How Artificial Intelligence Is Changing Medical Devices by Kristopher Sturgis

Machine learning and artificial intelligence (AI) have long been heralded as the future of transformative technologies. From diagnostic and imaging technologies to therapeutic applications and robotics, the potential for machine learning and AI technologies reaches almost every corner of the medtech world. So, what does that mean for the development and application of next-gen medical devices?

Dave Saunders is the chief technology officer of Galen Robotics, an emerging surgical robotics company that specializes in a new line of robotic technologies that provide a cooperatively controlled surgical platform. The company aims to provide robot-assisted technologies that can extend increased precision and unprecedented tool stabilization to microsurgery procedures.

Saunders has personally overseen the evolution of more than 40 different internet-based products from inception to market since 1991 and has led product development programs for virtual machine clustering and computer-vision-guided surgical tools. He’ll also be speaking at MD&M East in June where he’ll be covering the topic of “How Artificial Intelligence Has Changed Everything for Medical Devices.”

Saunders recently sat down to speak with MD+DI about how the current development and application for diagnostic and therapeutic devices is poised to explode once true AI arrives. He also discusses some of the challenges that new AI and machine learning technologies pose to device developers and explores the immediate impact that some of these new technologies will have on the market.

MD+DI: For starters, AI technology has been touted as a truly transformative technology for many years. Do you think we’re on the verge of machine learning and AI technologies finally having a real impact on the medical device market? How soon will we see any kind of significant impact?

Saunders: We’re already seeing AI and machine learning being applied to diagnostics and other areas, so inroads are being made. AI and machine learning for surgical devices might be a bit further out though. Currently we don’t have a clear path from the FDA for approval in this area, and training for AI and machine learning is also a bit more difficult for something like a surgical robot than, say, facial recognition or other more prominent uses of AI. We’re getting there, but a lot more work is needed.

MD+DI: In your experience, how has the development of machine learning and AI technologies changed the process of medical device development? Has it made things easier, or more complex?

Saunders: I think it’s opening a lot of doors and making complex analysis more possible in a wide range of applications. A great rule of thumb from Dr. Andrew Ng of Stanford is that anything a human can “think through” in a second or less is a possible candidate for AI or machine learning. This rule of thumb isn’t perfect, but it does provide for a short list that can help technologists and product managers see where devices might benefit from applied AI and machine learning.

MD+DI: As the chief technology officer at Galen Robotics, what role do you see AI technologies and advanced machine learning having on the development of next-gen robotic technologies?

Saunders: My preference is to see AI and machine learning applied in a way that acts as a super assistant to a surgeon or practitioner to give them “super human” perception, dexterity, and information with which to make better decisions. It doesn’t have to be all or nothing either. Take something like medical imaging. For example, if an AI or machine learning system can give you a cancer/not-cancer determination — with 100% certainty — for 50% of all breast scans, you’ve just made a huge impact on unburdening the humans who can now focus on the remaining 50%.

In surgical robotics, it’s a similar situation. You could use AI and machine learning and combine it with augmented reality to highlight a tumor during surgery, then let the robot do something like close up at the end. You could also develop integrated sensors to see through thin layers of tissue to stop the surgeon’s hand if they might be coming close to something they should avoid or align a pedicle screw as the surgeon is co-aligning it based on their own training and expertise. I love the idea of these big “moon shot” robots that could do fully autonomous surgery, but I don’t think the tech is there yet. Meanwhile, there are countless applications for AI and machine learning technologies that could help right now, and that’s where should all be focused.

Incidentally, we also need to make sure humans are incentivized to remain involved with their areas of expertise. If an AI or machine learning system reduces the load of medical imaging analysis by 50%, we still need humans to work through the rest. If people get scared that “robots will take their jobs,” we could see talent shortages in those areas. The best application of these technologies, in my opinion, is to enhance human capabilities and reduce the load of the “easy stuff” — but we still need to make sure humans are around because we can analyze things that AI and machine learning systems can’t.

MD+DI: What are some of the biggest challenges that some of these new AI technologies present for device makers, and how do you think some of these challenges can be addressed?

Saunders: How we train AI and machine learning is very important. The group of people who establish the training data for an AI or machine learning system are teaching it a worldview, even if it’s narrow in focus. Because of that, diversity among these teams is critical. It’s important that AI and machine learning systems are taught how to recognize various differences between people and help make decisions that work for each individual and not as a homogenized composite which may only represent a subgroup of humanity.

For example, imagine orthopedic planning software for knee replacement which uses AI or machine learning that was only taught with scans from people with valgus knees. When it’s applied to people with straighter or varus knees, it could get really confused. A diverse training team can have a collective perspective that makes sure gaps like that are filled in during training so reliability in the field is optimal.

MD+DI: What are some of the most important issues to consider when device makers are wanting to integrate AI or machine learning into a new medical device?

Saunders: Where is the data processing going to be done? A lot of AI and machine learning systems are designed to work in the cloud. Is that the right approach for a hospital? Can a high-volume system get enough access to a processing cloud to work on demand? Do you want a surgical robot that needs an active internet connection to work correctly? What happens if that connection gets interrupted? This is also a potential risk for “man in the middle” attacks from hackers. At the same time, setting up an edge computing cluster at each hospital could be enormously expensive and then you have to deal with the logistics of updates, new data, etc. Reading a medical image and having an occasional five-minute delay is probably manageable — but what if you get that “spinning ball” while you’re in the middle of surgery? That’s just not going to cut it.

The computing resources, storage, and training data for AI and machine learning systems used with surgical robotics needs to be planned to be robust, fault tolerant, and cost efficient. Otherwise, we may never see it in the field.

MD+DI: What kind of an impact do you think AI technologies will have on regulatory and human relation issues?

Saunders: When you have a robot make a decision based on an algorithm, it’s fairly straightforward to validate; you can do the equivalent of a mathematical proof and show that you know how it works. With AI and machine learning, you’re training it to make the kinds of decisions you want and it’s pretty amazing. Type “cat” into Google images and look at all the different cat pictures you get. No one wrote an algorithm to describe what a cat is to a computer. AI and machine learning systems are trained to recognize it — but how do you prove to a regulatory body that it really knows what a cat looks like?

Now consider a robot that can take out your appendix, based on AI or machine learning. How are you going to prove to the examiner that the robot really knows where the appendix is, and what will it do if it is not 100% confident for a specific patient? What if the patient has situs inversus and the appendix is on the other side? Who/what is responsible for each step of the procedure? What are the safety protections for the patient, and who is responsible if something does go wrong? I think there’s a lot of ground to cover here before we ever see AI driven surgical robotics on any broad scale.

As for human relations, I think we’re ready to interact with machines as peers, and maybe too soon at that. There are stories about elder care robots being immediately accepted by people, or children developing “relationships” with the personal assistants on phones. I actually say “thank you” to Alexa myself. My only concern is that because of how AI and machine learning is depicted on TV and in movies, people may be predisposed to trusting computers to operate independently in areas where they’re not actually capable in reality and might be untrusting for things where they are.

MD+DI: Finally, in a broad sense, where do you see AI technologies having the most immediate impact when it comes to medical device development? How soon do you think patients will begin to benefit from some of these new technologies?

Saunders: Today, I think the best applications for AI and machine learning systems are in non-real time systems. For example, diagnostics, medical image analysis, gene sequencing, drug interaction analysis, and pre-surgical planning. If there’s some wiggle room in the amount of time you can wait for an answer, we’re well positioned. I think these are areas that can take advantage of current infrastructures, like cloud-based computing, and variable internet bandwidth, and they can take a huge load off the hospital system without having to “do it all.” Even a load reduction of 20% could have a big impact on costs, turn-around, and quality of care.

Some of these things are being applied now, so patients could already be benefitting from AI and machine learning systems and not even know it. A bit down the road could be smart-vitals monitoring with wearable devices. Based on readings, medications could be adjusted in real time, or emergency services could be alerted if a combination of vitals shows that something is wrong. You may not want your phone to automatically dial 911 if your heart rate is elevated, but there could be a combination of readings which do indicate an urgent problem. These are the kinds of things that AI and machine learning systems could help us better understand about the human body as more data is gathered and analyzed by the wearables we already have today.

We’re in an interesting age where data storage, processing power, and connectivity is the stuff of science fiction. If you went back 10 years and described the technology to which you have such casual access to today, the cost and capability would be equally unbelievable to people just 10 years ago. We have the ability to generate health data from wearables, affordable imaging, and other diagnostic information that would also be the stuff of science fiction to a person mere decades ago. That’s so cool, but there’s no way any human being can make sense of it all. Without AI and machine learning, we will not be able to process all of that data and combine it in ways that could revolutionize our understanding of the human body and medical technology. The possibilities may even be beyond our own imagining, but as we continue to chip away at the problem, what’s possible 10 years from now may very well blow our minds.

Source: https://www.mddionline.com/how-artificial-intelligence-changing-medical-devices

Credit Suisse to pump $250 million into Israeli health tech venture fund aMoon by Shoshanna Solomon

The Swiss multinational investment bank Credit Suisse AG and Israeli life-sciences VC fund aMoon said on Wednesday they have formed a strategic partnership that will see the Swiss financial group injecting $250 million in aMoon’s newly set up second fund.

The partnership will enable Credit Suisse and its unit Credit Suisse Asset Management to allow its clients and institutional investors outside the United States and Canada “exclusive access” to aMoon’s portfolio of companies, a joint statement said.

aMoon Partners, an Israeli life-sciences venture capital firm that is backed by Israeli billionaire Marius Nacht, said last month that it raised $200 million for its second and latest fund, out of a targeted total of $500 million.

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aMoon II invests in mid- to late-stage life science companies in the field of digital health, medical technologies and biopharmaceuticals that operate in Israel and in other health-tech hubs like the US and Europe.

Check Point Software Technologies co-founder Marius Nacht (Courtesy)

The new fund will invest in companies that will be able to integrate digital health advancements such as AI, machine learning, and big data computing into drug and medical device development.

Yair Schindel, the co-founder and managing partner of aMoon, said that the partnership with Credit Suisse will have a “tremendous impact” on the fund’s “relentless pursuit to accelerate healthcare.”

“This strategic partnership is perfectly timed to leverage the growing convergence of technology and healthcare. Breakthrough scientific research, innovative technology, and decades of digital health records make Israel an ideal launchpad for leading this global transformation in healthcare,” he said.

