The world wants mobile medical apps (MMAS) ##and demand won t slow down any time soon. The demand for remote patient monitoring is growing dramatically says Jeannette Tighe from the Healthtech Advisory practice at Sagentia a global technology advisory
the world s aging population with its increasing need for medical care. In the United states alone Tighe notes almost 20 percent of Americans will be older than 65 by 2030 making them more vulnerable to Alzheimer s cardiovascular disease and other age-associated conditions.
This changing landscape is creating an exciting opportunity for the emerging area of connected health
#Benefits to medical device manufacturers include cost savings through not having to develop a completely new device leveraging existing platforms
and released draft guidance proposing deregulation of medical data aggregation systems. This clarification she says significantly reduces the risks of these opportunities for medical technology companies.
Currently most FDA-regulated apps are either stand-alone or act as accessories to existing medical devices and allow the smartphone to act as a##dumb-user interface
or a##data pipe to the cloud Pettigrew adds. However with the clearer regulatory pathway emerging concepts are now starting to push the boundaries
This device is aimed at treating patients with debilitating inflammatory diseases. It consists of an implantable microregulator a wireless charger and the ipad prescription-pad application.
Addressing Two Critical Questionssagentia believes there are two critical questions for medical device companies entering this space:
and incorporate it into a medical device? And equally important how do you make money from doing so?
MMAS should be treated like any other medical device. Risk analysis is key and careful system design will ensure that safety critical functions are implemented appropriately.
Once companies decide to incorporate an MMA they follow the same type of development roadmap used for any other medical device.
development under the ISO 13485 medical device standard.####As an example of how to manage the risks of including apps in connected systems Tighe cites the Verihaler which Sagentia has developed to monitor patient adherence to treatment for asthma or chronic obstructive pulmonary disease (COPD.
Verihaler uses wireless acoustic monitoring to provide valuable feedback to users physicians or other health-care providers promoting correct inhaler use
With such great opportunities available it s no surprise that many medical device companies have connected health on their agendas.
The world wants mobile medical apps (MMAS) ##and demand won t slow down any time soon. The demand for remote patient monitoring is growing dramatically says Jeannette Tighe from the Healthtech Advisory practice at Sagentia a global technology advisory
the world s aging population with its increasing need for medical care. In the United states alone Tighe notes almost 20 percent of Americans will be older than 65 by 2030 making them more vulnerable to Alzheimer s cardiovascular disease and other age-associated conditions.
This changing landscape is creating an exciting opportunity for the emerging area of connected health
#Benefits to medical device manufacturers include cost savings through not having to develop a completely new device leveraging existing platforms
and released draft guidance proposing deregulation of medical data aggregation systems. This clarification she says significantly reduces the risks of these opportunities for medical technology companies.
Currently most FDA-regulated apps are either stand-alone or act as accessories to existing medical devices and allow the smartphone to act as a##dumb-user interface
or a##data pipe to the cloud Pettigrew adds. However with the clearer regulatory pathway emerging concepts are now starting to push the boundaries
This device is aimed at treating patients with debilitating inflammatory diseases. It consists of an implantable microregulator a wireless charger and the ipad prescription-pad application.
Addressing Two Critical Questionssagentia believes there are two critical questions for medical device companies entering this space:
and incorporate it into a medical device? And equally important how do you make money from doing so?
MMAS should be treated like any other medical device. Risk analysis is key and careful system design will ensure that safety critical functions are implemented appropriately.
Once companies decide to incorporate an MMA they follow the same type of development roadmap used for any other medical device.
development under the ISO 13485 medical device standard.####As an example of how to manage the risks of including apps in connected systems Tighe cites the Verihaler which Sagentia has developed to monitor patient adherence to treatment for asthma or chronic obstructive pulmonary disease (COPD.
Verihaler uses wireless acoustic monitoring to provide valuable feedback to users physicians or other health-care providers promoting correct inhaler use
With such great opportunities available it s no surprise that many medical device companies have connected health on their agendas.
Of course, a diagnosis is far from a cure, and a call to improve educational opportunities is far too facileho could argue with that?
a world in which technology erases disability and in which the synthetic and biological worlds meld seamlessly.
shortly after returning home from the hospital he set up a workshop in the garage and put those skills to work designing
and by lowering the energy costs of walking reduce joint stress and fatigue. But bringing bionic devices into the clinic is not easy.
