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Four Tips for Success in Complex Development Projects

Managing the development of a complex medical device to ensure the right product is delivered on schedule and within budget is a tough task involving the need to balance hundreds of variables. The team at Stratos Product Development recently completed a “lessons learned” exercise for a multi-year, multi-million-dollar project. They learned several valuable lessons from this effort that can apply to any project.

  1. Ensure more time is allotted for communication as your team size grows.

    Skilled engineers are great at estimating the amount of effort it will take to complete their tasks. However, it’s easy for them to overlook the amount of time they’ll be spending interacting with the rest of the team, especially as the team grows. As project technical leads become responsible for more individuals, they must allocate more and more of their time for managing their team members – as well as interaction with other disciplines working on the projects – and less for direct project deliverables. Help your project leads delegate their technical tasks as their teams grow so they will have time to be the effective leaders the team needs.
     

  1. Make time for face-to-face meetings.
    In today’s product development world just about every project has team members that are contributing remotely. While teleconferences and video calls make this an effective way to work, there is no substitution for meeting in person. There are details that are lost when information needs to be communicated within the 30- to 60-minute confines of a meeting. Make the investment to fly the remote team members to your office once every one to two months so the whole team has the opportunity to work together in person. You’ll be amazed by the progress that is made and the loose ends that are tied up when team members have a day to sync up face-to-face.
     

  2. Let your development partners communicate directly.
    It frequently makes sense to outsource project responsibilities to specialized organizations and individuals. It’s tempting to position yourself as the conduit for information between your partners. This might seem to make it easy to stay informed about all discussions and decisions. The reality is that when you work this way you are playing telephone. You hired these groups because they have specialized skills that are outside your core competency. Putting yourself in the role of middleman creates inefficiency as any communication must be synced up with your schedule. Instead, give your partners direct access to one another but insist to be cc’ed on any emails and given a summary of important discussions—they will work much more efficiently together, and you’ll be the winner in the long run as your teams of experts collaborate and complete your project on time.
     

  3. Increase estimates for tasks to be completed by newly-hired team members.
    If you need to hire additional team members to staff your project, make sure that you allocate extra time for those tasks that are to be completed by those individuals. New employees can take a significant amount of time to ramp up, especially if the project is a complex one. Don’t get blindsided by a schedule slip because your new hires don’t perform at the same level as your experienced team.

Do you have other important product development lessons to share? Please post them in a comment and share your experience!

Malinda Elien is a project manager at Stratos Product Development. She has 14 years of experience in product development, project management and mechanical engineering. Elien previously worked for Microscan Systems designing optical scanning systems for medical environments. She has a SB and SM in Aeronautics and Astronautics from the Massachusetts Institute of Technology. She can be reached at melien@stratos.com.

Qualcomm Life to Make 2net Hub and Platform Available in Europe

Qualcomm Life, a subsidiary of global semiconductor company Qualcomm Technologies, announced that its wireless healthcare services will be available in Europe. The subsidiary's flagship product, the 2net Platform and Hub, will allow healthcare providers and medical device manufacturers to link their systems through a cloud-based solution. This will help healthcare providers monitor patient biometrics and other information quickly and easily. Qualcomm Life's 2net Platform and Hub has received Class I certification in Europe. In addition, the system has received Medical Device Data System (MDDS) approval from the United States Food and Drug Administration. The system uses secure end-to-end encryption and is designed to work with a variety of existing service platforms. The 2net Hub is designed to work as one of four potential gateways to the 2net Platform. In addition, the 2net Hub is a plug-and-play Class I Medical Device based on EU directive 93/42/EEC (MDD). In prepared remarks, general manager and VP of Qualcomm Life stated, "We have a number of customers in Europe and the U.S. who want to extend their mobile health solutions in multiple regions around the world, and they need to provide a reliable service that is not impacted by geographic boundaries." He continued, "Launching our wirelessly enabled healthcare ecosystem into Europe is another step toward the realization of our vision -- a world with access to healthcare anytime and anywhere." References www.qualcomm.com/media/releases/2012/11/11/qualcomm-life-launches-its-wireless-health-solution-europe-first-customers

How Will Genetic Sequencing Technology Play Globally?