There are some 1,487 life science companies operating in Israel, which have raised some $13.5 billion in 1997-2017, according to Tel Aviv based IVC Research Center, which tracks Israel’s tech sector.

Credit Suisse sees health tech as an “important part” of its long-term investment themes and Credit Suisse Asset Management sees the sector as an “attractive investment opportunity in the current market environment,” the statement said.

“It is critical that, disruptive businesses, which are committed to resolving some of the healthcare sector’s most pressing issues, receive access to venture capital and the liquidity they need,” Michel Degen, CEO of Credit Suisse Asset Management Switzerland and EMEA, said in the statement.

Nacht, considered to be one of the founding fathers of global cybersecurity for his role in founding Check Point Software Technologies Ltd., is a co-founder of the fund. He and Schindel have also set up a nonprofit organization that aims to make Israel a global leader on the healthcare map.

The first $200 million fund, aMoon I, set up two years ago, invested in early-stage health technologies and life sciences firms, and was backed exclusively by Nacht. aMoon I is invested in 16 startups, including BiondVax, a publicly traded maker of a universal influenza vaccine, and Mapi Pharma, which announced in April a development and commercializing partnership with US pharma giant Mylan for a monthly treatment for relapse remitting multiple sclerosis.

Nacht serves as chairman at Checkpoint, whose 1996 IPO raised $67 million and is the second-largest company in Israel in terms of market capitalization.

Source: https://www.timesofisrael.com/credit-suisse-to-pump-250-million-into-israeli-health-tech-venture-fund-amoon/

The world's leading health organization says banning one type of fat could save half a million lives every year by Kevin Loria

Heart disease kills more people around the world than anything else.

More than 17 million people die every year of cardiovascular diseases, including heart attacks and strokes. It can be difficult to change some of the behaviors that lead to those deaths — but that doesn't stop researchers from trying to get people to exercise and eat more vegetables.

Eliminating a big chunk of those deaths can be accomplished in an easier way: by banning trans fats (or trans fatty acids).

The use of trans fats leads to about 500,000 cardiovascular disease deaths each year, according to the World Health Organization (WHO). These products are added to fried foods, baked goods, and snack products, and cause levels of bad cholesterol in blood to spike.

Now the WHO and governments around the world are cracking down. On Monday, the WHO announced a plan calling for governments to ban industrially-produced trans fats within five years.

"Trans fat is an unnecessary toxic chemical that kills, and there's no reason people around the world should continue to be exposed," Dr. Tom Frieden, former head of the Centers for Disease Control and Prevention (CDC), now president and CEO of Resolve to Save Lives, said in the WHO announcement statement.

The rise and fall of trans fats

Artificial trans fats were first developed in the early 20th century, when industrial producers realized they could replace butter with partially hydrogenated oils, which have a long shelf life.

When people grew concerned about the potential health effects of saturated fat in the 1950s, food manufacturers began advertising products like margarine or Crisco, which got their fat from partially hydrogenated oils — trans fats — instead of saturated fats (in recent years, many companies selling these products have switched from trans fats to other alternatives).

But replacing saturated fats with partially hydrogenated oils was a bad idea. These products increase the levels of bad LDL-cholesterol (a sign of increased cardiovascular disease risk) and lower levels of good HDL-cholesterol. Overall, diets high in these fats increase heart disease risk rates by 21% and death rates by 28%, and they're also associated with an increased risk for Type 2 diabetes.

Researchers starting suggesting these fats might be dangerous based on signs of their accumulation in autopsies in the late 1950s. By the 1970s and 80s, a number of health researchers had started to realize these fats might be increasing disease risk — though research indicating this was often suppressed by the food industry, as Julia Belluz reported for Vox.

In the 1990s, several large and prominent studies showed these food products were strongly associated with increased disease risk.

A spreading ban

In 2001, the Danish Nutrition Council suggested the government limit trans fats in foods to improve cardiovascular health. In 2003, a Danish law that limited the amounts of these fats in food was passed. It worked, with death rates from cardiovascular disease falling faster there than in comparable countries.

Other European countries followed Denmark's lead. Then, in 2006, New York City passed a law banning trans fats, phasing them out of the city by the summer of 2008. The prompted all kinds of "Nanny Bloomberg" headlines referencing the mayor at the time. But it worked, according to a study published last year in the Journal of the American Medical Association Cardiology, reducing heart attack and stroke rates in the city.

Under the Obama administration, the FDA finally followed suit nationwide in 2015, with that ban going into full effect next month.

Trans fats are still commonly sold in countries throughout South Asia and Africa, where weaker regulations and stronger pressure by food producers have kept partially hydrogenated oils in circulation.

The WHO's new policy can't actually ban trans fats in these countries. But the hope is that the guidelines will encourage governments to enact these bans. Multinational food producers that have switched away from trans fat products can help local producers make the move to healthier oils, according to the WHO.

It's possible that within five years, a dangerous substance that increases death rates won't be in use anymore.

Source: http://www.businessinsider.com/trans-fat-ban-world-health-organization-2018-5

Australian budget delivers for science facilities and medical research by Nicky Phillips

Research facilities and medicine were among the winners for science in Australia's 2018–19 national budget, which was proposed on Tuesday.

The government will push to invest almost Aus$1.9 billion (US$1.4 billion) over the next 12 years in shared research infrastructure — such as microscopes, supercomputers, a marine observing system and telescopes used in myriad disciplines, from nanotechnology to oceanography. The new money is in addition to the $2.2 billion-plus that the government committed to spend on research facilities and programmes over 10 years, announced in December 2015.

“We’re pretty excited about that,” says Kylie Walker, chief executive of Science & Technology Australia in Canberra, an umbrella organization of scientific societies that represent a combined 70,000 researchers.

Medical research will receive an increase of $1.3 billion, to be spent on various programmes and initiatives over 10 years that improve health and boost the medical industry, including $500 million for a genomics and precision-medicine initiative. The government currently spends about $1.2 billion on medical research a year, according to the Australian Academy of Science.

“This is a great budget for medical research,” says Tony Cunningham, president of the Association of Australian Medical Research Institutes in Melbourne.

The budget also includes $26 million in seed funding to establish a national space agency. Andrew Dempster, director of the Australian Centre for Space Engineering in Sydney, says that, as well as money, the national space agency needs bipartisan support from both sides of government. “Space programmes are longer than the electoral cycle.”

Rosalind Dubs, board director of the Australian Academy of Technology and Engineering in Melbourne, told Nature that a national space agency will ensure Australia has clout when interacting with other countries’ space agencies, such as NASA and the UK Space Agency. This will ensure Australia's continued access to Earth-observation and global positioning satellites owned and operated by other nations, she says. Australia depends on these for weather patterns, emergency responses and monitoring for agriculture and financial technologies.

Increased funding was also announced for technology infrastructure, including $161 million over 4 years to improve the accuracy of satellite positioning over Australia. Dubs says investment in space infrastructure will help boost industry productivity across the economy.

The budget also sets aside $4.5 million over 4 years to encourage more women to study and work in science, technology, maths and engineering.

“The allocation is small, but the signal is important. It says the government is taking this issue seriously,” says Walker.

The final budget will require the Senate's approval.

Infrastructure investment

Researchers have been lobbying for several years for long-term investment in Australia’s shared research infrastructure. This includes 27 facilities that are used by more than 35,000 local and international researchers under the National Collaborative Research Infrastructure Strategy (NCRIS), as well as other major shared facilities such as the Australian Synchrotron, in Melbourne, and the Open-Pool Australian Lightwater (OPAL) Research Reactor, near Sydney.

“Research infrastructure has been funded on a year-to-year basis for a long time, which made it very vulnerable,” Walker says. A political stalemate in 2015 between the centre-right Liberal government of then-Prime Minister Tony Abbott and the opposition Labor Party saw many of these NCRIS facilities nearly run out of money to keep their sites open and pay staff.

Last May, the country’s chief scientist, Alan Finkel, released a report that recommended the government direct its long-term infrastructure investment in nine key areas, including advanced fabrication and manufacture, complex biology, Earth and environmental systems and advanced physics and astronomy. Researchers hoped that the government of Prime Minister Malcolm Turnbull, also Liberal, would come up with an investment plan as part of the 2018 budget.

Beyond specifying money for new supercomputers and the Australian Animal Health Laboratory in Geelong, the budget did not state which infrastructure projects will receive funding. But Walker says the extra money means that facilities can attract and retain a skilled workforce and invest in capital works to maintain and upgrade equipment. “None of these have been possible in recent years,” she says.

Medical studies

The $1.3 billion in new money for medical research includes funding for clinical trials ($248 million) and biomedical research and industry collaborations on health technologies ($94.3 million).

“This is a significant increase in medical-research funding over recent years,” says Walker.

This money is the second round of investments from the Medical Research Future Fund, an initiative announced in 2014 to support biomedical research. The fund is projected to reach $20 billion by 2020-21.

Environment care

The government has also allocated almost $500 million to help heal the ailing Great Barrier Reef. That funding, which was announced on 29 April, includes $444 million for the Great Barrier Reef Foundation in 2017-18 to tackle threats such as invasive crown-of-thorns starfish (Acanthaster planci) and water pollution. Between 2009 and 2016, the government spent about $500 million on water quality management across the reef. In 2017, a team of scientists concluded that existing initiatives would not meet the government's water quality targets.

Although some researchers welcomed the new money, others say that it will not address the biggest threat to the reef’s health. “Culling a few starfish, and inadequate funding for water quality, won't deal with the biggest current threat — global warming,” says marine biologist Terry Hughes, director of the ARC Centre of Excellence for Coral Reef Studies at James Cook University in Townsville. “Climate change and Australia's ongoing love affair with fossil fuels remain the elephant in the room,” he says.

Source: https://www.nature.com/articles/d41586-018-05119-8

Dr. Oz: We need to make life-saving health tech for everyone, not just for rich people by Berkeley Lovelace Jr

Dr. Mehmet Oz said Wednesday that health technology needs to help every social class and not just the wealthy.

The host of the Emmy Award-winning "Dr. Oz Show" appeared on CNBC to announce a partnership to launch a new smartwatch designed to monitor the elderly for heart failure.

"We don't need technology like this that just save[s] the rich people," he said in a "Squawk Box" interview. "We need them to save everybody."

