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3 Reasons Bluetooth Is Perfect in Healthcare Settings

Bluetooth could be a surprising answer for innovation in healthcare settings. Here's why.

Steve Hegenderfer, Bluetooth

BluetoothHospitals are fast-paced and hectic, providing vital services to hundreds of thousands of Americans every day. In fact, according to an American Hospital Association survey, 36.9 million people were admitted to registered hospitals in 2015, costing hospitals $678 billion in expenses. Rapid advancements in technology, however, offer hospitals new ways to improve patient care and operational efficiencies. So what innovative technology can hospitals use to better serve their patients and reduce costs? The answer may be more obvious than you think: Bluetooth.

The low energy and government-grade security features of Bluetooth make it an ideal technology for hospitals and Bluetooth functionality lends itself to a number of practical use cases, which will only be improved by the additional features of upcoming Bluetooth 5 and mesh technologies.

Let's look at each in more detail:

1. Low Energy

Bluetooth low energy functionality enables small sensors to run off tiny coin-cell batteries for months, and in some cases, years. This is what makes it possible for you to find Bluetooth technology in billions of devices, including Bluetooth beacons, and is what makes Bluetooth ideal for the myriad devices found throughout a hospital setting, like glucose monitors, blood pressure monitors, and even knee braces. With Bluetooth, hospital equipment can remain connected with little concern for battery life. And, in the case of energy harvesting Bluetooth chips, like those from Cyprus Semiconductor, Bluetooth sensors can be 'set it, and forget it' for life. In short, low energy means low maintenance which, in turn, means lower overhead costs.

See Hegenderfer discuss medical device interoperability as part of a panel at BIOMEDevice San Jose, December 7-8, 2016.

2. Security

Bluetooth adheres to U.S. federal security regulations, ensuring that all Bluetooth devices are capable of meeting and exceeding strict government security standards. This includes advanced privacy capabilities and government-grade AES 128-bit encryption that meet both NIST and FIPS compliance. Bluetooth has implemented security and privacy standards while providing flexibility for a manufacturer to deliver the best security and user experience for any given implementation. This means that, throughout a hospital, Bluetooth can be the technology that connects all devices, no matter the security requirements. Devices can be networked, operations can be streamlined, and you can rest assured patient charts and other sensitive data will remain secure.

3. Functionality

While low implementation and maintenance costs and advanced security are great, the technology is useless unless there are practical applications to back it up. With the capabilities afforded by Bluetooth, hospital use cases are limited only by the imagination. Two of the most obvious applications, though, are asset and patient management. Currently, expensive hospital equipment is tracked and managed by RFID chips or, in some cases, simple pen and paper. Both systems rely on a human to physically check in and out equipment. Realistically, a nurse running to get a crash cart in response to a cardiac alarm is not going to prioritize asset management over their patient. Using Bluetooth beacons, hospitals are starting to automate this system. Similarly, imagine if all patient ID bands were fitted with a Bluetooth beacon that would advertise their relevant chart and medical history to any physician that walked into the room. Imagine removing the wires from the dozens of devices connected to a patient. Not only would it be easier to treat a wire-free patient, but moving from room to room is also simplified as the devices in a room could be automatically synced with sensors on the patient.  Now imagine creating an entire mesh network of equipment, patients, and doctors across the entire hospital where you could use a tablet to view a live map of the hospital and pull up the exact location of any device or person within the network at any given time. In this world, devices would talk to each other as well as patients and doctors at all times to relay constantly updated information to the right place at the right time. This is the vision for many people around the Internet of Things, and it will be enabled with Bluetooth mesh technologies.

While these Bluetooth applications may seem far-fetched, the truth is that consumers have already adopted this technology in their daily lives. The popularity of wearable devices is at an all-time high, with nearly every wearable device incorporating a heart rate monitor and some form of health tracking. Consumers are already using Bluetooth to monitor and track their health at home.  And with experience in wearables and beacons, and with the advantages of low energy, security, and technical functionality, Bluetooth technology can help hospitals improve patient care and operational efficiencies. Considering the increased functionality of upcoming Bluetooth 5 and Bluetooth mesh technologies, paired with organizations like the Personal Connected Health Alliance and companies like Continua setting the standard for interoperable, connected health solutions, Bluetooth technology is set to become as prevalent in hospitals as it is in our daily lives. 

Steve Hegenderfer is director of developer programs and evangelism at Bluetooth SIG (Kirkland, WA)

Danaher Spending $4 Billion on Diagnostics Company

Danaher's announcement of its plans to acquire Cepheid comes months after it spun off some businesses to better focus on healthcare-related offerings. 

Chris Newmarker

Danaher (Washington, DC) said Tuesday that it will spend $4 billion to acquire Cepheid (Sunnyvale, CA), which has built a more than half a billion dollar a year business off a reputation for accurate and easy to use molecular systems and tests. 

