FEATURED EDITORIAL

Fixing Payment System Will Improve Access To Healthcare
Fixing Payment System Will Improve Access To Healthcare

To people who have understood the United States' healthcare payment dynamic, last week's news from the Mayo Clinic is not shocking. However, it is revealing, and the financing conditions that prompted Mayo’s decision must be factored into Obamacare, Trumpcare, or NextPresidentCare.

  • Cybersecurity: FDA Leads While CIA Leaks
    Cybersecurity: FDA Leads While CIA Leaks

    Ethical Intruder CEO David Kane shared with me recently his perspective on security challenges for medical devices, health IT, and hospitals - as well as strategies to overcome those challenges. 

  • Emerging Technologies And Price Cuts Push The Latin American Dental Implant Market Forward
    Emerging Technologies And Price Cuts Push The Latin American Dental Implant Market Forward

    With some marked regional differences, the Latin American market for dental implant fixtures and final abutments is evolving in response to emerging support technologies and competitive price pressures.

  • Sanmina’s Culture A Template For Medtech Growth
    Sanmina’s Culture A Template For Medtech Growth

    Having worked for two different device contract manufacturers, and having made decisions to outsource manufacturing to other contract manufacturers, I’ve had both good and bad experiences. Reflecting on one of my best experiences in outsourced medical device manufacturing, I reconnected with Tim McGinnis, VP of quality assurance and regulatory affairs for Sanmina’s medical division, to gain insight from his successes.

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INDUSTRY INSIGHTS

  • How Many FDA Premarket Applications Are Necessary For Your Combination Product?
    How Many FDA Premarket Applications Are Necessary For Your Combination Product?

    Often, an already-approved drug can further benefit patients when applied with a medical device. In such cases, the pharmaceutical product sponsor may utilize the 505(b)(2) pathway for regulatory approval of the combination product. But even when the regulatory pathway is known, submission strategies for regulatory approval of combination products can be challenging and confusing. The development and review of combination products in the U.S. typically requires the involvement of multiple centers within the Food and Drug Administration (FDA), under the oversight of the FDA’s Office of Combination Products (OCP).

Validation: A Key Stage In Mobile Health Development

To enter the rapidly growing mobile health space, companies must overcome the Mobile Health Development-crucial hurdle of validation. This process demonstrates that the app – in combination with the underlying technology platform / device – performs comparably to traditional products on the market..

IoT-Enabled Medical Devices Are The Wave Of The Future

Winning in the medical devices market of the future requires mastering advanced technologies – or finding a partner with these capabilities. The global Internet of Things (IoT) in healthcare market is forecasted to reach $410 billion by 2022. To succeed in this arena, device companies need to stay out in front of manufacturing innovations so they can quickly integrate information technology (IT) functionality into their products, accelerate time to market and control costs.

Using A Component Management Process To Scale Up Manufacturing Of Drug Delivery Devices

The best practice for fitting multiple parts into a single assembly at tight tolerances is to choose a single component supplier with a sufficient array of core competencies in advanced device manufacturing methods. The chosen supplier should also utilize a well-designed component management process that includes close attention to important elements, proper planning, and high performance levels to provide an affordable, highly scalable drug delivery device.

Segmentation Of The Diagnostics Market

The in vitro diagnostics (IVD) market is commonly segmented by techniques, products, application, end users, and geography. To better navigate the IVD diagnostic market landscape, understanding and recognizing how each segment is distinct, yet related to one another is critical for the company that wants to optimize its opportunities within this market.

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SOLUTIONS

Rapid Tooling And Medical Device Prototyping Rapid Tooling And Medical Device Prototyping

Donatelle’s rapid tooling and prototyping services help accelerate the design process and bring critical medical device products to market – faster. With an experienced team of engineers, mold designers, machinists, and toolmakers, they are able to produce near-net shape parts with near production tolerances, machined or molded, in as little as a few days.

