MEXICO CITY – Mexico is updating its medical device classification process, allowing the deregulation of more than 2,000 products considered low risk. The country’s Federal Commission for Protection against Sanitary Risks (COFEPRIS) said that by deregulating the lower-risk devices, it will be able to focus on enabling earlier access for innovative devices. The announcement marks the third deregulatory listing for medical devices, following the deregulation of 1,669 in the first stage and 573 in the second stage, according to BMI Research. The revised device classification is a move toward harmonization with international standards. Mexico is the leading exporter of medical devices in Latin America, and it ranks eighth internationally, according to COFEPRIS.
HERNDON, Va. – Iron Bow Technologies, an information technology solutions provider to health care, government and commercial markets, has been selected as a 2017 Innovation Award honoree for its clinical care device by the Washington Business Journal. The CLINiC is a consultation device that enables remote care via live video conferencing. “This recognition is validation that our efforts are making a difference in the delivery of care,” said Scott Sanner, general manager of Iron Bow Healthcare Solutions, in a statement. “It’s an exciting time to be involved in the advancement of transformational health care delivery and making a difference in the lives of individuals.” In addition to the CLINiC device, Iron Bow last year introduced the MEDiC mobile exam device and ViTAL, an intuitive, portable telehealth device designed to facilitate vital readings from a non-medical user to a licensed care provider.
‘We really need to be exactly what people want’
AUSTIN, Texas – It’s been a long road to market for UnaliWear, maker of the Kanega voice-controlled watch, but the light at the end of the tunnel is getting brighter as the company looks to launch the device in 2017.
“We hope to be in production in the fourth quarter this year,” said JeanAnne Booth, CEO and founder of UnaliWear.
A $100,000 Kickstarter campaign launched in 2015 originally called for the device to be available last year, but Booth wanted to be sure the Kanega was something users needed, so adjustments to the timeline were made along the way.
“We really need to be exactly what people want,” she said.
The Kanega watch is a voice-controlled device that features fall detection, medication reminders, emergency assistance, voice-activated directions and Guide Me Home assistance if the user gets lost. The waterproof device works independently of a home-based system or smartphone and has no buttons to push.
The watch uses artificial intelligence to learn the wearer’s lifestyle, and that information is updated each night.
The company has spent the past five months deep into a user experience test on the latest version of the device. Users included about 100 people across the country ages 23 to 97 with Multiple Sclerosis, Lou Gherig’s disease, Parkinson’s disease, epilepsy, Down’s Syndrome, blindness, disabled veterans and seniors.
Booth said the user experience test was invaluable to the company, as it brought to light some issues only a user would experience like battery charging and instruction language.
“The user experience test was fantastic—we knew it was the right thing to do,” she said.
Booth said UnaliWear will look to add biometrics to the Kanega device in the future.
“We want to wait on the biometrics until we have enough money to get through the U.S. Food and Drug Administration process independently, without having to rely on investors,” she said.
The company is continuing with a smaller user experience test on the final production version over the coming weeks.
‘Organizations need to start carefully examining what they’re doing’
MOUNTAIN VIEW, Calif. – Medical device makers and health care providers are unprepared for possible cyberattacks, according to a study released recently by security company Synopsys.
“This report doesn’t paint a good picture at all for the industry,” said Mike Ahmadi, director of critical systems security, software integrity group, at Synopsys.
Despite the likelihood of an attack, only 17% of device makers and 15% of health care providers are taking significant steps to prevent attacks, the report found.
More specifically, the report found that 67% of device makers believe an attack on one or more of their devices is likely and 56% of health care providers believe such an attack is likely. Further, only 22% of health care providers say they have an incident response plan in place in the event of an attack and 41% of device makers say they have such a plan in place.
Ahmadi said there is a lot of regulation from the U.S. Food and Drug Administration to bring a medical device to market, but security is not a big part of the process.
“Once the device is at market, it’s even less so,” he said. “And devices become less secure over time.”
In fact, the report found that more than half of health care providers do not test medical devices for security issues or are unsure if testing occurs at all. More than 40% of device makers do not test the devices they have released to find new or previously unidentified vulnerabilities.
Ahmadi said the problem is the lack of bite from the FDA. He believes the most effective way to get companies and health care providers on board with medical device security is through incentives, not punishments or fines.
“We need to move from FDA guidance to solid, enforced requirements,” he said. “It’s absolutely critical.”
Ahmadi said the FDA has taken notice of the Synopsys report and has invited his team to come in and talk about how to address the problems the report found.
“It’s clear the game has changed pretty quickly,” said Ahmadi. “Organizations need to start carefully examining what they’re doing in terms of medical device security.”
