FEATURED EDITORIAL

China Poised To Overtake U.S. And Japan As Top Telemedicine Market
China Poised To Overtake U.S. And Japan As Top Telemedicine Market

With the U.S.' investment in R&D and Japan's historically long hospital wait times, each has potential for a telemedicine boom. But China — with its 1.4 billion inhabitants — is poised to exceed the U.S. and Japan in this market, and there are three key reasons this may occur. 

  • India Introduces Sweeping — And Welcome — Device Regulations
    India Introduces Sweeping — And Welcome — Device Regulations

    Since 2002, American companies have lobbied for clearer oversight of medical device sales and manufacturing in India. As of January 2018, they will have their wish. 

  • Failure Analysis 101
    Failure Analysis 101

    A one percent failure rate should be unacceptable in any industry, especially healthcare. More aggressive and smarter testing will, in essence, cut that current failure rate in half. 

  • Engaging A Life Science Consultant: Common Pitfalls & Best Practices
    Engaging A Life Science Consultant: Common Pitfalls & Best Practices

    This article summarizes insights gleaned from interviews with multiple consultants, each of whom has at least 25 years’ experience in the life sciences space — and from conversations with the life science companies who hire such consultants to ensure that their systems meet the product quality attribute/specification requirements mandated by their respective regulators.

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INDUSTRY INSIGHTS

  • How Many FDA Premarket Applications Are Necessary For Your Combination Product?
    How Many FDA Premarket Applications Are Necessary For Your Combination Product?

    Often, an already-approved drug can further benefit patients when applied with a medical device. In such cases, the pharmaceutical product sponsor may utilize the 505(b)(2) pathway for regulatory approval of the combination product. But even when the regulatory pathway is known, submission strategies for regulatory approval of combination products can be challenging and confusing. The development and review of combination products in the U.S. typically requires the involvement of multiple centers within the Food and Drug Administration (FDA), under the oversight of the FDA’s Office of Combination Products (OCP).

Validation: A Key Stage In Mobile Health Development

To enter the rapidly growing mobile health space, companies must overcome the Mobile Health Development-crucial hurdle of validation. This process demonstrates that the app – in combination with the underlying technology platform / device – performs comparably to traditional products on the market..

IoT-Enabled Medical Devices Are The Wave Of The Future

Winning in the medical devices market of the future requires mastering advanced technologies – or finding a partner with these capabilities. The global Internet of Things (IoT) in healthcare market is forecasted to reach $410 billion by 2022. To succeed in this arena, device companies need to stay out in front of manufacturing innovations so they can quickly integrate information technology (IT) functionality into their products, accelerate time to market and control costs.

Using A Component Management Process To Scale Up Manufacturing Of Drug Delivery Devices

The best practice for fitting multiple parts into a single assembly at tight tolerances is to choose a single component supplier with a sufficient array of core competencies in advanced device manufacturing methods. The chosen supplier should also utilize a well-designed component management process that includes close attention to important elements, proper planning, and high performance levels to provide an affordable, highly scalable drug delivery device.

Segmentation Of The Diagnostics Market

The in vitro diagnostics (IVD) market is commonly segmented by techniques, products, application, end users, and geography. To better navigate the IVD diagnostic market landscape, understanding and recognizing how each segment is distinct, yet related to one another is critical for the company that wants to optimize its opportunities within this market.

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SOLUTIONS

Solid-State Silicon Photomultipliers (SiPM) For Near-Ultraviolet or Red, Green & Blue Light Detection Solid-State Silicon Photomultipliers (SiPM) For Near-Ultraviolet or Red, Green & Blue Light Detection

First Sensor offers a new series of innovative solid-state silicon photomultipliers (SiPMs) that are designed to detect ultra-low light levels down to single photons. These detectors are optimized for near-ultraviolet (Series SiPM-NUV) or red, green, and blue (Series SiPM-RGB) light detection with peak sensitivities at 420 nm or 550 nm. Key features include a low operating voltage, high gain and low noise, and immunity to magnet fields.

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.

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.

Caplugs Custom Medical Molding Caplugs Custom Medical Molding

Caplugs has been a global leader in plastic molding with six different molding processes and thousands of material options. The in-house team of engineers works with customers throughout their comprehensive process to design a unique solution process from creating concepts and rapid prototyping to packaging and inventory management.

Medical Micromolding Medical Micromolding

MTD Micromolding is solely committed to providing the highest quality micromolding services of advanced medical products. MTD offers their innovative skills in exploring and producing very small, delicate, and intricate components required for advanced medical applications and products such as specialized surgeries, bioabsorbable devices, and implant devices. With a constant demand for newer, smaller, never-before-seen micro medical devices, MTD is also prepared to assist their strategic partners in the development of new solutions.

Fischer Plastic Series Fischer Plastic Series

The Fischer Plastic Series is a family of high performance, fully insulated plastic connector bodies that are all compatible with Fischer’s metallic connectors. Key features include high reliable signal path, high signal and contact density, clear coding for easy operation, and resistance to large temperature variations.  

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FEATURED SUPPLIERS

Alconox, Inc. Alconox, Inc.

With more than 60 years of experience in formulation of quality aqueous cleaners, Alconox Inc. understands the cleaning needs of the medical device manufacturing industry including stringent FDA regulations and GMP compliance.

FMI, Inc. FMI, Inc.

FMI is dedicated to producing medical-grade silicone components for Class II and Class III medical devices. In fact, custom silicone moldings are the only products we manufacture and health care is the only industry we serve. That singular focus allows us to provide the highly customized components that medical device manufacturers depend upon for patient safety, efficacy and reliability.

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