meds magazine

An RTC Group Publication A Supplement to RTC magazine

MEDICAL ELECTRONIC DEVICE SOLUTIONS


MEDS

MEDICAL ELECTRONIC DEVICE SOLUTIONSMEDICAL ELECTRONIC DEVICE SOLUTIONS

MEDICAL ELECTRONIC DEVICE SOLUTIONSMEDICAL ELECTRONIC DEVICE SOLUTIONS


UP FRONTSoftware And Connectivity: Two Holy Grails

FOCUSSmall Modules at the Heart of Powerful Portable Devices

PULSETools Help Build Safe and Certified Software

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September 2011 MEDS Magazine 3


MEDSSEPTEMBER 2011

CONTENTS

digital subscriptions availablewww.MEdSMag.COM

Medical Electronic Device Solutions (MEDS) uncovers

how embedded technology will bring the biggest breakthroughs in electronic medical devices design. Whether large or small—MEDS is the most influential source of information for engineers, design-ers and integrators developing the newest generation of complex and connected medical devices. MEDS is currently a supplement of RTC magazine distributed in print to 20,000 engineers, and electronically to 17,000 in the embedded com-puting market. Learn more about MEDS at www.medsmag.com.

SPONSORSacces I/O Products .................................34

advantech ..................................................15, 33

Express Manufacturing ..................25

green Hills Software ................................7

Innovative Integration ......................29

LeCroy ..........................................................................24

One Stop Systems ....................................2

RTECC ............................................................................31

Sterling Smartware Solutions ......23

TdI Power ..............................................................26

wdL Systems ................................................27

wind River ...............................................................9

PULSE123D Optical Surface Profilometry Provides Substantial Cost Reductions in Manufacturing Contact LensesAndrew Masters, Bruker-Nano Surfaces Division

16How the iPhone Is Enabling a Revolution in Connected Medical DevicesPeter Eggleston

22Clinicians-in-Training Explore the Human HeartAndrew Vandergrift, NVIDIA

28Persistent Publish/Subscribe Alleviates Development Pains in Medical DevicesJustin Moon, QNX Software Systems

UP FRONT5EDITORIALMedical Instruments Meet the Embedded Systems IndustryTom Williams

6PubLISHER’S LETTERFuture Trends of Medical ElectronicsJohn Koon

FOCUS8NEWS & PRODuCTSA Collection of What’s New, What’s Now and What’s Next

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Published by The RTC GroupCopyright 2011, The RTC Group. Printed in the United States. All rights reserved. All related graphics are trademarks of The RTC Group. All other brand and product names are the property of their holders.

To Contact RTC Group and MEDS magazine:

HOME OFFICE The RTC Group, 905 Calle Amanecer, Suite 250, San Clemente, CA 92673 Phone: (949) 226-2000 Fax: (949) 226-2050, www.rtcgroup.com

EDITORIAL OFFICE Tom Williams, Editor-in-Chief 245-M Mt. Hermon Rd., PMB#F, Scotts Valley, CA 95066 Phone: (831) 335-1509 Fax: (408) 904-7214

PRESIDENT John Reardon, [email protected]

PubLISHER John Koon, [email protected]

EDITORIALEDITOR-IN-CHIEF Tom Williams, [email protected]

MANAGING EDITOR Sandra Sillion, [email protected]

COPY EDITOR Rochelle Cohn

ART/PRODuCTIONART DIRECTOR Kirsten Wyatt, [email protected]

GRAPHIC DESIGNER Maream Milik, [email protected]

WEb DEVELOPER Hari Nayar, [email protected]

ADVERTISING/WEb ADVERTISINGVP OF MARKETING Aaron Foellmi, [email protected]

WESTERN REGIONAL ADVERTISING MANAGER Stacy Mannik, [email protected] (949) 226-2024

MIDWEST & INTERNATIONAL ADVERTISING MANAGER Mark Dunaway, [email protected] (949) 226-2023

EASTERN REGIONAL ADVERTISING MANAGER Shandi Ricciotti, [email protected] (949) 573-7660

bILLING Cindy Muir, [email protected] (949) 226-2021


MEDS

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UP FRONTEdITORIaL

TOM WILLIAMS Editor-in-Chief

Electronics and embedded computer intelligence are certainly not new to the medical device community. One need only think of MRI machines, PET scanners, monitors and the whole host of electronic equipment already in place. Still, there seems to be something new starting to take place and that is associated with the pace of develop-ment.

Coming as I do from editing a major trade publication in the OEM embedded systems industry to editing one in the medical device industry, one of the first things I have noticed is that the pace of new product introductions for the medical sector is significantly slower than for the OEM computer market, where new products are constantly flowing in from vendors.

Part of this may have to do with the fact that electronic medical devices are “end user” products in the sense that physicians and medical technicians are those users. However, I also suspect that a large part of the difference involves compliance and certification. This is a completely different world from the one in which companies produce OEM products for building machines for factory automation or transportation systems. And in that arena there is already a certain degree of frustra-tion among suppliers with how long it takes a chip or a board to finally be designed in, proven, and then start generating real revenue once a customer’s design goes into actual production. I can only imagine how that seems when addressing the designers of medical devices and systems.

The FDA is (hopefully) not going to relax its requirements when it comes to compliance for medical devices, even though they are small, mobile and low cost, when they are still vitally impor-tant to a patient’s health and life. It is the OEM supplier segment that is going to have to come to terms with this fact of life. It will take some cultural readjustment.

The embedded computer industry has long followed the PC industry and sometimes the enter-prise industry in terms of technology developments. As some technology like nonvolatile memory or USB or PCI Express became widely accepted in the PC industry, it would find its way into the embedded arena, sometimes with modifications. Then there are always upgrades to these basic technologies—the “dot-number” phenomenon. Then, of course, there is the software. Many em-bedded modules are built so that they can easily take software upgrades over a network and keep functioning. All this is naturally subject to FDA regulation as well. Having the ability to regulate it is another matter.

The fact is that a small handheld device of today may contain more code than an MRI machine of a decade ago. That code is constantly being enhanced and expanded; new processors are coming out to run it faster and more efficiently. A given device may have two or three upgrades available within a year. Reconciling this pace of change and the urge to have the latest technology available, with the compliance requirements of the FDA, is going to represent an ongoing challenge. This even extends to iPhone apps that work with a medical device, and since they do not actually reside in the device, regulating them is going to be even more of a challenge.

Medical Instruments Meet the Embedded Systems Industry

6 MEDS Magazine September 2011

UP FRONTPUBLISHER’S LETTER

Over the past twelve months, I have attended multiple conferences and panel discussions relating to Medical Electronic Devices. There are three recurring themes:1. Healthcare cost is getting out of control and is

growing faster than in other comparable indus-trial countries. What to do?

2. Mobile Apps and Wireless solutions are hot. What does it mean?3. Safety compliance including FDA 510(k) clearance remains a

very important part of the medical electronic device develop-ment cycle. Can we speed up the process?

Healthcare CostSome would suggest that the healthcare cost growth is a

ticking time bomb. In 2009, spending on healthcare in the U.S. reached $2.5 trillion and is expected to reach $2.7 trillion in 2011. Furthermore, the U.S. has the fastest growth rate in healthcare cost when compared to other industrial countries, and there is no slow-ing down. It was forecasted that there would be a shortage of doc-tors and affordable hospitals. Various healthcare-related consortia suggest using technology to help fight the increase.

