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Organ Printing, Regulation in the Spotlight on MDT Live

March 27, 2015 | by Megan Crouse, Real Time Digital Reporter, @abmdigi | Comments

3D printing for medical devices is still a wild frontier without thorough regulation, which can both make building a product difficult and can spur innovation. Three experts sat down with Editor-in-Chief Sean Fenske this week to talk about...

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New Pumps and Valves Take the Pain Out of Designing Anesthesia Support Devices

April 1, 2015 11:20 am | by Richard N. Whipple, Marketing Communications Manager, & Jonathan DeSousa, Division Applications Team Supervisor; Precision Fluidics Division, Parker Hannifin Corp. | Parker Hannifin Corporation | Comments

Most next-generation medical devices are getting smaller and more portable to meet the needs of an ever changing hospital environment. But while device sizes are decreasing to help reduce weight and facilitate portability, device performance...

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3D Printing a Smile on Your Face

March 31, 2015 10:20 am | by Kaylie Duffy, Associate Editor, PD&D, @kaylieannduffy | Stratasys, Inc. | Comments

Although additive manufacturing equipment and materials have been around since the early 1980s, 3D printing didn't become common knowledge to much of the public until two decades later. Today, the applications for this technology seem almost...

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4 Best Practices to Keep Pace with Rapid Healthcare Software Development

March 30, 2015 10:45 am | by Eugene Borukhovich, VP of Healthcare, European Markets, SoftServe, Inc. | Comments

Fueled by advances in computing, wireless technologies, data warehousing, and analytics science—combined with the widespread adoption of smart devices, cloud computing, and SaaS information models—all markets and industries are under pressure...

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7 Criteria to Improve Reprocessed Medical Device Instructions

March 23, 2015 10:59 am | by Emily Mitzel, Consulting Manager; Alpa Patel, Senior Scientist; and Nick Workman, Study Director; Nelson Laboratories | Nelson Laboratories, Inc. | Comments

When it comes to the reprocessing of medical devices in the healthcare facility, simple is better. For decades, reusable medical devices have been used to enhance the health and well-being of patients undergoing medical procedures. Reprocessed...

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Safe Power for Medical Devices Used at Home

March 20, 2015 11:25 am | by Diane Cupples, Vice President of Marketing, Schurter Inc. | Schurter, Inc. | Comments

An aging population and the rising cost of healthcare around the world are a matter of concern to the general public these days. This is especially true in the U.S.A., where keeping costs under control becomes more and more challenging. In order...

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Models Add Efficiency to Bioabsorbable Implant Development

March 19, 2015 11:01 am | by Abhay Bulsari, Owner/Technical Manager, Nonlinear Solutions Oy; Kimmo Lähteenkorva, R&D Manager, ConMed Corp.; and Esa Suokas and Mikko Huttunen, Senior Scientists, ConMed Linvatec Biomaterials Oy | Comments

Product development of orthopedic bioabsorbable implants requires the knowledge of the dynamics of bioabsorption. Bioabsorption is simulated in vitro by hydrolysis experiments. Several variables including shear and bending strength, mass...

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3 Tips for a Successful Outsourced Device Launch

March 18, 2015 11:21 am | by Tom Nadal, Director of Business Development, CleanCut Technologies | CleanCut Technologies | Comments

Whether you’re a seasoned medical device professional or a recent grad stepping into your first full-time position in marketing, engineering, operations, quality, or regulatory at a medtech OEM, chances are you’ll be a contributing member...

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Coating Success Depends on More Than Material Selection

March 16, 2015 11:10 am | by Tim Kissling, Owner & President, Precision Coating Technology & Manufacturing Inc. | Precision Coating Technology & Manufacturing, Inc. | Comments

Many medical device designers have worked with coatings suppliers to identify the right material for an application, but have later encountered unforeseen issues that result in higher costs, production delays, and sometimes, even product...

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Photo Etching: Stimulating Innovation in Medical Product Design

March 13, 2015 11:26 am | by Albert Tsang, Technical Manager, Precision Micro | Precision Micro, Ltd. | Comments

Across industry, there is a concerted and accelerating trend towards miniaturization, and nowhere more so than in the medical device sector, where demand for minimally invasive diagnostic and treatment devices is growing exponentially...

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Improved Development Processes and Compliance with Cloud-Based PLM

March 12, 2015 11:44 am | by Alaine Portnoy, Director of Marketing, Omnify Software | Comments

LoneStar Heart, Inc., based in Laguna Hills, Calif., is developing cardiac restorative therapies for patients with heart failure that harness the heart’s ability to repair itself. Based on its integrated cardiomechanical and biomolecular...

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Hearing Aids Tune into a Wireless World

March 11, 2015 11:25 am | by Aidan Moore, Applications Engineer, ON Semiconductor | Comments

These are exciting times for hearing aid technology. If you haven’t looked at what’s available in hearing aids recently, you may be surprised to find a level of sophistication that was missing in previous generations. In fact, an increasing...

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Automating SOP Management Helps Medical Device Manufacturers Avoid Risk

March 10, 2015 11:23 am | by Mika Javanainen, Senior Director, Product Management, M-Files Corporation | Comments

Medical device manufacturers must comply with increasingly strict compliance requirements in order to sell products in the United States. The Current Good Manufacturing Practices (cGMP) and Quality System regulations (21 CFR Parts 211 and 820)...

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Medical Device Designers' Guide to FDA’s Substantial Equivalence

March 9, 2015 11:15 am | by Quynh Hoang, Lynette Zentgraft, Senior Regulatory Experts; Elaine Tseng, Partner, King & Spalding | Comments

A Premarket Notification or “510(k)” submission is the most common pathway by which medical devices receive authorization to enter the U.S. market, with over 3,500 510(k)s submitted to the U.S. Food and Drug Administration (FDA) yearly. FDA...

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5 Key Benefits of Using Rapid Prototyping for Product Design & Development

March 6, 2015 10:38 am | by Nikunj Patel, Design Engineer, Hi-Tech CADD Services | Comments

One of the prominent challenges that product designers face, is not having the ability to make clients or in-house management staff to realize how the product will look and feel actually. Despite the possible advancements in 3D CAD technologies...

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A Look Ahead: 3D Printing for Final Device Manufacture

March 5, 2015 8:30 am | by Clive Nicholls, Product Design & Development Manager, Owen Mumford | Comments

The applications of 3D printing in the medical industry will continue to grow throughout 2015 and beyond. Recent research by SmarTrech shows that by 2020 the number of 3D printers being shipped annually for medical use will have almost...

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