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5 Breakthrough Healthcare Startups

The 2016 HITLAB Innovators Summit and World Cup was held once again at Columbia University in New York. There were 74 technology companies that entered the competition, and five finalists were selected. All of these startups that entered the competition and others that help sponsor this annual event have the potential to help improve the way healthcare is delivered now and in the future through innovative technologies.

Near Infrared Imaging (NII), based in Wrentham, MA, has developed a technology for the enhanced visualization of veins. This technology, called the Vein-Eye, is a hands-free, non-invasive hospital cart that provides real-time imaging of the veins below the surface of the skin. Michael Feeney, president of Near Infrared Imaging, said, “Vein punctures can be very painful, especially for difficult patients who may be obese, very young, very old and/or have dark skin.” Multiple attempts to puncture a vein result in a very negative experience for both the patient and the provider.

The first specific successful application of the Vein-Eye is varicose vein treatment. The Vein-Eye is also targeting patients receiving dialysis, patients with severe burns, patients with Thalassemia Major Disorder and patients undergoing FLAP surgery, which is a technique involving lifting a tissue from a donor site to a recipient site. Roughly 25% of all patients, regardless of healthcare setting or illness, have delayed care due to the inability of a healthcare provider to establish an IV access to the patient’s vein. NII is also working to develop a patented technology that will detect real-time bleeding in the brain at the scene of the injury.

MedLogiq, based in Hazlet, NJ is bringing technology originally developed and used by the automotive and aviation industries to testing and monitoring product quality and performance in the medical device marketplace. This proven technology comes at a time of increased concerns about product defects in a wide range of medical-devices, resulting in serious injuries to patients and massive product liability lawsuits. The FDA has expressed serious concerns with these adverse events and has significantly increased actions against medical device manufacturers.

See also: 5 Apps That May Transform Healthcare  

Bill Acevedo, the CEO of MedLogiq, said: “Our solution provides value from proof of concept through end of life for medical device manufacturers and any other stakeholder.” Acevedo went on to say; “Medical device manufacturers don’t know what they don’t know.” There are many key questions that need to be asked and independently verified about medical devices. Is there a design defect? Was it built correctly? Is there a potential for patient harm or product liability? What data points are needed for continued monitoring of quality outcomes?

Jim Zerka, CFO, said: “Our main objective is to improve patient care and outcomes by reducing adverse events.” Acevedo closed his presentation by stating that this quality control technology was used by Ford to ensure manufacturing quality of every car coming off their assembly lines worldwide.

MedLogiq, along with their technology partner MAHLE Test Systems, has been granted access to the intellectual property for the generic infusion pump (GIP) from the PRECISE Center at the University of Pennsylvania to integrate their solution as the “maintenance processor” to accurately measure and report device performance. The GIP was built by the PRECISE Center to the FDA specifications to enhance safety monitoring, performance testing and event data recording capabilities for infusion pumps designed to administer fluids and medications to patients in a precise manner.

Green Sun Medical, based in Fort Collins, CO is revolutionizing the treatment of adolescent idiopathic scoliosis (AIS). AIS is a condition resulting from a curvature and rotational deformity of the spine. This condition develops in 3% of children under the age of 16. This results in the incorrect rotation of the spine and creates a prominent rib hump in these children. Most patients are diagnosed because of this rib hump, and when it progresses past 30 degrees they are prescribed a traditional brace. Current braces involve a 40-year-old technology, which is a rigid brace that the child must wear as much as 23 hours a day. Needless to say, these traditional braces are terribly uncomfortable and can create pressure sores, also known as bedsores or pressure ulcers, that can result in severe infections and must be worn until the child becomes skeletally mature. If the condition progresses past 50 degrees, surgical intervention is required, with the average cost exceeding $150,000. In addition, surgical intervention results in a 50% complication rate over the patients’ lifetimes.