The $53 per share price that Danaher quoted marked a 53% premium off Cepheid's closing price on the Nasdaq last Friday, and Cepheid's share price shot up accordingly on Tuesday, closing at $52.53 per share. 

Cepheid's fully automated GeneXpert systems, among other applications, provide test results for the management of infectious diseases. The company expects to bring in $618 to $635 million in revenues in 2016, up from $539 million the previous year. 

Danaher's President and CEO Thomas P. Joyce Jr. described Cepheid as an excellent complement to Danaher's existing $5 billion diagnostics segment, expanding Danaher's ability to grow.

"Cepheid's extensive installed base, test menu and innovative product offering contribute to its market leadership in molecular diagnostics and we expect it to strengthen our position in this high-growth segment," Joyce said. 

Danaher has been increasingly focused on healthcare-related businesses. In July, a new company called Fortive Corp. was created, containing what had been Danaher's test and measurement, industrial technologies, and petroleum businesses. The  life sciences, diagnostics, and dental businesses remained under the Danaher name. 

The $4 billion purchase of Cepheid marks a major acquisition in the medical device space, though dwarfed by the mega deals of past years such as Medtronic's $50 merger with Covidien. A recent report by EP Vantage noted: "The disappearance of the megadeal from the 2016 menu could be because the industry has consolidated as much as possible for now: any more overlap would cause too many antitrust issues to be worthwhile."

Both Danaher and Cepheid's boards have approved the deal, which is expected to close by the end of 2016 pending shareholder approval and customary closing conditions. 

Product Development Models Driving Innovation

Learn how to meet tough regulatory requirements and design devices hospitals will actually buy in this special conference track at MD&M Minneapolis on September 21. Qmed readers get 20% off with promo code Qmed16.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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[Money image courtesy of Tracy O per Creative Commons license]

How Apple, FDA Are Steering Mobile Health

Both Apple and federal regulators are increasingly scrutinizing the ever growing number of mobile medical applications that download to smartphones and tablets. Will Apple have more healthcare-related news on Wednesday?

Maureen Kingsley

Mobile medical applications (MMAs) have been hitting the market with increasing frequency ever since they first came onto the scene in the late 1990s

These apps represent a broad range of functionality, assisting users with everything from obtaining publicly available information about prescription drugs and looking up medical-office billing codes to measuring blood-oxygen saturation and displaying blood-glucose levels. Users include medical students, healthcare providers, healthcare patients, and employees in clinical settings. Truly, where modern medicine is concerned, app developers can increasingly say, "There's an app for that."

Needless to say, app "store" operators such as Apple and regulators such as U.S. FDA are now taking more responsiblies when it comes to categorizing MMAs and setting some guidelines for their development, marketing, and use.

Apple, for example, published developer guidelines this summer that begin to address the unique safety, privacy, and regulatory concerns of MMAs. For instance, Section 1.4 of the Safety portion of the guidelines tells developers, "If your app behaves in a way that risks physical harm, we may reject it." Specifically, Section 1.4.1 reads, "Medical apps that could provide inaccurate data or information, or that could be used for diagnosing or treating patients may be reviewed with greater scrutiny. If your medical app has received regulatory clearance, please submit a link to that documentation with your app."

The new guidelines out of Apple make sense, given CEO Tim Cook's excitement over what the high tech giant might be able to accomplish in the healthcare space. There could potentially be more healthcare-related news out of Apple's products announcement event on Wednesday.

Harnessing Sensors and Data Management

Sensors and data management are changing the game when it comes to medtech product development. Learn how to use these tools to create your next winning innovation at MD&M Minneapolis on September 22. Qmed readers get 20% off with promo code Qmed16.

Indeed, for its part, FDA considers some MMAs actual medical devices requiring 510k clearance or even a PMA before they can be made commercially available.

FDA maintains a list of example MMAs requiring regulation. This list includes "mobile apps that transform a mobile platform into a regulated medical device and therefore are mobile medical apps," such as those measuring and displaying the electrical signal produced by the heart; those that use a sensor attached to the mobile platform or tools within the mobile platform itself to record, view, or analyze eye movements for use in the diagnosis of balance disorders; those that use tools within the mobile platform (e.g., a speaker) to produce controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders, and many more.

The list of MMAs regarded and regulated by FDA as medical devices also includes mobile apps that connect to an existing medical device type for purposes of controlling its operation, function, or energy source, such as apps that act as wireless remote controls or synchronization devices for computed tomography or x-ray machines, and mobile apps that display, transfer, store, or convert patient-specific medical device data from a connected device, such as those that connect to a nursing central station and display medical device data to a physician's mobile platform for review.

Other MMAs, such as those designed to educate or train medical students and/or healthcare providers, and those providing reference information to patients, are not categorized as medical devices and are therefore left alone by FDA. The agency also announced this summer that apps that promote or support general wellness and fitness, such as calorie and exercise trackers, are not subject to FDA oversight.

Maureen Kingsley is a contributor to Qmed

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[Image by Edoddridge - Own work, CC BY-SA 3.0]

Cook Guidewires Recall Is Serious

FDA has designated the previously announced recall as Class I.

