FEATURED EDITORIAL

The Future Of Surgical Care In Emerging Markets
The Future Of Surgical Care In Emerging Markets

If, as most believe, the future of the medical device industry will be determined by emerging markets, manufacturers need to embrace the idea of needs-driven local innovation for unmet medical needs.

  • Future Market Trends For Wearable Devices
    Future Market Trends For Wearable Devices

    Last week, we spoke with the CEO and founder of Biotricity, Waqaas Al-Siddiq, about physician concerns due to a lack of clear delineation between medical grade vs fitness/lifestyle devices. In Part 2 of my discussion with Al-Siddiq, we explore some of the trends and market evolutions that will affect the wearable device industry in the next five years.

  • EU Hearing Device Market Faces Mounting Pricing Pressure
    EU Hearing Device Market Faces Mounting Pricing Pressure

    The European market for hearing devices has experienced significant growth in recent years. In 2015, the market was valued at just over €7.2 billion. Included in our analysis are the markets for hearing aids, hearing aid batteries, cochlear implants, and bone-anchored hearing aids.

  • 4 Strategies For Transitioning From “Device Manufacturer” To “Complete Solutions Provider”
    4 Strategies For Transitioning From “Device Manufacturer” To “Complete Solutions Provider”

    As hospitals and health systems grapple with value-based payments and new quality requirements, medical device and diagnostic companies are serving as enablers, reaching across the healthcare ecosystem to offer services that engage patients in real time, improve physician performance, and demonstrate value beyond any one device, diagnostic, or technology. Both established medtech players and newer entrants should consider these four factors when designing their offerings and contracting with customers:

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INDUSTRY INSIGHTS

  • Barcoding Standards And The Search For A UDI “Easy Button”
    Barcoding Standards And The Search For A UDI “Easy Button”

    As the FDA’s next deadline for the unique device identification (UDI) of Class II devices draws closer, medical device manufacturing companies are looking to further their UDI implementation, whether they are well on their way to success or they haven’t even started. Barcoding, or identifying products via GS1 regulatory standards, is essential for companies wishing to be up to date on UDI implementation. Unfortunately, companies may be delaying UDI implementation because they view the new regulations as something an organization can address quickly. This is not the case. This article discusses the importance of viewing UDI implementation as process that encompasses the entire company rather than just as a “quick fix.”  

Time To Innovate: Ensuring A Future Without The Medical Device Tax

The industry must be able to demonstrate that it has been able to use the tax suspension to innovate and grow in order to avoid the tax’s reinstatement. The ability to show results will be paramount, creating a need for more efficient online reporting.

How To Select A Pump For Surgical Ablation Applications

Radio frequency (RF) ablation uses RF energy to ablate or destroy unwanted tissues. When delivered via a catheter, it offers a minimally invasive treatment for a wide variety of conditions, including atrial fibrillation (AF). These systems typically include a peristaltic pump to provide cooling or temperature control, and this pump must be able to produce and control the high pressures (up to 130 psi) required in this application.

5 Antimicrobial-Related Trends In Medical Device Design

Shifts in healthcare have essentially changed suppliers’ role in the industry – especially when it comes to infection prevention. And, they’ve greatly impacted how both providers and suppliers think about the use of antimicrobials.

7 Considerations For More Effective Medical Device Labeling And Overlays

Labels often are an afterthought, because they don’t directly affect the capabilities of a medical device. However, they certainly affect the functionality of the device and users’ ability to effectively utilize all of its features. Consider these factors — and their importance — as you design your medical device overlay or inventory stickers.

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SOLUTIONS

Custom Packaging And Pouching Custom Packaging And Pouching

As demands in customer packaging and pouching grow in sophistication, ATL has kept pace by expanding our packaging capabilities. We have the engineering expertise to go beyond typical "cookie-cutter" type packaging modes in order to accommodate your one-stop supplier needs.

FluoroPEELZ™ Peelable Heat Shrink FluoroPEELZ™ Peelable Heat Shrink

Zeus offers the FluoroPEELZ™ peelable heat shrink designed with quick and easy peel away capabilities to improve product efficiency and safety, and to accelerate catheter production.

Pressure Relief Valves (For Plastic) Pressure Relief Valves (For Plastic)

The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.

Mid-Wave And Long-Wave Thermal Imaging Cameras: A6700sc And A6750sc Cameras Mid-Wave And Long-Wave Thermal Imaging Cameras: A6700sc And A6750sc Cameras

The A6700sc and A6750sc are high sensitivity thermal imaging cameras with long-wave and mid-wave models. Short exposure times and 640 x 512 resolution allows for freeze motion and accurate temperature measurements, making these cameras ideal for high-speed thermal events and fast moving targets in electronics inspections, medical thermography, manufacturing monitoring, and non-destructive testing applications.

Optical Component Prototypes Using Rapid Injection Molding Process Optical Component Prototypes Using Rapid Injection Molding Process

Protomold’s rapid injection molding process is a very useful option for prototyping lenses that need to be tested for fit and structural integrity in optical systems. Optical component prototypes produced using the rapid injection molding process can cost up to 90% less than parts produced with traditional tooling methods.

