LEAD STORIES
Scientists have filled ordinary ballpoint pens with a bio-ink that enables them to literally draw sensors on human skin to measure glucose levels. The research team says that the sensor technology shows potential for both clinical use by doctors and home use by patients.
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Prosthetic Leg Can “See” Where It’s GoingA team of engineers at Michigan Technological University announced plans to further develop its robotic ankle technology by adding an artificial vision system that could analyze visual information and adjust the user’s gait accordingly.
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Cardinal Health Acquires J&J’s Cordis For $1.94 BillionCardinal Health announced its acquisition of Johnson & Johnson’s (J&J’s) Cordis, a leading global manufacturer of cardiac and endovascular devices. The $1.94-billion deal is expected to be finalized at the end of 2015.
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Boston Scientific Buys Urology Assets Of Endo’s AMS For $1.6 BillionBoston Scientific recently announced the purchase of the urology portfolio of American Medical Systems (AMS), a subsidiary of Endo International.
INDUSTRY PERSPECTIVES
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Updating Your Quality Management System (QMS) For UDIThe 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.
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The Importance Of Liquid Silicone Rubber In Medical Device DevelopmentEvery 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.
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3D Printing For Medical Device Manufacturing: In-House Vs OutsourcingOver 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.
ARTICLES
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Optimize Low Volume, Non-Contact Liquid DispensingLaboratories charged with liquid analysis-based research will often encounter complications when attempting to dispense low microliter and nanoliter sized liquid droplets in their fluidic system set up. Parker Hannifin’s precision fluidics division recently developed a new type of syringe pump for low-volume, non-contact dispensing applications to overcome this very issue. Download the white paper to learn about this new technology and see if it can help you minimize your own low-volume liquid analysis applications.
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.
FROM THE EDITOR
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Companies To Watch: Novian HealthWith 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.
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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.
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Development Of A Pathogen Inactivation System To Stop Ebola And Other Deadly OutbreaksIt 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.
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...
PRODUCT SHOWCASE
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.
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.
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).
N Series Rugged Medical Connectors
The N Series of connectors are used in a variety of medical device and equipment applications like medical imaging, monitoring devices, and therapeutic equipment. The N Series is used in the most demanding of applications where the environment requires durability, ruggedization and extended operating life.
Medical Device Contract Manufacturing
Contract manufacturing for single-use medical devices is how Phase 2 got their start. They provide ultrasonic cleaning, injection molding, solvent and UV bonding, soldering, annealing, and more manufacturing services to both startup single-use medical device companies and larger-sized OEMs.
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.
LATEST HEADLINES
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Sensors You Can Draw: Measuring Glucose With Bio-Ink Tattoos Penned On The SkinScientists have filled ordinary ballpoint pens with a bio-ink that enables them to literally draw sensors on human skin to measure glucose levels. The research team says that the sensor technology shows potential for both clinical use by doctors and home use by patients.
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New Test Uses Immune “Hotspots” To Tailor Breast Cancer TreatmentUsing crime-lab statistical software, scientists have developed a breast cancer test that analyzes images of intense immune system activity.
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Using Magnets To Steer Instruments In Single-Incision SurgeryUsing a novel application of magnetic force, researchers from Vanderbilt University have developed minimally invasive surgical instruments that could be more effective and easier to use than current technology. By passing magnetic fields through tissue, the instruments can be operated without being physically manipulated, which could reduce the incisions required and improve function.
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Siemens Investigating Reports Of Fake Healthcare Equipment Deals In ChinaSiemens recently initiated an internal investigation into a Chinese media report that the company negotiated bogus healthcare deals with local distributors in China.
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Prosthetic Leg Can “See” Where It’s GoingA team of engineers at Michigan Technological University announced plans to further develop its robotic ankle technology by adding an artificial vision system that could analyze visual information and adjust the user’s gait accordingly.
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TÜV SÜD Japan Authorized To Conduct Marketing Certification For Class III Medical Devices
TÜV SÜD Japan Ltd. is now authorised to provide marketing certification services for designated Specially Controlled Medical Devices (Class III medical devices).
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Cardinal Health Acquires J&J’s Cordis For $1.94 BillionCardinal Health announced its acquisition of Johnson & Johnson’s (J&J’s) Cordis, a leading global manufacturer of cardiac and endovascular devices. The $1.94-billion deal is expected to be finalized at the end of 2015.
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Boston Scientific Buys Urology Assets Of Endo’s AMS For $1.6 BillionBoston Scientific recently announced the purchase of the urology portfolio of American Medical Systems (AMS), a subsidiary of Endo International.
FEATURED SUPPLIERS
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.