LEAD STORIES

Updating Your Quality Management System (QMS) For UDI

The Unique Device Identification (UDI) rule touches just about all parts of the FDA regulations for medical device makers. These are called conforming amendments, because they make the other parts conform to the concepts of the UDI rule. For example, complaints (820.198) and medical device reports (MDRs) (Part 803) need to include the UDI.

INDUSTRY PERSPECTIVES

  • Updating Your Quality Management System (QMS) For UDI
    Updating Your Quality Management System (QMS) For UDI

    The Unique Device Identification (UDI) rule touches just about all parts of the FDA regulations for medical device makers. These are called conforming amendments, because they make the other parts conform to the concepts of the UDI rule. For example, complaints (820.198) and medical device reports (MDRs) (Part 803) need to include the UDI.

  • The Importance Of Liquid Silicone Rubber In Medical Device Development
    The Importance Of Liquid Silicone Rubber In Medical Device Development

    Every product places demands on materials, but demands in the medical industry can be particularly stringent. When medical products and devices don’t perform as they should, the consequences can be serious, immediate, and costly.

  • 3D Printing For Medical Device Manufacturing: In-House Vs Outsourcing
    3D Printing For Medical Device Manufacturing: In-House Vs Outsourcing

    Over the past few years, 3D printing has been a hot topic in mainstream media. President Obama even discussed 3D printing during his 2013 State of the Union address, soon after the creation of the National Additive Manufacturing Innovation Institute (NAMII) in Ohio.

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ARTICLES

  • A New Approach To Contract Medical Device Manufacturing Relationships
    A New Approach To Contract Medical Device Manufacturing Relationships

    Contract manufacturing for medical devices is one of the fastest growing segments of the medical device industry. Why? Because in the race to bring new devices to market, device makers from the largest OEMs to small startups have found that it is more efficient to leverage the experience and facilities of outside organizations for device development rather than recruit, hire, and train people and purchase equipment and facilities.

Metal Injection Molding: A Cost Effective Alternative To Machining

Many design engineers and project managers know that metal injection molding can yield parts with complex shapes, outstanding strength, and excellent surface finishes. What they don’t know is that the technique is actually a cost-effective option for prototyping or low-volume production, particularly when compared to machining.

The Most Misunderstood Problem In Medical Injection Molding — And How To Solve It

Shear heating variations are a primary cause of numerous issues that are common when injection molding medical parts, including high scrap rates, weight and dimensional variation between cavities or between shots, long cycle times, warpage, and others. Yet more often than not these shear heating variations go unchecked, usually due to misunderstandings regarding shear heating in medical injection molding. This article will explain how shear heating develops, how it affects your parts, and how to control it to your advantage.

Wireless Dose-Compliance Monitoring In Drug-Delivery Devices

Incorporating wireless technology into medical devices is about more than just keeping up with the hottest technology trends; the benefits are real and significant, especially with regard to monitoring and encouraging dose compliance in the pharmaceutical and medical realm. Prior to embarking on the development of a wireless-enabled drug-delivery device, however, it is crucial to know what, specifically, the benefits are, and exactly what kinds of challenges and design considerations must be taken into account.

How To Overcome Interconnection Issues In High-Reliability Medical Electronics

Dovetail connectors are ideal for integration into high-reliability medical electronics for imaging, diagnostic, and therapeutic applications. Download the white paper to learn how their tolerance to shock and vibration, low insertion forces, high current ratings, high mating cycles, low contact resistance, and their configurable nature can help overcome interconnection complications encountered when connecting one element to another.

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FROM THE EDITOR

  • Companies To Watch: Novian Health
    Companies To Watch: Novian Health

    With its novel, laser-based technology, this early-stage company hopes to displace lumpectomy as the standard of care for eliminating breast tumors after early detection.

  • 3D-Printed Injection Molding: The Future Of Rapid Prototyping?
    3D-Printed Injection Molding: The Future Of Rapid Prototyping?

    3D printing has fundamentally changed the way medical devices are prototyped and tested; however, the technology can carry a product only so far into the development process, primarily due to material constraints. Injection molding (IM) can generate highly accurate prototypes in final production materials, but the process is not without its own drawbacks. Now, a hybrid prototyping process has emerged, offering medical device developers the best of both worlds — the speed and economy of 3D printing combined with the material and accuracy advantages of IM.

  • Development Of A Pathogen Inactivation System To Stop Ebola And Other Deadly Outbreaks
    Development Of A Pathogen Inactivation System To Stop Ebola And Other Deadly Outbreaks

    It wasn’t so long ago that the world was in an absolute panic over Ebola. One company that found itself smack in the middle of the global healthcare industry's response to Ebola was Cerus Corporation, maker of a technology that inactivates pathogens in transfused blood components. I recently had the pleasure of speaking with William “Obi” Greenman, the company's president and CEO. We discussed the Intercept system, the factors behind Cerus’ recent public stock offering, the modular premarket approval (PMA) pathway it used for Intercept, the story behind its Ebola involvement, and why it is uniquely positioned to help stop future infectious disease outbreaks.

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MED DEVICE INSIGHTS

Success in today’s medical device industry requires innovative ways of thinking about traditional and evolving problems. To this end, Med Device Online is pleased to bring you Med Device Insights, a new digital publication that imparts fresh perspectives and strategies from your peers and other thought leaders in the space. Our first issue includes original articles about:

  • A revolutionary new approach to rapid prototyping
  • The unintended consequences of new payment paradigms
  • Factors to consider when developing your India strategy
  • Using Internet-of-Things-style protocols for connected devices
  • Steps to identify the right clinical outsourcing partner
  • A company developing laser-based tumor ablation systems
  • And more...

