The Instant, Custom, Connected Future of Medical Devices


When Jeff Dachis suddenly and unexpectedly learned he had Type 1 diabetes at the age of 46 in September 2013, he was stunned. After all, he ran marathons, followed a healthy diet and never had an inkling of any medical troubles during previous annual physicals.

“I went to the doctor, got about six minutes with a nurse practitioner, an insulin pen, a prescription and a pat on the back, and I was out the door,” Mr. Dachis said. “I was terrified. I had no idea what this condition was about or how to address it.”

Feeling confused and scared, he decided to leverage his expertise in digital marketing, technology and big data analytics to create a company, One Drop, that helps diabetics understand and manage their disease.

The One Drop system combines sensors, an app, and a Bluetooth glucose meter to track and monitor a diabetic’s blood glucose levels, food, exercise and medication. It uses artificial intelligence to predict the person’s blood glucose level over the next 24 hours and even suggests ways the person can control fluctuations, such as walking or exercising to offset high sugar levels — or eating a candy bar to raise low glucose levels. Users can also text a diabetes coach with questions in real time.

With 30 million Americans living with diabetes, Mr. Dachis said he knew the potential market for his technology was big. Indeed, more than one million people have downloaded the app to date, he said.

One Drop is among a surging number of companies that are using “internet of things,” also known as IoT, technology to create new treatments in the health care sector.

“Advances like robotics, nanotechnology, genetic engineering, 3-D printing, artificial intelligence, and IoT are fueling an exciting era within health care innovation,” said Jeff Becker, a senior analyst and health care I.T. expert at Forrester. “Many of these efforts will undoubtedly fall flat, but some could end up as transformative as the X-ray itself.”

And consumers are paying attention.

About 79 percent of consumers surveyed in the United States said technology is important to managing their health, according to a 2019 report by Accenture.

The latest tech-related medical treatment advances run the gamut from implants that help paralyzed people walk to smart pills that detect when patients fail to take their medication.

Spinal cord research took a major step forward when a 29-year-old man, who had been paralyzed from the chest down since a snowmobile accident in 2013, was able to walk the distance of a football field with the help of a rolling walker. The milestone, which was published in Nature Medicine last fall, came after a team of researchers at the Mayo Clinic implanted an epidural electrical stimulator device into the man’s lower spine and gave him six months of intensive physical therapy.

“This is a revolutionary breakthrough,” said Kendall Lee, a neurosurgeon and director of neural engineering laboratories at the Mayo Clinic. He said the device had so far been successfully implanted in two people.

While the implant isn’t a cure, it offers hope to millions of paralyzed people around the world. But Dr. Lee was careful to note that the technology is still some time away from being publicly available.

“We were able to do the study under the F.D.A.’s investigational device exemption,” Dr. Lee said. “This is not something for the general population yet.”

At least three different research groups — Mayo Clinic, University of Louisville and the University of California, Los Angeles — are now aggressively expanding their trials to include more patients.

Then there’s the smart pill. The World Health Organization estimated that 50 percent of people with chronic diseases in developed countries fail to take their medicines as prescribed, whether from forgetfulness, concern about side effects or other reasons.

This noncompliance costs the health care system in the United States from $100 billion to $290 billion a year from emergency room visits, hospital stays and other costs related to worsening medical conditions, according to the Network for Excellence in Health Innovation.

AdhereTech built a smart pill bottle that alerts patients when it’s time to take a medication and sends an automated text or phone message if they miss a dose in real time. But it only tracks the use and contents of the bottle, so there’s no definitive way to detect whether a person has actually swallowed the pill.

The pharmaceutical maker Otsuka goes a step further: It worked with Proteus Digital Health to create a digital smart pill for Otsuka’s Abilify medication, which is used to treat schizophrenia, bipolar disorder and depression. The Abilify MyCite pill, which will be rolled out in the next few months, is embedded with a sensor that’s activated by stomach acids. The sensor is tracked by a patch worn on the person’s stomach, which then sends the information to a smartphone app, where the patient and doctor can track when the medication was taken — and even send notifications if it hasn’t.

