FEATURED EDITORIAL

The Impact Of U.S. Tax Reform And Trade Policy On The Medtech Industry
The Impact Of U.S. Tax Reform And Trade Policy On The Medtech Industry

This article - the second in a two-part series - examines the impact of a border adjustment and a border tariff on medical device companies, as well as the dynamics between the U.S., Mexico, and China.

  • 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.

  • Are You Asking Product Development Firms The Right Questions?
    Are You Asking Product Development Firms The Right Questions?

    If you’re trying to decide whether to hire a product development firm, or determine which one is best for your needs, the key questions you should ask establish a checklist to make sure the firm follows best practices, and reveals more nuanced aspects of how the firm performs its work. 

  • 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?

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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

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.

Engineering And Design Services Engineering And Design Services

KMC Systems offers decades of experience in solving complex medical engineering and design challenges, and in considering innovative, highly-automated solutions for the development of full-system instrumentation. KMC Systems engineers work collaboratively with customers to achieve optimal interdisciplinary solutions to laboratory automation challenges, Design for Manufacturability and Serviceability (DFM and DFS) challenges, and medical device verification and validation.

Medical Device Contract Manufacturing Medical Device Contract Manufacturing

Contract manufacturing for single-use medical devices is how Phase 2 got their start. They provide ultrasonic cleaning, injection molding, solvent and UV bonding, soldering, annealing, and more manufacturing services to both startup single-use medical device companies and larger-sized OEMs.

Detergent 8: Low-Foaming Ion-Free Detergent Detergent 8: Low-Foaming Ion-Free Detergent

Detergent 8 is concentrated to save you money, biodegradable, and readily disposable. Its penetrating wetting power saves you time. It’s free rinsing to give you reliable results and no interfering residues.

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.

Wearable Solutions For Continuous Health Monitoring Wearable Solutions For Continuous Health Monitoring

Wearable medical technologies allow for continuous health monitoring in the home so that patients can conveniently chart their wellness or progress electronically. Designers and engineers of high-tech medical devices have to consider the human skin interface during product development, not just as the last step before market. 3M has the expertise available to assist wearable medical technology manufacturers with selecting the right materials that work well with the human skin interface.

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FEATURED SUPPLIERS

Donatelle Donatelle

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

Heatron, Inc. Heatron, Inc.

Heatron was founded in 1977 and established a solid business in heating component design and manufacturing.  Our mission to help our customers accelerate their product development process by offering high performance products that differentiates them. With expertise in a multitude of key thermal technologies, our products are engineered to withstand the extraordinary demands placed on them.

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LATEST HEADLINES

  • AdvaMed Proposes Two New Safe Harbors Under Federal Anti-Kickback Statute For Value-Based Arrangements
    AdvaMed Proposes Two New Safe Harbors Under Federal Anti-Kickback Statute For Value-Based Arrangements

    The Advanced Medical Technology Association (AdvaMed) is proposing two new safe harbors to the federal anti-kickback statute that aims to protect value-based pricing arrangements and value-based warranties.

  • Velano Vascular Snags Third FDA Clearance For Needle-Free Blood Draw Device
    Velano Vascular Snags Third FDA Clearance For Needle-Free Blood Draw Device

    Velano Vascular announced that the company has secured a third FDA 510(k) clearance for its next-generation design of PIVO, a device that can collect blood samples through peripheral intravenous (IV) lines, preventing additional and unnecessary needle sticks for hospitalized patients.

  • Nokia Rebrands Withings Digital Health Devices
    Nokia Rebrands Withings Digital Health Devices

    Nokia is relaunching the entire Withings portfolio of digital health devices this summer under the Nokia brand, the company announced at the Mobile World Congress (MWC) in Barcelona.

  • ViewRay’s Next-Gen MRI-Guided Radiation Therapy System Cleared By FDA

    Announces Fourth Quarter and Full Year 2016 Financial Highlights, including Record Revenue and $133.2 million in Backlog ViewRay, Inc. (Nasdaq: VRAY) announced today that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the MRIdian Linac system, the company's next generation linear accelerator-based MRI-guided radiation therapy system.

  • Philips’ Noninvasive Liver Assessment Tool Cleared By FDA

    Royal Philips, a global leader in health technology, recently announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ElastQ Imaging capability, further expanding the functionalities of its EPIQ family of ultrasound systems.

  • Johnson & Johnson Completes Acquisition Of Abbott Medical Optics

    Johnson & Johnson recently announced it has completed the acquisition of Abbott Medical Optics (AMO), a wholly-owned subsidiary of Abbott. The all-cash $4.325B acquisition was originally announced Sept. 16, 2016, and includes ophthalmic products in three areas of patient care: cataract surgery, laser refractive surgery and consumer eye health.

  • Cagent Vascular’s PTA Serration Balloon Catheter Cleared By FDA

    Cagent Vascular, a developer of next generation technology for vessel dilatation in cardiovascular disease interventions, announces FDA 510(k) Clearance of its lead product, the Serranator Alto PTA Serration Balloon Catheter.

  • EU Finalizes Revamped Medical Device, IVD Regulations
    EU Finalizes Revamped Medical Device, IVD Regulations

    The Council of the European Union has completed the final versions of its long-awaited Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR), which update the regulatory framework for the marketing of medical devices and in vitro diagnostics in Europe, the world’s second-largest device market.

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Data Integrity - Detecting & Mitigating Risk March 14, 2017
1pm-2:30pm EST, Online Training
Root Cause Analysis Post ICH GCP E6 (R2): Beyond Fishbones and 5 Whys! March 27, 2017
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