FEATURED EDITORIAL

How Roche Approaches Home Monitoring With New Point-of-Care Device
How Roche Approaches Home Monitoring With New Point-of-Care Device

Beyond addressing an unmet medical need, diagnostics device makers serving the home point-of-care (POC) market must satisfy both the care provider and the patient if a product is to succeed. Add to that the challenge of keeping pace with the evolution of telehealth and mobile health platforms, and the uncertainty of new technology — specifically, that it doesn’t always deliver on its promise of a trouble-free solution.

  • The New Hotbed For Device Startups: Bangalore
    The New Hotbed For Device Startups: Bangalore

    Despite global medtech giants’ domination of India’s medical device industry and unfavorable domestic regulations, local startups hope to make lifesaving medical technology more accessible in a country where high-quality, affordable healthcare is scarce. Their products and ideas stand ready to impact markets across Africa, low-income countries in South America, Asia, and even Eastern Europe.

  • 3 Strategies To Achieve Big While Spending Small
    3 Strategies To Achieve Big While Spending Small

    Medtech entrepreneurs need to think like their investors and structure their operations accordingly. Excessive spending without achieving the critical milestones will not be tolerated; nor will an overly restricted cash burn that leaves a project limping forward.

  • 10 Med Device Regulatory & Commercialization Traps That Kill Valuation
    10 Med Device Regulatory & Commercialization Traps That Kill Valuation

    Historically, startups haven't gone through the entire product development process. They’ve done the heavy lifting with innovation and engineering, but are at a loss when it comes to navigating regulatory approval and figuring out how to successfully (and compliantly) commercialize. This is where value can be lost.

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INDUSTRY INSIGHTS

  • Barcoding Standards And The Search For A UDI “Easy Button”
    Barcoding Standards And The Search For A UDI “Easy Button”

    As the FDA’s next deadline for the unique device identification (UDI) of Class II devices draws closer, medical device manufacturing companies are looking to further their UDI implementation, whether they are well on their way to success or they haven’t even started. Barcoding, or identifying products via GS1 regulatory standards, is essential for companies wishing to be up to date on UDI implementation. Unfortunately, companies may be delaying UDI implementation because they view the new regulations as something an organization can address quickly. This is not the case. This article discusses the importance of viewing UDI implementation as process that encompasses the entire company rather than just as a “quick fix.”  

Time To Innovate: Ensuring A Future Without The Medical Device Tax

The industry must be able to demonstrate that it has been able to use the tax suspension to innovate and grow in order to avoid the tax’s reinstatement. The ability to show results will be paramount, creating a need for more efficient online reporting.

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.

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SOLUTIONS

Medical Silicone Processes Medical Silicone Processes

FMI is committed to providing the highest quality of silicone components for medical devices. Using the highest process controls alongside the most rigorous quality tools, FMI is able to ensure patient safety and 100 percent inspection of every single component before it ships.

Custom Packaging And Pouching Custom Packaging And Pouching

As demands in customer packaging and pouching grow in sophistication, ATL has kept pace by expanding our packaging capabilities. We have the engineering expertise to go beyond typical "cookie-cutter" type packaging modes in order to accommodate your one-stop supplier needs.

Electro-Mechanical Assembly Electro-Mechanical Assembly
Corry Micronics offers a wide variety of electro-mechanical assembly services, including...
Avalanche Photodiodes (APDs) With Enhanced NIR sensitivity Up To 950nm: Series 9.5 Avalanche Photodiodes (APDs) With Enhanced NIR sensitivity Up To 950nm: Series 9.5

First Sensor’s new Series 9.5 of avalanche photodiodes (APDs) are designed with an increased sensitivity in the near infrared (NIR) wavelength range up to 950 nm. Due to their fast rise time and very low dark current, these ADPs are ideal for applications with low light intensities and high modulation frequencies such as laser range-finding and laser scanning. Other applications for the photodiodes include safety scanners, 3D-mapping, environmental monitoring, high resolution LIDAR systems for autonomous driving, as well as high speed photometry, and fiber optical communication.