Qmed Staff

Cook Medical Roadrunner UniGlide Hydrophilic Wire Guide
Roadrunner UniGlide Hydrophilic Wire Guides (Image courtesy of Cook Medical)

FDA on Tuesday announced a Class I designation for a previously announced Cook Medical recall of thousands of guidewires with coating that is potentially contaminated with glass particles. 

FDA listed 8750 units of the Roadrunner UniGlide Hydrophilic Wire Guide involved in the recall. The guidewires were distributed between May 2 and June 17 of this year. 

Cook had already announced the recall, but the Class I designation drums home just how serious it actually was. The problem appears to have originated at the coatings supplier, Dutch company DSM Biomedical B.V. 

DSM alerted Cook to the possible glass contamination in the coating, issuing its own recall in the process, according to a statement from Cook.

Cook has described its recall as a precautionary method. The coating is meant to help in tracking and pushing of the guidewires, which aid the delivery of percutaneous catheters to the peripheral vasculature. The potential glass particles, ranging from about 4 microns to 280 microns in size, could potentially cause vessel damage, bleeding, and the presence of blood clot particles in the circulatory system.

Cook has asked hospitals and healthcare providers to quarantine affected products, and return them to Stericycle Expert Solutions (a third-party recall administration service provider). 

Product Development Models Driving Innovation

Learn how to meet tough regulatory requirements and design devices hospitals will actually buy in this special conference track at MD&M Minneapolis on September 21. Qmed readers get 20% off with promo code Qmed16.

The recall comes months after the Bloomington, IN-based medical device company announced it was voluntarily recalling about 4.1 million of its catheters with Beacon Tip technology because of complaints of the tips splitting or fracturing during procedures. The April recall expanded on a much smaller 2015 recall that involved 95,167 devices. Cook officials decided to recall all lots and sizes of the catheters to "assure patient safety."

Cook suffered another major catheter recall in February. The February recall involved 360 lots, or 17,827 devices globally, of single lumen central venous catheters and pressure monitoring sets and trays. 

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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These Robots Combine Engineering and Fighting Tactics

Medical device engineers at Zimmer Biomet and Stryker employed tactics with their BattleBots robots that would be recognizable to human fighters.

Qmed Staff

BattleBots Witch Doctor versus Rotator

The worlds of engineering and fighting seem to come together in the renewed BattleBots series airing on ABC, according to Qmed's fellow UBM media outlet Design News.

Engineers behind Witch Doctor, designed by a team led by Zimmer Biomet senior engineer Andrea Suarez, and Rotator, designed by a team led by Stryker senior staff engineer Victor Soto, are learning important lessons behind incorporating design principles with engineering.

Writes Design News Chris Wiltz: "The same tactics that will get a boxer or MMA fighter's hand raised at the end of the match are also very likely to keep your robot in one piece in the BattleBots arena."

(See Soto and Suarez discuss lessons learned, and how they are applied to medical device development, at MD&M Minneapolis Center Stage on Wednesday, September 21. Qmed readers get 20% off with promo code Qmed16.)

For example, a shorter fighters can be devastating for taller fighters if they can find a way to get to the "inside" of their taller opponents' ranges. (Think Mike Tyson in his prime.) Witch Doctor, a smaller robot, has a partner robot named Shamen that spews flames, helping to provide a distraction to get in on the inside of a larger opponent. The key is to have a dominant angle over the opposing robot.

Rotator seeks to bring some major hurt to its opponents with two spinning blade discs--one mounted on the top and one mounted on its underside--to combat such undertaking. One blade is more toward the front and one is more toward the front, however. In starting their match against Witch Doctor, Soto and team may have made a mistake by having Rototator start the game sideways. It was a "square stance" that offered an element of surprise, but also made it harder to defend Rotator from the head-on charge from Witch Doctor that quickly ended the game.

Read the full Design News story here. 

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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[Image provided by Victor Soto/Rotator, courtesy of ABC]

How Google Is Bringing AI to Healthcare

Google DeepMind has been forging research partnerships with the National Health Service in the U.K. 

Maureen Kingsley

UCLH Google DeepMind scanner

The concept of artificial intelligence put forth by movie studios in the past few decades centers around creepy, vacant-eyed robots that resemble humans and tend to "go bad" and destroy actual human lives. As with many Hollywood portrayals, however, the truth is far less fantastical and violent, yet just as fascinating: In real life, artificial intelligence, or AI, is finding useful applications in healthcare--via such programs as IBM's Watson Health--for processing patient data, suggesting potential diagnoses, making individualized treatment recommendations, and assisting physicians with planning and executing procedures, among other things.

Google DeepMind, a U.K.-based AI company co-founded by Mustafa Suleyman and acquired by Google in 2014, has been getting in on the act, too. DeepMind in late August announced a research partnership with the Radiotherapy department at University College London Hospitals (UCLH) NHS Foundation Trust, a provider of cancer treatment.

