on medications for years.

“If we could get people off their meds, that would be a real breakthrough and offer a great return,” he said.

John Stenson, a principal at PricewaterhouseCoopers, and the other moderator of the session, closed the conversation by asking how entrepreneurs should start a conversation with payers.

Migliori’s answer was take credible data from credible studies to the medical policy side of the organization. Paulus agreed and said he wanted to see a case study done at a hospital or a doctor’s office, not at an academic medical center. He recommended starting with a vice president at a hospital or the medical director.

Pezalla said he would like to flip the conversation and have entrepreneurs ask payers and providers, “How can we solve some of your problems?”

The design challenge? The end users of the MIT engineering students’ project were living with disabilities in developing countries thousands of miles away.

“In a lot of places, the roads are really terrible, so if you have a hospital wheelchair, you can’t necessarily go anywhere in it,” said Mario Bollini, the chief technology officer of GRIT. Incidentally, many of these countries also have high disability rates.

This predicament necessitated three years’ worth of summer trips to Kenya, Guatemala, East Africa and India to test the chair, redesign it and then do it all over again. But it’s a good thing they took those trips because, according to Bollini, today’s market-ready version of the chair looks almost nothing like the original version.

“We scrapped most of the other parts of the chair after first testing abroad and went with the simplest thing we could think of,” he said. “We literally welded an office chair to wheels to test the levers and that actually worked really well.”

The removable levers give the user a way to propel the chair farther across rugged terrain. But they’re removable, so the chair can be used like a traditional wheelchair inside.

GRIT has just completed a pilot test of 100 Leveraged Freedom Wheelchairs in India and is working on the manufacturing component. “Right now, (the cost) is $200 to $250 per chair, depending on the quantity,” Bollini said. “As we scale up, that price will go down, but in most places that’s still way too much for a person with a disability to pay.”

So for now, the startup is working with nonprofits and charities that buy and donate wheelchairs to developing countries. The design and development work has been completed with about $250,000 in grant funding from the MIT Design Lab, MassChallenge and the Inter-American Development Bank.

“One disadvantage of our chair is that it doesn’t fold,” Bollini said when asked about other companies also working in this space. “But most of our riders don’t have cars, so that’s not really an issue. But if you’re in a really tight city where space is a huge premium, having folding is pretty important.”

He added that the MIT team has gotten feedback from Whirlwind Wheelchair International’s and Motivation, two other companies that make rugged wheelchairs. “The way that we all see it is that no one wheelchair is perfect for everyone, so the more people in that space the better.

Cyrus Morton gave this example of how patent law has changed under the new America Invents Act.

Passed in September 2011, the final phases of the America Invents Act went into effect in March. Cyrus Morton, a partner at the Minneapolis office of Robins, Kaplan, Miller & Ciresi said this law represents the biggest change since the 1950s.

“This bill spent eight years in Congress and finally got passed when this administration pitched it as a jobs bill,” he said.

At the MedTech Investing conference in Minneapolis on Wednesday, Morton offered seven tips for how medical device companies should manage intellectual property and patent applications under the new law.

• File early and often.

Morton recommended filing discrete applications and more of them.

• Do not disclose invention before filing.

Morton said the new law really is a pure first-to-file system.
“The best practice is to absolutely not publicly disclose an invention before filing an application,” he said.

• No foreign use or sale before filing.

What happens abroad now may bar patents in America.

• Monitor applications and patents in your field.

Morton said there is a new derivation proceeding that involves determining whether the person who files the patent first is the real inventor. “If you have employees who have left or if you have disclosed something at a trade show, watch to see if someone has stolen your idea,” he said.

• Documentation is still key.

Don’t throw out your inventor notebooks and keep documentation for R&D also. Morton said that trade secret protection is now more attractive, especially for companies with important internal processes.

• Use virtual marking.

The new law makes marking much easier by creating a virtual option. Now all companies have to do is put a list of all patent numbers for all products on the company website. Products must still be marked with “patent” or “pat.” False marking is greatly limited now and can be raised only by a party that suffers competitive injury.

• Be careful about statements of value.

Morton advised companies to assume everything except communications with trial counsel will be discovered and used against them in court, including:

• Internal email and documents
• Licensing discussions
• Confidential discussions with strategic partners and investor

He also recommended that companies define the value of IP in terms of what the value is at that moment. “The value of IP changes over time and that should be reflected in any documentation of value,” he said.

A “early stage vs. late stage” panel at today’s MedTech Investing conference in Minneapolis talked about what questions they ask when determining whether payers will reimburse new products and services.