One of the emerging trends is the use of remote healthcare to help patients and their caretakers connect, to cut down office visits and hospital stays to save money. (Many names are used to describe this: digital health, telehealth, eHealth etc.) While this is still in its infancy, many developers are offering remote home healthcare solutions. They include digital scale, blood pressure monitors connected via a network to deliver data to the caretakers. Others are offering new innovations to enable doctors to listen to a patient’s heart rhythm from afar as if they were in the same office. MEDS will continue to report on the development of new innovations that aim at cost cutting.

Mobile Apps and WirelessRecently I saw a presentation about the future of a medical elec-

tronic device used in healthcare. A patient was coughing into a cell phone and a doctor from afar was able to receive the digital data and provide the appropriate diagnosis. Science fiction or not, more and more discussions are focusing on how mobile apps can be used in the medical field. West Wireless Health Institute, a non-profit organization based in San Diego, CA, is a strong proponent of using wireless to solve healthcare problems. In addition to education, they also fund R&D in this area. Wireless WiGig Alliance, another non-profit consortium, supports using the 60 GHz wireless signals in rapid sharing of medical information between patients and doctors.

While we are all familiar with the iPad and Android applica-tions, the merging of consumer electronics and medical technologies

may yield some very interesting chal-lenges. How would the FDA regulate the mobile apps? The FDA recently published a draft guidance docu-ment on mobile apps regulation and is seeking public comments (see be-low). On the surface, using a familiar interface to manage medical devices seems to be logical. But if you stop and think, you will quickly discover that the end-to-end reliability is most critical. I recently watched a doctor demo an iPhone as a handheld re-mote EKG machine display. Who is responsible if there is a malpractice? Additionally, a smartphone design changes every 18 months, while a medical electronic device takes 5 to 10 years to develop and get FDA clearance before going to market. How do these two technologies work together? The mobile apps may have three updates while the medical electronic device is still going through its clinical trials.

In this issue of MEDS magazine, we have an article that talks about such applications. MEDS will also monitor closely how the FDA will regulate this area in the upcoming months. Another challenge in the mobile and wireless areas is end-to-end security, and it will be interesting to see whether the iPhone, iPad or An-droid will take the lead.

Safety Compliance (FDA 510(k) Clearance)A panel discussion concluded that because the mission of the

FDA is to protect the public safety, don’t expect the FDA agency to speed up the clearance process because the industry desires shorter time-to-market. Safety compliance is an important process whether it is with the FDA, IEC, UL or others. One thing may help. Seek assistance from experienced designers or safety consultants when de-signing mobile medical devices. With their experience of FDA clear-ance, chances are they will be able to help you avoid unnecessary delays due to missing forms, insufficient data or wrong data entry in the filing process. MEDS will continue to provide updates, compli-ance information and training to help you with your product devel-opment and, hopefully, speed up your product development cycle.

Stay tuned.

Reference: http://www.fda.gov/MedicalDevices/DeviceRegulationand Guidance/GuidanceDocuments/ucm263280.htm

JOHN KOON Publisher

Future Trends of Medical Electronics

For nearly 30 years the world’s leading medical companies have trusted Green Hills Software’s secure and reliable high performance software for life-critical and safety-critical applications.

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VRI Selects MedApps to Extend the Home Healthcare PlatformMedApps, a mobile/remote health monitoring company, was awarded a major contract with Valued Relationships, Inc. (VRI), a large

provider of in-home health monitoring solutions. VRI will utilize MedApps’ products and services to help extend its growing home health program to monitor clients with chronic disease. VRI has purchased 3,000 mobile remote health monitoring devices to deploy across the United States. The initial wave of products will utilize the MedApps HealthPAL, with future deployments to include the upcoming HealthAIR. Both devices operate on the MedApps CloudCare platform to provide a user-centric remote patient monitoring solution.

“We think VRI’s ability to monitor the daily vital signs of patients with conditions like diabetes, hypertension and congestive heart failure will be enhanced with the MedApps System,” said Kent Dicks, CEO and founder of MedApps. “Our CloudCare platform is de-signed to provide the ultimate in ease of installation, configuration and maintenance to take the focus off the technology and put it back on the patients and care providers. This is a perfect alignment with VRI’s goal of increasing patient awareness and empowering them to be more involved in their own care management and improve their health situation.”

Green Hills Software Joins Continua Health Alliance

Green Hills Software has joined the Continua Health Alliance, a non-profit, open industry coalition of more than 240 healthcare and technology companies col-laborating to improve the quality of per-sonal healthcare through the creation of a system of interoperable personal connected health solutions. As a Contributing Mem-ber, Green Hills’ experience and knowledge in developing high-assurance solutions for safety- and security-critical medical ap-plications will help the Alliance achieve its vision of establishing an ecosystem of interoperable personal connected health systems that empower individuals and or-ganizations to better manage their health and wellness.

Green Hills Software plans to work with its coalition partners to develop and define Continua technical guidelines for future connected health applications. In addition, Green Hills Software intends to participate in Continua’s Test and Certifi-cation Program to qualify its products and services under the Alliance. From a tech-nology perspective, Green Hills Software will both leverage and expand the Green Hills Platform for Medical Devices, com-prised of its Multi integrated development environment, Integrity and μ-velOSity real-time operating system technology, and associated middleware and services, to en-sure Continua-certified medical device in-teroperability.

IbM Study Identifies New Generation of Connected Health Devices

Consumers have a growing appetite for health and wellness devices, and this rep-resents a burgeoning market opportunity for device manufacturers that has barely been tapped, according to a study from IBM. Conducted by the IBM Institute for Business Value, the study indicates that the growing demand for devices is driven by “informa-tion seekers”—people who will increasingly turn to technology to help manage health-related challenges to reach their wellness goals.

Whether connected online, to a PC, gaming device, tablet or smartphone, well-ness devices will become ubiquitous in the future, especially in caring for the sick, the elderly and those in need of medical assistance, but also for healthier people who want to achieve wellness goals. IBM scientists and healthcare experts envision a number of new devices to help individuals with the following challenges:

Dieting—A new generation of devices for dieting will also measure movement, speed and intensity. These devices will engage users if they aren’t moving enough or provide a movement task to accomplish. These devices will be integrated into tools for monitoring medication adherence, blood pressure and weight for a more complete pic-ture of the user’s health.

Elder Care—In the U.S., an estimated 5.4 million people have Alzheimer’s disease. For patients suffering from memory loss or impairment, devices for establishing loca-tion and compliance with medication regimes, connected to a digital pill box, will be commonly used.

Blood monitoring—The advent of a non-invasive blood test to automatically analyze blood via a wrist band will wirelessly transmit data to the doctor. When cholesterol levels spike, iron levels drop or white blood cell counts increase, users will know when to modify their medications, or seek medical attention.

Independence and mobility—Devices to keep people ambulatory will increasingly be used to monitor movement. These devices will provide coaching and tasks to improve coordination, range of motion and stability. They will also determine if the user is walk-ing steadily, getting out of chairs easily, or if he or she needs assistance.

Communication—New devices that tap brain waves will make it easier for the med-ically fragile and impaired to express their thoughts and sensations via a digital avatar of the human body. With the help of sensors, even non-verbal patients will be able to express how they are responding to specific treatments or pain, precisely indicate sensa-tions in their body, or ask for medical attention.

Committed to saving hundreds of thousands of lives a year, the innovators at Varian refuse to think small. That’s why they chose Wind River to provide the operating environment for their leading-edge TrueBeam™ radiotherapy and radiosurgery system. Building upon the reliable performance of our VXWorks platform, the Varian team created a system that is literally redefi ning cancer treatment—one capable of performing accuracy checks once every 10 milliseconds, and continuously monitoring more than 100,000 distinct data points throughout the entire treatment process.

