Medical Social Network News: Medical Device Sales: “Fascinating, Captain!” Part 5

By Rick Fromme

Despite some of the challenges many mid- and small-sized medical technology firms have been facing due to the medical-device excise tax, there continues to be robust research and development and FDA approval for exciting, innovative high-tech medical devices. Too, the job market in the medical device sector continues to increase. In fact, reports medcitynews.com:

“Most medical manufacturers actually increased their employee count for the year, according to a new report from EP Vantage. Of the top 15 device makers, only three experienced reductions in headcount – and two of those were simply because the companies spun off their pharmaceutical divisions. The remaining 12 increased their employee bases by six percent.”

That said, here’s this month’s look at some of most recently approved and/or up-and-coming medical devices and technologies from around the world.

Nymi Wristband Uses Your Heartbeat as Your ID

Imagine if your phone, computer, automobile home could recognize you and only unlock when you’re
nearby. How would they know it was you and not someone else? Your heart beat.

Devices running Nymi-associated apps can read the device's signal and react appropriately. For example, a smartphone with a Nymi app could unlock its screen when in range of the wristband's Bluetooth signal. A multiplicity of electronic devices, cars, and even homes with the app could also be configured to unlock, engage and receive respond to other commands when in range of the Nymi device.

The Nymi wristband, created by Toronto-based Bionym Inc., reads a wearer's electrocardiogram, or EKG. The wristband then transmits this specific ID based on the EKG to the wearer's devices.

EKGs are based on a number of factors, including variable measurements such as heart rate and stress. But the Nymi takes advantage of the fact EKGs also evaluate more “permanent” factors, such as an individual’s such as a heart's size, its position in the chest and other electrical signals. All of these characteristics contribute to the unique EKG wave's shape. Just like your fingertip, your heartbeat is unique. The Nymi tells the world who are you, allowing you to securely communicate your indentity to all your favorite devices and environments.

Each time a user puts the Nymi back on, the wristband performs a check to match the EKG with what it has on file from its initial reading. After that, the Nymi merely monitors whether it’s still in contact with the original wearer — it doesn't provide any data about the wearer's heart or other medical functions.

If the Nymi is removed, it will cease its Bluetooth transmissions and won't resume until it verifies that the correct user is wearing it.

Nymi EKG-Authenticating Wristband

New Hand-held Device Improves Melanoma Detection

A new hand-held device that uses lasers and sound waves may change the way doctors treat and diagnose melanoma, according to a team of researchers from Washington University in St. Louis. The instrument is the first that can be used directly on a patient and accurately measure how deep a melanoma tumor extends into the skin, providing valuable information for treatment, diagnosis or prognosis.

The motor, translation stage, ultrasonic transducer, and optical fibers are all incorporated in this handheld probe for easy operation. Credit: Image courtesy of Yong Zhou.

The technique relies on the photoacoustic effect, in which light is converted into vibrations. In the case of the new device, a laser beam shines into the skin at the site of a tumor. Melanin, the skin pigment that's also in tumors, absorbs the light, whose energy is transferred into high-frequency acoustic waves. Unlike light, acoustic waves don't scatter as much when traveling through skin. Tumor cells will produce more melanin than the surrounding healthy skin cells, and as a result, the acoustic waves can be used to map the entire tumor with high resolution.

Initially, this tool will be mainly used for improving how doctors plan and prepare for surgeries. It can measure a tumor's entire volume, something that's never been possible with melanoma. If researchers can determine how the volume relates to cancer outcomes, then this device could give doctors a new type of measurement for diagnosis and prognosis.

Melanoma is the fifth most common cancer type in the U.S. and rate of incidence is rising faster than all other cancers. It's also the deadliest form of skin cancer, causing more than 75% of skin-cancer deaths.

3D Printed Anatomy Marks a New Era for Medical Training

The creators of a unique kit containing anatomical body parts produced by 3D printing say it will

revolutionize medical education and training, especially in countries where cadaver use is problematical.

The “3D Printed Anatomy Series,” developed by experts from Monash University in Australia, is thought to be the first commercially available resource of its kind. The kit contains no human tissue, yet it provides all the major parts of the body required to teach anatomy of the limbs, chest, abdomen, head and neck.

The simple and cost-effective anatomical kit would dramatically improve trainee doctors’ and other health professionals' knowledge and could even contribute to the development of new surgical treatments.The kit, which is set to go on sale later this year, could have particular impact in developing countries where cadavers aren't readily available, or are prohibited for cultural or religious reasons.

Even when cadavers are available, they’re often in short supply, are expensive and, as anyone who has been near them will readily attest, are rather noxious due to the embalming process.

Conversely, the 3D printed series can be produced quickly and easily, and unlike cadavers don’t deteriorate or require special storage facilities and protocols, making it more cost effective.

After scanning real anatomical specimens with either a CT or a surface laser scanner, the body parts are 3D printed either in a plaster-like powder or in plastic, resulting in high resolution, accurate color reproductions.

FDA Approves Attain Performa Quadripolar Lead & Viva Quad CRT-D

The FDA has given Medtronic approval to introduce its Attain Performa Model 4298 quadripolar lead and the Viva Quad XT and Viva Quad S cardiac resynchronization therapy defibrillators (CRT-D) in the U.S.

Having four electrodes on a lead allows cardiologists to select from any one of 16 available pacing configurations. Additionally, the short distance between the inner two electrodes provides facilitates fine tuning of CRT-D therapy.

Furthermore, the new quadripolar lead reduces the incidence of phrenic nerve stimulation (PNS), a potential side effect that results in muscle twitching, hiccups or shortness of breath. The Viva Quad XT device is equipped with the proprietary AdaptivCRT feature, which preserves normal heart rhythms and automatically adjusts to patients’ needs to customize therapy. The system includes VectorExpress technology, which reduces lead programming time to two minutes by providing physicians with clinically actionable information to help them select optimal pacing configurations for each patient.

The Attain Performa lead addresses the clinical challenges that can compromise lead position, offering implanting physicians more options to maintain lead position and optimize CRT therapy. The Model 4298 lead has a canted shape, and steroid on all four electrodes for lower pacing thresholds.

Bacterial Robotics Building “BactoBots” Engineered to Destroy Skull-based Tumors

Cincinnati-based Bacterial Robotics is engineering a legion of so-called “bactobots” to do our bidding in the fields of health care, industrial waste management and numerous others.

It just received National Science Foundation funding to further development of a bacterial robot that can be used as a surgical tool. It’s developing an organism that recognizes a certain type of skull-based tumor called a cholesteatoma, which leads often to meningitis, brain abscess and death.

Code-named the Auribot, the engineered bacterium is being developed to augment current skull-based surgical practices.It gives surgeons a consumable product that uses lysis to destroy residual cholesteatoma cells after the primary skull-based surgery is complete.

The synthetic biology company is focused on taking natural genes that allow organisms to complete any given task in a natural setting and move them into task-performing bacteria

These microscopic bacterial robots can work as surgical devices, produce biofuels, clean water supplies, nearly that a bacterium would do.

In this edition of “Fascinating Captain!” I briefly addressed the current growth and job outlook for the medical device industry, even after the implementation of the ACA-mandated excise tax. I highlighted 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.