Image from Flickr: http://www.flickr.com/photos/95135261@N00/116028995/sizes/s/in/photostream/Noninvasive prenatal testing is "an unbelievable test case" for how genetic sequencing technology can influence human healthcare, said John Stuelpnagel, DVM, executive chairman of Ariosa Diagnostics (San Jose) and co-founder of Illumina (San Diego) at a panel discussion held on November 8 in San Francisco. Over the course of the next 10 years, sequencing technology will likely be used for a quickly growing number of healthcare applications, Stuelpnagel predicted. As the technology gets faster and less expensive, new markets for sequencing technology open up. "It will probably start with very serious illnesses [such as those] associated with early childhood disease and cancer where these people are very sick and they have exhausted a lot of their diagnostic testing options," he said. "It will influence their healthcare very quickly" and profoundly alter the course of human health testing.

Genetic sequencing technology is advancing so quickly, that it is outstripping even Moore's Law. To get a sense of the scale, consider that sequencing the first human genome cost roughly $3 billion. That amount is roughly the cost of sending up the Mars Rover, explained Gregory Heath, PhD, senior vice president and general manager, diagnostics at Illumina. "Imagine if in about 10 years you could send up a Mars lander for about $10,000," he said. "People would be doing that in their backyard." The costs of genetic sequencing have fallen by an order of magnitude in the past decade, he pointed out. Just last year, Illumina began offering human whole-genome sequencing services at $4,000 for projects of 50 samples or more.

A picture of the panel discussion, in which the panelists (shown on the right-hand side of the table) asked questions from journalists. Picture from @HarmonyPrenatal

Other panelists at the event included Jay Shendure, PhD of the University of Washington; and Mary Norton, MD, professor of obstetrics and gynecology at Stanford University. The panel was moderated by Ken Song, MD, CEO of Ariosa Diagnostics.

Genetic sequencing ultimately is poised to become a pervasive technology like PCR with a broad scope of applications. Heath divided the applications of genetic sequencing technology into four broad groups: detecting genetic disease--reproductive genetics in particular; cancer; infectious disease; and transplantation.  

"Cancer is probably the sweet spot where you have got great alignment of performance characteristics around the technology to the parameters of the disease," Heath added. "There are a lot of commonalities between cancer and prenatal testing."

The technology has recently become sufficiently fast and cheap that it could be soon used for infectious disease applications. "Certain things like fungal infections are very difficult to culture and you can sequence through them," he explained.

"A transplant decision from a donor for an organ is made within 24 hours. For bone marrow, it has got to be a little bit cheaper," he said. "You've got more time to match people up but you still need to be relatively inexpensive."

Ultimately, genetic sequencing could become similar to blood testing in terms of how common it is. "If sequencing cost five dollars, every time you go into the hospital, you are going to get sequenced," Heath said. "You might even use it at home to see if, say, this milk is still good," he joked.

In the shorter term, there could be surge in the applications for the technology in reproductive genetics. Related to that point, Illumina recently acquired UK-based Blue Gnome, a firm that plays in the in vitro fertilization space. "One of the applications of what they do is pre-implantation genetic screening. They are actually testing embryos before implantation," Heath said. The testing could be used to determine which embryos are best suited for implantation and which should be discarded because they would likely result in a miscarriage.

Where Does Sequencing Technology End Up?

In terms of scaling globally, currently the vast majority of all of the clinically relevant tests operate through a CLIA laboratory. They are centralized laboratories that have to be validated, Ken Song, MD pointed out. So the question becomes: how close does sequencing need to be to patients?

"My own belief is that the application tells us where it should be done," Stuelpnagel said. "The applications for infectious disease and preimplantation genetics require very quick turnaround and probably have a rationale for very near patient testing. For other things like whole genome testing for cancer diagnostics of [...] and non-invasive prenatal testing--a turnaround time of three to seven days makes no clinical difference and so the economies of scale and the ability to reduce cost are greater drivers towards centralization."