This new solution is transforming spinal bracing technology and treatment options for spinal deformities through the use of a comfortable dynamic brace with built-in sensors linked to an iPad that provides physicians and family members comprehensive brace pressure information and compliance data in real time through a “report card.” This report card allows for corrections and adjustments to the brace. This technology will prevent children from the pain and suffering of antiquated braces and prevent needless surgeries.

In addition, Green Sun Medical has created a new dynamic brace to help both adults and children with Kyphosis. Kyphosis is a forward rounding of the back and can result in a much exaggerated and very painful rounding. This can occur to anyone at any age but is most common in elderly women.

Green Sun Medical won the award at the Wilson Sonsini Goodrich & Rosati Medical Device Conference in June 2016 as the #1 new medical device in the U.S.

EarID, based in Cambridge, MA, screens and diagnoses ear infections with higher sensitivity and specificity than existing clinical methods by using new 3D imaging and data analytics on a cloud-based platform. EarID assists in ear infections monitoring and management by minimizing unnecessary antibiotic prescriptions and time lost from work by parents and from school by children. Ear infections are the #3 reason for absence from school by children and most likely cause a parent to also miss work.

See also: AI: The Next Stage in Healthcare  

Anshuman Das, a post-doctoral associate at the MIT Media Lab and MIT Tata Center for Technology+ Design, noted that the primary screening tools for ear infections has not changed since the 1800s, and his research has found that accurate diagnosis of ear infections is not currently met in pediatric care. The current diagnosis of ear infections relies on visual inspection of the eardrum, which is performed by a device called the otoscope, which gives very little quantitative information about the actual health of the ear. EarID overcomes these challenges by integrating the conventional otoscope with a structured illumination system that greatly enhances optical and anatomical information about a patient’s ear drum. In addition, the technology with enhanced diagnostic capabilities helps address the overprescribing of antibiotics, which is a well-known public health crisis. (https://tatacenter.mit.edu/portfolio/earid-smart-ear-imaging/)

UE LIfeSciences, based in Philadelphia, PA, is on a mission to make effective breast cancer screening accessible in the developing world and was the winner of the 2016 World Cup. Matthew Campisi, CTO and co-founder, noted that 50% of the breast cancer diagnosed today is in the developing world, with 70% in the Pacific Rim/Southeast Asia, where two-thirds of cases are first diagnosed in stage 3. The company’s technology is currently being used in India, where the death rate from breast cancer is twice that of the U.S. This technology provides a battery-powered handheld wireless device that can store and send data and is accessible anywhere in the world. It is painless and radiation-free and allows for early detection of breast cancer.

UE Life Sciences’ first product, NoTouch BreastScan, is an FDA-cleared device and in a recent clinical trial detected early stage breast cancer with 87% accuracy. The second product, iBreastExam, is a handheld breast scanner that uses a smart phone as its monitor. The development of this technology was funded by the PA Department of Health to address the fact that 90% of the developing world and millions of women do not have access to breast cancer early detection.

Exhibitors at the HITLAB Summit included several other healthcare technology companies such as AdhereTech, based in New York, which has invented a smart wireless pill bottle. AdhereTech was the winner of the first HITLAB World Cup in 2013. Its “smart” pill bottles are being used by patients in pharmaceutical and research engagements and can collect and send data in real time. This system automatically analyzes information, and, if the patient misses a required dose, he receives customized alerts and targeted interventions by cell phone, text messages, etc. This amazing technology requires zero patient setup and recharges just like a cell phone and lasts as long as 5 years. Josh Stein, the CEO, told me the entire purpose is “to see that patients are taking the correct medication at the right time. This is particularly critical for patients diagnosed with cancer.” (www.adheretech.com)

