FEATURED EDITORIAL

Coming Home: Designing For Medical Device Use Environments
Coming Home: Designing For Medical Device Use Environments

Understanding a product’s use environment is as key a building block to designing a usable and useful medical device as understanding the end user. Where a product is used, and who is using it, are inseparable factors, and anticipating how they interplay in device use is a critical and complex task.

  • 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. 

  • Preparing For New European Medical Device And IVD Regulations
    Preparing For New European Medical Device And IVD Regulations

    Although final publication of the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) is unlikely to occur before early 2017, companies now can map out transition and compliance plans with more certainty. Here, we’ll discuss the crucial considerations that firms should weigh in the meantime.

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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

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.

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 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.

Motion Control Products: DC-Motors Motion Control Products: DC-Motors

Canon offers a variety of brushless, coreless, and ironcore dc-motors that are custom manufactured to achieve the exact speed, power, and currents required for OEM applications. These motors are supplied with attached gears, pinions, pulleys, lead wires, and conductors in order to reduce OEM labor and material costs.

Solutions For On-time, Deficient-Free Delivery Of Medical Supplies, Medicines And Other Products Solutions For On-time, Deficient-Free Delivery Of Medical Supplies, Medicines And Other Products

For the person with diabetes in need of insulin, the heart patient awaiting a monitor or the individual expecting critical lab results, a delay of even one day isn't acceptable. Timely delivery of medical supplies or medication could mean the difference between recovery and relapse.

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FEATURED SUPPLIERS

The Tech Group The Tech Group

The Tech Group, a West company, is a leading global contract manufacturer of pharmaceutical packaging & drug delivery, diagnostics, and medical device products. With over 40 years of experience and eight facilities located throughout North America and Europe, The Tech Group is focused on serving the needs of healthcare companies by providing a single-sourced solution from product conceptualization through manufacturing and final packaging. Capabilities include; concept design, engineering development, prototyping, production scale up, validation and commercial manufacturing.

DOUG'S LATEST COLUMNS

Doug's Latest Columns

LATEST HEADLINES

  • 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.

  • GE Leaders: Healthcare Executing Well, Feels Sustainable
    GE Leaders: Healthcare Executing Well, Feels Sustainable

    GE Healthcare posted a strong second quarter, and the conglomerate's top executives believe that favorable markets and real opportunities for growth will keep the unit’s performance sustainable.

  • Medtronic CEO: Growth Will Be Driven By Innovation, Globalization, Value-Based Care
    Medtronic CEO: Growth Will Be Driven By Innovation, Globalization, Value-Based Care

    Medtronic wants to generate $40 billion in free-cash-flow (FCF) by 2021, senior leadership said during a recent Investor Day event in New York City. The company’s strategies for future growth include therapy innovation, globalization, and a leadership position in value-based healthcare.

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UPCOMING TRAINING COURSES

Best Practices in CMC Dossier Preparation – Facing Tough Challenges July 28, 2016
Special Time for EU and US Participants - 10:30am-12pm EDT, Online Training
Preparing for - and Surviving - a FDA Medical Device Inspection July 28, 2016
1pm-2:30pm EDT, Online Training
Cleaning Validation – Lessons Learned in the Trenches August 23, 2016
1pm-2:30pm EDT, Online Training
Cloud Computing In A GxP Environment: Three Key Success Factors August 24, 2016
1pm-2:30pm EDT, Online Training
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