But the technology goes far beyond pill-taking reminders, said Andrew Thompson, co-founder, president and chief executive of Proteus Digital Health. The sensor patch also tracks physical activity, heart rate, rest patterns and other metrics, which will help doctors and patients know whether a medication is working and the right dose has been prescribed.

The Abilify MyCite pill doesn’t come cheap: It will cost $1,650 a month, significantly more than the $30-to-$40-a-month cost of a generic version of the Abilify pill. However, most patients would only take the digital pill for two to three months — just enough time to collect data on pill-taking adherence, dosage and health impact to revise a treatment plan, Andrew Wright, Otsuka’s vice president of Digital Medicine, said.

Efforts are now underway for both Proteus and Otsuka to add the technology to pills for other chronic conditions. Mr. Thompson believes it’s the future.

“Years from now your grandchildren or your children will be incredulous that you put things into your body and didn’t know if they were real or fake, the right dose or the wrong dose, in-date or out-of-date,” Mr. Thompson said. “So yes, eventually this will be in every drug everywhere.”

In the world of prosthetics, scientists have found a way for tetraplegics — those paralyzed from the neck down — to feel touch by electrically stimulating parts of the brain. Paralysis can mean the loss of both control and feeling in affected areas, and while prosthetics can return motor function, sensing requires treatment of the nervous system itself.

Initially, the challenge seemed daunting, considering the brain contains 100 billion neurons, and matching up the neurons that control sensory nerves with the prosthetic hands and arms was tough, said Sliman Bensmaia, an associate professor in the department of organismal biology and anatomy at the University of Chicago, who was part of the research team. But after surgically placing an electrode implant into the brain, the team was able to electrically stimulate the portions of the brain that controlled sensation, allowing the patient to feel the size, shape and texture of objects and to tell when a finger was touched.

Plans are now in the works to expand human trials at the University of Pittsburgh, Johns Hopkins University and the University of Chicago. The biggest challenge now? Making the brain implant wireless and upgrading it so that it doesn’t wear out after five years.

“You can’t be having brain surgery every few years,” Dr. Bensmaia said. “We need an array or implant technology that lasts a lifetime.”

Dr. Bensmaia said the brain implant technology could someday have far-reaching applications, such as improving memory or retrieving information faster.

Another hot area: The use of 3-D printers to create patient-specific medical devices, like knee joints and spinal implants. The printers make it faster, easier and cheaper to make customized medical devices based on a patient’s M.R.I. and C.T. scans.

“They can be made in one-fifth to one-tenth” of the time that traditional custom-made devices are made, said Scott Hollister, a professor in the department of biomedical engineering at the Georgia Institute of Technology and Emory University. And 3-D printed devices often fit far better, cause fewer complications and require a shorter recovery period than off-the-shelf joint replacements that come in sizes small, medium and large.

At least 80 3-D-printed devices have received F.D.A. approval as of 2016, although their use has largely been confined to academic and research hospitals.

While many of these breakthrough technologies have shown promise in clinical trials, experts caution there’s no guarantee they’ll ever make it to market.

Mr. Becker, the Forrester analyst, cited the disastrous example of Theranos, which made false claims for years that it had a revolutionary blood-testing technology that only required a small amount of blood. The company raised more than $700 million, was valued at $9 billion at its peak in 2014, and made its founder Elizabeth Holmes a billionaire, before collapsing after scientists and regulators discovered the technology didn’t work.

“Theranos is the pockmark of health care I.T.,” Mr. Becker said.

But sometimes it’s not malicious — it’s just promising science that doesn’t pan out.

In 2014, the Google X lab, now called Verily, unveiled news — with much fanfare — that it was developing a smart contact lens that could monitor blood glucose levels in real-time by measuring tear fluid in the eye. The company’s partner on the project, Novartis, said it expected to have the device on store shelves within five years.

“This was huge news — the holy grail of life sciences — it was something that everybody wanted to be the first to bring to market,” Mr. Becker said.

But then, “we all waited for updates and nothing came — just radio silence.” Last November, the company announced that the project had been scrapped because of inconsistent testing results.

“So, clearly the science wasn’t there,” Mr. Becker said. “They prematurely announced it, got excited about it, they made a big splash, and it was all for naught.”

Source link