Citus Health, also based in New York, has created a solution named “Call Bell” to help revolutionize how home infusion companies connect with patients. Melissa Kozak, CEO, told me she invented this technology after spending seven years as an on-call nurse for a home infusion company “to help keep my patients out of the hospital.” Kozak experienced firsthand how home infusion patients often needlessly face tremendous anxiety along with many potential adverse events such as delays in receiving antibiotics, chemotherapy, nutrition etc. when patients’ home infusion care process breaks down. The current system typically involves after-hours call centers that are inefficient and typically provide an answering service, not a certified nursing expert. Call Bell allows patients to get answers quickly in real time to address IV support questions and troubleshooting along with answers to questions like, when will my nurse arrive, or when is my next delivery? In addition, this technology provides home infusion companies with accurate patient home infusion supply counts with vastly improved patient support and communications. Call Bell was designed to address the Holy Grail of healthcare, better patient care and better outcomes at a reduced cost.

See also: Consumer-Friendly Healthcare Model  

It was a real pleasure once again to meet so many amazing people developing state-of-the art solutions for an array of global public health issues through new technology. I wish them all continued success and look forward to the 2017 HITLAB Innovators Summit, Nov. 28 -30, 2017 held once again at Columbia University.

5 Apps That May Transform Healthcare

Talk about being in a room with a lot of smart people! Wow!

HITLAB, a healthcare innovation technology and teaching lab based in New York, just sponsored its second annual World Cup event at Columbia University for aspiring healthcare technology entrepreneurs and start-ups. The HITLAB staff, who blew me away with their creative energy, brought together the best and the brightest in academia, the business world, the insurance industry and the healthcare technology sector for this two-day event.

Out of 192 applicants, five finalists were selected to present potentially revolutionary technology and ideas on a wide range of global public health problems that have been around since the time Moses wore short pants and that someday soon may have the kind of impact Louis Pasteur and Steve Jobs did.

The beauty of these five finalists is that their solutions are so simple that even someone from Jersey City like me can easily understand. The health insurance industry and the malpractice insurance industry should stand up and take notice.

Noninvasix — Keeping Babies Safe

For starters, what if we could reduce brain injuries in newborns by 90%? That is what the CEO of Noninvasix (www.noninvasix.com ), Graham Randall, PhD, MBA, based in Houston, is working on.  The technology is designed to monitor the levels of oxygen molecules in the brains of infants; lack of oxygen causes many permanent brain injuries. This technology was originally funded by the Department of Defense and the NIH, among others, to address traumatic brain injuries in wounded veterans and other adults. Randall’s colleagues discovered a way to use this technology, known as an optoacoustic oxygenation monitor, to detect brain oxygenation levels in babies during active labor.

Gary Hankins, MD, who is the vice chair of the American College of Obstetrics and Gynecology Task Force on Neonatal Encephalopathy and Cerebral Palsy, said, “This technology has the potential to eliminate up to 90% of cases of hypoxic ischemic encephalopathy and subsequent permanent injuries such as cerebral palsy.” The problem with simply using current technology such as a fetal heart monitor-which dates back 40 years-is that it does not accurately measure the levels of oxygen in the brain. In fact, 80% of results are indeterminate or unknown. The new technology can help prevent brain hypoxia (or lack of sufficient oxygen) at birth, which is responsible for 23% of neonatal mortality in the world.

This technology may also help revolutionize obstetrics. OB-GYN physicians have the highest rate of malpractice insurance, with reported annual premiums as high as $200,000 in some states. More than 75% of OB/GYN physicians have been sued for malpractice, with an average of 2.7 lawsuits per physician. Most lawsuits relate to neurologically impaired infants, whose issues get blamed on the doctor during delivery. It has been reported that as many as 50% of OB-GYN physicians have cut back on their practice because of the fear of malpractice claims. Many have moved their practices to states that have less expensive premiums because of legislative caps on liability.