Google DeepMind and UCLH's radiotherapy clinicians are examining whether machine-learning methods can potentially reduce the amount of time it takes to plan radiotherapy treatment for head and neck cancers, which affect more than 11,000 individuals in the U.K. alone each year. (These cancers include oral cancer, oral-cavity cancer, and cancer of the sinuses, among others.)

Harnessing Sensors and Data Management

Sensors and data management are changing the game when it comes to medtech product development. Learn how to use these tools to create your next winning innovation at MD&M Minneapolis on September 22. Qmed readers get 20% off with promo code Qmed16.

Radiotherapy treatment for these cancers has improved survival rates, but because of all the delicate, intricate anatomical structures located in this area of the body, clinicians must plan and map-out treatment extremely carefully to ensure no vital nerves or organs are damaged. This detailed planning-and-mapping process is called "segmentation," and it involves drawing around different parts of the patient's anatomy and entering this information into a radiotherapy machine, which then uses it to target cancers and leave healthy tissue unharmed.

For some of these cancers, segmentation can take about four hours. Google DeepMind believes that through its collaboration with UCLH, it can "carefully analyze" up to 700 UCLH scans (wiped of their associated patients' identifying information) to determine the potential for machine learning to make segmentation faster and more efficient, according to a recent DeepMind press release.

"Clinicians will remain responsible for deciding radiotherapy treatment plans," the release states, "but it is hoped that the segmentation process could be reduced from up to four hours to around an hour." That would indeed be a significant time savings.

The Google DeepMind team says its goals for this work are two-fold: The first is freeing up clinicians' planning time to focus more on patient care, education, and research. The second is developing a radiotherapy-segmentation algorithm that can potentially be applied to other areas of the body.

Google DeepMind's first (and currently ongoing) collaboration with the U.K.'s NHS Trust was with Moorfields Eye Hospital, a 200-year-old institution, to explore how machine learning can potentially aid in faster detection, diagnosis, and treatment of two specific conditions that cause loss of vision: diabetic retinopathy and age-related macular degeneration.

Eye-care professionals currently use digital scans of the fundus (the back of the eye) along with scans optical coherence tomography scans to diagnose and determine treatment for these eye conditions. These scans are highly complex and require a long analysis time, which subsequently delays diagnosis and treament. Google DeepMind and Moorfields are investigating how machine learning could "help analyze these scans more efficiently and effectively, leading to earlier detection and intervention for patients and reducing the number of cases of patient deterioration," states Google DeepMind in a press release.

IBM Watson for Health: What's New

While Google's AI team expands its relationship with U.K.'s National Health Service, the humans behind IBM's AI-focused supercomputer, Watson, continue to leverage Watson's capabilities for healthcare purposes. Earlier this summer, Qmed reported on a smart tablet app under development that would use the Watson EMR Analyzer to allow radiologists to quickly view images along with patients' medical issues, clinical notes, lab results, medications, and more. Murthy Devarakonda, an IBM research scientist who is principal investigator for the Watson EMR Analyzer, presented this information at MD&M East in June of this year.

Other IBM Watson projects centered on what IBM refers to as "cognitive healthcare" include Medtronic insulin pumps that use Watson to predict dangerous changes in blood-glucose levels and the Talkspace app's use of Watson's Personality Insights API to match mental-health patients to online therapists.

Maureen Kingsley is a contributor to Qmed

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[Image courtesy of Google DeepMind]

4 Mistakes That Will Keep Your Device Out of the Hospital

4 Mistakes That Will Keep Your Device Out of the Hospital

For your product to successfully pass the value analysis gantlet, you'll need to avoid these blunders.

Jamie Hartford

The value analysis committee is the gatekeeper that determines which medical devices make it onto a hospital's approved products list. Comprising stakeholders such as administrators, physicians, supply chain professionals, and other stakeholders, the value analysis committee is tasked with evaluating whether products meet the organization's cost and quality criteria, and, ultimately, whether they are worth purchasing or not.

In other words, pleasing value analysis committees is imperative to the success of your device.  

Making any of these four mistakes is a sure-fire way to get a thumbs down.

Solving a Problem That Doesn't Exist

Terri Nelson, Mayo Clinic's director of value analysis, said she was recently presented with a new product: a box to hold disposable medical gloves.

While she conceded that it is possible that gloves do occasionally escape their box, she said it hasn't been identified as a big issue in her organization.

"This goes back to the question of, 'Is it really a problem?'" she said. "I don't need that, the end user doesn't' need that."

So why would a hospital spend money to solve a problem that doesn't exist?

The answer: It wouldn't.

Over-Engineering Your Device

Another mistake device companies make, Nelson said, is revamping an existing product by adding new bells and whistles that don't offer any tangible benefit.

"When it's over-engineered, it's not relevant any longer," she said.

The problem, explained Tom KraMer, president and managing principal at Kablooe Design, is often a result of engineers getting carried away.