Because in the fi ght against cancer, no detail is too small. And no effort too great.

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Interventional Radiology Researchers Leveraging Imaging and IT to Deliver Minimally Invasive Procedures

Today, Siemens Healthcare has an-nounced that its syngo.via advanced visu-alization software will be exclusively used by researchers from the National Center for Image Guided Therapy (NCIGT) at Brigham and Women’s Hospital in Boston. Supported by the National Institutes of Health, NCIGT is a research group dedi-cated to advancing image guided interven-tional techniques with some of the newest diagnostic imaging tools from Siemens Healthcare coupled with interventional surgical systems.

Co-directed by two radiologists, Fer-enc A. Jolesz, MD, and Clare M. Tem-pany, MD, the NCIGT’s physicians and researchers plan to install Siemens syngo.via across all radiology workstations to provide advanced visualization function-ality. Physicians also plan to develop new image guided therapeutic approaches and to improve a number of already validated interventional procedures, including im-age guided therapy in open brain surgery, radiation treatment of prostate cancer and gynecological tumors, breast conserving therapy, MRI-guided cryoablation, treat-ment of atrial and ventricular fibrillation, and brain tumor laser ablation.

As they refine their techniques in clinical suites that provide access to highly integrated advanced imaging modalities, radiologists with the NCIGT are turning to syngo.via to automatically prepare im-ages and enable timely navigation through cases—in line with disease-specific require-ments, and to quickly access information anywhere, from almost any modality, and share it with colleagues and clinical part-ners. Brigham and Women’s Hospital is the 500th site, globally, to install syngo.via for advanced visualization.

250 Watt Medical Power Supply in a Low Profile 3” x 5” Package

The new PPWAM250 Series of AC/DC power supplies from Power Partners offer 250 watts of performance packed design, and the supplies are compliant to UL/cUL60601-1 and TUV 60601-1 medical safety standards. Units also bear the CE Mark and are RoHS

compliant. This low profile 250W Series is suitable for a variety of patient vicinity medical and dental applications.

The PPWAM250 Series accepts a 90-264 VAC uni-versal input. Single output models have regulated volt-

ages ranging from 12 VDC to 48 VDC with no mini-mum load. The compact 3” x 5” x 1.38” footprint (open

frame model) makes the PPWAM250 Series an ideal choice for designs with space constraints. Units provide up to 250W of power

with 17 CFM of forced air.The series boasts high efficiencies greater than 85%, leakage currents as low as 300μA

at 264 VAC. Comprehensive protection circuitry, including overvoltage and short circuit protection, is inherent in the design. EMC Performance meets FCC and EN55011 Level B standards, and units have an MTBF of 100,000 hours at full load. Units are priced with the PPWAM250 Series starting at $87.00 in OEM quantity, with delivery from stock to 14 weeks ARO. Power Partners, Hudson, MA. (978) 567-9601. [www.powerpartners-inc.com].

Thin Wafer-Level VGA Cameras Offer High Quality Features in a Very Small Form Factor

A VGA wafer-level camera integrates wafer-level optics assembled with CMOS im-age sensors. Specifically, the Exiguus H11-A1 camera from Nemotek Technologie offers a very thin form factor, featuring one tenth (1/10) of an inch. Suitable for various ap-plications, from PC tablets, laptops, handsets to even automotive solutions that demand innovation, the Exiguus H11-A1 delivers higher image quality and better resolution and leads the industry as the next gen-eration of miniaturized camera solutions.

Nemotek integrates sensors from different suppliers with its own custom glass lens optics and packaging design, and is able to deliver cameras to the market faster than its competitors without compromising quality. In addition, its ability to customize wafer-level solutions ensures each camera de-sign is specifically tailored to meet customer requirements for ultra-small and compact camera needs.

The Exiguus H11-A1 is reflowable, offers full functionality and uses one element or two surface lenses. Offering automatic and manual control functions, the camera features 640 x 480 pixel resolutions. In addition, the Exiguus utilizes the benefits of glass wafers instead of traditional plastic and can withstand the harshest environmental conditions, making it ideal for several existing and new applications requiring cutting-edge camera technology. Exiguus H11-A1 is a wafer-level camera solution that provides high-end features like color saturation and correction, edge enhancement and lens shad-ing correction. The Exiguus product line is meant to serve all markets and will soon include another camera specifically dedicated to medical applications. Nemotek Technologie, Sala Al Jadida, Morocco. +212 538 014 000. [www.nemotektechnologies.com].


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Compact CT System Offers Enhanced Diagnostic Ability at Optimized Dose

GE Healthcare has announced FDA clearance of Optima CT660—a powerful and compact Computed Tomography (CT) system offering improvements from its predecessors in di-agnostic capabilities at low dose levels, and designed for sustain-ability and ease-of-use. Powered by GE’s advanced CT technolo-gies and applications, this intelligent platform is scalable from 32 to 128 slices through purchasable options and enables fast, high-performance imaging for patients in a variety of clinical settings, including cardiac, neurological, emergency room and routine CT.

Based on customer demand and designed with GE’s HD technologies, the Optima CT660 helps healthcare professionals deliver con-fident, personalized patient care—combining GE’s proven dose-optimiz-ing Adaptive Statistical Iterative Reconstruction (ASiR+) tech-nology, improved workflow fea-tures, and advanced applications for cardiovascular, oncology, neurology, CT angiography and other fields.

Traditionally, lowering CT dose increases noise creating an undesirable trade-off between clear images, required in today’s clinical environment, and reduced x-ray dose. To overcome this conventional CT challenge and achieve As Low As Reasonably Achievable (ALARA) dose levels, Optima CT660 utilizes GE’s industry breakthrough reconstruction technology called ASiR+. ASiR+’s design may allow for reduced mA in the acquisition of diagnostic images, thereby reducing the required x-ray dose.GE Healthcare, [www.gehealthcare.com].

3D MEMS Technology: Small Size, High Quality and Low Power Sensors

Healthcare applications account for approximately 15% of the total value of the MEMS (Micro Electro Mechanical Systems) market, and it is expected that the figure will rise to 25% by the year 2015. Sensor technology in healthcare applications enables improved care and a better quality of life for patients. Sensors in-crease the intelligence of life supporting transplants, and they can be used in new types of patient monitoring applications that allow patients to lead more independent lives. Detecting signals triggered by symptoms helps optimize medication and prevent serious at-tacks of illness.

VTI Technologies’ solutions are based on the company’s pro-prietary 3D MEMS technology that enhances healthcare devices in many ways. For pacemakers, for example, accuracy, low power and reli-ability are the key parameters: more accurate ac-tivity monitoring means the patient’s heart rate can be adjusted to match precisely the needs of the patient. VTI’s MEMS de-sign, which combines single crystal silicon and glass, ensures reliability, unprecedented accuracy and excellent stability over time. The power requirements of these sen-sors are extremely low, which gives them a significant advantage in small battery-operated devices. VTI’s 3D MEMS technology en-ables ever smaller sensors and batteries to be designed, thus meet-ing the miniaturization requirements of manufacturers of implant-able devices.

