Smart, New Medical Devices Coming to Market Faster

The FDA tries to keep up with medical device market shift to wearable devices that collect, analyze, transmit data

For June 2016

By Karen Haywood Queen

The medical device industry is evolving to create better tools to help aging patients and their doctors manage chronic conditions outside of a hospital. Many of these devices and apps look like and/or work with smartphones. The goals are to lower costs, deliver value-based results and meet consumer demand.


Other trends that impact manufacturers include an aging population, improved quality inspections and the regulatory process, according to a recent report by EWI (Columbus, OH), a nonprofit engineering and applied R&D company. The Affordable Care Act also plays a role.

While the market for traditional metal parts used in implantable devices for knees and hips will be fairly stable in the year ahead, changes are coming, said Bryan Hughes, director of medical technology at P&M Corporate Finance in Chicago. Some parts used in medical devices that have historically been made of metal are being replaced by plastic components

In some cases, the volume needed has finally increased to the point it made sense to transition from metal to plastic, he said.

“Volumes have gotten to a scale, creating a situation where it makes sense financially to invest in a mold to manufacture with molded plastic,” Hughes said.

Another driver in the trend has been concern over hospital-acquired infections. “Metal instruments have historically been a reusable item,” Hughes said. “They use the instrument, send it to central sterilization in the hospital, and then use it again. But the challenges and costs associated with instrument sterilizing have moved any number of products to single-use plastic.”

Meanwhile, a whole new wave of medical devices is also coming to market.

“There’s been a recognition that many medical devices were not designed with the consumer in mind,” said Brian Williams, director, strategy, Global Healthcare at PwC.

“We buy consumer devices driven partly by price but also by form, features and the software that powers those devices. We use smartphones to do our shopping, banking, read a book, bank, take photos. We are bringing those expectations of design, ease of use and convenience to healthcare. New medical devices won’t look as much like medical devices.”

Features and technology from consumer devices are making their way into medical devices in what Dale Robinson, business development director at EWI, calls technology fusion. Manufacturing technologies, such as printed flexible electronics will enable the next generation of health monitoring devices. Electronic circuitry is already being printed onto fabrics, he said.

An aging global population will help power growth of just under 6% per year in medical device revenue.

Other technologies that will enable these trends include noninvasive sensors, onboard data analysis algorithms and wireless data transmission, Robinson said. The biggest areas for growth include patient monitoring through clothing or jewelry that seamlessly collects and transmits data to providers, family caretakers of the elderly and parents of newborns, Robinson said. The next generation of battery technology will be smaller, flexible and have a higher energy density.

The winners in the device market will design products that have a measurable value, provide a clear health outcome and integrate with devices consumers already use, Williams said. Stand-alone devices won’t likely be as common.

“Innovation has become more important in healthcare today, given changes that have occurred in the market driven by the Affordable Care Act,” Williams said. “One component of that is reimbursement models that are value based as opposed to fee based. That puts additional pressure on manufacturers of devices to show the value of their product and tie that value to an outcome achieved by the patient.”

Pressure to lower costs plays a role. “The aging global population is huge in terms of overall medical device market growth,” Hughes of P&M said. “As you get above 70, the cost of treating chronic conditions such as COPD and congestive heart failure increases dramatically. To care for a patient per day in a hospital is $3000, in a skilled nursing facility is $450, at home is $50.”

From 2010-2014, medical device revenue growth increased nearly 7 %.

With home care in mind, companies that have in the past developed devices for use in hospitals are shifting their focus to the home health market, Hughes said.

Innovations that will make home care possible include improved and miniaturized implantable devices. Interventional cardiac defibrillators are now implanted and leadless—a great improvement over older technology, Robinson said. The devices are implanted into the heart and use much smaller batteries and electronic circuitry. The data processing chips will have higher density processing capabilities to enable better performance without increasing size. To assemble such devices, manufacturing technology has improved to create hermetic seals to prevent fluids from leaking into the device and micro-joining processes to connect the battery tabs and microprocessor to the electronic circuitry, he said.