"A lot of times, in the engineering world, we want to add all this flashy, cool, new technology, thinking that it's going to make the product win," he said. "But the problem is that it's not done with any vision toward the budget, clinical value, economic value, or user adoption."

Not Considering the Total Cost of Your Product

Part of the value analysis committee's job is to consider the total cost of ownership of any products, services, and equipment it evaluates.

"That means anything that adds to the cost of the product, including price, freight, and the cost of conversion--which can be huge," said Jim Van Drasek, systems director, materials management, at HealthEast Care System, a nonprofit healthcare provider organization in St. Paul, MN.

For example, when HealthEast was considering switching to new infusion pumps, it had to take into account that the organization's 2000 nurses would need to be trained on the new devices--a significant cost that must be considered.

Trying to Read the Value Analysis Committee's Mind

While hospital value analysis committees may seem like mysterious entities that do their work behind closed doors, they're more transparent than you might think.

"You can't read my mind, so we have made a conscious effort to . . . go to high-spend suppliers and go to their marketing departments so we can have a dialogue," Nelson said.

These kind of conversations, she said, can give device developers a heads' up about practice changes and other factors that could aid in new product development.

Hear more advice from Nelson, KraMer, and Van Drasek in a panel discussion, "Getting Your Product into the Hospital: Tips from Hospital Value Analysis Committees," on September 21, 2016, at MD&M Minneapolis.

Jamie Hartford is MD+DI's editor-in-chief and serves as director of content for medical brands in UBM's Advanced Manufacturing Group. Reach her at [email protected] or on Twitter @MedTechJamie.


How to Turn Human Cell DNA Into a 'Tape Recorder'

A new study shows how complex histories can be recorded in the DNA of human cells, allowing them to retrieve data from past events--a breakthrough that could lead to new methods for monitoring infection and cancer progression.

Kristopher Sturgis

MIT DNA Tape Recorder

Biological engineers at MIT have developed a new technique to enable human cells to recall events from the past, such as inflammation or infection, by sequencing the DNA of individual cells. The method, designed to operate as an analog memory storage system, could become the first of its kind to record the duration and intensity of events in human cells.

"We built a system that can continuously accumulate mutation in human DNA as a molecular 'tape recorder' of cellular history," says Timothy Lu, associate professor of electrical engineering and computer science at MIT and senior author on the work.

"The extent of accumulation of the mutations can be programmed to depend on the duration and/or intensity of biological activities of interest, like chemical signals or gene expression," Lu says. "Thus, our memory system actually encodes analog memory because it allows you to record quantitative information about a signal, as opposed to digital memory, which only allows you to store whether a signal has happened or not."

How 3-D Printing Will Transform Medtech

Find out how process innovations in 3-D printing are enabling next-generation medical devices at the MD&M Minneapolis conference on September 22. Qmed readers get 20% off with promo code Qmed16.

Many different methods have previously shown that digital information can be recorded in living cells, which have enabled scientists to program cells to flip sections of their DNA when a particular event occurs. Unfortunately, these methods only reveal whether or not a particular event occurred, without providing any details on how much exposure there was to a chemical or how long the event lasted. This new approach, based on the genome editing system known as CRISPR, aims to account for such details and store the information in the human genome.

CRISPR made new headlines over the summer when it received unanimous approval from a U.S. federal biosafety and ethics committee to begin human trials to create genetically-altered immune cells that fight cancer.

Samuel Perli, Ph.D candidate in electrical engineering and computer science at MIT and one of the lead authors on the work, explains CRISPR's role in the new recording method.  

"CRISPR is a genome engineering tool that enables one to generate mutations at specific locations on the genome," he says. "CRISPR is a two-component system comprised of the DNA cleaving protein Cas9, and a small guide RNA that specifies the DNA sequence to be targeted. By modifying the small guide RNA, we built a self-targeting guide RNA that redirects Cas9 to generate mutations on the DNA encoding the self-targeting guide RNA itself. This results in repeated generation of mutations that accumulate in a way that is commensurate to the duration of activity and intensity of the signals."

To show this, the team engineered a gene circuit that only expresses Cas9 in the presence of a target molecule. The group used TNF-alpha, a molecule produced by immune cells during inflammation, as a target for Cas9. The aim was that whenever TNF-alpha is present, the Cas9 cuts the DNA encoding guide sequence, which will generate mutations. The greater the TNF-alpha concentration, the more mutations will accumulate in the DNA sequence--allowing researchers to monitor the cells exposure to the molecule.

"A quick way this system can be used is to monitor the exposure to various signals that individual cells in a microenvironment of interest experience," Lu says. "Studying the heterogeneity of individual cells in a tumor or a differentiating tissue would be of great interest. One could also study the sequence of events that occur to regulate the differentiation of stem cells into mature cell types within animal models."

Essentially the group aims to show that this method could be used to engineer cells that can detect and record more than one input by producing multiple self-targeting RNA guide strands in each cell. Each RNA guide would then be linked to a specific input, and would only be produced when that input is present. By programming cells to record multiple events, scientists could use the system to monitor a wide variety of things from inflammation and infection to cancer and disease progression.