Investors have to consider multiple definitions of “value,” out-of-pocket possibilities, and the possibility of shifting the reimbursement work to an acquirer.

Kirk Nielsen of Versant Ventures said that when Versant invests, they consider the possibility that with early stage companies, it may be an acquirer who fights the reimbursement fight.

“We need to be prepared to take it all the way, but we often hope that for early stage projects, someone else will do it,” he said.

Another option is the patient paying out-of-pocket for a new product. Nielsen said that Versant invested in LenSx laser for cataract surgery with the assumption that people will pay extra for the product, just as people have paid more for better options with Lasik surgery.

Josh Baltzell of Split Rock Partners said that the value proposition for portfolio company Entellus Medical was moving the site of care from surgery center to a doctor’s office. Entellus provides minimally invasive treatment for sinusitis.

“Removing overhead was key to our thesis,” he said.

Noah Lewis of GE Ventures said GE favors diagnostics investments because the conversation has shifted away from a single-point solution as the value proposition for a new product.

“It’s muddy waters out there and we are trying to solve multivariate equations,” he said.

Baltzell agreed that it is more difficult to categorize cleanly different companies and that a services component is a natural evolution of the industry. He said Split Rock is excited to look at opportunities that solve problems for more than one constituency.

By comparison, Guido Neels of Essex Woodlands said his company has avoided investing in diagnostics firms because of concerns about reimbursement.

“If you look at the trend, diagnostics companies don’t have the multiples at exits,” he said. “It’s highly dependent on reimbursement, which goes down fast as volume goes up.”

Researchers in labs are using all kinds of technologies that consumers most likely will never see. I got a glimpse into this fascinating underground world of sensors this week at the Body Sensor Networks conference in Cambridge. It’s a technical conference focused more the sensors themselves than the applications of them, but there were a few posters and presentations around applications that really stuck out.

Pharmaceutical clinical trials

I talked with someone from Hidalgo, a UK-based company that develops physiological monitors commercialized under the brand Equivital, who shared that the company had a growing pipeline of pharmaceutical customers looking for better ways to collect data from clinical trial participants.

The company was first approached by a Big Pharma that wanted to monitor more than 200 participants across three countries, day and night, for extended periods of time during a Phase 3 study. Protocol for the trial required the pharma to securely collect core temperature and heart rate data from the patients. Hidalgo provided the sensors and software platform to export the data automatically into the clinical trial database.

Mental health screening

Alex Pentland, the director of the MIT Media Lab Entrepreneurship Program, talked during his keynote about applications for sensors in passively detecting signs of depression. The gold standard of screening for depression is a review of family and health history and an interview with the patient. But the problem is that humans won’t always be forthcoming and honest, which can lead to missed diagnoses. Rather than ask a patient about his social habits, why not use a tool he carries every day to interact socially – a cellphone – to find that data passively?

Other kinds of sensors could be useful here, too. One poster presented at BSN explored the use of sensors to pick up vocal biomarkers for depression. University of Southern California researchers have also used the sensor technology from the Kinect system to pick up visual sign of depression.

Quantifying motion beyond walking, running and jumping

One of the most interesting displays I saw was this one from University of Alabama Huntsville researchers. They developed an app that uses a smartphone’s sensors to capture and record the physical activity of a manual wheelchair user. The idea, one of the researchers told me, is that individuals who use a wheelchair still need exercise, but it’s hard for them to quantify their physical activity. mWheelness uses a magnet attached to the wheel, along with a mount for the smartphone, to do just that.

Evaluating joint mobility

A team at Tyndall National Institute is developing a glove made of bend sensors, pressure sensors and a 3-axis accelerometer to measure joint mobility in the hand. The intention is to provide a better way for physicians or researchers to evaluate and monitor arthritis.

The daily testing and monitoring responsibilities for diabetes patients has made them, and their physicians, a prime target for mobile health products and services. But research suggests that even in this population of patients, use of mobile technologies is still reserved to a small group of early adopters.

Dr. David Klonoff, an endocrinologist and clinical professor of medicine at University of California San Francisco, says doctors aren’t really prescribing these apps because they haven’t yet demonstrated the necessary value to patients, clinicians or payers.

In a talk today at the Body Sensor Networks conference in Cambridge, he said that in order for that to happen, a product has to not only be safe, but also make life easier for patients and clinicians.

