FEATURED EDITORIAL

Genetic Screening, Digital Biomarkers, And Cancer Diagnostics
Genetic Screening, Digital Biomarkers, And Cancer Diagnostics

This article, focused on the opportunities for innovation in cancer diagnostics, is the last in a four-part series exploring the role of medtech innovation as it pertains to the distinct stages of cancer care.

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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

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.

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.  

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

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.

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.

LATEST HEADLINES

  • FDA Issues Two Draft Guidances On Medical Product Communications
    FDA Issues Two Draft Guidances On Medical Product Communications

    The first deals with communication by firms of health care economic information (HCEI) to payors, including about investigational drugs and devices that are not yet approved or cleared for any use. The second pertains to medical product communications that include data and information not contained in product labeling, but concerning the approved or cleared uses of those products.

  • Blood-Repelling Titanium Surfaces Could Lower Implant Rejection Rates
    Blood-Repelling Titanium Surfaces Could Lower Implant Rejection Rates

    Scientists from Colorado State University (CSU) have demonstrated that hemophobic surfaces significantly reduce platelet adhesion and activation, a process that can lead to life-threatening blood clots.

  • Hitachi Integrates, Expands Healthcare Businesses Serving Americas

    Hitachi, Ltd. recently announced the formation of a new Americas business group focused on consolidating its various medical imaging offerings while expanding its focus on Healthcare Innovation & Informatics. Hitachi will  combine Hitachi Aloka Medical America, Inc. into Hitachi Medical Systems America, Inc. on April 1, 2017, which will then change its name to Hitachi Healthcare America Corporation.

  • FDA Touts EvGen, IMEDS Programs Ensuring Patient Safety
    FDA Touts EvGen, IMEDS Programs Ensuring Patient Safety

    The U.S. Food and Drug Administration (FDA) unveiled a website for its National Medical Evidence Generation Collaborative (EvGen), intended to bring wider access to high-quality scientific evidence supporting the safe use of FDA-regulated products.

  • Omron Introduces Smartwatch-Size Blood Pressure Monitor
    Omron Introduces Smartwatch-Size Blood Pressure Monitor

    Omron Healthcare has miniaturized blood pressure monitor technology into a wearable device the size of a wristwatch, which can track blood pressure while monitoring physical activity and sleep.

  • NICE Pauses Plans To Charge Manufacturers For Medical Device Appraisals
    NICE Pauses Plans To Charge Manufacturers For Medical Device Appraisals

    The U.K.’s National Institute of Health and Care Excellence’s (NICE) plan to recoup the appraisal cost of drugs, devices, and diagnostics by charging industry has been temporarily suspended.

  • FDA Describes How Interface Design And Human Factors Support Approval Of Generic Combination Products
    FDA Describes How Interface Design And Human Factors Support Approval Of Generic Combination Products

    The US Food and Drug Administration (FDA) has issued a draft guidance to assist submitters of abbreviated new drug applications (ANDA) in minimizing differences between the user interface of a proposed generic drug-device combination product and the user interface of its Reference Listed Drug (RLD).

  • Abbott's DRG Neurostimulation System Launches In EU

    Abbott (NYSE: ABT) today announced the European launch of the new Proclaim™ DRG Neurostimulation System, designed to deliver dorsal root ganglion (DRG) stimulation to patients suffering from chronic neuropathic pain. Through the Proclaim platform's Bluetooth® wireless technology and iOS™ software, the Proclaim DRG Neurostimulation System offers patients a more intuitive therapy experience, compared to current systems with traditional controllers that can be difficult to operate.

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UPCOMING TRAINING COURSES

Data Integrity - Detecting & Mitigating Risk January 26, 2017
1pm-2:30pm EST, Online Training
Update to ICH GCP E6 (R2) – Final Changes and Implementation February 15, 2017
1pm-2:30pm EST, Online Training
Risk-Based Approaches To Establishing Sample Sizes For Process Validation February 16, 2017
1pm-2:30pm EST, Online Training
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