"We have made available all of the reagents and resources needed to implement the technology on our website," Lu says. "It should be straightforward to implement the technology right away. We aim to apply this technology to tackle important questions in modern biology regarding the development and progression of disease." 

Kristopher Sturgis is a contributor to Qmed.

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[Image courtesy of MIT]

This Sensor System Predicts Your Risk of Falling Down

The new in-home sensor system measures gait speed and stride length to identify adults who are at high risk for falling, and alert healthcare providers to intervene before a fall occurs.

Kristopher Sturgis

Missouri Fall PredictionUniversity of Missouri researchers have designed a sensor system that can predict likely falls.

The imaging system, installed around the living space, to not only detect when falls occur, but recognize the signs of risk to prevent falls from ever happening, says Marjorie Skubic, professor of electrical and computer engineering at the university and director of the Missouri Center for Eldercare and Rehabilitation Technology.

"We have developed fall detection systems before, but a real win is when you can detect that someone has a high risk of falling, and get them help that prevents the fall in the first place," Skubic says. "A fall, or even the risk of falling, is often the turning point that forces older adults out of their home. It can have a huge impact on their independence and quality of life. If someone falls and cannot get help soon, this also impacts their chances of recovery. We have seen this with our own family members, so we want to detect falls and get people help as soon as possible."

The group worked with sensor systems in place at TigerPlace, an aging-in-place retirement residence in Columbia, MO, that works with the university to aid in the development of innovative senior care technologies. The system works by generating images and an alert email for nurses and caregivers, indicating when irregular motion is detected. This information can be used to assist nurses in assessing functional decline, and enable intervention that can provide treatment to prevent falls that result in serious injury.

Harnessing Sensors and Data Management

Sensors and data management are changing the game when it comes to medtech product development. Learn how to use these tools to create your next winning innovation at MD&M Minneapolis on September 22. Qmed readers get 20% off with promo code Qmed16.

As Skubic and her colleagues move forward with the sensing technology, she says that the main goal is to continue to refine a system that can predict and identify risk before it happens.

"The in-home gait analysis system is part of a larger system that recognizes very early changes in health and generates alerts," she says. "This is designed to get people help very early, to address health problems when they are still small and manageable."

Early results from an analysis of the sensor system found that a speed decline of five cm per second could be linked with an 86.3% probability of the patient experiencing a fall within the next three weeks. Additionally, the team found that shortened stride length could be linked with a 50.6% probability of falling within a three week period.

Ultimately, the research indicated that implementing the new sensor technology at TigerPlace enabled residents to live independently for four years on average, compared to the national average of just 22 months.

Despite the success of the in-home system, Skubic says that there are no plans to develop any kind of wearable technology for older adults, as the group aims to keep the system as simple as possible as they begin to roll the it out for commercial use. 

"Our research has shown that many older adults do not want to be bothered with wearing sensors," she says. "They are often unable to manage the charging of wearables and use them consistently. By embedding sensors into the environment, they do not have to do anything special. We've made the technology available now, and Foresite Healthcare has licensed the technology and has begun installing it in senior housing."

Kristopher Sturgis is a contributor to Qmed.

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[Image courtesy of University of Missouri]

In Today’s Medtech Job Market, Employees Hold the Upper Hand

In Today’s Medtech Job Market, Employees Hold the Upper Hand

For many, it's smooth sailing in the medtech industry. Salaries are rising, job satisfaction and security are high, and demand for experienced medtech professionals continues to exceed supply.

Yet certain pockets of the industry seem poised to rocket higher than others. What can employees do to ensure they continue to thrive in this strong but evolving marketplace?

No Longer Just a Trend

Over the past few years, the medtech job market has smiled on employees. Experienced candidates have been able to secure moderate salary increases and higher bonuses.

That dynamic has only strengthened in 2016, which Paula Rutledge, president of Orlando-based medtech recruiting firm Legacy MedSearch, said has been the strongest year for medtech hiring since before the Great Recession.

 Check out more findings of the 2016 MD+DI Medtech Salary Survey and to get in-depth details, download the full results.

"I think that trend is continuing. I may be ready to not call it a trend. I think it's just the new way of going forward," said Brian Cole, managing partner at Dallas-based MedTech Executive Search.

But it remains tough for companies to land quality candidates, said Amy Collins, a medical device recruiter at Smith Search Group, in Minnesota. Professionals laid off after large companies merge tend to be "snapped up quickly," she added.

"If you have device experience and a solid track record, you get hired quickly," Collins said.

Paying Top Dollar

All that has meant strong salaries for employees working in medtech. Respondents to MD+DI's 2016 Medtech Salary Survey reported a median salary of $118,750. That's an $11,750 increase over the median salary reported in the 2015 salary survey and an $8750 increase over the median salary from the 2014, although survey samples were not the same.

