FEATURED EDITORIAL

Kits, Packaging Configurations, And Unit Of Use – A UDI Primer
Kits, Packaging Configurations, And Unit Of Use – A UDI Primer

I often receive questions to clarify the difference among kits, packaging configurations, and unit of use, and these questions usually inquire about labels or entering data into GUDID. This article answers these questions in simple terms, without citing the regulations, and provides the “mental models” you need to distinguish among the cases and develop a compliant approach.

  •  3 Ingredients To Bake The Perfect Device Development Plan
    3 Ingredients To Bake The Perfect Device Development Plan

    The definition of what constitutes “innovation” in the medical device industry has become enigmatic in recent years. To drive commercial success in a crowded market, products need to address conflicting sets of user needs while simultaneously addressing market opportunities. 

  • European Diabetes Care Market Shaped By Innovation, Shifting Competitive Landscape
    European Diabetes Care Market Shaped By Innovation, Shifting Competitive Landscape

    The European market for diabetes monitoring, treatment, and drug delivery currently is undergoing significant changes. The major segments affected by these changes are insulin pumps, continuous glucose monitoring, blood glucose test strips, and insulin pen needles.

  • 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.

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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

  • GE Healthcare, Getinge Group Launch Flexible Angiography Solution For Hybrid OR
    GE Healthcare, Getinge Group Launch Flexible Angiography Solution For Hybrid OR

    GE Healthcare, in partnership with Swedish medical device firm Getinge Group, has launched a “highly flexible” angiography solution for hybrid operating room (OR) procedures.  The solution combines GE’s Discovery IGS 730 angiography system with Getinge Group Maquet brand’s Magnus operating table system, which broadens the capabilities and services available in a hospital’s Hybrid OR.

  • MHRA Explains Whether Or Not A Health App Is A Medical Device
    MHRA Explains Whether Or Not A Health App Is A Medical Device

    The United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has issued updated guidance to explain whether or not a health app is considered a medical device and is required to comply with regulatory requirements, including getting CE-marked.

     

  • Bluegrass Vascular Gains CE Mark For Inside-Out Access Catheter System

    Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced that it has received CE Mark approval and is launching limited commercial sale of its Surfacer® Inside-Out® Access Catheter System.

  • Lawmakers Want Answers From Mylan, FDA, FTC After EpiPen Price Hike
    Lawmakers Want Answers From Mylan, FDA, FTC After EpiPen Price Hike

    A spike in the price of EpiPen auto-injectors has drawn heated responses from patients, lawmakers, and the wider public, who are calling on authorities to rein in soaring prices for the lifesaving devices.

  • Industry Groups Optimistic Over Re-Authorization of MDUFA
    Industry Groups Optimistic Over Re-Authorization of MDUFA

    The FDA and several industry advocacy groups have reached a tentative agreement regarding the fourth re-authorization of the Medical Device User Fee Agreement (MDUFA), which is slated for delivery to congress in January of 2017. Under the re-authorization, the FDA will collect close to $1 billion in user fees, money that will be allocated to fund several improvements to the FDA’s review process.

  • FDA Clears Fortimedix’s Single-Port Surgical Platform

    Fortimedix Surgical today announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for FMX314, an innovative single-port platform for use in minimally invasive abdominal laparoscopic surgery.

  • Study: Medtronic’s Micra TPS Displays Solid Long-Term Performance

    In the largest and longest clinical evaluation of leadless pacing patients to date, Medtronic plc recently announced new long-term results from the Medtronic Micra Transcatheter Pacing System (TPS) Global Clinical Trial in a clinical trial update late-breaking session at the 2016 European Society of Cardiology (ESC) Congress in Rome.

  • GE Launches Next-Gen Portable Cardiovascular Ultrasound

    In the lead up to the European Society of Cardiology Congress in Rome Italy, GE Healthcare recently announced the global commercial launch[1] of its new generation of high-end portable compact cardiovascular ultrasound, the Vivid iq.

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Medical Device Recalls – Keys To Implementing A Successful Approach September 7, 2016
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