Laser Beam Profilers Laser Beam Profilers

Laser beam profilers are the optimal solutions for increasing chances of success in the design or applications of new lasers, or when a laser system is no longer meeting the desired specifications. Ophir Photonics offers a wide range of beam profiler choices including CCD and CMOS cameras, scanning slit sensors, InGaAs and pyroelectric cameras, and pinhole and knife edge sensors.

Motion Control Products: Coreless Motors Motion Control Products: Coreless Motors

Canon’s coreless motors are part of the family of dc-motor products that are custom manufactured to achieve the exact speed, power, and currents required for OEM applications. These motors feature a small footprint, high power output, and a low moment of inertial that provides quick response rates and high controllability. They are ideal for many applications including cameras and pumps. Customization and other options are available on request.

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.

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.

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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.

Alconox, Inc. Alconox, Inc.

With more than 60 years of experience in formulation of quality aqueous cleaners, Alconox Inc. understands the cleaning needs of the medical device manufacturing industry including stringent FDA regulations and GMP compliance.

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LATEST HEADLINES

  • Connectivity – Key To Future-Oriented Medical Care
    Connectivity – Key To Future-Oriented Medical Care

    Phillips-Medisize’s stand 1E28 at Medtec Europe, Stuttgart/Germany, April 4th to 6th, 2017, is designed for medical device professionals to discuss future products – from the first idea through to engineered-in scalability and batch production respectively. Several display cases reveal a clear view of numerous medical, diagnostic and drug delivery devices. They serve the discussion partners – potential customers, OEM manufacturers and the experts from Phillips-Medisize – as illustrative material to determine the typical steps and processes from the first model component to the ready-for-use solution.

  • Blocking Certain Immune Cells Could Prevent Scar Tissue From Forming On Implants
    Blocking Certain Immune Cells Could Prevent Scar Tissue From Forming On Implants

    New research has shown that, by selectively blocking certain immune cells, scientists may be able to prevent the formation of scar tissue on implanted medical devices, which could substantially improve their biocompatibility and extend their functional use.

  • Wirelessly Powered Pacemaker Implanted In A Pig
    Wirelessly Powered Pacemaker Implanted In A Pig

    Advances in technology engineered at the National University of Singapore (NUS) and Stanford University have improved the efficiency of energy transfers of electromagnetic power through tissue, effectively powering a pacemaker implanted in an adult pig.

  • FDA Officials Make A Case For Re-Authorization Of User Fees Before Senate Committee
    FDA Officials Make A Case For Re-Authorization Of User Fees Before Senate Committee

    Top officials of the U.S Food and Drug Administration (FDA) testified before a Senate HELP (Health, Education, Labor, Pensions) Committee to stress the rationale for re-authorizing user fee programs designed to streamline regulation and speed access to innovative and lifesaving medical products.

  • J&J’s Ethicon Completes Torax Acquisition

    Ethicon* today announced the completion of its acquisition of Torax Medical, Inc., a privately held medical device company that manufactures and markets the LINX™ Reflux Management System for the surgical treatment of Gastroesophageal Reflux Disease (GERD).

  • BioStable’s Aortic Annuloplasty Device Gains FDA Clearance

    BioStable Science & Engineering, Inc. announced recently it has received FDA market clearance for the HAART 300 Aortic Annuloplasty Device, the first commercially available internal annuloplasty device designed for aortic valve repair. BioStable expects the HAART 300 Aortic Annuloplasty Device to be available to select U.S. heart centers in the summer of 2017.

  • FDA Delays Final Rule On Off-Label Promotion By One Year
    FDA Delays Final Rule On Off-Label Promotion By One Year

    The U.S. Food and Drug Administration (FDA) is suspending the effectivity of its final rule on off-label promotion for another year.

  • Minimally-Invasive Brain Imaging May Be Possible With Surgical Needles
    Minimally-Invasive Brain Imaging May Be Possible With Surgical Needles

    By substituting a glass surgical needle for the endoscope, a proof-of-concept study in mice has demonstrated technology that might lead to a minimally invasive method for imaging deep brain tissue, one that could provide a better understanding of neurological conditions.

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