Those numbers square with what industry recruiters have observed. Cole said he's observing an average 7-8% bump in salary when employees leave their current position for a new opportunity. "Salaries have increased, without a doubt," he said.

Unfortunately, not all companies have kept pace with the industry's rising salaries.

"We've had more declined offers this year than we ever have before . . . based on salary," Rutledge said.

Some companies are drawing "a line in the sand," she noted, cautioning "that doesn't play, particularly as millennials are stepping up to take leadership roles."

Medtech--Emphasis on Tech

Some of the job growth in medtech is coming from a particular corner of the industry. Rutledge has noticed a significant amount of hiring from what could be called the "high-tech" categories of the industry: virtual reality, sensing, and robotics.

"I'm hearing a division between traditional med device--implants, specifically--and medtech, anything with a battery, a sensor, virtual reality, any kind of tech . . ." she said. "All the [companies] that we're working with that are doing massive hires have a tech component."

Consumer tech companies have entered the medical space through collaborations like the partnership between Dexcom and Verily (formerly Google Life Sciences); Google DeepMind's work on diabetic retinopathy and age-related macular degeneration; and Verb Surgical, the surgical robotics venture backed by Verily and Johnson & Johnson.

Rutledge said someone at a well-known venture capital firm recently told her that everything the firm is evaluating for potential investments has a health IT or medtech component. That kind of funding interest is fueling expansion and hiring within startups that play in those spaces.

Such companies are also targeting highly experienced executives from large industry players to help them build operations and commercialize products. "They're buying that brand name," Rutledge said. "They want the pedigree, but they want someone to have the pace of a startup."

That's welcome news to mid-career professionals who may have felt left out as major medtech companies merged.

"We've been very successful at pulling out incredible, high-level talent to work for much smaller companies with more of that early-stage excitement," Rutledge said. "With some of the mergers . . . there's so many of those folks who have been displaced or under-utilized." She added that many of these professionals are excited about working in the areas of robotics and sensing technology.

Another benefit of joining a small company might be a bigger salary. In the 2016 salary survey, reported salaries were often higher at companies with little revenue than at mid-sized companies. Professionals at companies with less than $10 million in annual sales reported a 14% higher median salary than those at companies with $10 million-$100 million in revenue and 9% higher than employees at companies with $100 million-$1 billion in revenue. Only at the largest companies, with revenue over $1 billion, did the median salary of $121,000 match that at the smallest firms.

That may seem confounding at first, but Rutledge speculated that it's a result of smaller companies "buying credibility" since they don't yet have the track record the biggest companies enjoy.

Other Hot Roles

Within traditional medical device companies, regulatory professionals still enjoy a hiring advantage.

"Regulatory obviously continues to be hot because there are not enough people being trained," Cole pointed out.

While quality assurance and quality control continues to be a good career path, Cole said job titles in this area are no longer the top priority for hiring, as was the case a couple of years ago. That's likely because FDA actions seem to be slowing down.

"Quality has tapered off," Cole said. "When FDA was going out throwing out warning letters and 483 letters, you saw a lot of these companies growing their quality departments by 40-50%." Now, "there's a demand in quality still, but it's not like it was two years ago."

As for disease areas, device companies focused on diabetes, cardiology, and neuromodulation continue to thrive and hire, according to Cole.

But not everyone enjoys a place in the sun. With consolidation and some companies shifting toward a rep-less business model, sales jobs may be tougher to come by.

"I think the sales reps should be concerned," Cole said. "I think you will see a smaller number of sales people every year."

Collins, who specializes in placing sales professionals, noted that sales salaries have remained stable but haven't increased, and there doesn't seem to be a lot of room for negotiation. Some sales reps working in medical supplies divisions at big organizations with overlapping call points are also experiencing streamlining.

"Those reps aren't having a ton of access with clinicians," she said. "I think it's turning into dealing with the value analysis committees and C-suite . . . versus a real clinical sale."

A small sample of sales and marketing professionals responded to MD+DI's 2016 salary survey. It's worth noting that while their average job satisfaction of 3.8 out of 5 was in line with some other titles, a higher proportion than other employees--almost one-quarter of respondents--reported they are actively looking for a new job.

Yet even within sales, there are areas of higher demand, including in the vascular arena and physical oncology, Collins said. Some parts of the United States--mainly the South, which has an aging population--are also seeing strong procedural volume, which has lead companies to hire more sales reps to handle the higher volume, she said.

Professionals in all positions working at traditional medical device companies with commoditized products may have more uncertain futures. Hiring seems to be especially slow within the spine industry, Cole said.

"Everyone is complaining about the me-too [products]," he said. "There's not a lot of innovation going on."

Other segments in which employees' fortunes may not be so favorable include orthopedics and diagnostics. Both the imaging diagnostics and patient diagnostics segments have seen salaries and job growth stagnate, Rutledge said.

