Top 5 Medical Technology Innovations

Against the backdrop of health care reform and a controversial medical device tax, medical technology companies are focusing more than ever on products that deliver cheaper, faster, more efficient patient care. They are also making inroads with U.S. Food & Drug Administration regulators to re-engineer the complex review and approval process for new medical devices.

Many in the industry have long felt overly burdened by what they consider to be an unnecessarily complex approval process. Critics claim it impedes innovation and delays the availability of better health care. To change that perception, the FDA last year announced a new Medical Device Innovation Consortium (MDIC) charged with simplifying the process of designing and testing new technologies. With input from industry, government, and other nonprofit organizations, public-private MDIC will prioritize the regulatory science needs of the medical device community and fund projects to streamline the process.

“By sharing and leveraging resources, MDIC may help industry to be better equipped to bring safe and effective medical devices to market more quickly and at a lower cost,” says Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

As the regulators, politicians, and corporate executives hash out these details, industry engineers and scientists continue to push through new ideas for improving and managing human health. Every year, industry observers like the Cleveland Clinic and the medical device trade press single out their favorite technology trends. These thought leaders agree that today’s best technologies strike a balance between reducing the overall cost of medical care and increasing safety and survival rates—and isn’t that what health care reform is all about?

Here are five emerging technologies to watch in the year ahead.

1. Cutting Back on Melanoma Biopsies

With the most deadly form of skin cancer, melanoma, a huge number of dangerous-looking moles are actually harmless, but has always been impossible to know for sure without an invasive surgical biopsy. Today dermatologists have new help in making the right call — a handheld tool approved by the FDA for multispectral analysis of tissue morphology. The MelaFind optical scanner is not for definitive diagnosis but rather to provide additional information a doctor can use in determining whether or not to order a biopsy. The goal is to reduce the number of patients left with unnecessary biopsy scars, with the added benefit of eliminating the cost of unnecessary procedures. TheMelaFind technology (MELA Sciences, Irvington, NY) uses missile navigation technologies originally paid for the Department of Defense to optically scan the surface of a suspicious lesion at 10 electromagnetic wavelengths. The collected signals are processed using heavy-duty algorithms and matched against a registry of 10,000 digital images of melanoma and skin disease.

The ATI Neurostimulator from Autonomic Technologies. Image: ATI-SPG.com

2. Electronic Aspirin

For people who suffer from migraines, cluster headaches, and other causes of chronic, excruciating head or facial pain, the “take two aspirins and call me in the morning” method is useless. Doctors have long associated the most severe, chronic forms of headache with the sphenopalatine ganglion (SPG), a facial nerve bundle, but haven’t yet found a treatment that works on the SPG long-term. A technology under clinical investigation at Autonomic Technologies, Inc., (Redwood City, CA) is a patient-powered tool for blocking SPG signals at the first sign of a headache. The system involves the permanent implant of a small nerve stimulating device in the upper gum on the side of the head normally affected by headache. The lead tip of the implant connects with the SPG bundle, and when a patient senses the onset of a headache, he or she places a handheld remote controller on the cheek nearest the implant. The resulting signals stimulate the SPG nerves and block the pain-causing neurotransmitters.

The Symphony tCGM biosensor from Echo Therapeutics. Image: EchoTX.com

3. Needle-Free Diabetes Care

Diabetes self-care is a pain—literally. It brings the constant need to draw blood for glucose testing, the need for daily insulin shots and the heightened risk of infection from all that poking. Continuous glucose monitors and insulin pumps are today’s best options for automating most of the complicated daily process of blood sugar management – but they don’t completely remove the need for skin pricks and shots. But there’s new skin in this game. Echo Therapeutics(Philadelphia, PA) is developing technologies that would replace the poke with a patch. The company is working on a transdermal biosensor that reads blood analytes through the skin without drawing blood. The technology involves a handheld electric-toothbrush-like device that removes just enough top-layer skin cells to put the patient’s blood chemistry within signal range of a patch-borne biosensor. The sensor collects one reading per minute and sends the data wirelessly to a remote monitor, triggering audible alarms when levels go out of the patient’s optimal range and tracking glucose levels over time.