Hospitals, healthcare systems and health insurers should also take notice because the rate of unnecessary surgery has been widely believed to be too high since I walked the hallowed halls of Columbia University 34 years ago. C-section rates have, in fact, nearly doubled over the past 10 years from 17% to 34% of all births in the U.S. The World Health Organization (WHO) recommends C-section rates in the range of 10-15%. The Joint Commission on the Accreditation of Hospitals now requires hospitals to report C-section rates, and many health insurers now pay a bundled rate for deliveries and not a separate, higher rate for C-sections. Many health researchers believe the high rate of unnecessary C-sections is because of the fear of malpractice lawsuits, and Graham Randall believes that false positives from fetal heart monitors also play a huge role. C-sections are the most common surgery in the U.S., with 1.2 million performed each year, and they carry risks such as blood clots and surgical infections to both mother and baby.

Ceeable — Preventing Blindness

Chris Adams, the CEO of Ceeable, based in Somerville, Mass. (www.ceeable.com), won this year’s World Cup competition. “I am here to prevent blindness,” he said. Ceeable was formed in 2014 to commercialize a mobile digital eye exam platform that was co-invented with Dr. Wolfgang Fink at Caltech with assistance from scientists at NASA, the University of Arizona, the Doheny Eye Institute at UCLA and the Jet Propulsion Laboratory in Pasadena.

This mobile field test is a perfect example of the potential for telemedicine. Current technology, used by ophthalmologists, optometrists and eye care clinics in strip malls across America and around the world are expensive, and not very mobile. Today’s eye exams are tedious. (Bats have much better eyesight than I do, so I have experience with tests.) The equipment typically costs $35,000 and weighs roughly 100 pounds.  By contrast, Ceeable only needs a tablet with a touch screen and the Internet to perform a 3-D early detection for glaucoma, muscular degeneration disease, other causes of vision problems and the actual onset of blindness.

The test is user-friendly and can be performed anywhere in the world. The test can even be performed at home, which is brilliant. Although health insurers pay for eye exams at no cost under the ACA, patients are typically limited to two visits per year. With this inexpensive mobile device, people at risk can perform tests as often as they like.

More than 285 million people worldwide suffer from diseases that cause blindness, such as diabetic retinopathy, glaucoma and age-related macular degeneration. The Ceeable technology is now deployed in vision clinics in the U.S., Mexico and Russia and will soon be available in developing countries.

Rubitection — Managing Bedsores

Sanna Gaspard, the CEO and founder of Rubitection, based in Pittsburgh, received her PhD from Carnegie Mellon University, and her start-up has developed a handheld diagnostic device and software system to modernize the detection and management of bedsores. Rubitection has been part of Project Olympus at the Carnegie Mellon incubator program.

When I met her, I interrupted her within 60 seconds and said, “I get it.” My mother ended up in a nursing home when she was overcome with organic dementia. She became so fragile from old age that the nurses could hardly touch her skin without it turning black and blue. They also had to check her frequently for bedsores. 

Turns out I didn’t get it about bedsores at all. What I didn’t know, until Gaspard told me, is that bedsores can be life-threatening. Complications from bedsores, such as infections, kill 60,000 people every year in the U.S. The average cost to treat bedsores in acute cases is $43,000 each and may reach $70,000; there are more than 2.3 million bedsore cases a year in the U.S., costing $11 billion in total.

Medical expenses resulting from bedsores are not reimbursable under Medicare if they developed after someone was admitted to a facility. The facility has to eat the costs.

Current technology that monitors for bedsores is very expensive and difficult to use. The current standard of care is typically a manual skin palpitation and visual inspection. The Rubitech Assessment System (RAS) provides a reliable early detection handheld device for patients at risk with bedsores, helping to address a global public health problem that I didn’t even know existed beyond discomfort and pain for the patient. Rubitection www.rubitection.com came in a well-deserved second place.

Now I get it.

Homeward — Getting the Medication Right

Joe Gough, president and CEO of Homeward Healthcare in Toledo, Ohio www.homewardhc.com, told how his six-year-old son was misdiagnosed at a hospital emergency room and was sent home with the wrong medication. All his vital signs crashed. Luckily, his life was saved upon readmission, and today he is a healthy young man. Many others are not so fortunate.