Hydrogels For Medical Devices Hydrogels For Medical Devices

Medtronic’s OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.

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FEATURED SUPPLIERS

The Tech Group The Tech Group

The Tech Group, a West company, is a leading global contract manufacturer of pharmaceutical packaging & drug delivery, diagnostics, and medical device products. With over 40 years of experience and eight facilities located throughout North America and Europe, The Tech Group is focused on serving the needs of healthcare companies by providing a single-sourced solution from product conceptualization through manufacturing and final packaging. Capabilities include; concept design, engineering development, prototyping, production scale up, validation and commercial manufacturing.

Heatron, Inc. Heatron, Inc.

Heatron was founded in 1977 and established a solid business in heating component design and manufacturing.  Our mission to help our customers accelerate their product development process by offering high performance products that differentiates them. With expertise in a multitude of key thermal technologies, our products are engineered to withstand the extraordinary demands placed on them.

DOUG'S LATEST COLUMNS

Doug's Latest Columns

LATEST HEADLINES

  • NIH Awards $2.3M To Fund Study Of Pancreatic Cancer-Fighting Implant
    NIH Awards $2.3M To Fund Study Of Pancreatic Cancer-Fighting Implant

    The National Institute of Health has awarded a $2.3 million grant to CivaTech, developer of an implantable device that provides targeted radiation treatment for cancer patients.  CivaTech plans to use the grant to fund a clinical study that will evaluate safety and efficacy of the CivaSheet device in patients with pancreatic cancer.

  • FDA Planning Board Unveil Priorities For Coordinating Center Overseeing Device Evaluation System
    FDA Planning Board Unveil Priorities For Coordinating Center Overseeing Device Evaluation System

    A Planning Board convened by the U.S. Food and Drug Administration (FDA) and the Duke-Margolis Center for Health Policy laid out the initial priorities for the proposed Coordinating Center in charge of the National Evaluation System for Health Technology (NEST).

  • Zimmer Biomet: Vanguard System Will "Revolutionize" Total Knee Replacement
    Zimmer Biomet: Vanguard System Will "Revolutionize" Total Knee Replacement

    Orthopaedic products manufacturer Zimmer Biomet has unveiled Vanguard Individualized Design (ID), which is touted as a first-of-its-kind total knee arthroplasty (TKA) personalized construct, with dual bearings to better preserve the natural tissues surrounding the knee joint.

  • FDA Draft Guidance Addresses Coordinated Development Of AST Devices, Antimicrobial Drugs
    FDA Draft Guidance Addresses Coordinated Development Of AST Devices, Antimicrobial Drugs

    FDA has published a draft guidance for industry outlining the agency’s approach to the coordinated development of antimicrobial drugs and antimicrobial susceptibility test (AST) devices. Though the agency wishes to better facilitate interactions between drug sponsors and device developers, FDA emphasized that applications will remain separate, and review timelines for separate products will not be influenced by each other.

  • FDA Approves Bayer's Newest Birth Control Device
    FDA Approves Bayer's Newest Birth Control Device

    Bayer announced that the U.S. Food and Drug Administration (FDA) has approved the company's newest intrauterine device (IUD), Kyleena (levonorgestrel-releasing intrauterine system) 19.5 mg, for the reversible, long-acting prevention of pregnancy for up to five years.

  • J&J’s Acclarent Wins FDA Nod For Eustachian Tube Balloon Dilation System
    J&J’s Acclarent Wins FDA Nod For Eustachian Tube Balloon Dilation System

    Johnson & Johnson (J&J) subsidiary Acclarent announced that the FDA has awarded de novo approval to its balloon dilation system, the Aera System, which joins J&J’s portfolio of minimally invasive therapies for ear, nose, and throat (ENT) conditions. Aera is indicated for the treatment of persistent eustachian tube dysfunction (ETD).

  • BD Unveils Next Generation Wireless Point-Of-Care Diagnostic Device
    BD Unveils Next Generation Wireless Point-Of-Care Diagnostic Device

    BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the launch of its next generation wireless rapid diagnostic system for detection of influenza A and B, respiratory syncytial virus (RSV) and group A strep, with new traceability and secure patient health record documentation features and functionality.

  • Artificial Heart Maker SynCardia Systems Acquired By Versa Capital Management

    SynCardia Systems, LLC (“SynCardia” or the “Company”), maker of the SynCardia temporary Total Artificial Heart (TAH-t), recently successfully completed its previously announced reorganization process and has been acquired by affiliates of investment firm Versa Capital Management, LLC (“Versa”).

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UPCOMING TRAINING COURSES

Reacting to “Human Error” – Moving Beyond “Retraining” As A Response September 27, 2016
1pm-2:30pm EDT, Online Training
Introduction to Biostatistics: Collecting and Summarizing Data September 28, 2016
1pm-3pm EDT, Online Training
New Pharma Compliant Google Ad Formats – Implementation Tips For Success September 29, 2016
1pm-2:30pm EDT, Online Training
Pediatric Clinical Trials: Special Considerations and Requirements October 6, 2016
1pm-2:30pm EDT, Online Training
Medical Device Design Controls 101 – A Practical Crash Course October 12, 2016
1pm-2:30pm EDT, Online Training
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