Pacemakers are not the only healthcare application for VTI sensors. Based on the company’s long experience in pressure sens-ing technology, VTI is today well positioned to offer a wide range of pressure sensors for healthcare applications. Device developers and manufacturers of many existing and emerging healthcare ap-plications have been able to reach their power and size require-ments thanks to VTI pressure sensor dies.VTI Technologies, Vantaa, Finland. +353 9 879 181. [www.vtitechnologies.com].


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The global contact lens in-dustry is undergoing major changes as shifting market de-mographics help to drive new technological development of

contact lenses and interocular lenses (IOLs). New versions contain surface structures at the nanometer level and aspheric designs with spherical and cylindrical shapes in differing axes. These new structured lens designs are geometrically more complex and difficult to manufacture, resulting in a higher number of iterations and rework that drive up manufacturing costs.

Traditional measurement methods such as Fizeau interferometers and 2D sty-lus profilers do not provide sufficient ac-curacy or the comprehensive 3D measure-ments needed for the manufacture of these nanometer features that control the geom-

etry of the finished lenses to the required tolerance levels. A new generation of non-contact optical profilers provides complete 3D surface measurements to a higher level of accuracy at high speeds. A typical lens manufacturing plant that produces 100 pins per year can expect to save around $1 million per year by reducing the number of pin iterations and rework.

Contact Lens TrendsThe original focus in the contact lens

industry was on consumers under 25 years of age with near-sightedness that could be corrected with spherical lenses. However, the dynamics of an aging population have changed this, and today the fastest growing segment of the contact lens and intraocular lens market is in the 40+ age category. This change is being driven by two primary dis-

eases, namely presbyopia (a gradual hard-ening of the lens of the eye that limits the ability to focus to short distances) and cata-racts (a clouding of the optical lens in the eye). Since both cataracts and presbyopia are age-related conditions, they generally occur together in later life. People over the age of 55 who have traditionally worn con-tact lenses typically suffer from nearsight-edness as well as presbyopia so they typi-cally require bifocal contact lenses. People undergoing cataract surgery also typically will suffer from presbyopia and therefore will require bifocal intraocular lenses.

Bifocal lenses can be designed in sev-eral different ways. The predominant meth-odology today is to create lenses with alter-nating optical powers structured within a concentric circular pattern. Each concen-tric lens is structured for either distance or near vision and the eye looks through both distance and near powers at the same time. The eye selects the correct power choice based on the distance to the object the eye is focusing on thereby providing continu-ous near and far vision.

To further complicate matters, many older patients also need correction for astig-matism, where the ocular system needs one

by Andrew Masters, bruker-Nano Surfaces Division

As the design of contact lenses and interocular lenses has become more complex, more accurate 3D measurement technologies are needed to reliably produce the master forms needed for manufacturing.

3D Optical Surface Profilometry Provides Substantial Cost Reductions in Manufacturing Contact Lenses


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power of correction in one axis and another power of correction in another axis. Toric lenses that correct for astigmatism generally have two powers orthogonal to each other and the corrective lens must be held static to maintain the proper angular orientation be-tween the two powers. Two different meth-ods for maintaining angular stabilization are a double slab-off and a prism ballast, both of which use gravity and blinking forces of the eye to hold the lens in place.

Manufacturing ChallengesAs a result, the market is being driven

toward contact lenses and IOLs that contain both surface structures at the nanometer level and aspheric designs with spherical and cylindrical shapes in differing axes. Cast molding is the primary manufactur-ing method used for producing these more complex lens designs. This method utilizes front and back curve molds that typically are molded from a tool commonly referred to as a “master pin” that is machined using a diamond blade. This master pin contains the nanometer-level structures that must be accurately replicated on the lens. Different master pins are used to create the front and back curve molds. The front and back curve molds are assembled in mold inserts. A poly-mer is injected in the mold and thermally cured. The lenses are then hydrated where they absorb 20% to 70% water by mass.

The master pins wear out after pro-ducing a number of molds, so contact lens manufacturing plants often must build new ones. Before each master pin can be used to make production molds, it must be first be tested by building a trial mold that is used to produce a limited pilot run of lenses. The lenses are then tested to see if they provide the right prescription. In most cases the first batch of lenses does not pro-duce the right prescription, so the pin must be re-engineered and re-machined, new molds must be produced, and finally a new batch of lenses must be molded and tested. In a typical lens manufacturing plant, it can easily take two to six iterations of this process to produce lenses that meet the pre-scription. Even after the lenses pass the test,

problems later develop in many of the pins that require the pin to be re-worked an ad-ditional time.

One of the main reasons that it is nec-essary to produce so many iterations of the master pins is because there are limitations in the methods available to measure the lenses. For pins producing spherical lenses,

the current metrology solution is a Fizeau interferometer. Fizeau interferometers mea-sure the form and shape of the lens surface profile and compare the radius curvature to a fixed reference. One of the limitations of this approach is the need to produce a golden reference for each lens prescription. Another limitation is that Fizeau interfer-

Figure 1 3D optical profiling measurement of a bifocal contact lens showing form.

Figure 2 3D optical profiling form measurement of an interocular lens.


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ometers are laser-based, so they are limited to a maximum step height measurement of one-fourth of the laser wavelength or ap-proximately 160 nanometers. Structured lenses being manufactured today contain step heights greater than 160 nanometers, so Fizeau interferometers are not an appro-priate metrology solution for these lenses.

For aspherical and stepped surfaces, the current metrology solution is a 2D stylus device. In ophthalmic applications the stylus is generally scanned in one X and one Y direction to capture the asym-metric nature of the lens and measure the individual step heights of structured lenses. Stylus measurements are contact-based and are slow compared to non-contact optical methods. The operator also has to position the stylus device manually. If the operator does not correctly position the stylus to in-tersect the apex of the lens, inaccurate mea-surements will be obtained. For structured surfaces it is insufficient to measure one X and one Y position, so the entire lens may need to be mapped. However, the 2D stylus is too slow for this task and risks damaging the surface being measured. The diameter of the tip also limits the features that can be measured. For example, if the stylus tip is 5 microns in diameter it cannot measure features smaller than 5 microns.

Emerging 3D Measurement Methods

A newer, quantifiable and repeatable method involves the use of white light in-terferometry, also known as optical profil-ing, to accurately measure the complete

3D surface profile of the lens. In an optical profiler, light approaching the sample is split and directed partly at the sample and partly at a high-quality reference surface. The light reflected from these two surfaces is then re-combined. Where the sample is near focus, the light interacts to form a pattern of bright and dark lines that track the surface shape. The microscope is scanned vertically with respect to the surface so that each point of the test surface passes through focus. The location of the maximum contrast in the bright and dark lines indicates the best focus position for each pixel, and a full 3D surface map is generated. Figures 1 through 3 show examples of the 3D surface maps produced by white light interferometry.

An advantage of the optical profiler is that a complete 3D surface measurement provides a much more complete represen-tation of the lens surface than is produced via a 2D stylus. This can greatly reduce the need for additional iterations and rework. Optical profilers have no step height mea-surement limitations so they can measure all types of lenses. In the latest generation of instruments, the ContourGT family of white light interferometers (Bruker-Nano Surfaces Division), 64-bit software and multicore processing provide a faster and more intuitive software workflow while fa-cilitating a higher rate of data collection. A patented illumination source provides in-creased light throughput, speeding up mea-surement time while simultaneously provid-ing enhanced data collection (Figure 4).