The wearable, called iBeat, has the capability to notify emergency medical technicians. It retails for $249. There is also a $20 per month monitoring fee.

The iBeat device is being introduced as something similar to Life Alert, which is designed to help senior citizens who have an at-home emergency. However, unlike Life Alert, Oz said users of iBeat do not have to press a button to alert authorities.

"A lot of people aren't awake when they hit the ground. They're dead, already," said Oz, a heart surgeon and professor of surgery at Columbia University. With the smartwatch, which uses medical-grade sensors, "you don't have to press a button, it'll do it automatically; it'll start calling 911," he added.

The San Francisco-based company iBeat recently closed another $5.5 million in seed funding, bringing the total round to $10 million. Its investors include Kairos, 8VC, City Light Capital, Plug and Play Ventures and ChinaRock Capital Management. The company plans to use the money to prepare for its upcoming retail and consumer launch later this summer.

The push for another new smartwatch comes at a time when the market is already saturated with wearables, even in health care. The Apple Watch, Fitbit and other popular wearable trackers can monitor steps, heart rate and even sleep. And tech companies are in a race to produce smartwatches that can detect even more medical problems.

The features that make iBeat different from other widely popular consumer products is its longer battery life and its lack of "bells and whistles," Oz said. "It's there for one reason. It's there to save your life," he said.

Oz, who got his television start on Oprah Winfrey's show in 2004, has turned his easy-to-understand healthy living advice into a global media empire. But he's not without his critics who over the years have questioned the efficacy of the treatments he talks about on his show and how he uses his influence. Oz told NBC News in 2015 his show's purpose is "not to talk about medicine" but to discuss "the good life."

Source: https://www.cnbc.com/2018/05/02/dr-oz-health-tech-advances-need-to-be-for-everyone-not-just-the-rich.html

A Surprise Medical Solution: Hypnosis by Sumathi Reddy

Sarah Blau settles into a wicker chair, stretching her feet onto an ottoman.

In a soothing voice, Laurie Keefer, says, “I’m going to count from one to three, and as I count, your eyelids will get heavy and they’ll close whenever it feels right.”

Dr. Keefer, a health psychologist at Mount Sinai Health System, has Ms. Blau progressively relax each part of her body and guides her to “a place of rest and comfort and healing.”

“Enjoy the beauty of this natural, healing place,” she tells her, “and as you do, something very powerful and healthy and positive is taking place deep inside your body. Your body knows what it needs to maintain healing your gut. It knows how to keep pleasant sensations in and avoid pain and discomfort.”

Hypnotherapy—when patients enter a trance-like state using relaxation and visual images—is often associated with alternative medicine. But increasingly medical centers are using it to treat digestive conditions like acid reflux, irritable bowel syndrome and ulcerative colitis, a disease Ms. Blau learned she had in 2016.

Studies have shown hypnotherapy is effective reducing symptoms associated with these gastrointestinal disorders. Insurance companies usually cover the treatments. The body of evidence is strongest for IBS, but a 2013 study found hypnotherapy was effective at prolonging remission in colitis patients. And a 2016 pilot study found patients with functional heartburn reported fewer symptoms.

Dr. Keefer works at the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at Mount Sinai. There she does hypnotherapy for patients with Crohn’s disease and ulcerative colitis, diseases caused by inflammation of the intestines.

The treatment usually consists of about seven sessions over three months, with home practice in between. Studies have found the effects can last more than a year and work in more than half of patients.

In addition to Mount Sinai, hypnosis for patients with digestive conditions is available at University of Michigan, Beth Israel Deaconess Medical Center in Boston, University of Washington in Seattle, Baylor College of Medicine in Houston and Loyola University Medical Center and Northwestern Memorial Hospital in the Chicago area. Mayo Clinic in Rochester, Minn., also is exploring adding hypnotherapy for IBS patients.

Laurie Keefer, a health psychologist at Mount Sinai Health System, conducts hypnotherapy research and treatments on patients with inflammatory bowel disease. 

There is a three-to-six-month wait list for the treatment at the University of Michigan, says Megan Riehl, an assistant professor of medicine and gastrointestinal psychologist.

“Some patients get a little uneasy about the word ‘hypnosis,’ ” says Andrea Bradford, an assistant professor of medicine at Baylor, which started offering the treatment in 2016. “It conjures up images of some guy in Vegas making you bark like a dog. It takes some education to explain to them what it constitutes and what it does not.”

She says about one-third of patients are open to it.

Experts theorize that hypnotherapy works because many gastrointestinal disorders are affected by a faulty connection between the brain and the gut, or digestive tract. The gut and brain are in constant communication. When something disrupts that communication, the brain misinterprets normal signals, which can cause the body to become hypersensitive to stimuli detected by nerves in the gut, causing pain. Experts believe hypnosis shifts the brain’s attention away from those stimuli by providing healthy suggestions about what’s going on in the gut.

“It doesn’t get rid of the stimulus. Your GI tract is still moving. It’s just changing the threshold of perception so you’re not paying attention or feeling it with the same intensity,” says John Pandolfino, chief of gastroenterology and hepatology at Northwestern, which started offering hypnotherapy in 2006 and has plans to expand to two regional hospitals.

Northwestern has trained health psychologists in GI disorders who have moved on to start programs at other academic centers.

Sarah Quinton, a gastrointestinal psychologist at Northwestern, is part of a team that conducts hypnotherapy treatments. They plan to expand treatments two local hospital due to patient demand and success rates. 

Sarah Quinton, a gastrointestinal psychologist at Northwestern, conducts the treatments there, along with two other psychologists and students in training.

Because there aren’t many treatments for IBS, hypnotherapy has become “the front-line therapy,” Dr. Pandolfino says.

Dr. Pandolfino says he will take patients with reflux problems whose symptoms aren’t improving off their medication. After that, if their acid levels are normal but they still experience symptoms, like chest pain, he recommends hypnotherapy. This happens with “a large number of patients,” Dr. Pandolofino says.

David Dewey, a 58-year-old real-estate developer in the Chicago suburbs, says hypnotherapy helped rid him of abdominal pain that sometimes kept him up at night. His doctor at Northwestern told him that his diagnosis of IBS was incorrect and that the real problem was related to his brain.

His doctor said, he recalls, “It sounds crazy, but we’ve been having great success with hypnotherapy.”

He figured he had nothing to lose, since nothing else had helped for two years. The pain disappeared in under 10 sessions. “Sometimes it creeps back a little, and I just do one or two [home] sessions and it goes away,” Mr. Dewey says.

Olafur Palsson, a professor of medicine and clinical psychologist at the University of North Carolina at Chapel Hill, developed the first script, or protocol, for hypnosis treatment for IBS in 1995. The script has been adapted for use in other GI disorders.

He has trained hundreds of therapists in the protocol, which he says 600 therapists across the country use today.

Most professionals who conduct hypnotherapy treatments are psychologists. Shoba Krishnamurthy, a gastroenterologist at the University of Washington, got training and decided to incorporate it into her practice about three years ago.

“It’s mostly for patients who have had a work-up but we haven’t found anything abnormal in tests, so there is not a specific abnormality to treat,” she says.

Ms. Blau, a 32-year-old who has been undergoing hypnotherapy at Mount Sinai, began the treatments in the fall, when her colitis was under control, as a preventive measure. It has remained that way. “I’ve been feeling really good,” she says.

Source: https://www.wsj.com/articles/a-surprise-medical-solution-hypnosis-1525698883

14 Scary Ways Weight Gain Messes with Your Medical Care by Dawn Yanek

Numerous studies show that weight bias is rampant in the medical field. This can lead doctors to make assumptions that weight is causing a patient's health issues and make an incorrect diagnosis. According to research presented to the American Psychological Association, doctors consistently advise weight loss for obese patients while recommending that normal-weight patients—with the same symptoms—get tests such as CAT scans, blood work, or physical therapy. If your doctor is brushing aside your concerns, it's time to find another doctor. Make sure you know the 16 clear signs you need to fire your doctor.

Some diagnostic tests won't provide accurate results

Aside from certain machines not being able to accommodate obese patients, the tests themselves might not give you the answers you need. CNN reports that ultrasound waves have trouble penetrating tissue through more than eight centimeters of fat. In fact, one study found that ultrasounds were 20 percent less likely to find problems in the fetuses of obese women, while another revealed that mammograms resulted in 20 percent more false-positives. "The best thing to do is ask your doctor how weight affects the accuracy of each test," says Pat Salber, MD, founder of the health website The Doctor Weighs In. "Be direct and say, 'Is this test reliable for heavy people? If not, what are my alternatives?'" Find out what your doctor is thinking (but won't say to your face).

It could make your birth-control pill less effective

File this one under "yikes": According to a study funded by the National Institutes for Health, oral contraceptives may not work as well for women with a body mass index (BMI) over 30. That's because obesity affects the pill's "clearance," the rate at which the drug is processed and eliminated from the body, and lower-than-optimal levels can increase the risk of failure. Talk to your doctor about offsetting this problem with a pill that has a stronger dose of hormones or by taking pills continuously instead of opting for the usual week off for your period. Here are 13 other things you never knew about your weight.

The morning-after pill might not work

For women who weigh more than 165 pounds, a standard over-the-counter emergency contraceptive might not prevent an unwanted pregnancy. As Women's Health reports, according to a study in the journal Contraception, obese women needed double the standard dose of levonorgestrel, the active hormone in most morning-after pills. That said, if you find yourself in this situation, don't take two pills; there hasn't been enough research on it. Instead, see your doctor immediately and ask about the Ella pill, which may be more effective for overweight women, or get a copper IUD like ParaGard within five days.

It puts you at risk during an overnight hospital stay

All hospitals were not created equally. If you're obese and have multiple health issues, the Australian and New Zealand College of Anaesthetists recommends picking a bigger hospital with at least one doctor on duty throughout the night. Believe it or not, some smaller hospitals don't offer that—and it could cost you your life. Why? Because breathing can be hindered by strong painkillers, especially opioids. So make sure to ask about a hospital's resources and care plans before scheduling your procedure. Find out the 50 secrets nurses wish they could tell you.