Another consideration is sample prep--"the upfront part of getting a tube of blood and getting into a condition that you can pipette onto a sequencer," Heath said. "That part is still pretty labor intensive." Another factor is the relative scarcity of medical technologists, which is increasing the need for automated prepping.

The other consideration is the interpretation of the massive amounts of data generated through sequencing. "Again, we don't have enough bioinformatics experts out there. If I was in college, I would try to major in that," he added. "We are going to have cheap sequencing. We are going to have relatively inexpensive and quick sample prep but [the lack of bioinformatics] is going to burden," he predicted.

Acknowledging these hurdles, the global uptake of genetic sequencing technology will likely be rapid, Heath predicted. "The rate genomics technology is adopted clinically could be helped by automation technology and the broader tech field. Companies like Illumina are essentially taking biological information and digitizing it, Heath said. "And there are a lot of people who know how to deal with digital information."

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

Laserdyne 430 Flexible Laser-Machining Platform

A manufacturer of multiaxis laser machining systems builds a flexible laser machining platform designed for a wide range of high-precision applications. The Laserdyne 430 is a three-axis system capable of expansion to 5-axis that is designed for precision cutting, welding, and drilling 2- and 3-D components. It operates at speeds up to 800 in./min in the X, Y, Z axis (0–20 m/min) with bidirectional accuracy of 0.0005 in. (12.7 micrometer). This accuracy is throughout the system’s 585 x 408 x 508-mm work envelope, making it ideal for the demanding process validation requirements and reliability concerns of the medical device and precision instrumentation industries.
 
Champlin, MN
 

MarSurf LD 130 and 260 Surface Measurement Instruments by Mahr Federal

A company offers systems for combined surface and contour measurement that feature travel lengths of 130 mm and 260 mm, respectively. The MarSurf LD 130 and 260 have maximum travel speeds of 200 mm/sec and measuring speeds up to 10 mm/sec to keep cycle times short. The company’s metrology systems also feature a biomimetic probe arm with magnetic mounting, which has been redesigned to place the tip in a position that improves the probe’s accessibility and thus expands the range of measuring applications. Other system enhancements include measuring program–specific automatic probe recognition, the introduction of dynamic measuring force for greater flexibility, and a reduced residual noise signal, resulting in a roughness error of no more than 20 nm Rz. A lighter-weight probe offering the same rigidity as before allows the probe to exhibit high dynamic response for optimized tracking of critical part surfaces, such as those associated with knee and hip implants.
Providence, RI
 

Precision Inc. High-Current Inductors

A designer and manufacturer of custom and standard magnetic components and assemblies for medical device applications has launched four new technologies within the company’s family of high-current inductors. Available in four standard sizes as well as in a variety of custom formats, the new high-current inductors feature a flat-wire, ferritecore construction that generates both real estate and cost savings while reducing power losses. The new high-current inductors can be used as a standard part drop-in replacement or as part of a custom technology design. These inductors also work with power management integrated circuits (ICs) made by major IC manufacturers such as International Rectifier, Microchip, and Texas Instruments. The technology can be integrated into key power conversion applications for medical devices. The high-density construction of the high-current inductors features a flat-wire, edge-wound copper coil that generates efficiency gains and space savings compared with alternative round-wire or Litz wire technologies.

Minneapolis
 

Proteus Digital Health Wants to Create a Real Healthcare System

Andrew Thompson, cofounder and CEO of Proteus Digital Health, has an issue with our current healthcare system: It doesn’t exist. At least, it doesn't exist in terms of meeting the health needs of the 21st century.

“We have a brilliant ‘sick care’ system that was built in the 20th century to deal with the issues that were dominate in that time, which were mainly acute,” Thompson says. “We now stand at the beginning of a new century with a new set of problems, and they’re mainly chronic. And what we need is a new healthcare system.”
 