Growth in Smart Medical Devices

More devices will be worn, both on the wrist and as part of clothing using technology that prints circuitry onto fabric, said Jeffrey C. Rasmussen, market research manager at the Industrial Fabric Association International (Roseville, MN).

“In the past, sensors and circuitry embedded into fabric were too big and too clunky,” Rasmussen said. “Manufacturers have been able to make them miniaturized, more stretchable and comfortable. It’s exploded in the last year. Some of the big apparel players in the market are Adidas, Nike and Ralph Lauren.” Such clothing is improving in terms of washability, he said, although research continues in that area.

Sensors are becoming better and more sophisticated. Devices now entering the market have sensors that measure more physiological parameters such as 2-lead EKG and pulse oximetry, Robinson said. Circuitry and biosensors imprinted into fabric and worn close to the heart and lungs for monitoring a person’s pulse and/or respiration rate tend to be more reliable than those worn on the wrist.

Other technology in this sector includes smart socks that send an alert if a baby stops breathing, a vest defibrillator, and smart blankets that can send alerts if a patient is developing bedsores.

Smart fabrics manufacturer Eeonyx has developed a patented formulation that allows it to apply conductive polymer coatings to textiles, fibers, and yarns—making them piezo-resistive, which means they are sensitive to and react to touch, Rasmussen said. This creates a custom pressure touch sensor in the fabric. In 2014, Eeonyx partnered with BeBop Sensors, which now uses co-designed proprietary Eeonyx smart fabric to create flexible electronics/circuits that can be incorporated into a single piece of fabric. Using DuPont designed conductive inks, BeBop Sensors’ stretchable circuits can be printed onto fabric, such as a shirt or jacket for a variety purposes including wearable controllers.

“Instead of wearing sensors in the shirt, the shirt is the sensor,” Rasmussen said.


With these devices in hand, consumers will monitor their own health, perhaps consulting with a medical provider by video or a smart device. “I can use my smartphone to gain access to a clinician in real time through video consulting,” Williams said. “In that distributed-care environment, innovation needs to advance to support convenient care.”

These new devices will be easier to use at home and easier on the eyes. For example, ResMed and other companies focused on oxygen treatment are developing better devices to effectively provide patients with oxygen at home—instead of in a hospital on a ventilator, Hughes said. “People don’t want a huge oxygen concentrator that takes up a lot of room and is loud,” he said. “We’re working with a company that has a pretty big, ugly device. They want us to make it look cooler.”

Some aren’t technically medical devices as defined by the Food and Drug Administration because they simply collect data. These wearable devices to monitor health information include products such as the Fitbit or Apple Watch, Robinson said.

Technology fusion will come into play again as tech companies such as Google, Fitbit and Verizon are moving into medical device territory, said Chris Schorre, vice president of global marketing at medical device consultancy Emergo in Austin, TX. “You are also going to see more companies that are making traditional medical devices looking for ways to add a wireless monitoring component to their products so they can connect to a smartphone or tablet. Consumers want their devices to do more than simply count steps or measure their heart rate, and doctors increasingly appreciate the benefits of remote patient monitoring.”

For example, Verily, formerly Google Life Sciences, has gone aggressively into life sciences, he said, citing the company’s research and development with Swiss manufacturer Novartis of a contact lens with a chip embedded in it to measure blood glucose (BG) levels.

“There are definitely going to be winners and losers,” Schorre said. “A lot of this technology will connect via a smartphone, tablet or other system. If Verily succeeds in getting its contact lens with an embedded glucose sensor cleared by the FDA, and users can constantly monitor their glucose levels with alerts on their smartphones, it’s going to have an impact on companies making traditional meters … at least among the 10—15% of people wearing contacts.”

As companies such as Google move into medical device territory, medical device companies will have to return the favor, Schorre said. “You are going to see more companies that are traditional medical device companies developing wireless technology to connect their products to a smartphone.”