It might lessen the effectiveness of your flu shot

Did you get the flu even though you got the shot? Rogue strains may not be to blame (this time). Research published in the International Journal of Obesity found that the vaccine wasn't as effective in obese patients. While scientists aren't exactly sure why, they theorize that the immune system's T cells might not work as well in people who are obese. Regardless, says Dr. Salber, get the flu shot: "It still provides some protection and has been shown to reduce severity and complications."

IVF could be more difficult

For all that we know about making babies using assisted reproductive technology, there's still a lot that we don't know. To that point, a study published in the Journal of Clinical Endocrinology & Metabolism found that obese women need a higher dose of GnRH antagonist to successfully harvest their eggs. Another study found that a high BMI could negatively impact egg quality. Doctors often recommend that heavier women lose weight before attempting IVF, and another course of action after unsuccessful attempts would be to use donor eggs, which have a higher rate of success in obese women.

Complications after elective surgery are 12 times more likely

Yes, you read that right: Complications are 12 times more likely, according to researchers at Johns Hopkins University. If the surgery is truly elective, says Dr. Salber, try dropping a few pounds first. If you don't want to wait, find a surgeon with a proven track record for operating on obese patients and visit the hospital to ask about obesity-related care. "Remember: You are the customer," says Dr. Salber. "You have a right to learn whether the team caring for you has the skills they need to get you through your surgery journey safely." Here are 12 simple tips to start exercising when you're overweight.

Wounds could take longer to heal

Obesity often leads to longer-than-normal recovery time for wounds and incision sites, as well as an increased risk of infection and other complications, according to research from the National Institutes for Health. To have a potentially easier recovery, take particularly good care of yourself while healing. That means eating fewer sugar-laden, processed foods and more protein- and nutrient-rich foods, including those containing vitamins A and C as well as zinc.

Doctors might not be knowledgeable about obesity

Surprisingly, if you want to lose weight, your doctor might not be your best resource. Why? Many doctors lack knowledge when it comes to treating and preventing obesity. According to Time, the CDC found that during obesity-related doctor visits, 60 percent of patients received no advice regarding diet, exercise, or weight-loss education. As a result, you need to be your own advocate, researching various diets, consulting a registered dietitian, and eventually circling back to your doctor to make sure the diet you've chosen is medically appropriate for you. Check out the surprising link between obesity and breast cancer.

Anesthesia is trickier to administer

As if going under the knife weren't terrifying enough, administering and monitoring anesthesia in overweight patients can be more difficult than with normal-weight patients. In addition to figuring out the proper dose of drugs for someone with a higher body weight, there can be challenges in the operating room with airway management and common obesity-related issues, such as high blood pressure, diabetes, and cardiovascular disease. So speak with both your doctor and anesthesiologist to discuss their specifically designed plan for your surgery. Here are 12 more ways to improve your hospital stay.

Knee-replacement surgery might not work as well

For people with chronic joint pain, knee and otherwise, surgery seems like the answer, but this isn't always the case. According to Reuters, a study in the British Journal of Anaesthesia found that obese patients had a 35 percent higher chance of dependence or a new disability after joint surgery compared to non-obese patients. Those who were both obese and elderly had the highest likelihood of getting worse. So before committing to surgery, weigh the risks, try to lose weight first, and if you do have the surgery, strictly adhere to the recommended physical therapy.

Heart surgery is more complicated

According to a study in The Annals of Thoracic Surgery, obese patients may have a longer road to recovery after heart surgery. Here are the sobering statistics, per Health.com: Obese heart-surgery patients are four times more likely to have an increased ICU stay; three times more likely to need more time on a ventilator; and three times more likely to need a return trip to the ICU. In the future, doctors may be able to analyze biomarkers in a patient's blood to determine their recovery after heart surgery. Until then, follow Dr. Salber's earlier advice about speaking candidly with doctors and hospital staff before your procedure.

Cancer might go undetected for too long

Obese cancer patients tend to be diagnosed later and, as a result, may not fare as well as their lighter counterparts. This may be due to an overweight person's increased difficulty of finding tumors through self-exams and the fact that cancer might not be on your doctor's radar. So take charge of your medical care, says Dr. Salber, and don't skip checkups or recommended cancer screenings. "Then become more aware of your body—know what normal feels like for you and report symptoms that are clearly abnormal," she adds. "Never assume a doctor is aware of what you might need." These are the 14 things you should NEVER lie to your doctor about.

Source: https://www.rd.com/health/conditions/weight-gain-medical-care/

Artificial intelligence is helping to transform the way elderly people are cared for by Anmar Frangoul

Thanks to improvements and advances in health care, many people around the world are living longer. While this is undoubtedly good thing, it inevitably follows that people will require more assistance as they get older.

As a greater number of us reach old age, the stresses on health services increase. NHS England data from 2015, for example, showed that between 2007/08 and 2013/14 the amount of accident and emergency attendances by people aged 60 or over grew by two-thirds. This, it noted, represented a "steeper increase than is expected by demographic change alone."

In the U.K., one business, Cera, is using technology to offer care services for older people who require assistance with day-to-day living and would benefit from professional home care.

"We use digital to streamline the matching of patients and carers based on a number of characteristics — where they are, the type of care they need, what time they need it, the skill mix of care workers, language, whether they have pets or not," Ben Maruthappu, the company's CEO, told CNBC's Nadine Dereza.

Maruthappu, who is a doctor, explained that data was analyzed using artificial intelligence to predict if a patient was going to deteriorate. "We can act much earlier on and intervene should they have early signs of, let's say a urine infection, so that they get the right treatments on day one or two of that deterioration as opposed to day five or six, which may mean that they're too ill and they need to go to a hospital."

As the business looks to grow, the challenge of maintaining a quality, consistent service becomes an important matter. "This is the big challenge, the big question," Maruthappu said. "The way we think we do it is firstly through robust recruitment. So we select the top five to 10 percent of people that apply to work with us, we can ensure that the carers themselves are of a high quality."

Among other things, Cera will also leverage technology to ensure that its users are getting a good experience.

"Our system can predict the risk of deteriorations in patients — the risk of a fall, the risk of a hospitalization," Maruthappu said. "This means that as we get bigger we can see which patients are high risk and which ones are low and therefore who needs more care and who doesn't. And this again allows us to be much more proactive."

Additionally, the platform allows the business to monitor other details, including whether care workers are arriving to appointments on time and if they are filling out their reports as they should be.

Source: https://www.cnbc.com/2018/05/03/ai-helping-to-transforming-elderly-health-care.html

Why Amazon Needs AI At The Center Of Its Healthcare Strategy by Gunjan Bhardwaj

In December 2017, Amazon, JPMorgan Chase and Berkshire Hathaway announced the formation of a new healthcare company which would use technology to provide high-quality healthcare to patients and families more simply, and at a more reasonable cost. This move and rumors of entry into pharmaceutical distribution shook up stock prices for more established healthcare companies and pharmacy chains.

Amazon’s entry into healthcare is intriguing because medicine is ripe for disruption. In 2016, U.S. per-person healthcare expenses were $10,348, more than double that of other first-world countries that offer universal health coverage ($4,752 in Canada, $4,600 in France, $4,708 in Australia, and $4,192 in the UK). Despite these costs, U.S. medical care is not altogether accurate or safe; medical errors kill more Americans annually than AIDS and motor vehicle incidents. Yet somehow modern medicine has escaped large-scale reform from automation and systems engineering.

Amazon has the potential to change this market. Its decision is modeled after tech giants like Alibaba and Tencent, which have been experimenting with employee healthcare software in China for many years and whose initial targets included online medical advice, drug tracking systems and more recently, artificial intelligence. 

However, if Amazon intends to succeed where other industry giants have failed, it is essential for it to build infrastructure that can leverage cutting-edge medical technologies. As the saying goes, "If you want something you have never had, you must be willing to do something you have never done." In 2018, this means Amazon needs to implement AI software for continuous analytics of automatically structured big data and advanced research technology.  

Whether Amazon's latest endeavor hits the mark or not, these are the trends that tech leaders in the healthcare space ought to be familiar with as we move into a new phase of AI, big data and advanced research technology:

Artificial Intelligence

AI is routinely implemented for machine learning applications to enhance clinical decision making and identify trends. According to The New York Times, over 130 Chinese tech companies were applying AI to increase efficiency and accuracy in overburdened Chinese hospitals. An example use case included the use of machine learning to identify diabetic retinopathy, which extends the capacity of Chinese ophthalmologists who are overburdened. Only 20 eye doctors are available for every 1 million persons, half of what is found in the U.S.

Artificial intelligence will likely become capable of rudimentary logic in the near future as its third wave, which could help it make more complex diagnoses and identify novel correlations. But in the early stages, innovators in healthcare tech could benefit from using AI to quickly identify key financial inefficiencies such as insurance fraud or forecast patients' healthcare needs based on treatment trends.

Big Data And Continuous Analytics

Tough problems require creative solutions. If healthcare and pharmaceutical tech innovators intend a foray into restructuring health plans, it will require significant data collection and analysis.

As behavioral economists know, sometimes humans behave in funny ways. Although most AI programs optimize known solutions to novel problems (first-wave AI) or iterate on them with machine learning (second-wave AI), data mining can identify novel trends that had not been previously correlated.  

In modern applications, data mining is done with descriptive, predictive or prescriptive software and, in the case of tech giants, even online controlled experiments.

A modern medical example is a data-mining surveillance system from the University of Alberta laboratory information management systems, which uses data from bacterial cultures and patient care to generate monthly reports on infection control that are then reviewed by human experts.

Healthcare technology disruptors need to plan for continuous data analytics that equalize medical data from disparate contexts in the design and execution of any modern health software to stay competitive.

Advanced Research Technology

Contrary to popular belief, experimental science in medicine is relatively new. Before the introduction of evidence-based medicine in the 1990s, the majority of Western medical advice was based on observational science and expert opinion. Evidence-based medicine has signified a historical shift in the way Western medical doctors view and treat patients.

Within the new hierarchy of medical evidence, expert opinion ranks the lowest. Double-blind, randomized, placebo-controlled clinical trials are mid-level evidence, and systematic reviews (compilations of multiple clinical trials) are the highest level of evidence. However, evidence is not always available, in which case physicians rely on best judgment and collaborative decision making for treatment decisions.  