The Ingestible Event Marker (shown in pill form) communicates with a bubble patch worn on the body that can in turn send information to a smartphone or other device.

What Thompson is talking about is a system that puts patient care in the hands of patients, allowing patients to actively work with their doctors and better manage their own well-being. The system for doing so would function on three imperatives. First, it would have to utilize the Internet. “Not plugging into the mobile Internet today is like saying you could run a hospital in the 20th century without electricity,” Thompson says. “The system also has to focus on delivering products that are relevant to the largest group of healthcare workers. . . and that’s not doctors and nurses. That’s you and me, because most healthcare work isn’t done in professional settings; it’s done in community settings by informal [caregivers], who typically outnumber professional [caregivers] by 10 to one.” Finally, medicines have to do their job. “Many medicines in the supply chain are fake, and even when they are real and reliable, as in the United States, they are frequently misused,” Thompson says. “We have this tremendous asset being developed at an enormous cost that, in the real world, doesn’t deliver as much as it could.”

For Proteus, the product that aims to meet all the attributes of the 21st century is a medicine that is also digital product. It combines pharmaceuticals with a platform that can deliver information and also educate and motivate patients to take care of their own health. In short, Proteus thinks of drugs the way Apple thinks of songs, as digital content.

Proteus Digital Health made headlines in July, when its Ingestible Event Marker (IEM) received FDA approval. The IEM is a sensor, about the size of a grain of sand, that when swallowed is capable of relaying information to an external sensor attached to the skin. As part of Proteus’s planned end-to-end personal health management system, the IEM has potential in a variety of healthcare applications—so much so that it has earned both awe and skepticism. But not many medical technologies can boast a satirical shout out on The Colbert Report. “Because nothing is more reassuring to a schizophrenic than a corporation inserting sensors into your body that beam information to all those people watching your every move,” host Stephen Colbert joked of the IEM’s potential for helping the mentally ill.

Minding The Gap
Although certainly mocking, Colbert’s jab is also indicative of the sort of forward-thinking behavior that has driven Proteus from its inception. Thompson and his cofounder George Savage met while attending Stanford University. They formed a partnership, working as entrepreneurs in the medical device industry for 23 years in Silicon Valley. Savage, who serves as chief medical officer, says the two of them where particularly fascinated by microelectromechanical systems (MEMS) technology and how the small electronic sensors could be used for medical applications. It was through this  exploration that they met their third cofounder, Mark J. Zdeblick, the current chief technology officer, whose background in MEMS would fill in the final piece of the puzzle.

Andrew Thompson George Savage

The idea for Proteus’s flagship digital health system emerged quite literally from making observations. “The ideas for digital drugs came from making fairly simple observations about the extent to which computing, and information, and customization were affecting the medical device industry but had yet to make any headway into the pharmaceutical industry, at least from a physician or consumer perspective,” Thompson says. Walking the floor of the American Heart Association Scientific Sessions trade show in 2003, Thompson was struck by how sophisticated medical devices were becoming.

“If you walked around the trade shows for medical products, you tended to notice a trend among the medical device companies for their implants, with more software and computers. More and more of the selling effort is aimed at customizing therapy for particular patients, recording their response to therapy, and sending that to therapists,” Savage says.

Yet Thompson observed the pharmaceutical industry had none of this. There was a gap, one with a lot of ramifications for the global health industry. It wasn’t long before Thompson was on the phone with Savage, brainstorming an idea for designing a product to function in this space. “Andy’s challenge to me, which I remember quite clearly, was, ‘Isn’t there something we could do with the kind of sensing technology we’re developing to do for ingestible drugs (which are 85–90% of all therapy) what the rest of the medical device industry is doing for implantable therapy?’” Savage recalls. After suspending his disbelief, Savage posited that such a product would have to be both incredibly safe and incredibly inexpensive. “And that means we’d use what we believe is a parts list of things that were in your diet anyway,” Savage says.

