FEATURED EDITORIAL

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.

  • A Guide to Developing Usable Instructions For Use For Medical Devices
    A Guide to Developing Usable Instructions For Use For Medical Devices

    Medical devices can be complex and may require users to understand specific information about storage, use, disposal, or reprocessing. Instructions for use (IFU) are therefore considered part of the product user interface. Here are some critical factors to consider when developing effective IFUs.

  • Solving Spinal Surgery’s “I Need A Third Hand” Dilemma
    Solving Spinal Surgery’s “I Need A Third Hand” Dilemma

    Facet joints are the joints between your vertebrae that guide your spine’s movement. About 10 percent of adults suffer from chronic back pain and 31 percent of those cases have facet joint involvement. There are several treatment options available including radio frequency ablation. Innovations in treatment devices are allowing providers to have a "third hand" during this procedure.

  • Skeletal Wonder From Down Under
    Skeletal Wonder From Down Under

    What a perfect day to talk about skeletons! What is a skeleton without a sternum and some ribs? A skeleton without a sternum and some ribs represents a person who may benefit from technologies by Melbourne, Australia-based medical device company Anatomics.

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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.

Metal Additive Manufacturing Metal Additive Manufacturing

PTI offers metal additive manufacturing to improve productivity and quality for sinks, over-long cycles, and the so called ‘impossible’ cooling challenges. PTI uses a power bed fusion process aided by 3D data that supplies a thin layer of metal powder to the machine base plate. Designers then use a laser beam to sinter the metal powder to form shapes, allowing creation of designs not possible with the subtractive manufacturing process.

Medical Device Prototyping & Design Services Medical Device Prototyping & Design Services

Carclo's product engineers have multiple years of experience with medical device prototyping and design. They address your medical device design needs by getting involved as early in the product prototype and design cycle as possible.

Standard Solutions and Containers Standard Solutions and Containers

B. Braun provides an array of parenteral pharmaceutical solutions, including those for use in standard IV, irrigation, nutrition, and anti-infective therapy applications. The EXCEL® and PAB® containers and the DUPLEX Drug Delivery Systems feature biologically inert, PVC-Free and DEHP-Free, non-toxic plastic construction for a safe and accurate method of administering IV medication.

Medical Device Supply Chain Management (Metals, Electronics) Medical Device Supply Chain Management (Metals, Electronics)

At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.

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.

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FEATURED SUPPLIERS

The Lee Company The Lee Company

The Lee Company is a leading supplier of miniature, precision fluid control products to a wide range of industries including medical devices and scientific equipment.

Zeus Zeus

We were among the first to work in the arena of minimally invasive techniques for revolutionary procedures such as neuromodulation. Our PEEK drawn fiber offers a non-metallic replacement for stainless steel. And when a major aircraft manufacturer needed an immediate design change on a harness assembly, Zeus delivered in record time.

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 EVENTS

Medical Plastics & Compounding Conference December 5, 2017
San Jose, CA)
Companion Diagnostics Forum (CDx) 2017 December 6 - 7, 2017
Princeton, NJ)
Data Integrity: Why Not Identifying Repeat Defects In Your Data Is Killing Your Performance December 7, 2017
1:00 PM - 2:00 PM EDT)
Duration:  60 Minutes
Price:  $299 – Includes Bonus handouts
1st Emirates Family Medicine Society Conference January 11 - 13, 2018
Dubai, UAE)
Pre-Filled Syringes Europe January 17 - 18, 2018
London)
Medical Devices Summit March 26 - 27, 2018
Boston, MA)
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