LONDON – The United Kingdom’s National Institute for Health and Care Excellence is launching a fee-based online tool to help health device makers get their products to market faster. The Medtech Early Technical Assessment (META) tool will help companies identify what evidence they already have and what gaps need to be filled to satisfy payers. The new tool will help developers of medical devices and diagnostics generate evidence to show their products are clinically relevant and cost effective. The tool will enable companies to better articulate the benefits of their products, and will help companies prepare for a dialog with health technology assessment organizations and payers, said Leeza Osipenko, head of NICE Scientific Advice, the institute’s fee-based consultancy service, in a statement. She said META is aimed primarily at small- and medium-sized companies.
EDEN PRAIRIE, Minn. – Reminder Rosie, a device designed to remind people with memory loss to take their medication and complete daily tasks, achieved 80% compliance for 86% of patients in a recent pilot study conduced by the Toronto Central Community Access Centre. The three-month study of 11 patients found the device to be especially helpful for those with mild dementia and cognitive impairment, and projected cost savings for home care professionals between $3,000 to $6,000 annually. Manufactured by LifeAssist Technologies, Reminder Rosie allows caregivers to record up to 25 personalized messages in any language.
ARLINGTON, Va. – Personal health analytics company Zansors has secured a patent from the U.S. Patent and Trademark Office for a wireless electrocardiogram (ECG) acquisition and monitoring device. The patent will allow heart-monitoring devices to be integrated into clothing, or secured directly onto the skin. “Focusing on a patient-friendly experience with wearables has led directly to this patent,” said Nicole Stout, vice president of medical affairs at Zansors, in a statement. The company announced in March that it received its first utility patent for a wearable patch comprising multiple separable adhesive layers for to combining electronics and health monitoring.
During a recent interview with reporter Dan Gorenstein of Marketplace, I shared with him that the U.S. Food & Drug Administration approved 15,000 medical devices from 2012-2016, with over 2,900 medical devices approved in 2016 alone (according to EmergoGroup). In researching that statistic, I learned some other fun facts about the FDA approval process.
Did you know that the average medical device approval from the FDA takes an average of 177 days? Neither did I.
Did you know that all 510(K) submissions are assigned a “K number” – the letter K followed by six digits? The first two digits of the 510(K) number indicate the year it was submitted for review. The next four digits are sequential starting at 0 and indicate the order in which the submission was received during the year.
Did you know that the first 510(K) ever submitted was by Zimmer Inc., which holds K760001, submitted on May 26, 1976.
Did you know that Boston Scientific Scimed Inc. owns K000001? It’s not the first 510(K) ever, but it was the first one submitted in the new millennium on January 3, 2000.
I’m sure 2017 will see it’s share of medical device approval submissions to the FDA and I’m sure we’re going to learn about some incredible technologies to help improve the way home health care is delivered. I’ll try to cover most of it right here, so stay tuned!
Thanks to medical device consultants EmergoGroup for the FDA fun facts.
KYOTO, Japan – Omron Healthcare has made a $25 million equity investment in cardiac device maker AliveCor, and the two companies will integrate their technologies, products and services in the cardiovascular disease field. In addition to the investment, Omrom will: incorporate its remote blood pressure monitoring service into AliveCor’s KardiaPro platform; distribute AliveCor’s mobile electrocardiogram monitoring units through Omron Healthcare’s sales networks; work with AliveCor to develop new algorithms and services for the prevention of cardiovascular disease; and work with AliveCor to develop new devices.
STILLWATER, Minn. – A collaboration with the Children’s Hospitals and Clinics of Minnesota is testing the mission behind Pops! Diabetes Care mobile diabetes management device.
The device adheres to the back of a smartphone and includes three stationary lancets next to three strips on a disposable module. The meter communicates via Bluetooth with a companion mobile app, which also allows caregivers and providers to remotely monitor the patient’s glucose readings and more.
“We’re all about creating a fabulous user experience,” said Lonny Stormo, CEO of Pops! Diabetes Care, a diabetes patient himself. “The majority of people with diabetes don’t want to use all of the new, complicated technology that’s out there for diabetes—including me.”
Children’s Hospitals was looking for an easy-to-use diabetes management system for its young patients and their families, as well as physicians and diabetes educators, and conducted a study around mHealth and diabetes last year. It found that what’s available in the mHealth app marketplace today is not meeting their needs.
Children’s Hospitals connected with Stormo at the 2015 MN Cup competition, in which Pops! was a runner-up, and began using the system last year.
“To collaborate on developing a product that potentially may simplify the 24/7 burden of diabetes management on pediatric patients is exciting,” said Dr. Laura Gandrud, a pediatric endocrinologist at Children’s McNeely Pediatric Diabetes Center, part of Children’s Hospitals, in a statement.
Remote monitoring has been the focus of the diabetes management space for many years, said Stormo, but data hasn’t always been accessible to the patient.
“People are willing to take their health care into their own hands and we’re trying to give them the right tools to do that,” Stormo said. “We’re hoping to see a change that enables people to be less dependent on a clinic or health professional to get better outcomes.”
Pops! will apply for U.S. Food and Drug Administration clearance later this year, and it’s planning to conduct a clinical trial with Children’s Hospitals, as well.