Bob Emerson a prosthetist at A Step Ahead Prosthetics who helps connect patients to research projects in Herr's group says it's challenging to persuade insurers to pay for devices like Biom.
Now he is going a step further collaborating with surgeons and other researchers on ways to allow bionic limbs to be controlled directly by the nervous system
Whereas brain-machine interfaces would require invasive surgery for brain implants he wants to connect electronic devices to the peripheral nerves at the site of the injury allowing people to control bionic limbs with their existing nerves
Amputation which is currently a fairly crude surgery might become a sophisticated procedure of setting up the body to interface with a bionic limb.
Indeed as artificial limbs become more powerful and functional they can sometimes be perceived as the opposite of a disability.
what her genes said about her chance of developing Alzheimer and heart disease. The report only delved into her genetic genealogy, possible relatives,
they are loading their DNA data into several little-known websites like Promethease that have become, by default, the largest purveyors of consumer genetic health services in the United Statesnd the next possible targets for nervous
a way to get xhaustive medical infoin reports that are imilar, but not as pretty.
its medical meaning is less certain. Consumer DNA tests determine which common versions of the 23,000 human genes make up your individual genotype.
As science links these variants to disease risk, the idea has been that genotypes could predict your chance of getting cancer or heart disease
you might well wish for a doctor at your side when you find out. don believe that this kind of risk assessment is mature enough to be a consumer product yet,
In barring 23andme health reports, the FDA also cited the danger that erroneous interpretations of gene data could lead someone to seek out unnecessary surgery
whether consumers should have the right to get genetic facts without going through a doctor. t an almost philosophical issue about how medicine is going to be delivered,
a professor at Stanford university who helped developed a DNA interpretation site called Interpretome as part of a class he teaches on genetics. s it going to be concentrated by medical associations,
Two of the sites appeared designed to steer users toward alternative medicine. Genetic Genie, a free service that carries ads for vitamins,
or lower, their risk for drug reactions, common diseases, or personality traits such as a lack of empathy.
Promethease makes little effort to combine the genetic risks for any one disease into a single comprehensible number.
That makes the report more like a jumble of facts than a diagnosis. Lennon says this is intentional.
if I had a high risk or genetic predisposition toward heart disease, diabetes, or Alzheimer. I don,
At least that the current view of the FDA and medical societies. But Deboe did take the report to her doctor.
It said she had a gene for caffeine sensitivity, and Deboe says her doctor agreed she should stick to decaf
and avoid drugs like Novocain. think that how people should be using thiss a conversation-starter with medical professionals,
she says. Under the Radar To Lennon and Cariaso the surge of interest in Promethease and SNPEDIA represents a triumph for a no-frills approach to genetics.
adding a link to a New yorker article that discussed the gene and its role in a rare childhood disease.
maintained by Konrad Karczewski, a postdoctoral researcher at Massachusetts General Hospital, now has 80 to 100 visitors per day, twice as many as last year.
You can find them in cars airplanes robots and medical implants. But their use has been limited in aircraft
and Increase targeted tree plantings in neighborhoods with high asthma rates. Over four months 1436 respondents contributed over 30000 responses and 464 new ideas to the survey.
Ultimately the carbon dioxide would probably get shipped to an offshore well for injection which is the method available in Norway.
#Nobel for Brain s Location Code The Nobel prize in Physiology or Medicine went to three researchers who made key discoveries about how the brain represents an animal s position in space orienting it
In July DARPA gave out $40 million in awards to try to develop brain implants that would help brain-injured soldiers recover lost memories
and making sure the genes are stable says Dean Price a professor of medicine biology and environment at Australian National University.
A sequencer this small might one day let police read off a genome from a spot of blood at a crime scene or permit doctors to pinpoint viruses in the midst of an epidemic.
to labs interested in sequencing hundreds of thousands of human genomes for medical research h
#Motorized Pants to Help Soldiers and Stroke Victims A soft exoskeleton being developed by researchers at Harvard could let soldiers carry heavy backpacks over long distances or help stroke victims walk more steadily.