The Battery is You
Proteus’ engineering team was given the challenge to build a computing system out of the ingredients you’d find in a multivitamin. The result—the IEM—is an ingestible sensor composed of a tiny piece of silicon (with a surface area of about 1 mm2) and sand-particle-sized traces of copper and magnesium, both being minerals most of people ingest daily in their diet.
The sensor works on the same principle as the potato or lemon batteries seen at middle school science fairs—generating power using an electrochemical reaction. The sensor is an 800 × 300-µm silicon wafer with a tiny circuit with a bit of magnesium on one side and copper on the other. When swallowed, the device gets wet, powers up, and the chip becomes a battery. The circuitry on the board then begins to modulate the current. “The concept was first explored for implantable medical devices and indeed ingestible medical devices back in the 1960s," Savage explains. "A pH-sensing capsule that was first marketed in 1969 that’s still sold today operates on the same principle using zinc and silver." Modulating that current creates a voltage fluctuation on the skin, which is recorded by an external sensor. The IEM doesn’t communicate via medical body area network or wireless. It’s not a radio or miniature antenna—it’s a power source made of the ingestible chip and you, the patient. “We aren’t the innovators in terms of coming up with the idea; we are in terms of miniaturizing it to the scale that we have and making it practical to include in dose forms,” Savage says.


A World of Digital Health
Although Proteus is excited by the recent FDA approval, Thompson stresses that the IEM is only the first step on an ambitious path. Once complete the system will offer options for patient care and monitoring and also for drug safety and delivery. By implementing the sensor directly into pharmaceuticals, for example, caregivers can remotely monitor how much and often a patient takes a drug. And, on the supply chain, chips with serial numbers can help ensure integrity down to the individual pill—a particularly valuable asset in the developing world, where a significant number of pharmaceuticals sold are counterfeit or fake.

But before all this, the next step is beginning the regulatory process for the rest of Proteus’s personal health management system. Thompson says Proteus doesn’t see this as an obstacle or challenge, merely the requirement of doing respectable business in uncharted waters. “New ideas are always things that are relatively challenging, Typically you have to displace something that is already out there.”

Proteus is proposing not only a new type of product, but a whole new way of doing things. Global medical expenditures are poised to triple over the next decade, as more people in the developing world gain access to affordable healthcare. At the same time, in the developed world there is a related challenge in that healthcare expenses are rising and an increasing number of patients are dealing with chronic disease over acute. “We have to improve the productivity equation,” Savage says. “Not just give more people access to health insurance and care. The challenges we face are common to any start-up when you’re trying to change the standard of care. The competition is the existing way of doing things.”

Thompson agrees. "Digital medicine is around where digital commerce was in say 1997 or ‘98," he says. "Everyone can see it’s coming. There’s lots of noise, lots of new things out there, but no one is quite sure what it’s going to look like. Some people are excited about it, some people are nervous about it, some people are dismissive."

"Three to five years from now there will be an ecosystem of between three and 10 companies that are significant players in this new digital health world. Some of them will be established players who have adapted and some will be very new companies that have built very large business.”

Thompson operates on the principle that perhaps the most important thing that can be done in U.S. and European healthcare in particular is to figure out how to deliver health services for less money. “It’s the beginning, not the end of the journey," he says "We now have some permissions to begin what we think will be a very important mission over the next several decades, but over the next few years there will be big changes." 

Digital platforms have fundamentally changed nearly every major industry. They've given us computer-augmented cars. They've taken us from vinyl records to downloadable MP3s. They've put movie theaters in our living rooms. And they've taken us out of malls and put every consumer good just a mouse click away. Isn’t it time they did the same thing for healthcare?


- Chris Wiltz is assistant editor of MD+DI.

AirStrip’s Push to Mobilize Medical Data

AirStrip Technologies (San Antonio) is a pioneer in the field of mobile patient monitoring. The company’s first product, AirStrip OB debuted in 2006, giving obstetricians access to live remote monitoring of expectant mothers on their mobile devices. It was the first FDA-cleared medical application to be included in Apple’s App Store.

