FEATURED EDITORIAL

Innovation Woes, Or: How I Learned To Stop Worrying And Love My Failed Device
Innovation Woes, Or: How I Learned To Stop Worrying And Love My Failed Device

Viewed at a high level, a large proportion of the medical device market is commoditized (think bandages and IV bags). However, there is a great deal of innovation going on, with exciting new technologies debuting across a wide range of product categories. Understanding how these technologies are differentiated from previous iterations allows us to forecast their likely impact on their respective markets.

  • EU MDR and Clinical Evidence: What You Need to Know
    EU MDR and Clinical Evidence: What You Need to Know

    The Council of the European Union has adopted the European Medical Device Regulations (MDR 2017/745), which were published in the Official Journal of the European Union and entered into force on May 26, 2017. Are you ready?

  • The 5 Most Common Problems With Your CAPA Process
    The 5 Most Common Problems With Your CAPA Process

    The FDA requires medical device manufacturers to have clearly documented procedures for corrective action and preventive action (CAPA). Unfortunately, many medical device companies fail to prepare a good approach to their CAPA process, which is so important to the health and success of your company.

  • FDA Registration for CMOs – Still Crazy After All These Years
    FDA Registration for CMOs – Still Crazy After All These Years

    Let’s face it: manufacturing in a regulated environment is more expensive than commercial manufacturing. With all due respect to the venerable prowess of medical device manufacturing professionals, even a lean, mean, 5S, Six Sigma, 8D machine cannot offset the cost created by a plethora of requirements, guidance documents, and standards.

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INDUSTRY INSIGHTS

  • Improving Health Outcomes With Personalized Apps
    Improving Health Outcomes With Personalized Apps

    Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs.

Micro-MIM Succeeds At Making Precise Micro Metal Parts

As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.

Plan For Success With Sustaining Engineering In Medical Device Development And Manufacturing

Sustaining engineering enables the developer to plan ahead, getting the development and design of the device done right the first time, and smoothing the transition to manufacturing. KMC's executive director of engineering, Scott Leon, weighs in on the subject.

How To Uncover The Hidden Value Of Culture In Supplier Selection

The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.

Taking Micromolding To the Next Level

Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production. 

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SOLUTIONS

Wearable Solutions For Continuous Health Monitoring Wearable Solutions For Continuous Health Monitoring

Wearable medical technologies allow for continuous health monitoring in the home so that patients can conveniently chart their wellness or progress electronically. Designers and engineers of high-tech medical devices have to consider the human skin interface during product development, not just as the last step before market. 3M has the expertise available to assist wearable medical technology manufacturers with selecting the right materials that work well with the human skin interface.

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.

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.

Hydrogels For Medical Devices Hydrogels For Medical Devices

Cardinal Health’s OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.

FluoroPEELZ™ Peelable Heat Shrink FluoroPEELZ™ Peelable Heat Shrink

Zeus offers the FluoroPEELZ™ peelable heat shrink designed with quick and easy peel away capabilities to improve product efficiency and safety, and to accelerate catheter production.

  PolyJet 3D Printing Services PolyJet 3D Printing Services

Proto Labs is proud to introduce PolyJet technology to their 3D printing capabilities. PolyJet technology is used to provide designers and engineers with the ability to manufacture elastomeric and overmolded prototypes without investing in tooling. This technology can create 3D-printed parts comprising both elastomeric and rigid materials, as well as multiple colors.

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FEATURED SUPPLIERS

MTD Micro Molding MTD Micro Molding

MTD is a focused micro medical device manufacturer that’s built for high performance in one area: the micro molding of advanced medical products. Our experienced team will consult with you to help you refine and develop your design, using the most advanced materials and micro molding technology. We’re here to help our customers it right – from design through production – so companies can produce a high quality device, and get it to market quickly.

Ophir Photonics Ophir Photonics

Ophir Photonics, a Newport Corporation, began making laser power meters, energy meters, and beam profilers in 1979, and we’ve never looked back. We have headquarters in the United States, Israel, Japan, and Germany, as well as distributors in over 50 countries worldwide.

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 EVENTS

1st Emirates Family Medicine Society Conference January 11 - 13, 2018
Dubai, UAE)
Pre-Filled Syringes Europe January 17 - 18, 2018
London)
The New Medical Device Reporting (MDR) Guidance – An Easily Digestible Compliance Breakdown January 25, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Medical Devices Summit March 26 - 27, 2018
Boston, MA)
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