LEAD STORIES

Cutting Through The Remote Patient Monitoring Hype

There is so much hype surrounding remote patient monitoring (RPM) — and related buzzterms like wearables, mobile apps, big data, the Internet of Things (IoT), and mHealth — that sometimes it is difficult to separate hyperbole from reality. What opportunities does RPM really afford medical device makers? What should they do to take advantage? How do wearables fit into the equation? Should the medtech industry fear or embrace the involvement of tech titans like Google and Apple? Read on for answers to these and other important RPM-related questions.

INDUSTRY PERSPECTIVES

  • Addressing Cybersecurity Vulnerabilities As Medicine Goes Mobile
    Addressing Cybersecurity Vulnerabilities As Medicine Goes Mobile

    Is your phone compromising the security of your heath data? The mobile health, or mHealth, field is exploding with a host of new Internet-connected apps and devices. With that growth comes new concerns around data security and device safety. By Scott Sheaf, senior software engineer, Battelle

  • Why Data Connectivity To Traditional IT Systems And EHRs Should Be A Priority In Your Device Designs
    Why Data Connectivity To Traditional IT Systems And EHRs Should Be A Priority In Your Device Designs

    According to a recent PriceWaterhouseCoopers report, a major area that’s lacking in medical devices is electronic health records (EHRs), health IT, and patient data connectivity. Only about 18% of device companies integrate data into clinical workflows and EHRs, which means there’s a very nice opportunity for upstarts and savvy incumbents. Any manufacturer that focuses on device integration and data connectivity from devices into traditional health IT systems like EHRs and billing systems will have a unique offering that customers will elevate during their product selection process.

  • U.S. Orthopedic Trauma Device Market To Exceed $8 Billion By 2020
    U.S. Orthopedic Trauma Device Market To Exceed $8 Billion By 2020

    The U.S. orthopedic trauma device market consists of a variety of devices used in the treatment of fractures throughout the body. The largest of such device segments in 2013 was the plate and screw market, which will continue to remain the dominant market segment going forward.  The intramedullary nail and intramedullary hip screw markets are also expected to experience high levels of growth in the same time frame. These three markets composed nearly 64% of the overall U.S. orthopedic trauma device market in 2013 and, as such, will be the main contributors to the overall market growth in the forecast period through 2020.

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ARTICLES

  • Best Practices For Interventional Cardiovascular Medical Device Trials
    Best Practices For Interventional Cardiovascular Medical Device Trials

    Companies seeking to bring implantable cardiovascular products to market, whether they are stents, valves, pacemakers, ventricular assist devices, or other novel technologies, face several significant factors in designing and conducting clinical trials. This paper addresses the four aspects of implantable cardiovascular device clinical trials that Novella Clinical considers most critical: regulatory requirements, reimbursement strategy, clinical challenges, and vendor selection.

Design Verification Testing: The FDA Cares, You Should Too

Design Verification failures are costly, and these costs may be paid not just by development budget and schedule, but may result in rejection of submissions, warning letters, recalls, loss of market share, or in the worse cases, patient harm. Design Verification is one of the most commonly cited sections in recent warning letters issued by the FDA that include findings related to specific sections of the Design Control regulation (21 CFR 820.30).

Medical Device Development: Thinking Globally, Acting Locally

Incorporating international and emerging markets at an early stage of product development is critical for long-term success in getting to market, but also in bringing costs down by getting started smart. Understanding market opportunities from a regulatory, reimbursement, and healthcare delivery perspective, as well as understanding market fluctuations, is the first step in planning a global strategy.

Managing Change Control To Comply With FDA And EU Regulations

When properly implemented, change control is a potent force for improving the efficiency and effectiveness of a quality system. Many organisations find change control management to be a major problem because of the extensive documentation it generates, and the difficulty of managing the large number of interrelated elements and departments that are often involved.

RF Design And Safety Of MRI Systems

Electromagnetic simulation software has become an indispensable tool in the development and analysis of magnetic resonance imaging (MRI) systems. Motivated by better image resolution, improved signal to noise ratio (SNR) and reduced scan times, the trend to design systems that operate at higher static (B0) field strengths comes with new challenges. The increase in static field strength implies a proportional increase in the B1 field frequency. As the wavelength becomes comparable to the electrical size of the patient and the MRI geometry, it becomes more difficult to achieve a homogeneous field distribution that is required for good image quality.