For a clinician, the thought of having two dozen patients’ daily glucose numbers delivered to his computer is overwhelming and unhelpful. “I need something to sort it out,” he said. “And, don’t even show me the data unless one of these three outcomes occur:”

• It saves the clinician time
• Improves outcomes for the patient
• Saves money for patient or provider

When physicians turn to the literature to look for that data, they find only a small amount of clinical data and even less economic data on mHealth. Payers, of course, want that cost savings data as well. “I’m being buffeted by patients who want something that’s safe and effective, by payers who are saying no way, and then the companies that are trying to make money,” he said.

But he thinks it’s just a matter of time until that kind of data becomes available, and mHealth finds a real place in diabetes management. “It’s a very nascent stage [...] but it is starting to take hold,” he concluded.

If that happens, it would open the door for even more ways for physicians to keep an eye on diabetes patients remotely. Aside from continuous glucose, Klonoff said there are also other remote readings that would be useful to the clinicians. “My first choice would be insulin, because in a closed-loop artificial pancreas system, you want to know the glucose and it would be a great luxury to know the insulin level,” he said. “Other than that, lactate and keto acids would be of interest, and hydration.”

Washington (Reuters) - Tanning beds and sunlamps will be required to carry stronger warning labels under new regulations proposed by the U.S. Food and Drug Administration, which is also recommending the machines not be used by people under the age of 18.

The FDA said on Monday that it plans to reclassify sunbeds from low-risk to moderate-risk products, meaning they will need to be cleared by the agency before being allowed onto the market.

Faulty equipment has led to patients being burned or exposed to too much radiation, Jeffrey Shuren, director of the FDA's center for devices and radiological health, said in an interview.

Skin cancer is the most common form of cancer in the United States, according to the Centers for Disease Control and Prevention. Basal cell and squamous cell cancer, the two most common forms, are generally curable; but melanoma, the third most common type, is deadly.

In 2009, the most recent year numbers are available, 61,646 people in the United States were diagnosed with melanoma and 9,199 people died, according to the CDC.

The FDA's proposed regulations stop short of recommendations made by the International Agency for Research on Cancer, part of the World Health Organization, which in 2009 concluded that commercial tanning devices were more dangerous than previously thought and recommended people under 18 be banned from using them.

The FDA's regulations also stop short of new rules being developed by some U.S. states.

More than 30 states regulate the use of tanning facilities to differing degrees. Delaware, New Hampshire and North Dakota, for example, ban the use of indoor tanning by anyone under age 14 unless medically necessary and they require parental consent for those between the ages of 14 and 18.

Some states, including Georgia, Illinois and Maine, ban tanning beds for children under the age of 14, and eighteen states require tanning bed operators to limit exposure time to a manufacturers' recommendations and provide eye protection.

In January 2012, California became the first state to ban tanning beds for all people under 18.

The Indoor Tanning Association argues vigorously that the decision on whether a teen is allowed to suntan is one for parents, not government, and it supports parental consent. But it is fighting the growing number of states issuing bans.

"Is the next step to ban teens from sun bathing at public beaches and pools?" the association asked in a statement last year in opposition to New Jersey's proposal to ban tanning bed use for those under 17.

"You also have to consider the health risks associated with banning teenagers from using tanning salons," it said. "They will just go outside with no adult supervision and no trained staff where they are much more likely to get sunburned."

The FDA's actions follow a 2010 meeting of a federal advisory panel which unanimously recommended that the agency reclassify tanning devices. Panelists had mixed views on whether to implement a ban on minors.

An estimated 5.6 percent of U.S. adults reported indoor tanning at least once in 2010, with the highest rates among white, female 18 to 25-year-olds, according to the CDC, which notes that frequent exposure to UV rays for people under the age of 35 increases the risk of developing melanoma by 75 percent.

"For right now our proposal tries to focus on providing better information for consumers," Shuren said, "including a warning on the tanning beds themselves that they shouldn't be used in people under 18," he said.

Depending on the feedback the agency receives to its proposal, it may make changes to the final order, he said.

(Reporting By Toni Clarke in Washington; Editing by Tim Dobbyn)

SAN FRANCISCO - Fitbit began shipping its Flex wristband today, finding its place among established wearable (but expensive) fitness devices in the market.

Flex is Fitbit’s answer to big-name companies like Nike and Jawbone who have their FuelBand and Up wristbands respectively. Bracelets seems to be the form-factor of choice for many exercise enthusiasts as they are easy to keep track of and don’t get in the way of your workout. They become an accessory as opposed to another device you have to find a pocket for.

