FEATURED EDITORIAL

Two Years in Wonderland:  An Updated Look at Alice
Two Years in Wonderland: An Updated Look at Alice

As medical devices and procedures become more reliant on computers and technology, the question of whether a patent is directed to a patent-ineligible abstract idea becomes increasingly relevant. Thus, it is important for the medical device community to understand how to claim their innovations in a way that passes Mayo/Alice muster.

  • U.S. Provides Template For A Successful European UDI Rollout
    U.S. Provides Template For A Successful European UDI Rollout

    A draft version of the new European Medical Device Regulations (MDR) recently was released, and it stipulates that UDI codes must be included on all medical device labels. Now is a crucial time for European manufacturers to look at how exactly U.S. manufacturers implemented UDI and what, specifically, the European manufacturers can learn from them.

  • How To Establish Sample Sizes For Process Validation Using The Success-Run Theorem
    How To Establish Sample Sizes For Process Validation Using The Success-Run Theorem

    This article demonstrates two methods using the success-run theorem, which uses the confidence level (how sure we are) and reliability value (valid, consistent results) to determine appropriate statistically valid sample sizes for process validation.

  • Medtech Category Insights In India: Medical Consumables And Implants
    Medtech Category Insights In India: Medical Consumables And Implants

    Due to critical differences in economic conditions — and unique unmet needs in the Indian market — what works well in the West may not succeed in India. While India’s medical devices and equipment market is growing strongly, a variety of factors specific to that market are impacting the performance of each product type. 

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INDUSTRY INSIGHTS

  • How To Select A Pump For Surgical Ablation Applications
    How To Select A Pump For Surgical Ablation Applications

    Radio frequency (RF) ablation uses RF energy to ablate or destroy unwanted tissues. When delivered via a catheter, it offers a minimally invasive treatment for a wide variety of conditions, including atrial fibrillation (AF). These systems typically include a peristaltic pump to provide cooling or temperature control, and this pump must be able to produce and control the high pressures (up to 130 psi) required in this application.

5 Antimicrobial-Related Trends In Medical Device Design

Shifts in healthcare have essentially changed suppliers’ role in the industry – especially when it comes to infection prevention. And, they’ve greatly impacted how both providers and suppliers think about the use of antimicrobials.

7 Considerations For More Effective Medical Device Labeling And Overlays

Labels often are an afterthought, because they don’t directly affect the capabilities of a medical device. However, they certainly affect the functionality of the device and users’ ability to effectively utilize all of its features. Consider these factors — and their importance — as you design your medical device overlay or inventory stickers.

Smoothing The Transition From Design To Manufacture: Best Practices

In the race to bring innovative products to market, ensuring a seamless transition from design to manufacturing is critical. Yet, in today’s marketplace, design and manufacturing engineers alike are faced with many new challenges.

Auto Injectors, From Planning To Launch: Preparing For The Overall Development Process

Looking at the rising trend towards self-administration therapies, injectable drug delivery devices such as pen injectors, autoinjectors and needle free injectors show a significant growth potential in the near future.

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SOLUTIONS

FluoroPEELZ™ Peelable Heat Shrink FluoroPEELZ™ Peelable Heat Shrink

Zeus offers the FluoroPEELZ™ peelable heat shrink designed with quick and easy peel away capabilities to improve product efficiency and safety, and to accelerate catheter production.

Medical Micromolding Medical Micromolding

MTD Micromolding is solely committed to providing the highest quality micromolding services of advanced medical products. MTD offers their innovative skills in exploring and producing very small, delicate, and intricate components required for advanced medical applications and products such as specialized surgeries, bioabsorbable devices, and implant devices. With a constant demand for newer, smaller, never-before-seen micro medical devices, MTD is also prepared to assist their strategic partners in the development of new solutions.

Solenoid Valves Solenoid Valves

Bürkert systematically follows the principle of maximum customer benefit when developing efficient solenoid valve technology. Regardless of whether you require a single component or a complex system solution, we always focus on optimum process reliability, efficiency, and economy.

Semiconductor Technology for Implantable Medical Devices Semiconductor Technology for Implantable Medical Devices

All mission critical functions are accessible within the MST group to provide miniaturized packages. Capabilities include design, substrate manufacturing, component selection and validation as well as all major semiconductor packaging processes.