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FROM THE EDITOR

  • Cutting Through The Remote Patient Monitoring Hype
    Cutting Through The Remote Patient Monitoring Hype

    There is so much hype surrounding remote patient monitoring (RPM) — and related buzzterms like wearables, mobile apps, big data, the Internet of Things (IoT), and mHealth — that sometimes it is difficult to separate hyperbole from reality. What opportunities does RPM really afford medical device makers? What should they do to take advantage? How do wearables fit into the equation? Should the medtech industry fear or embrace the involvement of tech titans like Google and Apple? Read on for answers to these and other important RPM-related questions.

  • Reverse Engineering A Human Heart Valve
    Reverse Engineering A Human Heart Valve

    The man who literally wrote the book (two books, in fact) on the aortic valve has devised a new artificial valve design that that he says will revolutionize transcatheter aortic valve implementation (TAVI). And if everything goes according to plan, his heart valve could reach European patients in 2015 and U.S. patients soon after. Find out how he and his startup company developed this technology — by using the natural aortic valve for their design output.

  • Do You Make These 5 Usability Mistakes In Your Medtech Development Process?
    Do You Make These 5 Usability Mistakes In Your Medtech Development Process?

    Major healthcare systems are starting to pay much closer attention to usability during the medical device procurement process. They are establishing internal human factors teams, having usability experts evaluate technologies prior to purchase, and sharing their learnings with other healthcare systems. If you fall prey to these five usability design pitfalls, your device won’t stand a chance in this new user-centric procurement environment.

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PRODUCT SHOWCASE

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Custom Manufactured Achromats

Custom Manufactured Achromats

Achromats are a specialty at LaCroix Optical Co. Our manufacturing engineers will work with production specialists to optimize the manufacturing process utilizing a combination of CNC and conventional manufacturing methods. Special proprietary alignment devices are used to ensure the optical axis of the elements can be maintained to within seconds.

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High Speed Gigabit Ethernet CCD Camera: Spot Insight

The SPOT Insight Gigabit CCD cameras combine high resolution, high frame rate, and low noise to provide superior performance for imaging applications. Recent SBIR/STTR grant recipients receive a discount on the Insight Gigabit and all SPOT cameras — learn more in the SPOT Imaging Solutions booth 131 at SPIE.

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Optical Thickness Gauge: 157 Series

Optical Thickness Gauge: 157 Series

The Model 157 optical thickness gauge uses proven optical interferometer technology to measure the absolute thickness of specialty plastic films, medical membranes, and ophthalmic products. High accuracy and exceptional repeatability results in the most reliable measurement available.

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LATEST HEADLINES

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    Heat-Seeking Missile Tech Used For Malaria Diagnosis

    Researchers at Monash University and the University of Melbourne have devised a way to use hardware from heat-seeking missiles to produce a test for early and reliable malaria diagnosis. In the project, researchers used a special infrared sensor called a focal plane array (FPA), which was originally created for use in Javelin anti-tank missiles, to seek out the presence of malaria in a blood sample. When the FPA was used in conjunction with an infrared imaging microscope to test a blood smear, it successfully detected the infrared signature from fatty acids in the malaria parasites, enabling researchers to consistently identify malaria-infested blood at early stages of infection.

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    New Software Could Improve Consistency Of Cancer Diagnosis

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    Can Squid Skin Help Power Future Biomedical Devices?

    A team of researchers at the University of California, Irvine (UCI) has discovered that a protein called reflectin, which is naturally present in squid skin, is a conductor of positive electrical charges — a quality that could be relevant for future medical device applications.

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UPCOMING TRAINING COURSES

The Seven Characteristics Of A World Class Supply Chain

July 22, 2014
1pm-2:30pm EDT, Online Training

Communication With FDA: What Do We Say And How Do We Say It?

July 23, 2014
1pm-2:30pm EDT, Online Training

Monitoring Informed Consent (IC): Frequently Asked Questions

July 24, 2014
1pm-2:30pm EST, Online Training

Remote Monitoring of Clinical Source Data – Why Not?

July 28, 2014
1pm-2:30pm EDT, Online Training
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