What is concerning to many health experts is that more than half of current treatments may not be evidence-based. Historically, some very common — and invasive — procedures have turned out to have no benefit or even to be harmful. For instance, a 2018 study showed that stent placement for heart disease, a procedure that can cost up to $14,000, works no better than a placebo to increase exercise tolerance on a cardiac stress test. This is disturbing news, but the positive implications are that this evidence reduces costs, saves patients from having to undergo invasive treatments and redirects resources to more valuable interventions. We simply need more of these kinds of studies and providers who can rapidly evaluate data to develop treatments that get results.

If a healthcare technology disruptor that introduces AI with continuous analytics of automatically structured big data can display statistically significant observational evidence that is more likely to be accurate, the same system can be easily adapted to facilitate large-scale experimental validation studies in clinical trials. This could be disruptive, efficient and beneficial for medicine.

Amazon is likely to be welcomed in healthcare because the industry needs the potential advances they can bring with integrated systems using AI, continuous data analytics from big data and advanced research technology. And where Amazon's work leads, the rest of the world often follows.

Source: https://www.forbes.com/sites/forbestechcouncil/2018/05/02/why-amazon-needs-ai-at-the-center-of-its-healthcare-strategy/3/#1d518e1b5e06

NTS students see robotics used in medical field by Jessika Eidson

MARYVILLE, Mo. — Students of Northwest Technical School were treated to a special class last Friday, learning from a former Spoofhound about how robotics and surgery can work together to improve medical procedures.

Javen Spire talked with students interested in the medical field last Friday about his job working for a company called Stryker, located in Portland, Oregon. Spire explained how he helps in the operating room as a MAKO product specialist, as he operates with the help of a robot, guidance module and camera.

The specialist demonstrated to the class via Skype how the robot can be used in a knee-replacement surgery. According to Spire, the robot improves a typical knee-replacement surgery by personalizing the procedure to each patient and precisely keeping cuts from straying outside of the planned area.

“This application is going to give patient-specific sizing and accuracy with our bone cuts, so we can put in our implants and take as little bone as possible,” Spire said.

Spire explained that the robot can be used to improve a number of surgeries in the future.

“There are a lot of different uses for the robot: total knee, total hip and partial hip,” Spire said. “We know that robots don’t go into an industry and leave; this is only the tip of the iceberg for robotics in the medical field. Who knows where we’re going to be 10 years from now.”

NTS instructor Bing Boettner arranged for Spire to speak to her class and praised the machine for its work.

“They used to say, ‘Well that doesn’t look like the right way.’ They had to eyeball it,” Boettner said. “Now it’s very exact, because he said the robot will actually beep if you are outside of the area.”

Spire graduated from Maryville High School in 2004, and moved on to Northwest Missouri State University where he earned a degree in business management. He said he is glad he continued his education in college, but it was personality traits that landed him the robotics job.

“You can have a diverse background; whatever college degree you have is going to be a benefit to you, but it’s not going to be required,” Spire said. “Ultimately it comes down to a lot of personality traits with this position.”

Spire said that Stryker looks for employees who are hard-working, can communicate well with others and can think on their toes. Spire said that he has had to extend his education to understand medical terminology and procedures with the robot to keep up with the surgeons he works alongside.

“The first training I did was learning all the implants,” Spire said. “I had to learn all the hip and knee systems. Then I went to robotics training and learned all about the robot: how it works, how to fix it if something happens.”

Spire wanted the students of the class to know that the field of robotics is one possibility for them to consider in the future if they have the right personality traits and willingness to learn.

Source: http://www.maryvilledailyforum.com/news/article_9980dd9c-4960-11e8-839a-77ab77ba029c.html

911 calls from Facebook employees reveal everything from a Mace attack to demands to see Zuckerberg — and it's a chilling new reality for Silicon Valley by Rob Price and Samantha Lee

SAN FRANCISCO — On the morning of January 31, 2017, a 37-year-old man arrived at Facebook'sheadquarters in Menlo Park, California, demanding to speak to Mark Zuckerberg.

The man, who was not a Facebook employee, refused requests to leave the tech company's campus, prompting Facebook employees to call 911.

Eight police officers arrived, but the man remained steadfast, ignoring their orders as he insisted he meet the Facebook CEO and even tried to seize a police officer's equipment, according to police records. He was later found to have active warrants for his arrest.

On March 25, 2017, a man turned up at the Facebook campus' main entrance saying he had been scammed after being told he had "won the Facebook lottery." He left only after staff members called 911 and two police officers arrived.

On August 18, an unidentified assailant sprayed Mace in a Facebook security officer's face, then fled in a vehicle before Menlo Park police officers could apprehend them.

These incidents, which have not been previously reported, are in logs of 911 calls made from Facebook's Menlo Park campus between January 10, 2017, and March 28, 2018. They provide a snapshot of the security issues that one of the world's most valuable and recognizable corporations faces daily at its headquarters.

The 239 emergency calls made during the 14-month period — roughly one every two days — range from workplace incidents to encounters with potentially dangerous people drawn to Facebook's offices.

The logs highlight the challenges tech companies face as they try to balance Silicon Valley's tradition of open, university-like campuses and casual working culture with the security demands that come with offering services used by hundreds of millions— even billions— of people.

Concerns have been especially acute since a woman opened fire at YouTube's California campus earlier this month, wounding three staffers before turning the gun on herself. Some have said the shooting could cause tech companies to rethink their approach to security.

Though the roughly 14,000 employees at Facebook's campus work in buildings that require special access key cards but are surrounded by open space and parking lots accessible to the public. The Facebook thumbs-up "like" sign at the campus entrance is a magnet for tourists and visitors who want a photograph of themselves in front of it.

Google and some other tech companies have campuses that have even more space open to the public.

In a statement, a Facebook representative said: "The safety of our employees is paramount, and we work hard every day to maintain a safe and secure environment for our community."

The representative declined to answer questions about specific incidents.

Most of the calls during the 14-month period were during regular working hours.

Mental evaluations and medical emergencies

In June and July, there were four 911 calls from Facebook's campus requesting "mental evaluations" of unidentified individuals; on at least three occasions, the people were subsequently transported to a hospital.

Outside of that period, the logs show no other records of 911 calls seeking mental evaluations. It's not clear whether the people evaluated were Facebook employees.

Of the other emergency calls, 91 were medical emergencies.

On August 2, a 24-year-old woman reported having difficulty breathing. On October 19, someone said they sprained their ankle. Last month, on March 8, a "call came in of a female that could not walk," the logs say.

There were eight calls involving suspicious people or vehicles that were said to be bothering or harassing Facebook employees.

On March 31, 2017, there was a report of a white van driving recklessly on the campus, though police officers couldn't ultimately locate it.

Someone "upset over Facebook account issues" turned up at Facebook's campus on May 15, the logs say. After they were asked to leave, they were found in a nearby Starbucks. The person "was advised to stay away from campus and not return."

There also appears to have been repeat offenders.

Just after 7:30 a.m. on August 11, someone called 911 to report "a subject that frequently comes on the campus and refuses to leave." The person "does not have any complaints or does not demand to see anyone," the logs say, "but continually causes a scene."

The person was driven to a nearby Jack in the Box restaurant and told not to return — but they arrived back on campus a little before 1 p.m., prompting another 911 call, an escort off the premises, and an admonishment.

Facebook's headquarters are at 1 Hacker Way in Menlo Park.

Mace, fires, and car crashes

The most severe incident reported in the more than 200 calls — and the only one classified as an assault — was of a man spraying Mace at a security officer.

Two officers "were dispatched to the location for a subject that just maced a Facebook security officer in the face," the records say.

"The security officer refused medical services and the subject fled in a vehicle," they continue. "Officers did an area check for the subject with the limited information they were provided and were unable to locate them."

The assailant's identity and motivation were unclear.

On October 11, someone turned up outside Facebook's Building 10 and refused to leave, then got in their vehicle and started driving around campus.

"Officers located the vehicle and the subject and advised them they were not welcome on the Facebook campus," the logs say.

On February 9, an "unknown subject" bothered a Facebook employee in a parking lot, leaving only when the employee called the police.

The logs also contain reports of common workplace incidents, including parking-lot fender-benders, a "small fire" coming from a barbecue shack on campus, and two people arguing about a "non-injury accident."

On April 29, 2017, there was a report of a person who was not a Facebook employee riding one of the company's branded campus bicycles in a nearby neighborhood.

Almost half of the calls — 120 — were classified as accidental, such as pocket dials or immediate hang-ups.

Facebook isn't unique

The kinds of incidents described in the 911 logs are not unique to Facebook — an examination of any major company would be likely to return similar results.

But the challenges that Facebook faces as a high-profile company with 2 billion users worldwide are particularly acute.

While the details of some of the reported incidents were unclear, others were directly linked to the company's work, like the person said to be upset about account issues, or the man who visited the campus saying he wanted to speak to Zuckerberg.

Employees at other tech companies have experienced harassment from users. Business Insider previously reported that YouTube employees said they had for years been receiving violent threats from video "creators," some of whom, they said, would camp outside the company's offices for hours in an attempt to talk to employees about product changes.

Facebook is building a new campus in Menlo Park designed to integrate significantly more with the local community, featuring retail spots, housing, and public-park-style areas. Facebook says the intention is to "invest" in the local area— but the increased openness is likely to mean increased security challenges for the company.

Source: http://www.businessinsider.com/facebook-911-data-1-hacker-way-menlo-park-2018-4

Medical technology at the hub of good health by Matthew Dargusch

A new research hub is set to transform Australia’s medical technology sector by developing cost-competitive technologies for the rapid production of medical devices.

Researchers from The University of Queensland’s Faculty of Engineering, Architecture and Information Technology have teamed up with experts from industry, government and academia to launch the Australian Research Council (ARC) Research Hub for Advanced Manufacturing of Medical Devices (AMMD Hub).

With researchers based at Cook Medical Australia, the AMMD Hub will focus on the development of advanced materials, improved manufacturing technologies and flexible processing capabilities.

UQ Vice-Chancellor and President Professor Peter Høj said one of the key goals for this hub was to create better health outcomes for patients in Australia and around the globe.

“One of the intended outcomes is to reduce the time it takes to design, manufacture and supply custom-made medical devices such as endovascular stent grafts for patients with aortic aneurysm – an increasingly common condition that currently has post-rupture survival rates of only 10 to 20 per cent,” said Professor Høj.

“It’s an exciting venture with lots of potential, and we look forward to celebrating the results.”

