FEATURED EDITORIAL

6 Considerations For Conquering The U.S. Robotic Surgery Market
6 Considerations For Conquering The U.S. Robotic Surgery Market

As a capital-intensive innovation, robotic surgery has often found itself on the opposing side of value-based health care and the associated emphasis on cost effectiveness. Nevertheless, the uptake of robotic surgery in the U.S. has been significant, with annual procedure volume exceeding 500,000 since 2015.

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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

Lab Testing and Sterilization Validation Services Lab Testing and Sterilization Validation Services

REVOX has put together a team comprised of engineers, chemists, microbiologists, project managers, business consultants, and quality and regulatory professionals that are subject matter experts with strong expertise and experience in their fields. With such a team, REVOX can work to enable their sterilization technology to work to its fullest potential for medical devices. The company offers rapid 30-day sterilization development, materials and microbiological laboratory testing, supply chain optimization services, and regulatory development expertise.

As with any sterilization method, the REVOX room temperature PAA sterilization process must prove sterility using one of two testing methods—the overkill method or the bioburden method.  

Laser Beam Profilers Laser Beam Profilers

Laser beam profilers are the optimal solutions for increasing chances of success in the design or applications of new lasers, or when a laser system is no longer meeting the desired specifications. Ophir Photonics offers a wide range of beam profiler choices including CCD and CMOS cameras, scanning slit sensors, InGaAs and pyroelectric cameras, and pinhole and knife edge sensors.

Electro-Mechanical Assembly Electro-Mechanical Assembly
Corry Micronics offers a wide variety of electro-mechanical assembly services, including...
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.

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.  

Etched Mica Heaters Etched Mica Heaters

Heatron’s etched mica heaters are designed with tight traces and high watt density for greater control in applications with larger dimensions in an operating temperature range of -150°C to 500°C. Additional features include high rigidity, minimal out-gassing after first power up, and mounting holes for even application of heat.

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FEATURED SUPPLIERS

KMC Systems KMC Systems

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

Phase 2 Medical Manufacturing, Inc. Phase 2 Medical Manufacturing, Inc.

Phase 2 was founded in 1995 to focus exclusively on contract manufacturing of medical devices. We have grown from 5 people at our founding to over 150 associates in our organization today. We work with startup medical devices companies through large OEMs in getting products to market, design for manufacturability, and operational efficiency.

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