Again, I immediately could relate to misdiagnosis and incorrect medications. My dad was diagnosed with congestive heart failure, and his cardiologist told me he had two months to two years to live. Several months later, I got a call: “You have to come home because your father is in the hospital, and we need to amputate both his legs because he is not getting enough blood circulation down there. We need you to tell him.”

I hopped on the next flight. When I told my dad the situation, he had the perfect answer: “Throw me out the window now.”

Turns out he was on all the wrong medications, and the poor circulation in his legs was actually more because of blockage in his carotid artery. The plan to amputate his legs would have done nothing to save his life. I got him admitted to a new hospital with a new cardiologist. My dad got to live a couple more years before he finally took his first day off from work, at his funeral. We buried him with both his legs.

So, I get misdiagnosis, wrong medications and poor discharge planning.

Gough and the researchers at Homeward Healthcare have created interactive software for hospitals, patients and payers that the patient can control on a touchscreen tablet from her bedside. Multimedia, real-time discharge planning that includes a patient dashboard will produce better outcomes, free staff time and resources and vastly improve communications.

Gough had begun his presentation by telling us that most people toss their discharge instructions as they walk out the hospital door — but no more. His technology has great potential to reduce hospital readmissions. A key component is a psychosocial assessment to determine who is at risk of not following the discharge plan.

There are also reminders about the correct use of proper medications, and I get the need for that, too. Patients must own their care plan. My oldest brother, upon release from a hospital a few years ago, was told he needed to lose weight and stop smoking. The first thing he did when he got home was have a large bowl of ice cream and a cigarette. I threw his discharge plan in the waste basket.

It is estimated that $26 billion is spent annually from readmissions. The reduction of readmission rates is now a major initiative under both Obamacare and the Joint Commission on Accreditation of Hospitals. The Homeward Healthcare technology is now being used in 23 hospitals, and I am told nurses doing discharge planning just love it.

Ristcall — a Mobile, Smart Watch Nursing Station

Srinath Vaddepally, the CEO and founder of Ristcall, with offices in both Philadelphia and Pittsburgh, has designed a wireless, wearable smart device for both hospital patients and nurses. I like to think of it as a mobile smart watch nursing station.

The idea for this technology, designed with researchers from Carnegie Mellon, came about when, as a hospital patient, Vaddepally fell in his hospital room and could not reach the call button on the bed. Turns out 70% of all patient falls in a hospital occur in the patient’s room, with 40% occurring while walking to the bathroom. The average cost to a hospital for a patient fall is $20,000 per case, and the annual reduction in Medicare reimbursements can reach $200,000.

Ristcall (www.ristcall.com) has a great point. How do you call a nursing station if you are lying on a floor and can’t reach the call button? In addition, how can you reach a nurse who is busy caring for multiple patients and is not at the nursing station?  Even when you ring the traditional call button, the nurse has no idea why you are calling; he has to walk to your room to find out.

As I told Dr. Michelle Odlum, a postdoctoral research scientist at the Columbia School of Nursing, nurses rock! They are the heart and soul of our healthcare system, but they are often overworked, and they don’t have eyes in the back of their heads.

Now, with the help of Project Olympus-which provided incubator space at Carnegie Mellon-nurses can soon have a real-time alert for all traditional patient requests. Nurses will be able to rock even more.

If you are a healthcare technology entrepreneur, I highly recommend applying for this award or sponsoring next year’s HITLAB World Cup Summit. It will be held once again at Lehner Hall at Columbia University in New York, from Nov. 28 to Dec. 2, 2016.

For more information, visit www.hitlab.org.

It was a real pleasure to meet these outstanding World Cup finalists and the HITLAB staff. I learned a great deal and made friends I feel I will now have for a lifetime.

Why Medical Records Are Easy to Hack

If hacked credit and debit card account numbers are like gold in the cyber underground, then stolen healthcare records, containing patient information, are like diamonds.