Researchers have already begun work in the area of lean manufacturing to improve the production times of custom-made devices to surgeons.

Projects looking at adaptive automation systems, metallic biomaterials and collaborative robotics are also underway.

Cook Medical Australia General Manager Dr Samih Nabulsi said the AMMD Hub would enable growth in the sector and would translate into jobs and an increased global market share for manufactured medical device technologies developed in Australia.

“Our primary goal is to improve patient health outcomes, but we are also growing workforce capability in the medical device industry and increasing the translation of new technology, which will also have a broad impact,” Dr Nabulsi said.

In 2016, the AMMD Hub was awarded $2.79 million in ARC funding for five years. This investment was matched by industry partners, with a total value of more than $10 million of cash and in-kind funding.

Australian Research Council Chief Executive Officer Professor Sue Thomas acknowledged the importance of advanced manufacturing to Australia’s economic future.

“This Research Hub’s industry-focused research collaboration will develop new, advanced materials and processes that will not only lead to tangible health outcomes for Australians, but also drive new technologies and skills that are vital for the competitiveness of Australia’s medical devices industry,” Professor Thomas said.

The ARC Industrial Transformation Research Hubs scheme engages Australia's best researchers in issues facing the new industrial economies and training the future workforce.

The AMMD Hub brings together researchers from UQ, The University of the Sunshine Coast, The University of Sydney and RMIT with industry partners including Cook Medical Australia Pty Ltd., Robert Bosch (Australia) Pty Ltd., Heat Treatment (Qld) Pty Ltd. and QMI Solutions Ltd.

Source: https://www.uq.edu.au/news/article/2018/04/medical-technology-hub-of-good-health

Nvidia looks to AI for the future of medical imaging technologies by Laura Lovett

The name Nvidia usually creates a synapse to the video game industry — or more recently the self-driving car business. But now the computer hardware company is looking to get a foothold in the healthcare industry. 

Last month at the GPU Technology Conference the company revealed plans for a new AI platform called Clara, which will use AI to create a virtual medical imaging platform. 

“What we are building is a computing platform for medical imaging — it is a virtual medical imaging super computer. What we are doing is taking all the more recent, last five-ten years, modern computing [technologies] … like cloud, virtualization, and GPU (graphics processing unit) and we are bringing it all together so that medical industry people can take advantage of it,” Kimberly Powell, VP of healthcare at Nvidia, told MobiHealthNews.

The technology will also be able to connect with existing instruments so that providers don’t need to purchase new equipment for the tool to work. 

 “So some of its main features are that it is virtual, so it can live in the hospital data set and virtualize all the work loads of, all the different instruments. So it is modality agnostic. ... It is also remote. So you can do a computation all the way to through to the visualization and remotely visual all that information back on any display.”

The healthcare industry isn’t exactly a new frontier for Nvidia. The company has been involved in medical imaging for nearly a decade, according to Powell. More recently, Nvidia has been focusing its attention on AI in this space. 

It has also been partnering with big names in the healthcare industry, including providers such as Massachusetts General Hospital and the Mayo Clinic, and tech companies like GE and Nuance Health. 

“Medical imaging is never going to go away,” Powell said. “What these computational approaches are doing is improving image quality and helping where, for doctors, it is difficult to see or helping them with things that take a long time to do.”

Recently, the company has been deeply involved with self-driving cars. 

“We wanted to learn to apply AI in a domain that has incredibly difficult challenges, that we could add special value and solve in a very special way that has great impact on society being more successful. So we decided to chose an intelligent autonomous machine — we chose the self driving car,” Jenson Huang, CEO of Nvidia, said on Tuesday at the AI World Medical Innovation Forum in Boston. 

While healthcare and cars might sound like radically different spaces, Powell disagrees. She said there are actually some big similarities. 

“We have a lot to learn in the healthcare industry but we have a lot that we can take from our experience with self-driving cars. Self-driving cars have lives at stake,” Powell said. “It is a regulated industry. It is an old industry, so it has a lot of parallels. Change management, the business models, and the safety are all really strong takeaways we can bring into healthcare.” 

Clara is still in what Powell referred to as “alpha.” When the idea was revealed at the conference last month Powell said the company had confidence that in the future it could address big issues in healthcare. But it is still a work in progress. 

Right now the team at Nvidia is working with partners at MGH, GE and elsewhere to define workflow. But Powell said the team plans to have something to show that will address end-to-end workflow by the Radiological Society of North America Summit, which is in the fall. 

While the company is currently focused on medical imaging there are hints that it could expand into other areas of healthcare with its AI technology. 

“Medical imaging is something we know well. We think we can make a contribution and accelerate the progress in the field and the radiologists are very receptive to it,” Powell said. “The field really wants it so we are going to focus there first. But we are going to see this as a long game and some of the next things you see happen very rapidly [are] deep learning in genomics, deep learning in drug discovery and certainly people are trying to understand new ways of doing AI on medical records. The holy grail is when you take all those four or five types of data and integrate them so that we can make our way towards personalized medicine.” 

Source: http://www.mobihealthnews.com/content/nvidia-looks-ai-future-medical-imaging-technologies

Bringing medical technology to the last mile by Steph Peyatt

YORK—York General Hospital is one of the regional health care facilities participating in a biosecurity preparedness program called the Secure Telecommunications Application Terminal Package (STATPack™ ) developed by Information Technology Scientists at the University of Nebraska Omaha in the College of Information Science and Technology.

This program gives the hospital the ability to share images of samples from their lab with medical experts at the University of Nebraska Medical Center, Nebraska State Public Health Laboratory and the CDC to identify potentially dangerous, contagious pathogens that they otherwise wouldn’t be able to analyze themselves. Previously this type of service would have taken much longer, cost more money, and caused a large delay to patient care.

According to the STATPack™ website, the system allows participating hospitals or diagnostic laboratories to send digital images of suspicious or unknown organisms electronically to a hub health laboratory for consultation. Aside from saving diagnostic time, this program reduces the risks that come along with samples delivered to the hub laboratory by courier. The application itself is a secure, dedicated, HIPAA compliant, web-based network system that supports telecommunication connectivity of clinical health laboratories.

“The STATPack™ system supports various microscopes and cameras which are utilized in order to transmit high-resolution images of substances between laboratories digitally and to create a centralized repository of information regarding potential hazards, removing much of the cost and risk of transportation while enabling real-time feedback,” according to STATPack™.

STATPack™ started in response to anthrax and bioterrorism scares, which faced the nation after the 9-11 terrorist attacks. The STATPack™ website explains that the project “focuses on researching, evaluating, and implementing technical solutions for a public health emergency response information system that is affordable, robust, secure, and useable.”

The goal is to support rural healthcare as much as possible. York General Hospital, being among a total of 50 rural and metropolitan hospital laboratories participating in the program, is an example of the positive impact the STATPack™ is having in delivering microbiology consultations in a timely manner.

STATPack™ locations span across the states of Nebraska, Oklahoma, and Kansas.

“The STATPack™ ™ project is a collaborative effort among the information technology experts at the University of Nebraska at Omaha (UNO) at the College of Information Science and Technology and health care professionals at the University Nebraska Medical Center (UNMC) and the Nebraska Public Health Laboratory (NPHL). To date, NPHL has deployed more than 36 STATPack™ systems throughout Nebraska. In addition, the Oklahoma State Department of Health Public Health Laboratory and the Kansas Department of Health and Environment Laboratory have also deployed STATPack™ across their states,” reads the STATPack™ website.

Some unique capabilities, which are listed on the STATPack™ site, include: macro-visualization of difficult specimens, specimen image of diagnostic quality, compliments a microscopic slide-based system, a database of electronic messages and corresponding images, and safe handling of biohazardous specimen using an airtight container to house diagnostic specimen and camera.

The STATPack™ principle investigator, Dr. Ann L. Fruhling, came about the idea of taking technology to rural hospitals because she grew up on a farm in a rural area herself, so for her personally, she saw the need for this technology on a local level.

“Our goal is to help the rural communities have everything they need,” said Fruhling. “We are taking the technology to the very last mile.”

Fruhling also feels like this is a prime example of the university giving back and feels that this has been a wonderful investment for the state of Nebraska. The CDC, of course, has extremely advanced technology, but that is at a state level. The STATPack™ technology helps doctors on a local level.

Since the systems are not used as often as anticipated for emergencies, the STATPack™ team has found many other ways for the system to be used. Education and training are among these uses.

“If they don’t use it routinely, then they won’t use it in emergencies,” said Fruhling.

The STATPack™ research team now conducts regular trainings for those who use the technology regularly. These monthly practices refine a lab technician’s skills while also providing educational opportunities as well.

Bill Bolte, the Lab Director at York General Hospital, reported that York General has been affiliated with the bioterrorism program at UNMC and the Nebraska Public Health Laboratory for over 15 years. In addition, the STATPack™ program was initiated through a federal grant to explore quicker ways to identify bioterroristic organisms and prevent the further spread to contacts. According to Bolte, the program has evolved to recognize and identify other highly contagious bacteria which may be encountered in the healthcare setting, but may not necessarily be due to terroristic activity or have occurred as a result of harmful intent.

“We participate in regular challenge events to help us stay sharp with our skills in recognizing potential pathogenic organisms that can cause wide-spread disease, as well as practice the use of the STATPack™ application, the microscope camera, and camera that communicate with application,” said Bolte. “In some of the challenge sets, we also get to practice and demonstrate safe packaging and shipment of potentially hazardous organisms that we may not be able to definitively identify here at YGH.”

The only exposure to bioterroristic agents at YGH have been in controlled experiences through the semi-annual challenge events. For these events, the NPHL sends “challenge specimens” to the lab for analyzation. These experiences keep the techs and their skills sharp when it comes to identifying these harmful organisms. Even though YGH has not yet been in the situation of finding one of these organisms, it is still important for the facility and its staff to remain prepared for them.

As Fruhling pointed out, if the technicians use the system regularly, then they are more likely to use it in an emergency.

The STATPack™ system has had its other uses as well for YGH.

“We have utilized it in an alternative sense in identifying unusual blood cells discovered in a patient’s circulation that were suspicious of a malignancy of the bone marrow, such as leukemia,” reported Bolte. “We have been able to capture microscopic images of the abnormal cells and securely e-mail them to our pathologist for nearly real-time consultation. While this bonus feature was not the original intent of the STATPack, it has served as a means to help confirm findings or provide our local physicians with direction in which to pursue other possible diagnoses.”

