FEATURED EDITORIAL

Beyond Validation: How Meeting Only Minimum Usability Requirements Can Affect Devices After FDA Approval
Beyond Validation: How Meeting Only Minimum Usability Requirements Can Affect Devices After FDA Approval

Because FDA requirements focus heavily on usability issues related to safety, device developers can fall into the trap of assigning less meaning to usability problems that won’t cause harm. But, it is not always possible to catch all unanticipated use errors during validation, and usability problems not directly related to safety risks can still affect purchasing decisions and device acceptance.

  • Medtronic’s CardioInsight, A Nanocoated Stent, And A Hug
    Medtronic’s CardioInsight, A Nanocoated Stent, And A Hug

    Thinking about flowers, candy, and cards? (If not, your Valentine’s Day may be in jeopardy.) While you’re thinking, why not explore some good news for the traditional Valentine symbol, the heart?

  • Prototypes To Production: 5 Steps To A Smooth Manufacturing Transfer
    Prototypes To Production: 5 Steps To A Smooth Manufacturing Transfer

    A product's entire evolution, from thoughtful design through prototypes and iteration, inherently becomes the footing for an efficient transition to manufacture. The steps discussed here identify what to expect, and how to respond as a team to move a well-designed device to volume production.

  • 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.

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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

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.

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.

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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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