Another area where the supply of talent may be outstripping demand is the executive suite, Cole said. "There's enough VP-level and CEO-level people out there actively looking," he said, adding that it's likely a result of consolidation and acquisitions in the industry.

The Fun Stuff

Tech's increasing focus on the healthcare space may be gradually ushering in unconventional perks for some employees.

Rutledge has seen some medtech companies--particularly startups--undertake a "Google-ization" of their office space, adopting "funky, cool" workspaces.

While still not the norm, some professionals participating in the 2016 salary survey reported unique benefits like flexible working hours, on-site fitness centers, and updated workplaces. One employee reported receiving every other Friday off, while a few others noted perks like onsite summer childcare, free or low-priced food, and additional vacation time.

While benefits overall haven't changed significantly in 2016 for most employees, Cole said some may be getting higher bonuses than in the past.

"Now bonuses are kind of coming back, and it's the norm again," he said.

Companies are rewarding employees with retention bonuses--a new phenomenon--and some professionals are reportedly receiving more than 100% of their bonus, Rutledge said.

"It's not every case, but I'm seeing a lot of cases where companies are putting their money where their mouth is with bonuses," she added. "Even some of the small companies [are paying] deferred bonuses" as a retention program.

In MD+DI's 2016 salary survey, more than two-thirds of full-time medtech professionals said they received a bonus in the past 12 months. The median bonus was $10,000, though many professionals reported bonuses many times that amount.

Device Tax Suspension

The device tax suspension that went into effect at the beginning of the year seems to have had a mixed impact on salaries. In a small survey conducted for the Medical Imaging and Technology Alliance earlier this year, more than two-thirds of executives said the tax suspension made them likely to hire more U.S.-based employees and more than three-quarters said they were likely to invest more in research and development. Executives at the biggest medtech companies also said publicly at the beginning of the year that they expected to increase investments in their businesses as a result of the suspension.

Calling the suspension a "tailwind" for some smaller companies, Rutledge explained that she has seen medtech companies start to reinvest in people and plant equipment as a result. Over the past several months, companies have started expanding and investing in manufacturing, she said, noting that this has in turn helped the secondary market in contract manufacturing.

Collins said she hasn't seen outright expansion but did note that companies have been backfilling sales positions this year. "They're more conservative on their expansion plans . . . I think they want to see what is going on," she said.

Cole hasn't observed a significant impact from the device tax suspension but did note a benefit to R&D. "I do believe if the tax were still there, it would probably slow down hiring," he said. "Most companies are spending that money trying to develop [their] product pipeline, so from an R&D perspective, I do think it was a big benefit."

Because it takes years for a medical device to reach commercialization, "it'll be a while before you need more marketing people or any others for those [products]," Cole said.

Stay Put or Look Around?

Overall job satisfaction is high in the medtech industry--an average of 3.9 out of 5, according to the 2016 survey.

"For the first time in a long time, I'm seeing fewer people actively looking [for a new job]," Cole said. "I think there were several years where everybody was out looking, and most of them have settled in and need to hang out, put some tenure in the company. They seem to be a lot more content."

In this year's survey, 12% of respondents said they are actively looking for a new job, down slightly from the 13% who reported doing so in 2015. Almost a third said they are strongly considering a new job search, about the same as last year.

But that contentment is not necessarily a boon for careers.

"The reality is, some of the CEOs and executives I talk to say the best time to look for new jobs is when they're at the top of their game," Cole said. "Look at sports [stars], look at Kevin Durant, look at all the NBA, NFL stars. When they have their best years, it's when they're out trying to market themselves better. I find a lot of mid- and lower-level [management] people don't have that mentality."

Still, younger medtech professionals continue to live up to millennial stereotypes, moving from job to job frequently, which isn't always a good thing. "More job stability to really anchor your success and your learning curve of the industry prior to making your next move" is a good idea, Collins advised.

Yet there may be a benefit to millennials' restlessness. Medtech startups that want to hire experienced medical device professionals don't want employees who have spent their entire careers at one place. In this case, loyalty isn't paying off.

"[Employers] don't want linear experience," Rutledge said. "CEOs will say . . . 'How can they help us accelerate our R&D if they've only seen it done [one] way?'"

Advice for Employers

In an employees' market, medtech companies can and should do a better job of attracting their ideal candidates.

"I think companies could do a lot better job onboarding . . . talking about what career paths look [like] for professionals," Cole said. "I think the companies either aren't recognizing or aren't willing to change or try to really take care of top talent well enough."

Some companies have been slow to offer higher salaries. "Those are the [companies] that aren't getting top talent," Cole added.

In general, salaries are being discussed earlier in the hiring conversation, and companies should thoroughly research what they need to be paying to attract top talent, Rutledge said.

"Employees, candidates . . . they know what they're worth," she pointed out.

Companies also need to work on retaining top talent.

"I think organizations need to learn how to keep their people engaged, too," Collins said.

Cole echoed that sentiment. "It's not about the money," he said. "I get people moving all the time for the opportunity and career growth path. That's really what it should come down to."