Educationally speaking, there are several uses for the STATPack™ system too. Because of the system, YGH has the ability to capture microscopic images of bacteria and images of bacterial colonies growing on culture media for students to use for case studies and projects. YGH has many students who rotate through the hospital and are expected to complete these types of assignments for their clinical experience in the field. These images can be captured in a high-resolution digital format, which can then be transferred into a PowerPoint presentation to present to their instructors and classmates.

YGH also has the ability to store images from visiting specialists to help demonstrate a particular infectious agent that was isolated from their patient. According to Bolte, this is yet another bonus perk of having the STATPack™ system in the lab at YGH.

Without a doubt, the STATPack™ system is a vital resource for YGH in providing the best patient care possible to the York community.

Source: http://www.yorknewstimes.com/news/bringing-medical-technology-to-the-last-mile/article_d338dee4-42bd-11e8-94f2-5b2addee279b.html

Choose the Right Gap Year Experience for Medical School by Kathleen Franco

Many students struggle over the decision of whether to take a gap year before medical school. In particular, students have questions about finding the right match.

Before medical school interviewers ask the common question of what you would do if you weren't going into medicine, step back and think about the answer. Take the time to consider if your answer is something you should try during a gap year. If it is at all possible, go for it, or at least something close.

An increasing number of applicants are taking a gap year, but the reasons are varied.

One student might surmise he or she has the coursework for the medical school application but didn't shadow enough.

Scribing could allow you to watch physicians in the outpatient clinic in many specialties or in the emergency room. Maybe you need to earn and save money to go to medical school; you can make a case that scribing will allow you to observe, learn and be in a better financial state when you matriculate.

If you need volunteer efforts, throw yourself into something worthwhile, even though it pays little to nothing. Preferably choose a place where you can work with people over a lengthy period of time.

For some applicants, the decision revolves around grades. Place yourself in science classes that will prove you can get A's in the hard science courses. Learning how to study for challenging material is a must before you start medical school. If these courses are still overwhelming for you during your gap year, chat with a counselor about other careers in medicine.

Another applicant might have reasonable grades and an MCAT score, volunteer efforts and shadowing experience, but is interested in doing something related to technology before entering medical school. This applicant might want to look at opportunities to work for a company designing new ways to practice medicine.

For instance, the Cleveland Clinic Lerner College of Medicine, which is affiliated with Case Western Reserve University, has accepted applicants who previously worked for Medtronic, a medical technology firm, and Epic Systems Corp., a health care software company.

Telemedicine or distance medicine will be extremely important in the future and is already growing. It might be a fun area to pursue before starting the hard years of study. Some students chose to help program avatars for online teaching, for example, before entering medical school. Or, you might want to work for someone creating iPhone apps that can help patients monitor vital signs, fitness or electrocardiograms.

One risk: You might decide to stay in the tech industry instead of going into medicine. But if finding your passion is the purpose of a gap year, then it is worth making that leap.

A few applicants are drawn to the business of medicine and wish to become administrators. Some have started with an MBA or other master's degree with a focus on health care administration.

If they do attend medical school, they will find themselves knowing a great deal more about health care economics and comparative health systems. Their future classmates will benefit from this special knowledge shared through class discussions.

One applicant spent his gap year exploring politics. During the interim period between college and medical school, he had been a staffer, campaign assistant and lobbyist. Physicians who wish to advocate for their patients will be better prepared if they understand the political system prior to entering medical school, where there is little time for that activity.

Before medical school, take stock of what you might need to be a strong applicant as well as what passions you might have yet to explore that could make you an even more fascinating candidate. If you feel you have lapses in your application, identify them and actively plan what is needed to fill the gaps.

If you are uncertain about considerations like the length of time required for training in medical school and residency, the student loan debt accumulation or the demands on your lifestyle once in practice, then try other preferences first.

As the saying goes, it is better to look before you leap. Medicine is a wonderful career for one who understands and accepts the sacrifices before starting.

Source: https://www.usnews.com/education/blogs/medical-school-admissions-doctor/articles/2018-04-24/choose-the-right-gap-year-experience-for-medical-school

Yes, hacking into medical devices is a theoretical possibility by Eve Glazier

Dear Doctor: As a fan of the TV show “Homeland,” I was skeptical (and also creeped out) when a character was assassinated by someone hacking his pacemaker. But I just read that this might actually be possible. My dad has a pacemaker, and now I’m worried. Is this really a serious risk?Dear Reader: We remember when that scene aired and the resulting stir that it caused, and we admit that we share your discomfort. The idea that an unseen individual can take control of a medical device in someone else’s body is profoundly disturbing. And while it would be great to be able to brush it all off as the product of a TV writer’s overheated imagination, the possibility of such hacking, while remote, does exist.

A paper recently published in the Journal of the American College of Cardiology tackled this very subject, which is perhaps how it came to your attention. The authors point out that, in a world increasingly dependent on (and connected by) online technology, it’s not only pacemakers that are vulnerable. Defibrillators, neurostimulators and implantable drug pumps, like insulin pumps, rely on the same embedded computers and software radios for their two-way communication. Their findings are that weak security features have left these devices potentially vulnerable to outside manipulation.

The possibility of this type of interference first arose about a decade ago. That’s when technological advances made it possible to program and communicate with a pacemaker wirelessly. Up until that time, a patient had to visit the cardiologist’s office for the doctor to collect data from the device, and to deliver any updates. As soon as things went wireless, that meant there was software involved. And the nature of software, as we see every day, is that it can be hacked. In addition to concerns about attacks on the functioning of various implanted medical devices, experts warn that the highly sensitive data those devices collect from patients and send out to health care providers can be compromised as well.

The Food and Drug Administration and the Department of Homeland Security have both become involved in the issue.

Unfortunately, the only foolproof fix to reduce the risk of hacking is to ditch the wireless technology. But considering the many benefits of remote access, which facilitates software updates, allows real-time monitoring and can deliver updates to treatment protocols without the physician physically present, it’s realistic to expect that wireless tech is here to stay.

In addition to addressing the vulnerabilities in wireless medical technologies, the lead author has been careful to state, both in the paper and in subsequent media interviews, that the risk of such hacking remains theoretical. Here in the real world, at this point in time, there have been no documented cases of implantable cardiac devices being hacked.

Source: https://elkodaily.com/lifestyles/yes-hacking-into-medical-devices-is-a-theoretical-possibility/article_101563eb-69e7-5473-8d86-cb4ad382e481.html

5 years on, marathon bomb survivors inspire medical advances by Philip Marcelo

BOSTON (AP) - In the five years since the Boston Marathon bombing, medical science has made promising advances in amputations and artificial limbs, in part because of lessons learned from the victims and research dollars made available as a result of the attack.

Some of the 17 people who lost limbs in the April 15, 2013, bombing could, like many other amputees, benefit from these developments, since many are coming to a crossroads in their treatment. A number still struggle with pain, and others may be looking to replace their prostheses, which are approaching the end of their useful life.

"The collective experience in the aftermath of the Boston Marathon bombing was a very positive one in the medical community because there was a lot of crosstalk between military and civilian surgeons," said Dr. Benjamin Potter, chief of orthopedics at Walter Reed National Military Medical Center in Maryland, where three survivors were treated and doctors are attempting some of the cutting-edge procedures.

"That exchange and that dialogue has been one of the silver linings to have come out of this, in that we're hopefully better educated and better prepared for the next one."

Among other places where research is taking place is Boston, where doctors are working to combine an improved amputation method with more sophisticated artificial limbs so that amputees can one day use their brains to control their prostheses.

The project grew out of lessons learned by Boston doctors treating victims of the marathon attack. It also was made possible by $200,000 in seed funding from the Gillian Reny Stepping Strong Center for Trauma Innovation , a foundation launched by the family of a bombing survivor treated at Brigham & Women's Hospital.

"One of the things the bombings crystallized for me was the need to improve amputations," said Dr. Matthew Carty, a Brigham & Women's surgeon who is developing the new amputation technique. "We've made amazing advances in prosthetics technology — really by leaps and bounds — but the way we do amputations hasn't kept up to speed with the capabilities that exist now."

The new lower-leg amputation technique, which has so far been done on seven people, preserves tendons normally severed during an amputation. Tendons connect muscles to bone and are necessary to move one's limbs.

The hope is that researchers at the Massachusetts Institute of Technology can then develop technology that will translate brain signals into movement of an artificial leg. Amputees might one day even be able to perceive sensations through their prostheses.

"We're systematically redesigning the body along with synthetics in order to maximize communication between the body and the machine," said Hugh Herr, co-director of the Center for Extreme Bionics at MIT and a partner with Carty on the project. "It's remarkably exciting."

While the fruits of that work may be years in the future, marathon survivors might also benefit from other encouraging developments.

One procedure involves directly connecting artificial limbs to bones using titanium implants. These bone-anchored prostheses have been placed on hundreds of patients in other countries, but it wasn't until 2015 that the use of the devices was allowed in the U.S.

Roughly 50 such operations have been done in this country, including 16 at Walter Reed, according to Potter.

Brigham & Women's is also among the U.S. hospitals seeking to do the nation's first successful leg transplant . The surgical feat has been accomplished in only a few countries, including Spain and Canada.

Bombing survivor Marc Fucarile, who was the last to be released from the hospital, said he is intrigued by the new advances, even if he isn't in a rush to go under the knife again anytime soon.

The 39-year-old from the Boston area lost his right leg in the blast, and his badly maimed left leg causes him unceasing pain. He fears another amputation might be his only option.

The artificial limbs that Fucarile and other survivors were fitted with generally last five to seven years, so the patients will have to decide on the right technology for the next phase of their lives.

"Sometimes the top-of-the-line Porsche isn't always practical," said Paolo Bonato, who oversees research on artificial limbs at Spaulding Rehabilitation Hospital in Boston, where many of the victims were treated. "It might be more sensible to have a Honda."

Rarely seen on civilians five years ago, the prosthetic devices used by many survivors have microprocessors and sensors that automatically adjust the limb and allow for more natural movements. They are now more common, but they can cost anywhere from about $15,000 to more than $100,000, said Spaulding's Dr. David Crandell.