The benefits of white light interfer-ometry were demonstrated in a recent ap-

plication at a major lens manufacturing facility. The plant produces 100+ master pins per year to produce 48 different de-signs ranging from +6.0 to +30.0 diopters in 0.5 diopter increments. Manufacturing costs vary depending upon manufactur-ing region; however, an average cost per iteration is in the order of $2,500, includ-ing fully loaded engineering and small batch manufacturing costs. Using 2D stylus metrology, the plant required four iterations for the average master pin and an additional 67 pins had to be reworked after being accepted for production. A to-tal of 667 iterations were on average re-quired to produce the 100 pins per year, for a total cost close to $1.7 million dol-lars per year.

Using white light interferometry, the number of iterations required before pro-duction acceptance was significantly re-duced as were the number of pins requir-ing rework after production acceptance. The benefits and savings associated with employing white light interferometry were such that the initial capital outlay for the tool is paid within a matter of months.

Bruker-NanoTucson, AZ.(520) 741-1044.[www.bruker-nano.com].

Figure 3 Optical profiling 3D characterization of a used interocular lens revealing wear at lens edge.

Figure 4 ContourGT-K1 Bench-Top 3D Optical Profiler.

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Cell phones are undoubtedly the most ubiquitous hand-held platform in the world, and have become attractive deployment platform can-

didates for medical devices. It’s no wonder then that software application developers as well as traditional medical device manufac-turers are recognizing the tremendous po-tential for smart phones as an alternative to custom embedded devices and custom user interfaces for their new medical devices. In addition, the use of these wireless devices is enabling a new level of medical device connectivity. And when it comes to smart phones and medicine, it seems that Apple’s iPhone is leading the revolution.

A recent survey by Manhattan Re-search “Taking the Pulse U.S. 11.0,” an an-nual report that examines how physicians are using technology, found that 75 percent of physicians in the United States have pur-chased an Apple mobile device and that the

iPhone was their favored smart phone plat-form. However, with the use of these mo-bile platforms comes unknown variables, not the least of which is FDA regulation. We surveyed a variety of manufacturers who have come to market with medical de-vices based on the iPhone, and asked them to share what made them choose this plat-form over other smart phone alternatives.

AirStrip Technologies, a medical software development company focused on mobility in healthcare, specializes in “space-shifting” real-time and historical medical data that is intended to be visual-ized. To allow them to rapidly develop and deploy native mobility applications, Air-Strip has built a custom technology plat-form, AppPoint, designed to take raw data from bedside medical monitoring devices and “airstrip” this data up to the Cloud, to be subsequently rendered on a native device such as an iPhone. The AppPoint platform and products deployed on it eliminate the

physical and geographical boundaries of medical information, getting data to peo-ple when and where they need it.

AirStrip’s initial application built on AppPoint was AirStrip OB, used for remote labor and delivery monitoring (Figure 1). Since a woman is often in labor for a period of time, the attending physician cannot be with her constantly to monitor her prog-ress. AirStrip saw the opportunity to em-ploy smart phones as a means to extend the presence of medical devices from patient bedside to wherever the physician might be. With OB, the physician can see exactly what the attending nurses are seeing at the patient bedside, even with the weakest of cell signals.

In bringing OB to market, AirStrip went through a process of getting their proprietary mobility platform and OB classified as a type II medical device. Bruce Brandes, an executive vice president and chief strategy officer for AirStrip, reports that although they were not instructed by the FDA to obtain clearance for their mo-bility platform and products, AirStrip chose to undergo certification anyway since their applications support remote, real-time di-agnostic capabilities for clinicians. Once they proved the concept, AirStrip started to build other applications on AppPoint such as AirStrip Cardiology for EKG man-agement, now on the market, and AirStrip Patient Monitoring, now in development.

by Peter Eggleston

For small, mobile medical devices, designers are discovering a ready-made user interface and connectivity technology in the Apple iPhone, which can run apps to present data from medical devices and deliver that data where needed.

How the iPhone Is Enabling a Revolution in Connected Medical Devices


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Brandes comments that “Each new applica-tion requires a new FDA clearance, but the fact that we build our products on the pre-viously certified AppPoint engine results in faster and easier preparation for clearance of these new products.”

While Airstrip focuses on creating products for physicians that interact with hospital-based medical devices, Withings is creating products for patients to use in their homes or on the go. In setting out

to build its medical products, Withings chose a phone for a platform, the iPhone in particular, as a way to use a familiar in-terface to interact with rich information. This essentially turns the iPhone into the user interface for a medical device such as Withings’ blood pressure cuff, which just received FDA clearance (Figure 2).

Cedric Hutchings, Withings’ founder and general manager, describes why they selected the iPhone as a deployment plat-form. “The iPhone sets a reference for sim-plicity to the user. Simplicity is the key and the most important point if a manufacturer wants a new device to be adopted by the consumer and to be used in the long term.” In fact, partnering with Apple in the ‘Made for iPhones (MFI)’ device program allows Withings to provide a very simple and consumer-friendly interface. “It couldn’t be simpler,” explains Hutchings. “The user simply plugs a monitoring device into the iPhone and automatically the right app is launched. All the user has to do is push start to begin the measurement.”

On the topic of whether the iPhone platform has advantages over other smart phones for the development and deploy-

ment of medical products, Hutchings noted that Apple is managing a program for de-vice compatibility and this enables certain “features” that are not in other platforms yet. “The iPhone is not as open a platform for third-party development (compared to other smart phone platforms), which is not always a good thing for product developers such as us. But the good thing is if a manu-facturer is compliant with this architecture and compliant with the iOS and device, you are provided with a more regulated and hence stable and predictable platform on which to develop and deploy your medi-cal device.”

Hutchings is convinced the iPhone in particular will enable a new generation of devices as it allows for the creation of “con-nected” rather than “connectable” devices. “You can create connectable devices, for instance where you take a regular blood pressure monitor and add connectivity like Bluetooth,” states Hutchings. “But with current technical constraints, this is not a very user friendly end to end solution and you end up having a more complex device than the non-connected version.” Hutch-ings goes on to say, “In this scenario the

Figure 1 AirStrip OB delivers vital patient waveform data—including fetal heartbeat and maternal contraction patterns—in virtual real time directly from the hospital labor and delivery unit to a medical professional’s mobile wireless device.

Figure 2 The Withings blood pressure monitor makes taking your blood pressure as easy and straightforward as making a phone call.


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user needs to pair the pressure cuff with a device, needs to have software on their device to talk to the cuff, and then needs to do something with the measured data, and so on. With a connected device, the app takes care of the user experience. Con-nectivity will enable a more simple experi-ence, and this will enable a revolution.” In support of this view, Hutchings offers that the Withings pressure cuff is not a piece of the hospital that sits at home. Rather it is consumer-centric, something that empow-ers consumers to be involved in their own health. And since both the Withings blood pressure cuff and scale are distributed in the Apple store, this selling of health de-vices by Apple demonstrates the breaking wave of consumer adoption of connectable health devices.

Large traditional medical device companies are also seeing opportunity in developing for iOS devices. Take An-don Health, for instance, one of top three blood pressure manufacturers in the world. Adam Lin, the SVP and general manager for iHealth, states iHealth was formed last year by Andon. As Lin recounts, “We looked at what Apple was doing in the iOS

space and we had a vision for a new class of iOS-based peripheral products. We then made a critical decision to form a new com-pany to develop and market these devices, and our first product is the BP3 blood pres-sure monitor.” Lin goes on to state that the iHealth products are also currently being offered to customers in the Apple Stores, and will be expanding to big box stores in the fourth quarter of this year as well.