The AirStrip platform was the first FDA-cleared product to be included in Apple's App Store.

Following that, the company rolled out patient monitoring and cardiology platforms. At present, the company’s technology is now in use in more than 400 hospitals across the world. 

Citing the technology’s capabilities in maternal fetal monitoring, cardiology, and patient monitoring, Leslie Saxon, MD, a professor of clinical medicine at the USC Keck School of Medicine, says that “AirStrip has developed software products that are really meaningful that solve major problems.”

Building on that point, Daniel Kraft, MD, chair of the medicine track at Singularity University and executive director of FutureMed, says, “As medicine and healthcare become increasingly digital, mobile, and connected, platforms like the one AirStrip has pioneered can generate critical actionable information, leading to better outcomes at lower costs and higher convenience.” Kraft points out that the platform enables physicians to obtain relevant information in real time and access dashboards that can filter and intelligently present data to the clinician.

The ability to beam patient data wirelessly to physicians isn't only convenient; it also helps address a key problem: the shortage of caregivers. The United States alone is projected to have nearly 63,000 fewer doctors than it needs by 2015, based on estimates from the Association of American Medical Colleges.

The Dawn of the Virtual Physician

Alan Portela, AirStrip Technologies' CEO 

A study released late in 2011 by CompTIA found that more than half of physicians use a smartphone for work purposes and that number is expected to steadily rise. In 2012, physician mobile use increased by 45%, according to a Bulletin Healthcare study. “Physicians are becoming mobile professionals, and you need to create the concept of a virtual physician,” says Alan Portela, CEO of AirStrip Technologies.

“You need to look at their entire workflow and figure out how to mobilize all of the components that physicians need in order to support their workflow.”

Recently, the firm has shifted its focus from solely developing healthcare apps to an enterprise-wide solution suite. “We figured out that if we want to really support the workflow of physicians and bring disruptive innovation to the industry, we need to mobilize the two most important clinical data sources: medical devices and EMR/EHRs," Portela says.

To add electronic medical record (EMR)-mobilizing capabilities to its suite of  HIPAA-compliant products, the company acquired a mobile EMR extender developed by Palomar Healthcare (Escondido, CA). “They developed the same thing that we did for mobile medical devices for EMR,” Portela says. “They created an agnostic native mobile EMR extender that has the ability to connect to Cerner, Meditech, McKesson, and other EMR systems and provide a single consolidated view of the EMR data." Airstrip acquired intellectual property for the technology and plans to integrate both the mobile EMR extender and mobile medical device access capability before the end of 2012. 

Portola is also looking for third-party vendors to capture images. "We want to be able to mobilize DICOM images so you have medical devices, EMRs, and medical images as part of a single, fully integrated solution.” The EMR systems will use military-grade encryption technology.

Cutting Costs and Improving Quality of Care

The technology can help improve quality in critical care, cardiology, and obstetrics by quickly alerting remote clinicians when there is a problem. Consider, for instance, how the technology can help a patient who has suffered a heart attack.

AirStrip's platform enables clinical data to be viewed on the iPad, iPhone, and a variety of other mobile platforms. 

“Say we are dealing with a ST-segment-elevation myocardial infarction (STEMI)—a complete blockage of the artery,” Portela says. “What happens today is that many of those patients basically get picked up by the ambulance and the event to balloon time is somewhere between 90 and 120 minutes. That is the national standard door-to-balloon time, from the emergency department to the cath lab.”

By contrast, the following scenario is made possible by AirStrip’s technology: A patient has a heart attack and about 15 minutes later, an ambulance that uses AirStrip’s technology arrives. A paramedic immediately takes an EKG, which is sent within seconds to the cardiologist at a hospital and the emergency department. Alternately, the EKG could be sent to a call center for preliminary diagnosis of the patient’s problem and determine which hospital in the vicinity is best equipped to handle it. “Already you are triaging and figuring out which place you are supposed to go, based on the patient’s condition,” Portela says. “This is done by a specialist that is either on call at the hospital’s emergency department or at a call center.” In the end, the patient gets to the cath lab in about 35 minutes.