#Gene-Silencing Drugs Finally Show Promise The disease starts with a feeling of increased clumsiness.
There is no cure. The disease is caused by malformed proteins produced in the liver so one treatment is a liver transplant.
But few patients can get one and it only slows the disease down. Now after years of false starts and disappointment it looks like an audacious idea for helping these patients finally could work.
In 1998 researchers at the Carnegie Institution and the University of Massachusetts made a surprising discovery about how cells regulate
because it suggested a way to shut down the production of any protein in the body including those connected with diseases that couldn't be touched with ordinary drugs.
fight diseases like FAP by using RNAI to eliminate bad proteins (see The Prize of RNAI and Prescription RNA.
At one point the idea of RNAI therapy was on the verge of being discredited. But now Alnylam is testing a drug to treat FAP in advanced human trials.
Alnylam has more than 11 drugs including ones for hemophilia Hepatitis b and even high cholesterol in its development pipeline and has three in human trials progress that led the pharmaceutical company Sanofi to make a $700 million investment in the company last winter.
Its founders among them the Nobel laureate and MIT biologist Philip Sharp had solved one of the biggest challenges facing the idea of RNAI therapies.
The early mechanisms were too toxic at the doses required to be used as drugs. As a result delivering RNA through the bloodstream like a conventional drug seemed a far-off prospect.
The company tried a shortcut of injecting chemically modified RNA directly into diseased tissue for example into the retina to treat eye diseases.
and requires frequent visits to the hospital for hour-long IV infusions something patients desperate to stay alive will put up with but likely not millions of people with high cholesterol.
This approach allows for the drug to be administered with a simple injection that patients could give themselves at home.
The combination of low cost and ease-of-use is allowing Alnylam to go after more common diseases not just the rare ones that patients will go to great lengths to treat.
Because we ve made incredible improvements in the delivery strategy Meyers says we can now go after big diseases where we can treat millions of patients potentially.
he had been searching for the next great delivery mechanism one that could greatly expand the diseases that can be treated by RNAI.
Alnylam sees the potential for billions of dollars in revenue from liver-related diseases. Yet most diseases involve other tissues in the body.
Dahlman and his colleagues at MIT are some of the leaders in the next generation of RNAI delivery targeting delivery to places throughout the body.
which are associated with a wide variety of diseases. The studies showed that the method could be used to reduce tumor growth in lung cancer for example.
Treating cancer is one area where RNAI s particular advantages are expected to shine. Conventional chemotherapy affects more than just the target cancer cells it also hurts healthy tissue
which is why it makes people feel miserable. But RNAI can be extremely precise potentially shutting down only proteins found in cancer cells.
which could make cancer treatments far more effective. Lab work like this is far from fruition but if it maintains its momentum the drugs currently in clinical trials could represent just a small portion of the benefits of the discovery of RNAI i
#Fingerprinting Infants Helps Track Vaccinations in Developing Countries Billions of dollars a year are spent vaccinating children in developing countries
but about half as many immunizations are administered as could be because of unreliable vaccination records. Biometric researchers from Michigan State university have developed a fingerprint-scanning system for children under five years old that could replace ineffective paper vaccination records.
Until now biometrics experts believed fingerprints of babies and toddlers were too unreliable because image sensors are designed for the ridges and valleys of adult fingertips.
Paper-based vaccination records are lost easily and don t reliably provide health workers with up-to-date information on patient history.
The Bill and Melinda Gates Foundation funded the research specifically for recording vaccinations but the patient-identifying system has broader applications says Anil Jain a distinguished professor at Michigan State university s Computer science and Engineering Department and coauthor of the paper.
and death certificates to health care records school enrollments and voter registration. The Michigan State university researchers needed to process images taken from fingerprint sensors using software to compensate for the small size of the children s fingerprints as well as their sometimes wet and oily skin.
because the Benin clinic was outdoors with dust and high humidity but Jain believes match accuracy can be improved to 95 percent in these types of conditions.
Compared to the status quo of not getting vaccinations for life-threatening diseases mothers are not asking these questions
In the Networked Economy personalization of the customer experience in almost every field from retail to medicine will be become the norm. 2. ENABLING OPEN INNOVATION.