When devices are designed to collect and transmit data to healthcare providers for diagnostic analysis and therapeutic advice from a physician, they turn a corner to become FDA-regulated medical devices, Robinson said.

One leader in that space is Glooko Inc. (Palo Alto, CA). Glooko was founded in 2011 by a mobile app developer, a technologist, and a then-Facebook senior executive. Its diabetes management platform, Glooko MeterSync, downloads readings from more than 40 of the most popular blood glucose meters, insulin pumps and continuous glucose monitoring systems to Android and iOS mobile devices.

Other companies are moving into that sector. Late last year, the FDA granted 510(k) clearance for LabStyle Innovations Corp.’s Dario Blood Glucose Monitoring System. The system includes a device housing that includes a blood glucose meter, lancing device, test strips, lancets, control solutions and a mobile application. The mobile app allows the user to look at glucose test results using Apple’s iOS 6.1 or above smart mobile device technology. It helps manage the disease by recording the BG results and other user-entered information such as carbohydrates, activity, and insulin use.

Medical Device Market Speeds Up

“There have been big changes in the speed of innovation,” Williams said. “We are seeing more new products, new apps, new solutions that meet consumers where they are than we saw even a few years ago. It’s driven by an innovation cycle associated with technology. It doesn’t take long to develop a new piece of software that does something novel.”

That innovation cycle is moving much faster than the regulatory environment for traditional healthcare infrastructure is accustomed to, Williams said. The FDA has continued to tweak the process in an effort to keep up with changes while maintaining safety.

Producing or launching an innovative product in the US has been challenging compared to releasing the same product in Europe because the FDA’s system of approval and clearance depends on predictive devices—comparing a new device to one that has already been cleared or approved by the agency, Schorre said.

The FDA classifies medical devices as Class I, II and III. Class I devices, such as dental floss, are deemed to be low risk. Class II devices, such as condoms, are higher risk than Class I and are subject to more controls to reasonably assure the device is safe and effective. Class III devices are the highest risk—“anything where failure of the device would injure or kill a patient or user,” Schorre said—and require the greatest regulatory controls. Active implantable devices, such as pacemakers, are Class III.

Some Class I devices, nearly all Class II devices and a few Class III devices must be cleared by the FDA via a 510(k) process, also known as Pre-Market Notification. Most Class III devices are subject to the far more stringent PreMarket Approval (PMA) requirements, which involve clinical trials.

Launching an innovative product in the US market is sometimes challenging compared to releasing the same product in the European market. That’s because the FDA has a predicate-based regulatory system, which relies on comparing a new device to one that has already been cleared for sale by the agency. “The problem with that system is, if your device is new, innovative and quite a bit different from one already cleared by the FDA, then the FDA is going to treat it as a new device,” Schorre said. “They will initially default to classifying it as ‘high risk.’ You may have to [clear] significant hurdles so it can be a Class II product—to convince the FDA that it’s not high risk and doesn’t require clinical trials. But obviously, just because a device is innovative and new doesn’t mean it’s high risk.”

US Regulators Try to Catch Up

Because of the different European approval system, “We sometimes advise clients to seek approval for their innovative products in Europe first,” he said. “The regulatory system in Europe is rules-based and is therefore more flexible …. [G]oing to Europe first can be faster and cheaper because the manufacturer might avoid having to jump through unexpected hoops that would be required for FDA clearance of an innovative but lower risk device,” Schorre said. “Getting approval in Europe first will not necessarily make getting approval in the United States easier. The primary benefit is that companies making new technology can generate sales more quickly and be generating post market clinical use data that might eventually support a FDA submission.”

In the future, clearance for mobile medical apps might be more well-defined in the United States. “The FDA is leading the charge in developing standards for mobile medical apps, but some want the FDA to take the next step in being more specific about what is allowed and what is not,” Schorre said. “That has not been happening in the rest of the world. Other countries will look at how the United States is regulating apps and issuing guidance and most likely will emulate what the FDA has been doing. To their credit, the FDA understands they will always be a step behind in regulating mobile medical technology and do not want to be the ones to hinder its development.”

