FEATURED EDITORIAL

Leveling The Workload
Leveling The Workload

In the last edition of Thinking Lean, we discussed quick changeover, a system for reducing setup time on equipment and allowing for smaller batches. In this edition, we will cover a more generally applicable concept known as leveling production.

  • 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.

  • Managing QMS Disparities Between Drugs And Devices For Combination Products
    Managing QMS Disparities Between Drugs And Devices For Combination Products

    Combination products represent a remarkable opportunity to extend the potential patient population for biologics and improve the delivery of drug therapies. This is one of the most dynamic segments in the life sciences , projected to grow to $115 billion by 2019.

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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

Electro-Mechanical Assembly Electro-Mechanical Assembly
Corry Micronics offers a wide variety of electro-mechanical assembly services, including...
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.

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.

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.

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.

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.

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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. 

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

  • Handheld Device Lets Patients “Test-Drive” Lens Implants
    Handheld Device Lets Patients “Test-Drive” Lens Implants

    A new handheld device may better equip patients in their decision-making process when choosing an intraocular lens (IOL) implant. The SimVis, developed by Spanish scientists, was tested with cataract surgery candidates, and researchers found patients had a clear preference for certain implants based on their experiences with the device.

  • "Interscatter" Tech Converts Bluetooth For WiFi-Connected Implants
    "Interscatter" Tech Converts Bluetooth For WiFi-Connected Implants

    Engineers at the University of Washington (UW) have devised a new method of wireless communication that converts Bluetooth transmission from mobile devices into Wi-Fi signals. Using this "interscatter" communications technology allows medical devices and implants with limited power sources to gain the ability to send data using low-power Wi-Fi signals to smartphones and smartwatches.

  • SeaSpine Acquires Israeli Spine Technology For Estimated 52.5M
    SeaSpine Acquires Israeli Spine Technology For Estimated 52.5M

    SeaSpine has acquired Israeli medtech NLT and its platform of minimally invasive fusion technologies for degenerative spine disease. SeaSpine CEO Keith Valentine remarked that the deal, potentially worth $52.5 million in cash and stock, marks the newly spun-off company’s commitment to innovation through acquisition.

  • Edwards First To Gain U.S. Approval Transcatheter Aortic Valves In Intermediate-Risk Patients
    Edwards First To Gain U.S. Approval Transcatheter Aortic Valves In Intermediate-Risk Patients

    Edwards Lifesciences has received from the U.S. Food and Drug Administration (FDA) expanded indication approvals for its Sapien 3 and Sapien XT transcatheter heart valves in intermediate-risk patients suffering from aortic valve stenosis. With the approval, Edwards brings significantly more patients into its captive transcatheter aortic valve replacement (TAVR) market, ahead of Medtronic and others.

  • European Commission Issues Guidance On Standalone Software As Medical Device Or IVD
    European Commission Issues Guidance On Standalone Software As Medical Device Or IVD

    The European Commission is offering guidance to define the criteria for the qualification and classification of standalone software used in a healthcare setting as a medical device or in vitro diagnostic (IVD).

  • Regenerative Bandage For Diabetic Foot Ulcers Mimics Natural Healing Process
    Regenerative Bandage For Diabetic Foot Ulcers Mimics Natural Healing Process

    A novel wound dressing for diabetic foot ulcers uses biomaterials science to compensate for the healing limitations experienced by diabetic patients.  Researchers from Northwestern University claim the “regenerative bandage” promotes healing four times faster than a traditional bandage, and promotes a more natural healing process, without unnecessary and dangerous side effects.

  • FDA Grants De Novo Clearance To Levita's Magnetic Gallbladder Surgery Device
    FDA Grants De Novo Clearance To Levita's Magnetic Gallbladder Surgery Device

    Levita Magnetics has launched a first-of-its-kind magnetic surgical system for gallbladder removal shortly after receiving de novo clearance from the U.S. Food and Drug Administration (FDA). The device is said to be so unique that FDA had to create a new category to accommodate this new technology.

  • Molex To Acquire Phillips-Medisize Corporation

    Molex, LLC, a global manufacturer of complete interconnect solutions, announced recently that one of its subsidiaries has entered into a binding agreement to acquire Phillips-Medisize Corporation, a global leader in outsource design, development and manufacturing services for the medical industry that is a portfolio company of San Francisco, CA-based Golden Gate Capital, a private equity investment firm with approximately $15B of capital under management.

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UPCOMING TRAINING COURSES

Cleaning Validation – Lessons Learned in the Trenches August 23, 2016
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Cloud Computing In A GxP Environment: Three Key Success Factors August 24, 2016
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Analyzing and Understanding ISO 13485 Proposed Changes August 30, 2016
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