Private details such as Social Security numbers, birth dates, physical descriptions and patient account numbers historically have been recorded on paper and stashed away in physical file folders and cabinets.

But the Internet all too rapidly has become our hub of commerce and social interaction. And that shift has included a mandate by the federal government to go paperless. The result: Healthcare records now exist in digital form, stored in ways that make them easy to hack.

Infographic: The ripple effect of medical identity theft

The criminal opportunities have not escaped organized cyber crime gangs that are stepping up hacking and stealing.

The Ponenom Institute found that many healthcare organizations get attacked multiple times each year, suffering losses ranging from several thousands of dollars to more than $1 million per incident. The total loss to the industry can be as much as $5.6 billion annually.

“In the dark Internet, there seems to be more activity around the theft of medical information, not just to commit medical identity fraud, but to farm that data for a very long time (for other purposes),” says Larry Ponemon, chairman of Ponemon Institute, which has been conducting medical identity theft research since 2010.

More: Protecting your digital footprint in the post privacy era

Stolen healthcare data can be worth 10 to 50 times more than payment card data in the cyber underground. Electronic health records fetch around $50 per record, according to the FBI. Some experts put that number as high as $500 for some type of medical records.

Credit and debit card numbers, by contrast, can sell for as little as $1 to $2 per account number.

“There’s an enormous online marketplace for these records,” says Kurt Stammberger, senior vice president of marketing at Norse, a security company that monitors malicious and criminal Internet traffic. “It’s like eBay — people bid, and there’s a ‘buy now’ price.’ ”

Costly exposures

Healthcare companies are taking major financial hits—and writing off this exposure as an extraordinary cost of doing business. Details on the pain level for breached companies are surfacing, thanks to data breach disclosure rules under the Healthcare Insurance Portability and Accountability Act (HIPAA.) For instance:

  • WellPoint, a managed-care company, settled a case with the U.S. Department of Health and Human Services for $1.7 million last year. WellPoint allegedly left electronic records of more than 600,000 people accessible over the Internet because of a security weakness.
  • New York and Presbyterian Hospital and Columbia University agreed to a $4.8 million settlement earlier this year after substandard security led to 6,800 patient records becoming accessible by search engines online.
  • Individual consumers are getting harmed financially, as well, to the tune of $12.3 billion last year. Ponemon’s 2013 Survey on Medical Identity Theft found that more than one third of victims paid an average of $18,660 out of pocket to recover from data theft. That included being compelled to reimburse healthcare providers for services supplied to an impersonator.

    Prevention hurdles

    Healthcare experts, privacy advocates and law enforcement officials acknowledge that the fundamental problem is mushrooming and won’t be easy to stabilize.

    Part of the challenge is financial. The Affordable Care Act mandates that providers expend 80% to 85% of premiums on quality care—and that doesn’t include any provisions to prevent services from going to an identity thief.

    According to Forrester Research, only 18% of healthcare organizations’ tech spending budget goes to security, compared with 21% across all sectors. And most providers plan a minimal or zero increase in budget.

    More: 3 steps for figuring out if your business is secure

    “The mission of healthcare providers is to take care of patients, and anything that can interfere with patient care takes a back seat,” says Paul Asadoorian, product-marketing manager at vulnerability management vendor Tenable Network Security. “Security is one of those things.”

    Meanwhile, individual victims of healthcare data theft can be left twisting in the wind.

    The financial services industry maintains a central database where stolen identities can be flagged; the healthcare industry has nothing of that sort. In fact, it even lacks a simple standard for authenticating the identity of anyone who steps forward to request patient care.

    There is no standardized practice for assuring the identity of a patient via an insurance ID card combined with another form of ID, observes Ann Patterson, senior vice president and program director for Medical Identity Fraud Alliance (MIFA). “That poses challenges for healthcare providers, when their main concern is quality of care,” Patterson says.