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Home that Afternoon: New Techniques and Technology, Cost Pressures Drive Transition to More Outpatient Procedures

Heath Journal ArticleThe Health Journal / Published 2010 / By Karen Haywood Queen

Almost 25 years ago, Kathy Santini had to have open abdomen surgery to remove her gallbladder. Laparoscopic gallbladder surgery, where the surgeon makes a few puncture marks and removes the organ through the belly button, was a new technique that many surgeons weren’t yet using.

“I was in the hospital four or five days,” says Santini, now vice president of surgical services at Bon Secours Richmond Health System. “I had to be off work for six weeks so the lining under my skin could close and heal. And I could work only half days at first. I had a bunch of restrictions. Once you open someone’s abdomen, you’re affecting a lot of systems. It was a big deal.”

Today, 54 percent of gallbladder removal patients have outpatient surgery, meaning they are able to go home within 23 hours, according to a 2010 report for the Agency for Healthcare Research and Quality (AHRQ). Looking beyond gallbladders, 63 percent of all surgery patients in hospitals did not have to stay overnight in 2005, compared to 51 percent in 1990 and just 16 percent in 1980, the AHRQ says.

Any surgery is still a big deal. But new surgical techniques and technologies that minimize incision size, blood loss and tissue trauma have made faster recoveries possible, says John S. Hudson, director of surgical services at Sentara CarePlex Hospital in Hampton. For example, a laparoscope—a long metal tube with a camera lens at the end— allows a surgeon to see what he or she is doing without having to make a long incision. In some cases, a surgeon is able to remove the tissue or affected organ through one of the body’s natural openings.

Often, the benefits of the new techniques go beyond just avoiding a stay in the hospital.  Patients who have laparoscopic procedures generally return to normal function and work several weeks earlier, Hudson says.

The cost factor

The other factor driving the shift to outpatient surgery is pressure on insurance companies and other third-party payers such as Medicare and Medicaid to reduce rising health care costs, according to the AHRQ and physicians.

“A lot of this got driven by the insurance business,” says Dr. Wilhelm Zuelzer, Chief of Perisurgical Services at VCU Health Systems in Richmond. “It’s ultimately cheaper to do an outpatient surgery rather than inpatient.”

Across the board, the mean charge for all ambulatory surgeries was $6,100 compared to $39,900 for inpatient surgeries, the AHRQ says. But it’s difficult to make an exact comparison between the same surgery done as an outpatient and inpatient basis because surgeries and patient conditions that do require a hospital stay are, by their very nature, more complicated and likely to be more expensive.

Patients can get outpatient surgery in hospital outpatient centers and in a growing number of stand-alone outpatient surgery centers. Since the stand-alone ambulatory surgery centers don’t have the added expenses of hospital emergency rooms and critical care units, they can offer even more savings compared to a hospital outpatient department, notes Jay Schukman, regional vice president
and medical director with Anthem Blue Cross and Blue Shield in Virginia.

Top outpatient procedures

The top six outpatient surgeries and procedures performed in ambulatory surgery centers billed to Medicare in 2009 were all related to cataracts and digestive tracts.  Procedures done on the eye, ear, nose and mouth were predominantly outpatient.

Colonoscopy and biopsy was the most commonly performed outpatient procedure, an AHRQ study found. About two-thirds of procedures on the skin, digestive tract and urinary tract were outpatient, AHRQ says.

The most significant shifts in the last decade have been in the areas of gynecology and general surgery, due to the use of laparoscopic techniques, Hudson says. Gynecologists now perform hysterectomies using a total laparoscopic approach, allowing women to go home the same day and often return to work within a few weeks. The once common tubal ligation for prevention of pregnancy is now rare, replaced by a simple procedure performed in the doctor’s office, he says. Weight loss lap band surgery is also being done on an outpatient basis, he says.