#Wireless Power for Minuscule Medical Implants Medical implants like pacemakers deep brain stimulators and cochlear implants could someday be joined by still more bioelectronic gadgets devices that regulate insulin levels control
or treat brain injuries (see Nerve-Stimulating Implant Could Lower Blood pressure). But before we re all riddled with electronics researchers have to figure out how to power it all.
and existing wireless methods such as those used for cochlear implants won t work with devices buried deep in the body.
Wireless systems like the one used in cochlear implants sit permanently on the skin and derive power from electromagnetic induction in
The plate would most likely sit on the skin providing constant power to an implant.
Nonetheless Poon says that is sufficient for this kind of low-power medical device. It also met safety regulations limiting the amount of radiation delivered to a given amount of tissue in humans.
and measuring how it scatters off blood vessels (this is often done in hospitals with a device that fits over your fingertip).
and a detail of a Vincent Van gogh self-portrait and applied algorithms that warped the image by taking into account the specific eye condition it was told to account for.
#More than A hundred Genetic Variants Tied to Schizophrenia To a large extent, schizophrenia and other psychiatric disorders are caused illnesses by genes.
Now teams of scientists from research centers around the world, looking at the genetics of nearly 80,000 people, have worked together to identify 108 genetic loci associated with the disorder.
It is the largest genetic study ever conducted of a psychiatric disorder. Researchers are finally beginning to gain some scientific understanding of many common brain disorders,
including schizophrenia. The lack of such understanding to date has meant there hasn been a true new breakthrough drug to treat these disorders in 50 years.
And while wee still far from turning new insights into effective and safe drugs at least the emerging knowledge is giving researchers some options in exploring potential treatments.
touted the results as a turning point in how we view brain disorders. ive years ago, we didn know a single gene related to these psychiatric diseases,
not a single pathway, said Eric Lander, Broad director. It was echoed a perspective by Steven Hyman, director of Broad Stanley Center for Psychiatric Research:
ee turned with this Nature paper and related research what had been a scientifically forbidding and featureless landscape into a landscape with toeholds and opportunities and glimmers of hope. i
#Can Technology Fix Medicine? After decades as a technological laggard, medicine has entered its data age.
Mobile technologies, sensors, genome sequencing, and advances in analytic software now make it possible to capture vast amounts of information about our individual makeup and the environment around us.
The sum of this information could transform medicine, turning a field aimed at treating the average patient into one that customized to each person while shifting more control and responsibility from doctors to patients.
The question is: can big data make health care better? here is a lot of data being gathered. That not enough, says Ed Martin,
interim director of the Information Services Unit at the University of California San francisco School of medicine. t really about coming up with applications that make data actionable.
and the challenges they will face as they push to remake health care. The groups that control the most medical data today are insurance companies and care providers,
and their data analysis is already beginning to change health care. Express Scripts which manages pharmacy benefits for 90 million members in the U s
. and processes 1. 4 billion prescriptions a year, has scoured its data from doctorsoffices, pharmacies, and laboratories to detect patterns that might alert doctors to potential adverse drug interactions and other prescription issues.
Doctors can now know 12 months in advance, with an accuracy rate of 98 percent, which of their patients may fail to take their medicine.
Taking steps to avert that problem could improve patientshealth and reduce the $317 billion spent in the United states each year on unnecessary ER visits and other treatment.
Today many companies and health-care providers are adding other layers of information to create an increasingly precise
patient-specific brand of medicine. New mobile technologies, for example, could provide information about a patient everyday behaviors
or how they might react to treatments. e want to believe that most of the things we do in medicine are based on evidence,
is that medicine could become more analytical and evidence-based. Data is also changing the role of patients,
and even stress. And companies like Apple are hoping to become repositories for all this information,
but it can become essential for the millions living with chronic conditions like diabetes, heart disease, and depression.
and provides the patient doctor with treatment recommendations based on the data and established medical guidelines.
Over time, both companies will aggregate this information to help doctors study and improve treatment overall. t like one of the largest clinical trials in history,
Families affected by Phelan-Mcdermid syndrome, a rare condition in which a deletion on chromosome 22 causes problems such as learning and memory deficits, are building a database of information from genomic tests, clinical medical records, extensive family surveys and histories,
That increasingly important as researchers begin to see connections between Phelan-Mcdermid, autism, and other conditions.