Check out Med Device Insights today!

PRODUCT SHOWCASE

Medical Device Product Development

Medical Device Product Development

ProMed has been a contract manufacturer of custom implantable medical device components for over twenty years now. They offer materials selection analysis, cost analysis, prototypes in their specified material in five business days or less, reduced tooling costs, reduced qualification times, IQ, OQ, and PQ validations, and process failure mode and effects analysis (PFMEA).

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.

Custom Packaging And Pouching

Custom Packaging And Pouching

As demands in customer packaging and pouching grow in sophistication, ATL has kept pace by expanding our packaging capabilities. We have the engineering expertise to go beyond typical "cookie-cutter" type packaging modes in order to accommodate your one-stop supplier needs.

Semiconductor Technology for Implantable Medical Devices

Semiconductor Technology for Implantable Medical Devices

All mission critical functions are accessible within the MST group to provide miniaturized packages. Capabilities include design, substrate manufacturing, component selection and validation as well as all major semiconductor packaging processes.

Metal Injection Molding

Metal Injection Molding

Metal injection molding (MIM) is a mature and established metalworking process for creating fully dense, net-shape metal parts. The MIM process is economical and allows parts to be delivered much faster than traditional metal injection molding.

Insert Molding for Medical Devices

Insert Molding for Medical Devices

Insert molding techniques can streamline the production of your next medical device and eliminate the need for additional secondary operations. This type of molding can result in consistency, stability, the potential for reduced size and weight, and design flexibility.

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LATEST HEADLINES

  • Nikon Moves Into Medtech With $400M Acquisition Of Optos
    Nikon Moves Into Medtech With $400M Acquisition Of Optos

    Looking to expand into the medical technology sector, Japanese camera and optics company Nikon recently announced a takeover of UK-based retinal imaging firm Optos in a deal worth 259.3 million pounds, or approximately $400 million.

  • Boston Scientific Gains FDA Clearance For SpyGlass DS Direct Visualization System
    Boston Scientific Gains FDA Clearance For SpyGlass DS Direct Visualization System

    Boston Scientific announced FDA clearance for its SpyGlass DS Direct Visualization System, an updated version of their single-operator technology for examining bile and pancreatic ducts. The updates include better picture quality and several improvements that help simplify the procedure.

  • Paper-Based Test Diagnoses Ebola, Other Fevers In 10 Minutes
    Paper-Based Test Diagnoses Ebola, Other Fevers In 10 Minutes

    Using multicolored silver nanoparticles, a team from the Massachusetts Institute of Technology (MIT) recently developed a diagnostic device that can simultaneously test for several hemorrhagic fevers.

  • Pregnancy Test + Nanotechnology = Fast, Cheap Kidney Failure Test
    Pregnancy Test + Nanotechnology = Fast, Cheap Kidney Failure Test

    Scientists in the U.K. are developing a $15 device that could potentially diagnose kidney failure at home. The device combines the technology of a home pregnancy test with nanotechnology to provide fast results that could potentially link to a doctor’s office through mobile technology.

  • Cyberonics, Sorin Agree To $2.7B Merger And Relocation To U.K.
    Cyberonics, Sorin Agree To $2.7B Merger And Relocation To U.K.

    Houston-based Cyberonics announced plans for a $2.7 billion merger with Italian device maker Sorin S.p.A. that will relocate the base of operations for both companies to the U.K. The merger will combine Cyberonics’ neuromodulation expertise with Sorin’s portfolio of cardiovascular devices.

  • Superbug Victims File Suits Against Olympus For Injury, Wrongful Death
    Superbug Victims File Suits Against Olympus For Injury, Wrongful Death

    Attorneys for the victims of a superbug outbreak at a Los Angeles hospital have filed lawsuits seeking damages against the manufacturer of tainted duodenoscopes implicated in the outbreak.

  • Skin Test Could Lead To Earlier Alzheimer’s, Parkinson’s Diagnoses
    Skin Test Could Lead To Earlier Alzheimer’s, Parkinson’s Diagnoses

    Scientists have isolated a biomarker in the skin that could potentially help diagnose neurodegenerative diseases such as Parkinson’s and Alzheimer’s. Since the biomarker can be found in a skin biopsy rather than a more invasive brain biopsy, the test could shed additional light on the diseases and lead to an earlier pathological diagnosis.

  • Bionic Reconstruction Enables 3 Men To Replace Nonfunctioning Hands
    Bionic Reconstruction Enables 3 Men To Replace Nonfunctioning Hands

    Three Austrian men were the first to undergo a new “bionic reconstruction” procedure, which enabled them to use mind-controlled prosthetic hands. The patients all suffered from brachial plexus injury, which has been called an “inner neurological amputation” because it completely separates the hand from its owner’s control.

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UPCOMING TRAINING COURSES

Analyzing and Understanding ISO 13485 Proposed Changes

March 18, 2015
1pm-2:30pm EDT, Online Training

QSR Acceptance Activities: Avoiding The Top Regulatory Citations

March 26, 2015
1pm-2:30pm EDT, Online Training

Coping With Change – A Primer for Staff and Managers

March 31, 2015
1pm-2:30pm EDT, Online Training
More Upcoming Courses

FEATURED SUPPLIERS

Canon USA, Inc.

Canon USA, Inc.

Canon Optoelectronic Components, Integrating the Latest Technologies. Canon has been developing industrial components with super-high levels of precision and accuracys using its optical technologies gained and accumulated for over half a century.