LEAD STORIES

Patients Use World’s First Mobile Pacemaker Station

England’s National Health Service (NHS) has launched its first mobile pacemaker station in the town of Southampton. The station has been designed to allow patients with pacemakers to conduct regular check-ups without having to visit a doctor.

  • New Gene Therapy Could Make Electronic Pacemakers Passé
    New Gene Therapy Could Make Electronic Pacemakers Passé

    Researchers at the Cedars-Sinai Heart Institute in Los Angeles have developed a minimally invasive gene transplant procedure that they say could one day provide an alternative to implantable electronic pacemakers.

  • 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.

  • Heat-Seeking Missile Tech Used For Malaria Diagnosis
    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.

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

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.

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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.

More From The Editor

PRODUCT SHOWCASE

Thermal Research Camera: T650sc

Thermal Research Camera: T650sc

FLIR’s T650sc is a battery powered, handheld thermal imaging camera ideal for applications that involve thermographic studies and temperature measurements. It covers the -40°C to 2,000°C temperature range and employs a 640 x 480 infrared microbolometer detector.

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.

Luminox: Low-Foaming Neutral Cleaner

Luminox: Low-Foaming Neutral Cleaner

Low foaming for use in mechanical and spray washers. Neutral pH for non-corrosive cleaning, safe handling, and easy waste disposal. No chelation or alkalinity waste treatment problems. Concentrated for economical use. Free rinsing to eliminate interfering residues. Biodegradable and phosphate free.

PMC12 Series: Couplings

PMC12 Series: Couplings

The 1/8" flow polypropylene PMC12 offers many of the same configuration options as the PMC. The polypropylene material adds greater chemical resistance for more demanding applications. PMC12 couplings are also gamma sterilizable.
Class A Solid State Amplifier: 150W1000

Class A Solid State Amplifier: 150W1000

AR’s solid state amplifiers are often used in medical EMC compliance test efforts. The 150W1000 is a class A solid state amplifier which provides 1500 watts of output power from 80 to 1000 MHz. It has superior gain flatness, an exceptional noise figure, and better efficiency and harmonics than competitive products.

High Speed Gigabit Ethernet CCD Camera: Spot Insight

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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