#Mathematicians Explain Why Social Epidemics Spread Faster in Some Countries Than Others Psychologists have puzzled always over why people in Sweden were slower to start smoking and slower to stop.
Treating smoking like an epidemic in this way finally reveals what going on. They say their results can explain the rate of change of smoking in various industrialized countries.
That an interesting result with significant implications for government health policies. It shows that differences in culture affect the dynamics of social spreading processes in a measurable way.
and hopes to sell them to manufacturers of wearable electronics, medical devices, smart labels, and environmental sensors.
While gene drives may have commercial and public health uses, 10 scientists published an editorial today in the journal Science calling for more public discussion,
and researchers have been developing gene drive approaches to alter mosquitoes to slow the spread of malaria and dengue fever.
with the idea of releasing them in the wild to cause a population crash, thereby reducing malaria.
For the health-care industry it complies with medical privacy laws. For legal and financial clients it integrates with electronic signature services.
and the few materials researchers have been able to develop with good thermoelectric properties have been rare, expensive, or toxic.
The U k. project will focus on people with cancer, as well as adults and children with rare diseases.
Because all Britons are members of the National Health service, the project expects to be able to compare DNA data with detailed centralized health records (see hy the U k. Wants a Genomic National Health service.
While the number of genomes to be sequenced is 100 000, the total number of Britons participating in the study is smaller, about 70,000.
That is because for cancer patients Genomics England intends to obtain the sequence of both their inherited DNA as well as that of their cancers.
Genomics England began talking early this year to potential bidders, including Chinese company and Illumina rival BGI (see nside China Genome Factory.
#3-D Mammography Shown to Improve Detection of Invasive Breast cancer A new 3-D imaging technology that typically isn covered by health insurance allows radiologists to detect more cases of invasive breast cancer than traditional mammography,
In an analysis of nearly half a million women published in the June 25 issue of the Journal of the American Medical Association,
was linked to a 41 percent increase in the detection of invasive cancers as well as a 15 percent drop in the recall rate,
Daniel Kopans, who founded the breast imaging division at Massachusetts General Hospital and developed tomosynthesis, says the latest evidence could push hospitals to move toward the new screening method. ltimately,
radiologists will recognize that if they miss a cancer because they weren using tomosynthesis, they could end up being sued by someone who said,
hy didn you use tomosynthesis? Why did you do my screening as a 2-D mammogram??
he says. Currently in the United states, doctors recommend that women over 40 get screened for breast cancer every year,
but some researchers argue that the rate of false positives causes patients undue anxiety and creates a burden on the health system.
Some medical groups say screening is overused and should instead occur every two years starting at age 50.
Traditional mammography uses side-to-side and top-to-bottom x-rays of the breast. Such 2-D mammograms can create superimposed shadows that look like cancer,
and they sometimes fail to detect cancer lesions behind normal tissue. In tomosynthesis approved by the FDA in 2011, a series of x-ray images are taken in an arc across the breast,
resulting in pictures from multiple angles. A computer algorithm then creates a stack of thin layers that a radiologist can read, much like the pages of a book.
The JAMA study was funded by Hologic, which is currently the only company to have approved an FDA tomosynthesis system in the U s. General electric sells a system in Europe).
Etta Pisano, dean of the College of Medicine at the Medical University of South carolina, says there still isn enough evidence to say
or even how often women should be screened. aybe radiologists should have a mixture of technologiesomo might just make sense for women with dense breasts,
Some doctors say 2-D mammography isn going to be retired, since it better at detecting the tiny calcium deposits that are evidence of ductal carcinoma in situ (DCIS), one of the earliest forms of breast cancer.
so radiologists can more accurately analyze the size, shape, and location of any abnormalities and judge whether the tumors are invasive. ight now the prohibitive issue is the costatients can afford to pay for this expensive technology,
and there no reimbursement to the health-care system, says Emily Conant, professor and chief of the breast imaging division at the Hospital of the University of Pennsylvania
and senior author of the JAMA study. think the data supports implementing tomosynthesis for screening,
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