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

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.

In Vitro Diagnostics

Battelle brings together deep experience in bioinformatics, biologics, chemistry and related fields to deliver innovative in vitro technologies with unparalleled accuracy and detection limits — all at unprecedented speed and with significant cost savings.

Medical Micromolding Medical Micromolding

The margin for error when it comes to critical components for medical device manufacturing is zero. That's why Accumold ensures robust production processes, extremely tight requirements, and part-to-part consistency. 

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.

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.

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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. 

FLIR Systems, Inc FLIR Systems, Inc

The largest commercial infrared company in the world, FLIR has nearly 50 years of experience building and integrating high-performance infrared cameras. FLIR cameras play pivotal roles in a wide range of industrial, commercial, and government activities in over 60 countries.

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LATEST HEADLINES

  • 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.

  • Medtronic’s Updated Evolut Pro TAVR Gains FDA Approval

    Medtronic plc recently announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the CoreValve Evolut PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. 

  • Siemens Healthineers Combines CT Technology With HeartFlow’s Non-Invasive CAD Diagnostic
    Siemens Healthineers Combines CT Technology With HeartFlow’s Non-Invasive CAD Diagnostic

    Future generations of Siemens Healthineers’ computed tomography (CT) machines will include the only commercially available diagnostic tool capable of collecting fractional flow reserve (FFR) data for coronary artery disease (CAD) non-invasively. 

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