By Rick Fromme
This edition of our ongoing medical device series, “Fascinating Captain!” indeed runs the gamut. From an innovative type of biomaterial that acts as internal “scaffolding” to assist internal tissues, to a remote-controlled exoskeleton that can help paraplegics better ambulate themselves, to non-wearable wearable technology, one thing is clear: the breadth and scope advances in medical device technology continues to be far reaching, with life-changing implications for many.
A Peep into Your Sleep (a.k.a., An App for Your Nap)
Misfit Wearables, a company known for its aesthetically pleasing wearable, Shine, is now collaborating with Beddit, a Finnish sleep analysis company. The move pairs Beddit’s thin, unobstrusive sleep monitor, which fits under a mattress, with Misfit’s tracking app for iOS and Android networks.
It presents a logical option for Misfit Wearable users who don’t necessarily want to wear their tracking device to bed, but still wish to gather insights on their sleep patterns. Furthermore, Beddit’s under-the-bed sleep monitor offers deeper analysis than what's was available when just using Shine. The new device partnership analyzes heart beat, respiration and movement, which then wirelessly transmits the data through Misfit’s app via Bluetooth.
Misfit's partnership with Beddit adds integration with its existing fitness app and Shine fitness tracker, plus new algorithms to work with Beddit. It also provides a way for Beddit, which has targeted hospitals and sleep clinics, to have a stronger reach into the consumer market, a campaign it started last year.
The “non-wearable” wearable also offers another way for Misfit to set itself apart from other wearable companies.
This is Misfit's second move to expand its landscape of connected devices in several weeks, after adding a Pebble app for fitness tracking this past June.
Chip Off the Old Pill
A remote controlled birth control device may be available for consumers within the next four years. Created by MicroCHIPS, a Massachusetts-based drug delivery implant developer, the chip will be inserted under a woman’s skin and can be activated and deactivated by remote control. It works by administering a low dose of the hormone levonorgestrel once a day.
The chip emits the 30 microgram dose of levonorgestrel, which is administered via an electric charge, powered by an internal battery, which causes a seal around the hormone to melt and allows it to be released into the body.The chip will last for approximately 16 years; then the user simply visits her doctor’s office for a replacement.
Remote control operation is wireless but is designed to be tamper-proof. That is, someone wouldn’t be able to turn off the birth control from across a room. Rather, the remote must be practically touching the skin to work. All communications between the remote and the chip are encrypted, too.
The project is backed by the Bill & Melinda Gates Foundation, which funds innovative health projects. It also funded a campaign in 2012 to improve contraception access in developing countries.
EarlySense, based in Waltham, MA, is now releasing a new FDA-cleared Chair Sensor that gleams the heart rate, respiratory rate, and motion from the patient’s buttocks. This is the first contact-free sensor for assessing vital signs from a chair.
The sensor, which looks like boxy pillow, is placed on the seat of a chair. A nearby monitor hooked up to the sensor displays and tracks patient’s’ vitals in real time, passing on the readings to the nursing station. In addition to raising alarms when the heart or breathing rates are abnormal, the technology also warns clinicians when a patient is trying to get up from the chair, which ensures someone can assist at a moment’s notice.
Clinicians have long known that ambulating patients from bed to chair improves healing, reduces the risk of complications, and shortens length of stay. Being positioned in an upright position appears to be of most benefit in the early post-operative period by improving lung function and reducing potential pulmonary complications. But to date, there wasn’t an automatic, contact-free solution for keeping patients safe in their chairs while being to assess key physiological vital signs.
The EarlySense Chair Sensor is a tool that empowers clinical staff to provide proactive, effective, timely interventions when patients are deteriorating or at risk of falling, therefore, accelerating recuperation and reducing risks.
The FDA has approved marketing of the first motorized device intended to act as an exoskeleton for people with lower body paralysis (paraplegia) due to a spinal cord injury. ReWalk, created in Israel, is a remote-controlled, “exoskeleton, motorized device worn over the legs and part of the upper body that helps an individual sit, stand, and walk with assistance from a trained companion, such as a spouse or home health aide.
According to the U.S. Centers for Disease Control and Prevention, there are approximately 200,000 people in the U.S. living with a spinal cord injury, many of whom have complete or partial paraplegia.
ReWalk consists of a fitted, metal brace that supports the legs and part of the upper body; motors that supply movement at the hips, knees, and ankles; a tilt sensor; and a backpack that contains the computer and power supply. Crutches provide the user with additional stability when walking, standing, and rising up from a chair. Using a wrist-worn, wireless remote control, the user commands ReWalk to stand up, sit down or walk.
ReWalk is for people with paraplegia due to spinal cord injuries at levels T7 (seventh thoracic vertebra) to L5 (fifth lumbar vertebra) when accompanied by a specially trained caregiver. It’s also for people with spinal cord injuries at levels T4 (fourth thoracic vertebra) to T6 (sixth thoracic vertebra) where the device is limited to use in rehabilitation institutions. The device is not intended for sports or climbing stairs.
The FDA is requiring Argo Medical Technologies, Inc. to complete a post-market clinical study that will consist of a registry to collect data on possible adverse events related to the use of the ReWalk device, as well as to prospectively and systematically assess the adequacy of its training program.
Doctor’s Gotta’ Brand New Bag
The once-iconic doctor’s bag has lost much of its luster within the past few years as technologies available in health care facilities have made a lot of what’s inside relatively less useful. Yet, mobile technology is rapidly catching up, presenting today’s and tomorrow’s doctors with advanced diagnostic and medical tools that make doctor’s bags – once a quaint image from the past – a high tech marvel. Medgadget editor Shiv Gaglani shows off three recentlyreleased devices that are taking the doctor’s bag into the 21st century.
Fibralign Wins MedTech Award
Fibralign Corporation was the winner of the 2014 MedTech Innovator competition held during the 22nd Annual Medical Device Conference, hosted by law firm Wilson Sonsini Goodrich & Rosati.
Fibralign's first product, BioBridge, is developed to address Secondary Lymphedema, a global, chronic debilitating disease that affects over 120 million people and has no cure.
BioBridge, a unique extra-cellular matrix scaffold with specially designed fibrils oriented in specific 3D orientations, is much like the body’s own tissues. It alters the mechanical response of implanted scaffolds in the body, which recent research demonstrating it has a major impact on the type of tissue that can be engineered. The company successfully completed a large animal study that validated BioBridge-treated diseased lymphatic tissue. Fibralign is now preparing for 510(k) submission and a clinical study.
As the first place winner, Fibralign won prizes valued at $150,000, including $100,000 in cash provided by RCT Ventures, $25,000 in cash provided by Johnson & Johnson Development Corporation and $25,000 worth of state-of-the-art lab space at Janssen Labs.
In this edition of “Fascinating Captain!” I shared with you some of the innovative medical devices that have recently received FDA approval and/or that may one day find their way into the ever-expanding medical device marketplace. If you found this article interesting and useful, please share it with your colleagues and friends. As always, I’m eager to read your comments and questions below.
Rick Fromme combines entrepreneurial enthusiasm with an insider's knowledge of the medical industry to co-found MedMasters.com. Both his drive and perspective helps provide health care professionals with a superior mechanism with which to communicate, network and market their strengths. Prior to founding MedMasters.com, Rick operated a highly successful medical device distributorship. Other milestones in his 12-year career in the medical industry include a key position at a medical device start-up company that was later sold to the Ethicon Endo division of Johnson & Johnson. You may also reach Rick by connecting with him on Facebook, Twitter, Google+, LinkedIn and YouTube.