AirStrip has also observed that the recovery time for such patients is faster. “For patients with a STEMI, we started seeing a decrease in the length of stay in the ICU by 0.85 days—almost a full day,” Portela says. “When our statisticians found out about this, they came to us and they said, ‘Why do you think this is happening?' It is very simple: For these patients, there is less time for the heart to be damaged. If you have a complete blockage to the heart, if you clear that artery in 35 minutes instead of two hours, there is going to be less damage to the heart.”

While activating the cath lab can be life-saving for many patients, a false cath lab activation is expensive, costing roughly $7500. “Somebody will have to pay for that, and believe me, it is not the payer,” Portela says. Because AirStrip technology can help diagnose problems before the patient arrives at the hospital, it can drastically reduce false cath lab activations. 

Returning to the case of patients who have suffered a STEMI, following treatment in the cath lab, they will typically spend a few days in the ICU. Then, a patient is sent to a step down area, and a doctor on staff will sign off when a patient is ready to go home. “What happens today is that approximately 7% of those patients who are going home had some dysrhythmia that was not detected by the doctors,” Portela says. “For those people, the odds are that they will come back to the hospital less than 30 days after discharge.” This is a concern for hospitals, which, as a result of healthcare reform, will be financially penalized for such readmissions.

AirStrip technology can address this problem by improving the cardiologists' ability to diagnose problematic EKGs while patients are in the step-down unit following the ICU. “Keep in mind that cardiologists are mobile professionals, and they typically don’t spend much time in the step-down area,” Portela says. “They can, however, analyze those patients’ EKGs on an iPad or a smartphone. Immediately, they can detect that there is a dysrhythmia. At that point, they will order additional studies to see what is happening. They will also look at previous EKGs and [determine] whether this was a condition that existed before or is it something that happened after the heart attack.” If a cardiologist doesn't respond to critical EKG data after a chosen interval, the system sends the data to another cardiologist. 

To get a better understanding of how the technology affects clinical outcomes, Scripps Health chief academic officer Eric Topol, MD, is planning to lead a clinical trial of the company’s technology. The study, which is still in the planning stages, will be conducted at a large hospital chain over 12 hospitals in Texas. “We are going to be using randomized physicians and intensive care units to see whether continual monitoring to a physician's tablet or phone promotes better outcomes for patients in the ICU,” Topol says.

Intellectual Property Considerations

In August 2012, AirStrip Technologies received U.S. patent protection for technology used to transmit physiologic data natively to mobile devices (U.S. Patent No. 8,255,238). In October, the company filed a suit against mVisum (Camden, NJ), alleging that the patent had been infringed.

AirStrip’s president and CMO, Cameron Powell, MD, was quoted in MobiHealthNews as saying that the patent covers “taking any type of physiologic data—whether that’s from a sensor in the shoe, a home monitor, a blood pressure cuff, or a monitor in the hospital—and then re-rendering it on a native . . . application on a mobile device.”

“[AirStrip’s software] architecture is based on a centralized collection device within the hospital, then transmission of the information to mobile users,” says Bill Betten, medical technology director at UBM TechInsights and a member of MD+DI’s editorial advisory board. “The patent claims information associated with obstetric information, specifically contraction rates and fetal heart rates, as well as limited physiological parameters such as heart rate
and respiration rate.”

The patent could prove to be valuable. The global market for remote monitoring services exceeded $29 billion in 2011, according to IMS Research. Unsurprisingly, a growing number of companies are interested in entering the field. AirStrip’s patent, however, covers transmitting native diagnostic-quality data and appending notes to it, Portela says, while Citrix-based approaches accomplish neither of those objectives.

Speaking broadly of the company’s patent strategy, Portela says AirStrip wants to preserve the quality of care for mobile technology. “We are witnessing the beginning of the whole mobile mHealth industry,” he says. “The last thing we want is for vendors to take shortcuts.”