High Accuracy Laser Beam Dimensional Measurement: NanoScan™ 1 High Accuracy Laser Beam Dimensional Measurement: NanoScan™ 1

The NanoScanTM 1 is a scanning slit beam profiler that acquires laser beams with 12-bit digitization. It then measures and analyzes the laser’s beam and pulse frequency to help determine accuracy and stability. The system can measure beam sizes from microns to centimeters, and from power ranges in the microwatts to over kilowatts, often times without the need for attenuation. Additionally, the beam profiler can be outfitted with different detector types in order to work with lasers operating at wavelengths from UV to far IR.  

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.

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FEATURED SUPPLIERS

Canon USA, Inc. Optoelectronic Components Canon USA, Inc. Optoelectronic Components

Canon U.S.A., Inc., is a leading provider of business-to-business, industrial and consumer digital and optical imaging solutions to the United States, Latin America and the Caribbean (excluding Mexico) markets with an increasing intent for more customized, localized products.

FLIR Systems, Inc FLIR Systems, Inc

The largest commercial infrared company in the world, FLIR has nearly 50 years of experience building and integrating high-performance infrared cameras. FLIR cameras play pivotal roles in a wide range of industrial, commercial, and government activities in over 60 countries.

DOUG'S LATEST COLUMNS

Doug's Latest Columns

LATEST HEADLINES

  • Boston Scientific Builds Momentum With Cardiac Rhythm Devices, Gains Flexibility
    Boston Scientific Builds Momentum With Cardiac Rhythm Devices, Gains Flexibility

    Boston Scientific credits its “category leadership strategy” for the company’s staggering 27 percent net income growth in the second quarter of 2016. CEO Mike Mahoney commented that Boston Scientific is aiming for “as much financial flexibility as we can have” and is on track to sustain momentum in its cardiac rhythm management business (CRM), which had lagged due to a lack of MRI-compatible products.

  • FDA Finalizes Guidance On Adaptive Clinical Study Designs
    FDA Finalizes Guidance On Adaptive Clinical Study Designs

    Final guidance from the U.S. Food and Drug Administration (FDA) for staff and sponsors lays out how to plan and implement adaptive designs for clinical studies when used in medical device development programs and submissions for Premarket Approval Applications (PMA), premarket notification (510(k)) submissions, de novo submissions (Evaluation of Automatic Class III Designation), Humanitarian Device Exemption (HDE) applications and Investigational Device Exemption (IDE).

  • Baxter Revenue Boosted By Hospital Products Business, Strategic M&A
    Baxter Revenue Boosted By Hospital Products Business, Strategic M&A

    Baxter achieved better-than-expected second quarter sales and significant growth in its hospital products business. CEO José Almeida reported that the company is on track with its strategy outlined earlier this year, with continued growth resulting from a “disciplined focus” on portfolio management, innovation, and capital allocation for M&A.

  • FDA Clarifies Use Of Real-World Evidence In Regulatory Decision-Making
    FDA Clarifies Use Of Real-World Evidence In Regulatory Decision-Making

    The U.S. Food and Drug Administration (FDA) has issued draft guidance that clarifies how it intends to evaluate real-world evidence (RWE) to support regulatory decisions.

  • Philips CEO: Full Focus Now On Health Technology
    Philips CEO: Full Focus Now On Health Technology

    Following the successful listing of its lighting business on the Euronext Amsterdam Stock Exchange in May, Royal Philips can now focus squarely on its HealthTech business, according to its chief executive.

  • Zimmer Biomet Launches Signature Solutions For Value-Based Healthcare
    Zimmer Biomet Launches Signature Solutions For Value-Based Healthcare

    Zimmer Biomet announced its plans to leverage the company’s years of consulting experience with its cultivated portfolio of technologies and analytical tools to create an “end-to-end” suite of clinical services called Signature Solutions. The intent of the service is to drive greater efficiency and improve patient outcomes in hospitals while working with the hospitals’ existing infrastructure.

  • Boston Scientific Announces Acquisition Of Cosman Medical

    Boston Scientific Corporation (NYSE: BSX) today announced that it has acquired Cosman Medical, Inc., a privately held Burlington, Mass. manufacturer of radiofrequency ablation (RFA) systems.

  • Bio-Inspired Microrobots Shapeshift, Move With Magnets
    Bio-Inspired Microrobots Shapeshift, Move With Magnets

    Taking inspiration from bacteria, a team of Swiss scientists has developed a platform for developing microrobots that can be customized for various medical indications, such as delivering drugs or performing delicate surgical operations, including unblocking clogged arteries. These tiny robots shapeshift in response to heat and can be remotely controlled using electromagnetic fields.

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