FEATURED EDITORIAL

“We Are Only Diabetes”
“We Are Only Diabetes”

Medical device companies often face difficult choices regarding their products, from design tweaks and regulatory red tape to determining whether to solve needs in-house or outsource.One uniquely difficult decision, though, is whether to diversify — and how much — or to specialize.

  • Reviewing FY2017 FDA 483s: Training Failures Or A Learning Paradigm?
    Reviewing FY2017 FDA 483s: Training Failures Or A Learning Paradigm?

    How do we act on the data of previous 483s? What do we do with that data? Similar to the annual product reviews, we gather data on FDA observations, make graphs, and then … file it away. But there is an alternative.

  • A Regulatory Perspective: FDA Final Guidance For Design Changes Requiring New 510(k) Submissions
    A Regulatory Perspective: FDA Final Guidance For Design Changes Requiring New 510(k) Submissions

    In response to technological advancements, broadening medical knowledge, and clinical use, medical device designs frequently evolve and come in many forms. Designs often change in response to industry pressure for increased customer satisfaction and device safety, maximized performance, maximized manufacturability, and cost efficiencies.

  • The Medical Device Excise Tax Is A Disaster!
    The Medical Device Excise Tax Is A Disaster!

    Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), recently issued a statement in response to President Trump’s State of the Union Address, "While the passage of an additional two-year suspension of the medical device tax is a recognition of how important it is to bolster America’s leadership position in this industry, Congress must permanently repeal this disastrous policy in order to fully realize the long-term investments in patient care and job creation that are critical to growth.” Did he really say – disastrous? Oh yes he did!

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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

Optical Thickness Gauge: 157 Series Optical Thickness Gauge: 157 Series

The Model 157 optical thickness gauge uses proven optical interferometer technology to measure the absolute thickness of specialty plastic films, medical membranes, and ophthalmic products.

  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.

Flexible Electronic Assemblies For Medical Ultrasound Imaging Flexible Electronic Assemblies For Medical Ultrasound Imaging

Micro Systems Technologies (MST) offers an array of highly reliable flex circuit assembly solutions for ultrasound imaging used in diverse medical diagnostic areas. From 1D to 3D and beyond, the advanced flexible electronic assemblies deliver enabling capabilities in PCB manufacturing and assembly technologies.

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.

Solid-State Silicon Photomultipliers (SiPM) For Near-Ultraviolet or Red, Green & Blue Light Detection Solid-State Silicon Photomultipliers (SiPM) For Near-Ultraviolet or Red, Green & Blue Light Detection

First Sensor offers a new series of innovative solid-state silicon photomultipliers (SiPMs) that are designed to detect ultra-low light levels down to single photons. These detectors are optimized for near-ultraviolet (Series SiPM-NUV) or red, green, and blue (Series SiPM-RGB) light detection with peak sensitivities at 420 nm or 550 nm. Key features include a low operating voltage, high gain and low noise, and immunity to magnet fields.

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. 

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FEATURED SUPPLIERS

FMI, Inc. FMI, Inc.

FMI is dedicated to producing medical-grade silicone components for Class II and Class III medical devices. In fact, custom silicone moldings are the only products we manufacture and health care is the only industry we serve. That singular focus allows us to provide the highly customized components that medical device manufacturers depend upon for patient safety, efficacy and reliability.

Cardinal Health, Inc. Cardinal Health, Inc.

Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, health systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide.

The company provides clinically-proven medical products and pharmaceuticals and cost-effective solutions that enhance supply chain efficiency from hospital to home. Cardinal Health connects patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management.

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 EVENTS

Mock Regulatory Inspections: How to Get the Most Bang for Your Buck February 22, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
FDA Regulations for Analytical Instrument Qualification and Validation: Comprehensive Best Practices March 1, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Authoring and Implementing Standard Operating Procedures (SOPs): Best Practices for Success March 6, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Clinical Study Requirements – Understanding Differences Between the US and EU March 7, 2018
1pm-2:30pm EST, Online Training)
Price:  $299 - Includes Bonus Handouts!
Quality Agreements & FDA – What You Must Know to Comply with the 2016 Final Guidance March 13, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Right to Try Legislation: Impact on Industry, Health Authorities, and Patients March 14, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Monitoring Medical Device / ISO 14155 GCP March 15, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response March 20, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
The Value of The Medical Affairs Organization – A Comprehensive Overview March 21, 2018
1pm-2:00pm EDT, Online Training)
Duration:  60-Minutes
Price:  $199 - Includes Bonus Handouts!
Medical Devices Summit March 26 - 27, 2018
Boston, MA)
Cleaning Validation – Lessons Learned in the Trenches March 28, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Pre-Filled Syringes East Coast April 11 - 12, 2018
Boston, MA)
Building a Best in Class Medical Affairs Organization: Strategies for Success April 18, 2018
1pm-2:00pm EDT, Online Training)
Duration:  60-Minutes
Price:  $199 - Includes Bonus Handouts!
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