FEATURED EDITORIAL

Liquid Biopsy: Market Drivers And Obstacles
Liquid Biopsy: Market Drivers And Obstacles

This article examines present and near-term opportunities for liquid biopsy, as well as what’s needed to elevate this innovative diagnostic tool to a standard of care.

  • The FDA, Device Cybersecurity, And What To Expect In 2019
    The FDA, Device Cybersecurity, And What To Expect In 2019

     The U.S. Food and Drug Administration’s Premarket Submissions for Management of Cybersecurity in Medical Devices draft guidance appears to draw inspiration from CaCPA and the EU’s General Data Protection Regulation (GDPR) – is the FDA merely a follower, or is it leading the way in medtech cybersecurity regulation?

  • “The 12 Months Of Quality:” Tips For Building A Voluntary QA Culture In 2019
    “The 12 Months Of Quality:” Tips For Building A Voluntary QA Culture In 2019

    Rather than 12 days of gifts, here are 12 months of suggestions to assist you in helping your organization bring its quality efforts and programs to the next level. As you think about where you want to be in 2019, consider these thoughts as strategies for building more credibility, cachet, and value around quality.

  • An Intro To Tools And Methodologies To Improve Change Management
    An Intro To Tools And Methodologies To Improve Change Management

    This is the first in a two-part article describes a change management model derived from the concept of co-creation, a process in which brands and consumers work together to create better ideas, products, and services. This first part discusses the tools and methodologies that provide a foundation for improving change management.

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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

Lab Testing And Sterilization Validation Services Lab Testing And Sterilization Validation Services

REVOX has put together a team comprising engineers, chemists, microbiologists, project managers, business consultants, and quality and regulatory professionals that are subject matter experts with strong expertise and experience in their fields. REVOX can work to enable sterilization technology to work to its fullest potential for medical devices. The company offers rapid 30-day sterilization development, materials and microbiological laboratory testing, supply chain optimization services, and regulatory development expertise.

HD Performance Handheld Infrared Camera: FLIR T1030sc HD Performance Handheld Infrared Camera: FLIR T1030sc

FLIR offers the new T1030sc Long-Wave Infrared Camera designed to capture images with 1024 x 768 pixels at 30 frames per second (fps). The camera provides high thermal sensitivity, fast raw data streaming, and a high speed interface (HSI) connection for streaming lossless HD radiometric imagery at 120 Hz or up to 480 Hz with windowing.

  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.

Graphics Inspection Systems for Packaging Graphics Inspection Systems for Packaging

Inspect digital artwork files and proofs pixel by pixel to an approved file to check for errors.

Low Volume Molding Low Volume Molding

PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.

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.

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FEATURED SUPPLIERS

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.

Donatelle Donatelle

Donatelle has been in business over 45 years providing medical device contract manufacturing services helping companies develop innovative and life-saving products. 

 EVENTS

Reimbursemnt and Contracting January 23 - 24, 2019
Philadelphia, PA
6th Annual Reimbursement and Contracting January 23 - 24, 2019
Philadelphia, PA
Drug Delivery Partnerships (DDP) January 28 - 30, 2019
Palm Beach Gardens, FL
Patients Registries & Real World Evidence Summit January 30 - 31, 2019
Miami, FL
4th Human Factors Engineering and Usabilities Studies Summit February 4 - 5, 2019
San Francisco, CA
PAP 2019 March 5 - 6, 2019
Baltimore, MD
IVT's Statistics in Validation March 6 - 7, 2019
Philadelphia, PA
Medical Device Validation Week March 12 - 14, 2019
Minneapolis, MN
Life Sciences Accounting and Reporting Congress March 20 - 22, 2019
Philadelphia, PA
15th Annual Pharma Forum 2019 March 24 - 27, 2019
New York, NY
20th Annual Computer and IT Systems Validation April 23 - 25, 2019
San Diego, CA
6th Annual FMV Congress May 1 - 2, 2019
Philadelphia, PA
5th Annual Endpoint Adjucation May 1 - 2, 2019
Philadelphia, PA
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