Fitbit’s Flex shares a lot of the same functionality as the FuelBand and Up wristbands. It will track your steps and calories burned, how far you actually went, and it will look at your sleeping patterns and make suggestions based off of that data. The difference is, it costs $100 in comparison to the FuelBand, which goes for $150, and the Up, which goes for $130.

It can also wirelessly connect to your phone or computer using Bluetooth 4.0. That means you won’t need to pull out a wire to view your activity data on your phone and can start evaluating yourself anywhere. Its social components keep you engaged through competition to see who can walk the most steps in a week as well.

One thing that’s missing, however, is the ability to track your “climbs.” That is, if you’re walking up stairs, the Flex won’t be able to tell that you’re on an incline and burning more calories. Fitbit’s other devices have this feature, but it’s curiously missing from Flex. For those who live in areas like, say, hilly San Francisco where Fitbit is headquartered, this could be a deterrent.

hat tip Engadget; Flex image via Devindra Hardawar/VentureBeat

This article originally appeared on VentureBeat

CHARLESTON, W.Va. -- Jessica Boggs, 30, isn't sure what made both of her hips deteriorate just over four years ago.

"In November of 2008, I woke up one day and could put no weight on my left leg. It was throbbing," the Charleston resident said. "My primary doctor thought I pulled a muscle. In January 2009, I got an X-ray, and it showed my bones starting to deteriorate rapidly."

She went through four surgeries, two to save the bone with plates and screws. By February 2010, both of her hips had been replaced. Her condition forced her to use a wheelchair, crutches and a cane.

"It was a pretty emotional time. I was bedridden. It had a lot of emotional effect on me," she said. "You have no access to the outside world. You feel so helpless because you can't go out on your own. But I came out stronger because of it.

"We have no idea -- there was nothing in my medical history to show this. I wasn't obese. I don't smoke. I haven't taken steroids. We just have no idea; It was a fluke case," Boggs said.

The average age of people needing joint replacement surgery is getting younger, said Dr. James B. Cox, orthopedic surgeon with Teays Valley Orthopedics.

"Typically the population who undergoes hip or knee replacement surgery is an older set," Cox said.

"But we are seeing younger and younger people who require hip replacement surgery."

The average age range 10 years ago would have been 70 to 75, he said. Now, the average patient is 65 to 70. Some are much younger.

Dr. Phillip Surface, an orthopedic surgeon at Ortho Clinic in South Charleston, said about 15 percent of his patients are younger than 50.

There are several possible reasons problems are starting earlier in life.

It's no secret that obesity remains a problem nationwide. Among the myriad risks associated with being overweight is wear and tear on joints.

Extreme sports also have seen an increase in popularity, leading to more sports-related injuries.

"It may be related to lifestyles -- a certain group of people who are more athletic -- and they're wearing their joints out quicker," Surface said. "You have another group of younger folks on the opposite end who are not as healthy. Diabetes and obesity are more prevalent. These two groups of younger people are showing up with bad joints."

But another factor is a simple change in philosophy among doctors, Surface said.

"Some of that change is coming from the orthopedic surgeon community itself . . . People who trained in the East Coast were very conservative about hip and knee replacements in young people and would avoid it," Surface said. "The West Coast mentality was if they need it, do it. The attitude is shifting from the West Coast here."

Joint replacements in younger people were sometimes avoided because of possible complications.

Artificial joints wear out faster than natural joints, and the person was likely to need another replacement surgery in 10 to 12 years, Surface said. The second surgery tended to be much more complicated, and the outcomes aren't as good.

In addition to a mindset shift and advances in technology, people are developing arthritis at younger ages.

Cox said when doctors would see arthritis in younger patients -- in their 40s, 50s and 60s -- they would try to hold off on joint replacement because he would expect a joint to last 15 to 20 years at the most.

"Some implants that are available to us now, we expect them to last a lifetime," he said. "With that in mind, we're not as reluctant to move forward with hip replacement."

Like many people who receive joint replacements at an early age, Boggs likely will have more surgery at some point. She hopes to get 20 to 25 years out of each hip, and she hopes for technology advances by then.

Until then, she is happy being able to walk and run as she used to. While she steers clear of skiing or anything that might put her at risk for new injuries, she has seen no complications from the surgery.

There was a least one silver lining during Boggs' ordeal. She met her husband while going through the experience. On their first date, he carried her up 25 stairs because she couldn't walk on her own.

"He walked into my life at my lowest. I don't want to go through that again, but I did meet my husband through it," she said.

Contact writer Candace Nelson at Candace.Nelson@dailymail.com or 304-348-5148. Follow her at www.twitter.com/Candace07. ___