When explaining why iHealth chose to create a product based on the Apple iOS as opposed to another device, Lin explains “we felt that with iOS’s strong penetration and growth rate, the maturity and sophisti-cation of the app development process, and Apple’s commitment to develop the app accessory space, it was the right decision.” Lin also went on to offer that he thinks the real power and functionality of connected medical devices will be in the application and will result in better integration. “Ap-plications have to be intuitive and not add another layer,” states Lin. “It is the integra-tion, not the form factor that will be the limiting and driving factor in bringing data monitoring devices from the hospital into the home.”

FotoFinder Systems GmbH is a maker of digital imaging products, and recently released a unique device that docks with an iPhone to turn it into a handheld digital dermatoscope for performing skin exami-nations (Figure 3). Valeska Heinrich, mar-keting manager for FotoFinder explains why they decided to create a product based on the iPhone. “Dermatology imaging sys-tems exist but these are too expensive in rural areas and most parts of the world. However, with smart phones, doctors have handheld devices that can take pictures, so we decided to take advantage of that to create a digital connected dermatoscope.” When asked why they decided to create a medical product based on the iPhone and

Figure 3 Slip your iPhone into FotoFinder’s handyscope and instantly have a digital dermatoscope for mobile skin examinations.

Figure 4 Mobile MIM is a remote diagnostic imaging tool specifically designed for use by medical professionals for remote viewing of medical imagery.

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not another smart phone platform, Hein-rich reported that they felt the iPhone had the best camera on the market, so they de-cided to convert it into a dermatology cam-era. She also adds that Apple offers quality standards for its applications unmatched by other manufacturers. “Android is wide open and there are numerous different de-vices based on this OS. This would require us to develop, test and support a new optic interface for each unique device. Also, the iPhone is popular and widespread among doctors!”

MIM Software, a provider of medi-cal imaging software, recently received a 510(k) clearance for its iPhone-based Mo-bile MIM, an application for the remote diagnostic viewing of CT, PET, MRI and SPECT images. To protect against in-stances where Mobile MIM is installed and run on a new iPhone model that has not been tested, Mark Cain, the CTO of MIM Software, states that their applica-tion includes registration that communi-cates with their servers, and that this com-munication includes the device model. “Our servers will send a message back to the device if it isn’t one that we have fully verified as capable of performing accord-ing to our app’s intended use. A message will be presented to the user with instruc-tions that it is not to be used for diagnosis until the model has been verified. In this way, when Apple releases new hardware, the user is told if we haven’t tested it yet.” Cain points out that manufacturers rarely get new Apple hardware sooner than con-sumers do, so they can only begin testing when it hits the market. After testing is complete, the registered users will be noti-fied of the results, positive or negative. In the same way that MIM verifies the new hardware models, they also verify iOS up-grades. “When the upgrade happens, if we haven’t yet verified the OS, the registered user will be notified that the verification is pending. Should an OS update cause the app to not perform properly, we can notify the user of the problem,” states Cain.

When asked why MIM is developing for the iPhone as opposed to other smart phone platforms, Cain reports, “The pro-cess of getting 510(k) clearance can take some time. The consistency afforded by Apple hardware really helps here, espe-cially if the medical device specifically

involves the characteristics of the hard-ware. In our case, image display for di-agnosis is inextricably tied to the quality of the display. Having a smaller variety of models, a consistent manufacturing process, and a device life cycle that is long, we can start a 510(k) process and end it using the same devices. Compare this with Android where the number of devices on the market changes monthly; you can understand the difficulty associ-ated with quality assurance.”

In considering connected medical de-vices, it is interesting to think about some advice offered by Rick Hampton, wire-less communications manager at Partners Healthcare, who is cautious on how the FDA is approaching medical products based on handheld platforms such as the iPhone and other smart phones. “The top thing for folks to understand is that the FDA has long regulated software associated with medical devices,” Hampton states. “Until recently, this software was embedded in and a component of a medical device. As medical devices became smarter and more of a generic computing platform, the soft-ware itself has become a medical device.

“With the FDA broadening its regu-latory scope for software as a stand-alone medical device, companies really need to look at the medical device regulations to find out if their software product will meet the description and perform any functions of a medical device as defined by the FDA. Compared to developing hardware, devel-oping software can seem much easier and most people do not believe that something so easy to do can result in a medical device. The last thing you want is to find out your product is going to be regulated as a medi-cal device after it gets into the market.” In fact, Hampton recounts that he meets a lot of developers who believe medical devices must be highly sophisticated machines like CT scanners and used only in hospitals. This is absolutely false. Indeed, compa-nies looking to jump onto the smart phone healthcare revolution could become medi-cal device manufacturers and not even be aware of it!

AirStrip TechnologiesSan Antonio, TX.(210) 805-0444.[www.airstriptech.com].

FotoFinder SystemsBirnbach, Germany.+49 8563 97720-0.[www.handyscope.net].

iHealthMountain View, CA.(855) 816-7705.[www.ihealth99.com].

MIM SoftwareCleveland, OH.(866) 421-2536.[www.mimsoftware.com].

Partners HealthcareBoston, MA.(617) 278-1000.[www.partners.org].

WithingsParis, France.+33 6 11293028.[www.withings.com].


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In 2006, three clinicians at University College London Hospitals (UCLH) Heart Hospital, Drs. Sue Wright, An-drew Smith and Bruce Martin got to-gether to share their frustration about

the lack of a realistic model of the human heart that could be used to teach cardiac anatomy. They came up with the idea of creating a virtual heart, and quickly real-ized that if it were based on an anatomical 3D data set, such a model could be used to generate a simulated ultrasound image. The idea had significant implications for train-ing, as it could also be used to simulate the experience of transesophageal echocardiog-raphy (TOE or TEE), an examination dif-ficult to practice, as it relies on inserting an internal probe to capture images of a pa-tient’s beating heart.

When these clinicians shared their idea with a team of creative artists at a UK animation/visual effects company called Glassworks, things began to take shape. The goals were to create an anatomically accurate, computer-generated heart model that could instantly produce an authentic ultrasound representation, be animated to beat in real time to show changes in the heart’s shape during the cardiac cycle, and enable the doctor to view slices of the scene to gain valuable diagnostic insights.

Glassworks Develops the Virtual Heart Model

The clinicians and Glassworks named the project HeartWorks and relied on the

high-performance computing and visual-ization power of Nvidia Quadro profes-sional graphics solutions in the develop-ment and use of this first-of-its-kind clini-cal training tool.

Nvidia has a stated committment to supporting technology innovation in medi-cal imaging and life sciences. Its technology enables medical device providers to develop and commercialize solutions that meet the

high-performance computing (HPC) and demanding visualization requirements of the healthcare community. Through its in-volvement in recent years there have been some marvelous advancements and some unusual partnerships come together to de-liver those innovations. HeartWorks is a prime example.

A small team of artists and developers at Glassworks began collating a vast set of digital heart images, including attending open-heart surgery to experience the hu-man heart beating live. Wright, Smith and Martin worked with leading surgeons, car-diac morphologists, ultrasonographers and other experts to consult with Glassworks as

by Andrew Vandergrift, NVIDIA

UCLH Heart Hospital teams with Glassworks to create the HeartWorks real motion heart modeling system.

Clinicians-in-Training Explore the Human Heart

Figure 1 This module allows real-time simulated TTE imaging of the virtual heart us-ing a life size manikin torso. The torso has soft skin with accurate, palpable anatomical landmarks to aid positioning of the handheld ultrasound probe. The screen display allows the user to identify the position of the probe on the virtual chest as well as to see the orientation of the ultrasound plane.