The Telemedicine System from InTouch Technologies. Image: InTouchHealth.com

4. Robotic Check-Ups

A pillar of health reform is improving access to the best health care for more people. Technology is a cost-effective and increasingly potent means to connect clinics in the vast and medically underserved rural regions of the United States with big city medical centers and their specialists. Telemedicine is well established as a tool for triage and assessment in emergencies, but new medical robots go one step further—they can now patrol hospital hallways on more routine rounds, checking on patients in different rooms and managing their individual charts and vital signs without direct human intervention. The RP-VITA Remote Presence Robot produced jointly by iRobot Corp. and InTouch Health is the first such autonomous navigation remote-presence robot to receive FDA clearance for hospital use. The device is a mobile cart with a two-way video screen and medical monitoring equipment, programmed to maneuver through the busy halls of a hospital.

The Sapien transcatheter aortic valve from Edwards Lifesciences. Image: Edwards.com

5. A Valve Job with Heart

The Sapien transcatheter aortic valve is a life-saving alternative to open-heart surgery for patients who need new a new valve but can’t endure the rigors of the operation. Manufactured byEdwards Life Sciences (Irvine, CA), the Sapien has been available in Europe for some time but is only now finding its first use in U.S. heart centers—where it is limited only to the frailest patients thus far. The Sapien valve is guided through the femoral artery by catheter from a small incision near the grown or rib cage. The valve material is made of bovine tissue attached to a stainless-steel stent, which is expanded by inflating a small balloon when correctly placed in the valve space. A simpler procedure that promises dramatically shorter hospitalizations is bound to have a positive effect on the cost of care.

Learn more about the latest innovations in bioengineering.

Michael MacRae is an independent writer.

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10 talks on the future of stem cell medicine

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Will the next generation think about diseases like Alzheimer’s and diabetes the way we think about polio and the whooping cough? Susan Solomon, the co-founder of the New York Stem Cell Foundation (NYSCF), certainly hopes so. In this fascinating talk from TEDGlobal 2012, Solomon delves into the foundation’s work on research with stem cells, which she calls the “black boxes for diseases.”

“[Stem cells] are our bodies’ own repair kits. They are pluripotent, which means they can morph into all of the cells in our bodies,” says Solomon. “Right now there are some really extraordinary things that we are doing with stem cells that are completely changing the way we model disease, our ability to understand why we get sick and even develop drugs. But … this field has been under siege, politically and financially.”

While much of the fray is about embryonic stem cells — still the gold standard when it comes to cells — Solomon explains that another type of pluripotent stem cell (called iPS cells) can now be created by, essentially, reprogramming skin cells. These cells hold great promise for allowing researchers to see how diseases develop in humans, rather than in rodents.

Currently, developing a drug takes an average of 13 years, costs $4 billion, and has a 99% failure rate. And because it’s impossible to test a new drug on a large and representative sample of the human population, even a drug that tests well with many people will have side-effects for others, based on their genetic makeup. This is a problem that’s sometimes not apparent until the drug is on the market and being prescribed to patients — like in the tragic case of Vioxx.

“That’s a terrible business model, but also is a horrible social model,” she says. “The way we’ve been developing drugs is essentially like going into a shoe store and no one asking what size you are … They just say, ‘Well, you have feet. Here are shoes.’”

From the TEDGlobal stage, Solomon outlined an exciting new approach—her team at NYSCF has developed a machine that creates stem cell linesthat, until now, had to be crafted by hand. NYSCF expects to produce 2,500 stem cell lines by the end of the year. The idea is to eventually produce a comprehensive array of 25,000 stem cell lines — which act like avatars for a wide sample of people — that researchers would have access to as they test new drugs. This could help avoid disasters and also let people know ahead of time of what side-effects they, specifically, can expect with a given medicine.

Two months after her talk, Solomon tells the TED Blog that interest in NYSCF work is growing. Pointing to a recent article in The New York Timesabout how future lung cancer treatments could be tailored to individuals, Solomon said, “It’s really the leading edge of where this field is going.”