Dr. Gregory FitzHarris, a colon and rectal surgeon at Sentara Surgery Specialists in Hampton, is enthusiastic about a less invasive technique for removing large polyps in a patient’s mid to upper rectum, lesions that are too far up to reach with a retractor. With the old technique, the surgeon opens up the patient, remove a portion of the rectum and resections the rectum. The patient stays in the hospital three days to a week and is off work four to six weeks. Using the newer technique (official name: transanal endoscopic microsurgery), the surgeon blows up the rectum with carbon dioxide and removes the polyp. The patient is usually back to work within two days, he says.

“I just did one lady and I finished the surgery around 10:30 a.m. and she went home around 3 p.m.,” FitzHarris says. “Most leave the same day. There’s very little pain involved and very little disability.”

Patient selection is important

Outpatient surgery isn’t for every procedure or every patient. People who are older or obese and have what doctors call core morbidities—high blood pressure, diabetes and heart problems. “We have to fine tune the outpatient surgery,” Zuelzer says. “You have to individualize it. You have to look at the home situation.”

A younger, healthier patient with good social/family support may be able to have procedures done on an outpatient basis that an older patient with chronic conditions and poor social support may not, Hudson says. Important considerations are pain management, post-procedure monitoring and therapies, and insurance coverage.

“There’s no reason for a patient to be in the hospital if he doesn’t need to be,” says Shirley Gibson, interim vice president of nursing for VCU Health System. “The hospital is a very expensive place to be. [However, with] inpatient you have nurses there always, you have the labs there always. You can look in on the patient, pay attention to nuances.”

If a patient doesn’t have family or friends who can step in and help, the patient may be transferred from the hospital to a skilled nursing care facility instead of going home, at about one-eighth to one-tenth the cost of a hospital, Schukman says.

Doctors, their patients and hospitals don’t always have much choice—at least if they want the extra time in the hospital to be reimbursed by the patient’s insurance company. “It’s not where somebody can say ‘I want to stay in the hospital three days,” Zuelzer says. “A herniated disc used to be three days in the hospital. Now it’s considered a 23-hour outpatient procedure. If the patient or doctor says ‘I don’t feel comfortable going home today’ it’s still a battle with insurance.”

Some in the medical field worry that too much pressure is coming from health insurance companies to save money by discharging patients quickly. For example, Santini says the hospital has just been informed by an insurance company that laparoscopic gastric bypass surgery is now an outpatient procedure. That means the hospital now has to negotiate with the insurance company for every patient they feel needs to be hospitalized.

“If a procedure is designated outpatient by a third party payer and you’re there for 48 hours, you’re still an outpatient,” Santini says. “They call that ‘an outpatient in a bed.’”

Physicians can advocate for insurance companies to cover a longer stay, but often, “They’re not going to reimburse for more than they pay for an outpatient procedure,” Santini says. “Outpatient rates are obviously a lot lower than inpatient rates. For a procedure that has been polled as outpatient, we sometimes don’t come anywhere near making the cost, let alone breaking even or making a profit.”

On the flip side, some patients have requested to remain in the hospital solely for convenience, says Schukman says.  “Someone might say, ‘My husband doesn’t want to take off work today to pick me up, so I’m going to stay overnight and he can pick my up tomorrow. When they’re paying several thousand dollars a day for a hospital room, it’s not appropriate to stay for convenience. You’re paying that bill and we’re all paying that bill in our insurance rates.”

Tree of Life: Giving People with Brain Injuries Hope and a Future

The Health Journal /Published 2010 / By Karen Haywood Queen

Health Journal: Brain Injury TreatmentWhen “Lisa” came to Tree of Life in 2002, she drank too much, needed psychiatric care for depression, could not walk up steps or on uneven ground, had gained 50 pounds and needed 24-7 care because of her brain injury, suffered in a car accident. Now Lisa, who wishes to remain anonymous, has lost the weight, gained a boyfriend, conquered the drinking problem and run a 5K. She works part time in retail and lives in a supervised apartment.