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the system began to develop.To create the complex realistic heart model and real-time

animations, the Glassworks artists and animators used animation software running on workstations equipped with Nvidia Quadro graphics processing units (GPUs). These professional graphics so-lutions provided the processing power necessary to render high-quality images at 30 frames per second—keeping the animations realistic and smooth.

“Immersive technology, where users can interact with 3D images on a screen, has been limited historically by the state of graphic technology, and by budgets,” said Hector McLeod, founder of Glassworks. “Nvidia’s breakthrough with their mas-sively parallel GPU technology has changed that. What the Nvidia GPU does within HeartWorks is load and display extremely com-plicated models, and render them at 30 frames a second, in a series of events that are themselves complex. In any given frame we’re tapping the GPU to examine the model, slice it, annotate the views and display the two visualizations—the model and the ultrasound—in less than 1/30 of a second.”

Glassworks software engineer David Llewellen added, “Nvidia Quadro easily handles the sheer quantity of data we’re pushing through it. The model has a high polygon count—250,000—and we’re generating two simulations, plus we have a whole system of anatomic labels. To get the model to look graphically superior we also have highly detailed textures, the majority using OpenGL and running the GL Shader Language. We need all of that process-ing power at once to make sure HeartWorks delivers a real-time experience.”

Glassworks and the UCLH Heart Hospital clinicians com-mercialized HeartWorks through Inventive Medical Ltd. in London, which integrates, installs and supports the system for hospitals, labs and universities. When it is delivered to clients, the HeartWorks product is a turnkey system that includes the HeartWorks software—the interactive, virtual heart model and the ultrasound simulation program; a high-performance work-station equipped with an Nvidia Quadro professional graphics card; a monitor/keyboard/mouse; and a probe and torso man-nequin to enable a hands-on experience for teaching the TOE/TEE procedure (Figure 1).

HeartWorks in Action at Duke universityOne of HeartWorks’ early adopters was Duke University, spe-

cifically, the Department of Anesthesiology, Division of Cardio-thoracic Anesthesia and Critical Care Medicine. The Department bought the simulator early in 2009 to teach residents and fellows in their advanced Transesophagael Echocardiography program. First, second and third year residents use it primarily to learn basic echocardiographic views and anatomy, and fellows in the advanced program utilize it to examine more subtle features.

“Simulation technology has enabled us to take a quantum leap forward in our teaching,” said Dr. Madhav Swaminathan,

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MD, FASE, FAHA, of Duke University School of Medicine’s Division of Car-diothoracic Anesthesia. “This particular system essentially simulates the beating heart clearly. To explain how an ultra-sound image is formed and how it corre-lates to anatomical features is extremely difficult. When you’re changing the image plane with a probe it’s hard to understand

what parts of the heart you are seeing on the screen—because the heart is three di-mensional, and you’re using 3D on a 180 degree plane. A simulator makes it pos-sible to see side by side not only how an ultrasound image is generated, but what the cuts mean in a controlled, relaxed en-vironment where you don’t have to worry about interfering with a patient’s clinical

care or taking too much time. This virtual environment technology gives residents a jump start.”

Dr. Swaminathan further explained that the primary advantage of the simu-lation technology is the real-time inter-action residents and fellows experience. “When you can see the heart beating and modify aspects of it, cut it, and manipu-late it at will versus being forced to do it the way a teacher wants is a significant breakthrough in echo education.” (Fig-ure 2) For a look at the stunning photo-real, animated beating-heart model, visit www.heartworks.me.uk.

Following its success with the TOE/TEE application simulator, the UCLH Heart Hospital/Glassworks team began developing another HeartWorks device, a TTE, which simulates the experience of an external ultrasound examination. It utilizes the same virtual heart model as the original HeartWorks application, but the interac-tion via probe generates a slice plane that goes through the lungs and ribs, which are also visualized.

In the development of the new TTE application, Glassworks is investigating further leveraging Nvidia’s Quadro GPU technology by writing shader tools in the Nvidia Compute Unified Device Architec-ture (CUDA) programming language to give them an additional performance boost. “We’d love to make further optimizations that make things run even faster, and look even better,” said Glassworks’ Llewellyn.

Figure 2 Wireframe representation of the heart model. The model can also be viewed in slices or as a solid, 3D beating model.

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“We will make full use of whatever devel-opments Nvidia brings along next.”

What’s Next?It’s those “next developments” that

are always being designed for at Nvidia; to anticipate challenges and deliver solu-tions that clinicians and device manufac-turers can apply to meet those challenges in new ways. Nvidia CUDA program-ming language enables dramatic increases in computing performance by harnessing the power of the GPU. The latest gen-erations of the Quadro and Tesla GPUs, based on the Nvidia Fermi architecture, for workstation and server side applica-tions, are designed to deliver performance that greatly accelerates any medical pro-fessional’s workflow with the potential to help improve patient outcomes.

Specifically, Nvidia GPUs and GPU computing with CUDA have the ability to not only perform compute-intensive image reconstruction for generating high-resolu-tion and complex 3D images, but also the ability to process the image data for real-time clinical enhancements, annotations and even computer-aided diagnosis. We be-lieve features like these are critical to the im-provement of patient outcomes. HeartWorks streamlines the training process of preparing physicians and technicians to become profi-cient in reading and responding to the new paradigm of interactive medical imaging.

Today’s medical device vendors are offering solutions that acquire, compute, render, display and store larger amounts of information than ever before. This trend will continue well into the future. Positron Emission Tomography (PET), 4D ultra-sound, 3D advanced applications and Hy-brid Imaging, the combination of modali-ties like CT and PET, are but a few of the examples of innovation that have changed the way clinical exams are or will be per-formed. Mobility is also a reality for today’s healthcare professional. Information and applications no longer reside within the imaging department. The proliferation of various handheld devices along with web-based applications allow for the accessing of information from any location.

Keeping all of this in mind, the overall objective is to improve diagnostic accuracy

that in turn helps improve patient outcomes without sacrificing efficiency—which is an absolute requirement given the demands on our healthcare system today.

GlassworksLondon, UK.+44 (0)207 434 1182.[www.glassworks.co.uk].

HeartworksLondon, UK.+44 (0) 203 447 9360.[www.heartworks.me.uk].

NVIDIASanta Clara, CA.(408) 486-2000.[www.nvidia.com].

Untitled-1 1 5/11/11 10:27:16 AM

www.wdlsystems.com


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when determining how best to add software intel-ligence to their products, medi-

cal device designers need to look beyond current requirements. Demands for human machine interfaces (HMIs), wireless net-working, data storage and other capabilities are evolving quickly, and designers need to create flexible systems that can accom-modate new technologies and components with minimal development effort or impact on the original design.

Choosing the right messaging model for a medical device can mean the differ-ence between an efficient and flexible sys-tem developed and certified on schedule and under budget, and an inefficient and brittle system with all its attendant de-velopment pains. The persistent publish/subscribe (PPS) messaging model offers many advantages over other messaging models, especially in devices with many disparate components and technologies (Figure 1).

Two other more commonly used mes-saging systems—asynchronous and syn-chronous messaging—can present chal-lenges to the design of complex systems.

Asynchronous messaging (Figure 2) is well known and widely implemented. It is the solution of choice for many systems, but it pushes the burden of error handling, end-to-end semantics and buffer manage-ment up to the application level.