A mockup showing a patient dashboard from AirStrip Technologies.

Looking to the Future

“We have had a hospital-centric approach to healthcare for the last 20 years,” Portela says, adding that the approach is gradually changing to a patient-centric approach. Ultimately, preacute care will become a greater focus and with it will come more home monitoring.

There are 133 million people in the United States suffering from at least one chronic disease. The cost of addressing chronic diseases is projected to grow, from $1.3 trillion in 2007 to $4.2 trillion dollars by 2023, based on a study from the Milken Institute.

Remote monitoring technology could be used to address this problem. Payers could create a new reimbursement framework that enables healthcare organizations to hire mobile-enabled case managers. “The impact that we can have in healthcare and the economy in the nation is huge. We are about to start the biggest [healthcare] transformation ever,” Portela says.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

This Week in Devices [11/9/2012]; Boston Scientific to Acquire Vessex Vascular; Turning the iPhone into an ECG; A Pacemaker Powered by Your Heartbeat

This Week in Devices [11/9/2012]

It's all about the heart this week: Boston Scientific is set to purchase renal denervation device maker Vessex Vascular. A company has created an iPhone app to record ECG. Engineers develop a pacemaker that can be powered by a heartbeat.
 
 
Boston Scientific to Purchase Vessex Vascular
Boston Scientific is entering the high blood pressure treatment market with a a reported $425 million purchase of Vessex Vascular, a manufacturer of renal denervation systems. The company had been developing similar devices on its own but says it will now shift resources over to Vessex. Though renal denervation systems are used in Europe, none have been FDA approved for use in the U.S. This aquisition by Boston Scientific could be seen as a move directly at competitor Medtronic, who is expected to have an renal denervation device approved by 2014. [Wall Street Journal]
 
 
An iPhone ECG
A company, AliveCor, has created an attachment and app for the iPhone 4 and 4S that allows users to quickly and easily get an ECG reading of their heart and even send the information to their healthcare provider. The device has not yet received FDA approval but industry leaders like Dr. Eric Topol have trumpeted devices like this as a good step in preliminary testing and providing faster, more efficient healthcare. [Wired]

 
A Heart-Powered Pacemaker
Aerospace engineers from the University of Michigan in Ann Arbor have developed a prototype pacemaker that can be powered by the very heart it is treating. The device used piezoelectricity to convert motion into electricity – meaning the device can be powered by a patient's heartbeat. The new technology could be a big step in overcoming the cost and inconvenience of battery-powered pacemakers, which need to be removed every 5-7 years as their batteries die. [Medical News Today]
 

Researchers Create Body-Powered Electronic Implant

A close-up of a chip, equipped with a radio transmitter, that is powered by a natural battery found in the mammalian ear. (Image by Patrick P. Mercier)
Managing a power source for a medical implant has been a daunting challenge for many healthcare researchers and scientists. However, new technology from the Massachusetts Eye and Ear Infirmary (Boston) and the Division of Health Sciences and Technology at Harvard-MIT (Cambridge) may change that.

Scientists at the shared research center created a specialized microchip that is powered by the body's natural chemistry. While the microchip is only able to generate a very small current, the device generated enough current to power a small radio transmitter.

The microchip works by exploiting concentration gradients of potassium and sodium ions in the ear. When an ear is functioning properly, it converts mechanical sound vibrations into an electrochemical signal. This signal can then be sent directly to the brain. One important part of the ear is the cochlea. In the cochlea is a membrane that pumps sodium and potassium ions to create a gradient.

This imbalance of ions creates an electrical voltage that can be exploited by small electronic implants. According to researchers, this voltage is the highest that can be found anywhere in the body. However, this voltage is still extremely low.

To avoid hearing loss, researchers could only exploit a small amount of this electrical current. By creating a small radio transmitter that sent signals every few minutes, researchers were able to power the device without causing negative changes in hearing. To date, the technology has been successfully tested in guinea pigs.

For more information on this technology, visit the MIT News.