But Solomon stressed that it will be extremely difficult to change the current systems of drug development.

“All the established companies have been using mouse-and-rodent testing forever,” she said. “A lot of people’s careers are staked to a method that is outdated. It’s like the tech sector; this is really the high-tech sector for biomedical research.”

To hear more about the NYSCF, watch Solomon’s talk. Below, watch 9 more talks about the incredible promise of stem cells.

Cancer detection tech: Jorge Soto live at TEDGlobal 2014

CANCER

Cancer detection technologist Jorge Soto is developing a simple, non-invasive, open-source test for early detection of multiple forms of cancer. He demonstrated a working prototype of this cancer detection platform for the first time today on the TED stage in Brazil.

About a year ago, Jorge Soto’s aunt started suffering back pain. It was a normal injury for someone who played tennis for 30 years, but when she wasn’t feeling better after a while, doctors decided to do further tests. First they did X-rays. Then they did a biopsy. Finally, they discovered that his aunt had stage 3 lung cancer, even though she had no risk factors — this is a woman who never smoked or drank, who had been playing sports half her life. Perhaps that’s why it took almost six months to get her properly diagnosed. Does this story seem familiar? It should — one out of three people will be diagnosed with some type of cancer during their lifetime, and one out of four will die because of it, notes Soto. The process of going back again and again back for new tests, describing symptoms to different doctors, is stressful and frustrating for everyone. Yet even though we know that catching cancer early is the closest thing we have to a silver bullet against it, most of us still have to wait for symptoms to indicate that something’s wrong. Why? Because that’s the way cancer diagnosis has been done since the beginning of history. “We have 21st-century treatments and drugs, but 20th-century procedures and processes for diagnosis,” says Soto. That’s exactly what he and his team want to change.

Together with a team of scientists and technologists from Chile, Panama, Mexico, Israel and Greece, Soto has been on a journey to make cancer detection at the early stages easier, cheaper, smarter, and more accessible than ever before. Now that progress in biotech is not just being accelerated, but also democratized, Soto and his team believe they have found a reliable and accurate way of detecting several types of cancer at early stages, through a blood test detecting small molecules called microRNA. “The virus creates a unique pattern for each type of cancer. making microRNAs a perfectly, highly sensitive biomarker,” says Soto. Yet we cannot use existing DNA-based tech to detect them, because they’re much smaller than DNA.

For the first time in public, Soto demonstrates a working prototype of the early cancer detection test that he and his team have built. “Imagine that the next time you go to your doctor, a lab tech takes a few drops of blood and extracts RNA.” The tech then spreads your RNA sample across several plates, each one of which contains biochemistry markers looking for a specific RNA. Then, the plates go into a test box — in this prototype, a blue cylinder about as big as a layer cake. The tech puts the plate inside the box to be processed for a specific reaction, measuring how much and how fast each biomarker shines. The next step is to hook up a smartphone to the test box, to act as a connected computer and camera. When the test is over, the phone sends the pictures up to an online database for processing and interpretation. The final processing step compares specific microRNA and how they have reacted over time with the existing data and documentation around microRNA patterns related to certain cancers. The whole test takes about 60 minutes, allowing doctors and patients to get results in real time. Currently the entire platform is a working prototype — but it works. “This is what pancreatic cancer looks like,” says Soto in a tech demo onstage, using pre-existing data. Although the test is still in the early stages of development for broader use, so far Soto and his team have used it to successfully identify pancreatic, lung and breast cancer in humans. His end goal: a simple, non-invasive, accurate and affordable test that uses state-of-the-art microbiology and data science to tackle cancer. To bring that possibility closer, Soto and his team are making the entire design of the device open source. “Cancer detection should be democratized,” he says.

Right now cancer detection often happens at stage 3 or 4. That’s too late, and too expensive, for both families and humanity. “Today my aunt is fighting bravely, but I want fights like hers to be very rare,” says Soto. “I want to see the day when cancer is treated easily because it can be routinely diagnosed in the very early stages.” When that happens, the way we see cancer may radically change.