As a result, architects designing a system that uses asynchronous messag-ing must develop a messaging protocol or protocols to ensure the correct behavior of messaging across all applications, as they must also ensure that these applications have sufficient memory allocated for mes-sage buffers under high-load conditions. While these design tasks may require no great effort in simple systems, they can pose daunting challenges when designing or upgrading complex systems.

Synchronous, or send/receive/reply, messaging (Figure 3) is less common than asynchronous messaging. It is of particular value for real-time environ-

ments, where many processes require responses to their messages before they can proceed.

Synchronous messaging may not be the optimal choice for complex systems that must easily integrate disparate appli-cations. Synchronous messaging closely couples sender and receiver. Every server communicates directly with its clients and must know how to respond to all cli-ent messages, so a change to one software component may require changes to other software components.

Persistent Publish/Subscribe

Publish/subscribe messaging has been around for a long time. In 1987 K. P. Bir-man and T. A. Joseph described a similar messaging model—virtual synchrony. Twenty years ago Nortel Networks imple-mented a model for fault monitoring on telephone switches, and today a quick In-ternet search provides many examples of publish/subscribe implementations. Persis-tent publish/subscribe builds upon these models by offering data persistence across reboots and can support applications that must integrate many devices and compo-nents, and a sophisticated HMI.

PPS is an object-based service with publishers and subscribers in a loosely coupled messaging architecture. Any PPS client can be a publisher, a subscriber, or

by Justin Moon, QNX Software Systems

PPS messaging can ease the integration of diverse components and technologies in a medical device while maintaining a consistent user interface.

Persistent Publish/Subscribe Alleviates Development Pains in Medical Devices

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both. Publishers modify objects and their attributes, and write them to a file system. When a publisher changes an object, the PPS service informs all clients subscribed to that object. Clients can subscribe to multiple objects, and objects can have multiple publishers and subscribers. Thus, multiple publishers can use the same ob-ject and its attributes to communicate in-formation to all the clients that have sub-scribed to that object.

PPS clients must know which PPS ob-jects are of interest. If they publish, they need to know what to publish and when; if they subscribe, they need to know to which objects they must subscribe, and which object attributes interest them. However, PPS clients do not have to man-age errors, and the only buffers that con-cern them are those they need for open(), read() and write() POSIX API calls. Be-cause PPS subscribers use read() calls to

retrieve data, they do not need to manage buffers for these objects. They only need to decide if they want their reads to be blocking or non-blocking, and to confirm that they can parse what they read. The PPS service handles the rest.

PersistenceA PPS service maintains data across re-

boots. It keeps its objects in memory while it is running, but saves them to persistent storage, either on demand or at shutdown. It restores its objects on startup, either im-mediately or on first access. Of course, the persistent storage depends on a reliable file system and storage media.

PPS messaging can also simplify sys-tem startups. For example, in a system that uses a conventional messaging model, if a client starts up after the server, this client must request new data from the server in case something changed between the time

the server started up and the time the cli-ent started up. This requirement is also true if a client loses contact with a server, and for every client on the system. With PPS, however, the publish and subscribe service restores its objects on startup and main-tains them as they change. Any client—no matter when it starts or reconnects—needs only to read these objects to acquire cur-rent data.

With PPS, the publisher and the sub-scriber do not know each other; their only connection is an object that has a meaning and purpose for them. This model gives designers great flexibility when creating a system. They can, if necessary, delay de-cisions on module connection points and data flow until runtime. Developers can adapt the connection points as they build the system, or even set them to change dynamically as the system runs, because these points are neither hardcoded nor di-rectly linked.

PPS messaging also simplifies the integration of new components. Since the publisher and the subscriber do not need to know each other, developers add-ing components need only to determine what the new components should pub-lish, and what data these components need other PPS clients to publish. They could add, for instance, ECG or EEG components to a medical device aggrega-tor without having to fine-tune the APIs and without increasing system complex-ity (Figure 4).

Proof of ConceptAs part of the medical device program

at QNX Software Systems, we designed and built a proof of concept to run on the limited computing resources available to a portable medical device. This application brings together a typical set of devices us-ing a Continua-based interoperability man-ager, PPS, and a sophisticated HMI built with the cross-platform application and user interface framework Qt (pronounced “cute”).

We chose Qt for the user interface and the Continua Enabling Software Library (CESL) from the Continua Alliance for the interoperability manager because both of these technologies are widely known in the medical device industry. Qt offers a well-defined set of UI widgets in a C++ develop-ment environment, and has a long history

Figure 1 This medical device proof of concept aggregates and displays data from a blood pressure monitor, spirometer, pulse oximeter, ECG and insulin pump. These components connect to a Continua interoperability manager and use PPS messaging to communicate with a Qt HMI. PPS also pro-vides messaging to a remote manager for secure Internet communication to a cloud-based database and a portable tablet.

Process 1

Asynchronous messages

Asynchronous messages

Process 2

Process 3

Figure 2 With asynchronous messaging, a process sends its message and contin-ues, picking up the reply when and if it arrives.

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of successful implementations on devices that have received FDA and other required certifications.

Qt offered all the elements needed to build clear, effective screens that support exacting design requirements, including layout, layering and multimedia support. Similarly, the communication protocols in the Continua library offered not only a simple method for communicating with

disparate medical devices, but also stan-dardized protocols with a history of suc-cessful deployment in medical devices.

Simplified ArchitectureA PPS service can be designed to

use either binary or human-readable ob-jects. Binary objects are very small, but human-readable objects are preferable in all but the most constrained environ-

ments. They allow developers to debug from the command-line using standard file system utilities, such as cat for sub-scribe and echo for publish, or to create a simple program that subscribes to an ob-ject and prints out debugging informa-tion, including a list of PPS objects and their attributes.

PPS messaging provides the applica-tion with a flexible architecture. Very little work would be required, for instance, to replace the Continua library with another library, or to replace Qt with another HMI technology. Similarly, changing the HMI technology would require no changes to the interoperability manager or to the remote manager, just as changing these managers would require no changes to the HMI.

PPS messaging also facilitates the ad-dition of new devices, which can be con-nected to the system using standard Conti-nua protocols over USB, Bluetooth, or even TCP. For example, we could add an EEG to the proof of concept simply by using Con-tinua protocols to connect it to the interop-erability manager, creating appropriate PPS objects for communication and adding the relevant displays and controls to the HMI. Further, PPS messaging simplifies testing and functional safety validation, because adding new components does not require revising and re-validating the messaging between all other components.

Finally, PPS simplifies re-branding, localization and user interface updates. Because the HMI communicates with the rest of the system through PPS objects, de-signers do not have to change a line of code below the HMI. They only need to ensure that a new HMI subscribes and publishes to the same PPS objects as the previous HMI. Product lines can be built with ex-actly the same underlying system, but with different features enabled or with different HMI designs for example, to accommodate different alphabets and writing systems.

QNX Software SystemsOttawa, Ont.(613) 591-0931.[www.qnx.com].

Continua AllianceBeaverton, OR.(503) 619-0867.[www.continuaalliance.org].

Process 1

Synchronous messages

Synchronous messages

Wait for reply

Process 2

Process 3

Figure 3 With synchronous messaging, a process blocks until it receives a reply from the intended receiving process.

Database

Internet

Data aggregatorQt HMI

Remote manager

PPS objects

USB/Bluetooth

USB/Bluetooth

CESL

Pulse oximeter

ECG

Blood pressure

TCP

Spirometry

Simulated agent

Interoperability ManagerVendor-Continua

Figure 4 System components that communicate through PPS do not need to know each other, so system designers can add new measuring devices or change the HMI without revisiting the entire system.

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