Mid-Wave And Long-Wave Thermal Imaging Cameras: A6700sc And A6750sc Cameras Mid-Wave And Long-Wave Thermal Imaging Cameras: A6700sc And A6750sc Cameras

The A6700sc and A6750sc are high sensitivity thermal imaging cameras with long-wave and mid-wave models. Short exposure times and 640 x 512 resolution allows for freeze motion and accurate temperature measurements, making these cameras ideal for high-speed thermal events and fast moving targets in electronics inspections, medical thermography, manufacturing monitoring, and non-destructive testing applications.

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

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.

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.

DOUG'S LATEST COLUMNS

Doug's Latest Columns

LATEST HEADLINES

  • Baxter, Satellite Healthcare Partner To Improve Patient Access To Latest Dialysis Technology
    Baxter, Satellite Healthcare Partner To Improve Patient Access To Latest Dialysis Technology

    Baxter has signed a four-year agreement with Satellite Healthcare, a non-profit organization that provides kidney dialysis and other related services. Baxter’s latest technology in peritoneal dialysis, hemodialysis, and continuous renal replacement therapy will be incorporated into Satellite Healthcare’s service offerings for over 7,000 patients in the U.S.

  • Medtronic Beats First Quarter Estimates, Optimistic On HeartWare, Mazor
    Medtronic Beats First Quarter Estimates, Optimistic On HeartWare, Mazor

    Medtronic's first quarter net income rose due to lower costs and tax payments, enough to offset a slight decrease in sales partly attributed to a down product cycle in the United States. Company executives, however, foresee a rebound in upcoming quarters as new products gain regulatory approval. Also, new acquisition HeartWare is expected to establish itself as a key performance driver going forward.

  • Batteries Made From Melanin Could Power Ingestible Devices
    Batteries Made From Melanin Could Power Ingestible Devices

    Scientists from Carnegie Mellon University (CMU) have developed a battery made from melanin, a naturally occurring compound in human skin, eyes and hair, which they say can power a 5 milliWatt device for 18 hours.

  • FDA Finalizes Guidance On Benefit-Risk Determinations, Patient Preference Information
    FDA Finalizes Guidance On Benefit-Risk Determinations, Patient Preference Information

    The U.S. Food and Drug Administration (FDA) has issued final guidance on factors in making benefit-risk determinations for premarket approval (PMA) and de novo classifications, as well as related final guidance on patient preference information to help FDA evaluate the benefit-risk profile of certain devices.

  • Industry, Patient Groups Seek Clarity From FDA On Sharing Patient-Specific Device Data
    Industry, Patient Groups Seek Clarity From FDA On Sharing Patient-Specific Device Data

    Patient organizations and industry groups want the U.S. Food and Drug Administration (FDA) to clarify salient points in its draft guidance on how manufacturers should share patient-specific data with patients.

  • FDA Clears Bio2 Medical Catheter Indicated For Use In High-PE Risk Patients
    FDA Clears Bio2 Medical Catheter Indicated For Use In High-PE Risk Patients

    Bio2 Medical is pleased to announce the Angel® Catheter has received 510(k) clearance from the United States Food & Drug Administration (FDA).

  • FDA Clears Additional Lumbar Interbody Fusion Device Sizes From Amedica

    Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company that develops and commercializes silicon nitride as a platform for biomedical applications, is pleased to announce the U.S. Food and Drug Administration (FDA) clearance of expanded Valeo® II Lateral Lumbar sizes.

  • FDA Clears First Computerized Cognitive Test For Concussion
    FDA Clears First Computerized Cognitive Test For Concussion

    The FDA has for the first time cleared a computerized diagnostic device designed specifically to evaluate a patient’s cognitive function immediately following a head injury and a suspected traumatic brain injury (TBI), otherwise known as concussion. While the Immediate Post-Concussion Assessment and Cognitive Testing (imPACT) device cannot conclusively diagnose TBI on its own, or direct a course of treatment, the tool offers point-of-care quantitative evaluation to assist trained healthcare providers in making treatment decisions.

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