Lisa and others who’ve suffered traumatic brain injury say they have been transformed by a comprehensive rehabilitation program at Tree of Life, a private facility for brain injury patients located in Richmond.

Lisa originally went to a residential facility and outpatient rehab in Michigan, where she lived at the time of her accident, say her parents, who live in Williamsburg. But instead of getting the help she desperately needed, Lisa was raped by one of the center’s drivers.

“She was so without hope [after that] that she said she no longer wanted to live,” says Lisa’s mother. “She was extremely depressed. She was extremely damaged mentally.”

So Lisa’s parents, who, because of the nature of their daughter’s injuries, have also requested anonymity, began looking for another place where their daughter could at least be safe and possibly rehabilitated.

“We went to see a lot of places in Michigan,” says Lisa’s father. “Every one we saw was like a dog kennel. People were just shoved into rooms. They didn’t even have their sheets changed sometimes. Basically, it was a storehouse for damaged people.”

Then they found Tree of Life. “We were welcomed with open arms,” says Lisa’s father. “The house was very warm, very family-oriented. The people who spoke to us were so kind, so welcoming. I knew this was the place where she could recuperate.” An added bonus: Tree of Life is less than an hour’s drive from their home in Williamsburg.

Internationally known neuro-rehabilitation physician Dr. Nathan D. Zasler started Tree of Life in 1997 with a five-bedroom house and one patient. The goal: to help people with brain injuries achieve as much independence as possible. Zasler teaches in the departments of physical medicine rehabilitation at both Virginia Commonwealth University and the University of Virginia schools of medicine and has lectured and written extensively on the unique challenges of rehabilitating brain injury patients.

Zasler saw the need for a long-term program, one that worked with such patients beyond the acute rehab and therapy patients receive immediately following an accident or other event that caused the brain injury.

Tree of Life has grown to a full staff including physical therapists, cognitive behavioral therapists, neurorehabilitation psychologists and others. During the day, staff-to-patient ratios are at least one-to-one, Zasler says.

Tree of Life is not a hospital, nursing home or adult day care center. Therapy works toward getting patients back into the community as fully as possible. Patients come from all over the East Coast and as far west as Illinois and Michigan, he says.

A typical day might include formal one-on-one therapy, a group therapy session, recreation time, music, art, and a meal out at a restaurant. Average transitional length of stay is six to 12 months.

The cost is high—about $650 a day. But that cost includes room and board and more important, 24-7 access to Zasler, Tree of Life’s medical director, and Dr. Michael F. Martelli, director of neuropsychology. A patient who needed 24-7 supervision from a certified nurse assistant might pay almost $400 a day, not including room and board, Zasler says.

The recovery time for people with brain injuries is longer than usually funded by commercial or government insurance, Zasler says, so almost all of the patients rely on workers’ compensation to help pay for care. “Unfortunately for people with these type of injuries, insurance won’t pay for long-term care or transitional care,” he explains.

Among Zasler’s goals: to educate private and federal insurance programs across the country about the many benefits of neuro-rehabilitation services. Even though a rehabilitated patient may still be considered 100-percent disabled and not necessarily able to get a job on his or her own, even a part-time job and the social life enabled by the program offers a huge benefit.

“It’s more than just the financial benefits of working,” Zasler says. “There are the psychological benefits, the social benefits. Many of these people with brain injuries are socially isolated. We’re getting these people out of their homes and into the community.”

Lisa is still in the program, living mostly independently in one of Tree of Life’s apartments. She still needs the supervision, her parents say. “But if you would talk to her now, you might not even know she had a brain injury,” her mother says. “Her recovery is absolutely a miracle. Yes, it’s due to her efforts. It’s also due to Tree of Life. They gave her hope. It’s an incredible transformation.”

Tree of Life employs the “bio-psycho-social” model in treating patients—another way to say the program approaches treatment from the physical, emotional and social aspects (i.e., treating the “whole person”).<b> “We want to understand who the person was before their injury,”</b> Zasler says. “One of the mistakes other programs make is they don’t take enough time to figure [that out].”