FEATURED EDITORIAL

How An ACA Repeal Could Impact Medtech
How An ACA Repeal Could Impact Medtech

Given that Republicans hold only a simple majority in the Senate, it is expected that their power to dismantle the ACA will be limited to those provisions that are tied to the budget. This article — the first in a two-part series — will discuss how repealing certain parts of the ACA will impact the medtech industry.

  • 50 Shades Of FDA: Some 2017 Guidance Documents Will Require Clarity
    50 Shades Of FDA: Some 2017 Guidance Documents Will Require Clarity

    Among the dozen "A-List" guidance topics that FDA has slated for finalization in 2017, three already have been released. That's good progress. But, at least three of those guidance initiatives put forth directives that medical device companies may find difficult, if not impossible, to follow.

  • Digital Health, Connected Health, mHealth –  What Are They, And Who Pays For Them?
    Digital Health, Connected Health, mHealth – What Are They, And Who Pays For Them?

    Government and private insurance health plans struggle for clarity when writing contracts for their members’ healthcare coverage. In each state, these contracts have to be filed and approved by the state departments of insurance and commerce. Is it any wonder there is a need for simplicity, clarity, and consistency in the services each state and private insurer covers?

  • Qualcomm Partner Provides Telehealth Simplification
    Qualcomm Partner Provides Telehealth Simplification

    Integron's president discusses how his company developed a growth strategy to approach companies with existing in-home therapies looking to connect their devices. The end result was remote patient monitoring and connected health offerings that have been deployed to 56 countries around the world.

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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, ensuring that patients and providers can rely on the output to make appropriate medical decisions.

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

Avalanche Photodiodes (APDs) With Enhanced NIR sensitivity Up To 950nm: Series 9.5 Avalanche Photodiodes (APDs) With Enhanced NIR sensitivity Up To 950nm: Series 9.5

First Sensor’s new Series 9.5 of avalanche photodiodes (APDs) are designed with an increased sensitivity in the near infrared (NIR) wavelength range up to 950 nm. Due to their fast rise time and very low dark current, these ADPs are ideal for applications with low light intensities and high modulation frequencies such as laser range-finding and laser scanning. Other applications for the photodiodes include safety scanners, 3D-mapping, environmental monitoring, high resolution LIDAR systems for autonomous driving, as well as high speed photometry, and fiber optical communication.

mHealth Solution For Clinical Trials mHealth Solution For Clinical Trials

Mobile health momentum is building as new technologies emerge. The first steps in your journey — including regulatory strategy and device/data validation —can be challenging.

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.

Medical Device Supply Chain Management (Metals, Electronics) Medical Device Supply Chain Management (Metals, Electronics)

At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.

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.

Motion Control Products: Coreless Motors Motion Control Products: Coreless Motors

Canon’s coreless motors are part of the family of dc-motor products that are custom manufactured to achieve the exact speed, power, and currents required for OEM applications. These motors feature a small footprint, high power output, and a low moment of inertial that provides quick response rates and high controllability. They are ideal for many applications including cameras and pumps. Customization and other options are available on request.

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FEATURED SUPPLIERS

KMC Systems KMC Systems

COBAS BIO Clinical Chemistry Analyzer|COBAS FARA|Clinical Diagnostic Instrumentation

Donatelle Donatelle

Donatelle has been in business over 45 years providing medical device contract manufacturing services helping companies develop innovative and life-saving products. 

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