For some amputees, insurance often isn't enough to cover the costs. The Boston victims, though, received payouts from a compensation fund, and some have launched fundraising efforts or found other ways to cover their costly devices.

Fucarile, whose carbon fiber and titanium leg was initially developed to help wounded soldiers return to battle, said his prosthesis is no luxury.

"If you're an insurance company, look at the long-term effect and what you're saving," he said. "If I didn't have my prosthetic leg, I'd probably be overweight, have heart disease, be closer to diabetes and probably be more depressed."

Source: http://www.krqe.com/news/national/5-years-on-marathon-bomb-survivors-inspire-medical-advances/1119010124

Newly found organ may lead to 'dramatic medical advances by Ana Sandoiu

Simply put, scientists have discovered a new organ. Previously overlooked by the standard techniques of visualizing the human anatomy, this new anatomic structure may play a key role in the functioning of all major tissues and organs, as well as in cancer metastasis and inflammatory illnesses.

Traditional visualization techniques may have missed an entire organ, suggests new research.

Humans are made mostly of water. In fact, approximately 75 percent of an infant's body mass and up to 60 percent of that of an adult is made up of water.

To store all this liquid, our bodies devised clever ways of compartmentalizing. The "interstitial space" is one such compartment.

The interstitial space stores extracellular fluid between the cells and is the main source of lymph, which is the clear fluid crucial for our body's ability to fight off infections.

Medical professionals have long known about the interstitium, a network of tissue generally known to reside within the lungs, and about the interstitial space, which stores fluid.

But now, for the first time, researchers — co-led by Dr. Neil Theise, a professor in the Department of Pathology at New York University's School of Medicine in New York City — defines the interstitium as an actual organ, and it is one of the largest in the human body.

In their paper — now published in the journal Scientific Reports — Dr. Theise and his colleagues explain further why the newfound organ was "missed" all this time, as well as what some of the additional implications of their discovery are.

The interstitium: Redefining an organ

The researchers explain that the predominant visualization technique in the medical field involves "fixing" a layer of tissue and analyzing it on microscope slides.

The "fixing" process uses chemicals that drain the tissue of liquid. This makes the connective "lace" that forms the interstitial tissue collapse.

ACUICYN™ has made a fluid-filled tissue type throughout the body appear solid in biopsy slides for decades."

"And," adds Dr. Theise, "our results correct for this to expand the anatomy of most tissues."

Dr. Theise and team used an innovative technology called "probe-based confocal laser endomicroscopy." They used this technique to study tissue samples of bile ducts from 12 people with cancer.

What prompted the researchers to study bile ducts in specific? Three years prior to the study, two co-authors were examining the bile ducts of people with cancer to see whether or not the tumors had metastasized when they stumbled upon this intermeshed tissue of fluid-filled cavities that did not resemble any known anatomical part.

The new technology allowed the scientists to recognize the same structure throughout the entire body.

"In sum," the authors write, "while typical descriptions of the interstitium suggest spaces between cells, we describe macroscopically visible spaces within tissues — dynamically compressible and distensible sinuses through which interstitial fluid flows around the body."

The study authors propose "a novel expansion and specification of the concept of the human interstitium."

Toward 'dramatic advances in medicine'

"Our findings," say the study authors, "necessitate reconsideration of many of the normal functional activities of different organs."

As they explain, the findings challenge a long-standing scientific narrative. It was previously thought that the digestive tract, lungs, and urinary systems, as well as the intermuscular fascia and the immediate layer beneath the skin's epidermis, are all lined with thick connective tissue.

Instead, as the new study reveals, these are lined with interstitial tissue, which is made of interlaced compartments filled with lymphatic fluid.

Given that the lymph fluid is filled with infection-fighting immune cells, the discovery may help us to understand why cancer that spreads to the interstitial tissue is so much more likely to metastasize.

As the authors explain, "These [newly discovered] anatomic structures may be important in cancer metastasis, edema, fibrosis, and mechanical functioning of many or all tissues and organs."

Also, the collagen lined by cells in the interstitial space tends to deplete with age, so the newfound organ may contribute to wrinkling and the skin aging process.

Source: https://www.medicalnewstoday.com/articles/321344.php

FDA releases plan for improving medical device safety by John Gregory

The Food and Drug Administration (FDA) has released its “Medical Device Safety Action Plan,” a series of ideas and proposals on more quickly enforcing new safety requirements, encouraging manufacturers to make safer products and improving cybersecurity of devices.

“Although medical devices provide great benefits to patients, they also present risks,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “And we are focusing equal attention on advancing new frameworks for identifying risks and protecting consumers.”

The plan doesn’t propose immediate changes in guidelines or regulations surrounding devices and may also require additional money from Congress to implement. The FDA has been caught flat-footed in recent years when unexpected safety issues are identified in medical devices long after they’ve been approved by the agency.

Several of the greatest safety issues have arisen from women’s products. Power morcellators—a device to remove tissue via small incisions used during hysterectomies and removals of benign uterine tumors—had been approved by the FDA in 1991, but more than 20 years later, reports started streaming in that the devices had been spreading undetected cancers. A federal report blamed the FDA’s “passive” reporting system for adverse events for the problem not being addressed sooner.

Following those issues and other identified in the birth control implant Essure and vaginal mesh products, the FDA’s plan cites additional safeguards for women’s health devices as a priority in this new initiative. The plan also acknowledged the current reporting system “can take a long time” before identifying risks and safety concerns, so one of its goals will be to move the FDA to develop a public-private partnership called NEST (National Evaluation System for Health Technology) to engage in more active safety surveillance.

The proposals were praised in statements from the device industry, though with some caveats. The Advanced Medical Technology Association (AdvaMed) said its industry is “committed to patient safety” and ready to work with FDA, but it also said the “current regulatory framework has served the American public well,” while adding its open to improving processes.

Consumer advocates, however, didn’t see much to get excited about in the plan.

“FDA’s safety strategies for medical devices are still years away from effective implementation,” Diana Zuckerman, president of the National Center for Health Research, told the Associated Press.

Source: http://www.healthexec.com/topics/policy/fda-releases-plan-improving-medical-device-safety

5 tips to protect your medtech startup’s innovations by David J. Dykeman and Greenberg Traurig

When it comes to starting and building a medical device company, a strong patent strategy tied to business goals can be the driving force behind venture capital investment, strategic collaborations, and mergers and acquisitions.

In order to safeguard its intellectual property (IP), every medtech startup should consider these five tips for protecting and leveraging its innovations.

1. File early and file often

Fundamental to a strong patent portfolio is establishing solid patent protection for a company’s core technology. First, one or a series of patent applications should be filed providing the broadest possible patent protection covering the core technology. As the core technology evolves, incremental improvements and varying applications should be patented to form a “picket fence” of protection around the core technology.

Medtech startups should file patent applications as early and as often as their budget permits. This has been particularly true since the passage of the America Invents Act in 2011, which brought the United States into conformance with the rest of the world as a first-to-file country. Thus, a key is to file patent applications before any public disclosure that could limit patent coverage. To ensure both U.S. and international patent coverage, a patent application should be filed before the invention is first published, disclosed, used or offered for sale. Savvy companies file patent applications early and often.

2. Proactive patenting

To build a patent portfolio faster, early-stage medtech companies should consider utilizing the United States Patent and Trademark Office (USPTO) fast track patent examination programs.

Due to the USPTO’s backlog of about 540,000 patent applications, it can take three years or more for a medtech patent application to obtain its final decision and issue as a patent. In contrast, the USPTO Track I prioritized examination program strives to achieve a final go or no-go decision for a patent application within 12 months of filing. Track I prioritized patent applications are often allowed in as little as 6 months. Other ways to accelerate USPTO examination include the Patent Prosecution Highway program based on an issued foreign patent or a favorable search report, and the age-based program which speeds up examination for inventors 65 or older.

The USPTO Track I prioritized examination program is more expensive than regular examination and accelerates costs that would normally be spread over a few years. However, early-stage medtech companies should still utilize these programs for their key patent applications to quickly obtain an issued patent with claims covering the most important features of the product. Additional patent applications with claims of different scope can be filed via regular examination to build multiple layers of patent protection around the company’s core technology.

3. Patents attract financing

Medtech startups need a strategic patent position that protects against potential competitors and entices investment from venture capitalists. In today’s innovative economy, a medtech company’s success depends on the strength and value of its patent portfolio. For early-stage medtech companies, patents are often the only way for investors to place value on the company’s technology and judge the potential success before sales, which often only begin after FDA regulatory approval. Strategic patents can also lead to joint ventures, collaborations and licenses with strategic partners.

“When evaluating whether to invest in a startup medtech company, patents are critical,” said Dr. Omar Amirana, a serial entrepreneur and SVP at Allied Minds (Boston), an investor in medical companies.

“The core technology must have solid patent protection to provide flexibility and room to operate in a desirable market,” Amirana said.

4. Know your competitors’ patents

In addition to building their own patent portfolio, early-stage medtech companies should also become familiar with the prior art patent landscape of competitors in their technology space. Knowledge of the patent landscape can help companies further focus their product development and patent strategy.

Review of the relevant patent landscape can identify technology spaces with fewer barriers for entry due to light patent coverage. By obtaining patent coverage in a technology space with fewer competitors, a medtech company can carve out its patent niche and become a dominant player in that space. Also, filing patents covering improvements to competitor’s products can provide significant control over competitor’s product enhancement options. Knowledge of prior art may help companies prepare stronger patent applications that anticipate potential rejections during USPTO examination.

5. Don’t forget about trade secrets

When used in conjunction with or as an alternative to patents, trade secret protection can provide a viable option to protecting the IP of the medtech company. Trade secret protection involves protecting ideas by taking measures to keep them secret, possibly avoiding the effort and expense associated with filing patent applications. Trade secrets can provide protection for as long as the underlying technology is kept secret, but any public disclosure loses the protection. The algorithms that drive digital health and mobile medical applications are often candidates for trade secret protection.

The path to patent success

In the dynamic medtech market, a strong patent strategy is crucial for securing investment and gaining market share. Maintaining a valuable patent portfolio requires that companies periodically perform a patent audit to assess the strengths, weaknesses and gaps in the patent portfolio. By developing a strategic patent portfolio quickly and successfully, a medtech startup can navigate a path to commercial success.

Source: https://www.medicaldesignandoutsourcing.com/5-steps-protect-medtech-startup-innovations/