Blogs
Changing from Gamma to E-Beam
May 21, 2013 2:38 pm | by Larry Nichols, COO, and Bob Starrett, CTO, NUTEK Corporation | NUTEK Corporation | CommentsOrdinarily, changing from a validated gamma sterilization process to E-beam sterilization requires running a dose mapping study and doing a dose verification study similar to a routine quarterly dose audit. The standard radiation validation requirements of ISO 11137 require that data be “available to show that, using the same sterilization dose, microbial inactivation is not affected by differences...
Preparing for Medical Electronics RoHS Compliance
May 20, 2013 2:33 pm | by George Karalias, Director of Marketing & Communications, Rochester Electronics | Rochester Electronics | CommentsNext July, certain medical electronics will fall under the scope of RoHS—the European Union’s Restriction on Hazardous Substances. In terms of the electronics industry, that is now a tight deadline for manufacturers. Medical devices that have so far been exempt from RoHS fall into scope under the RoHS Recast (RoHS 2) beginning in July 2014.
Addressing Health Data Security with Today’s Devices
May 17, 2013 3:13 pm | by Kasey Panetta, Managing Editor, ECN | CommentsWhile the advent of electronic health data offers impressive potential when it comes to treatment and diagnosis, it brings with it a host of security issues. The issue is cumbersome and often slow-moving regulatory bodies are scrambling to keep up with the quickly changing landscape of the medical world and they’re leaving a path of semi-regulation in their wake.
Remove the ‘Frankenstein Effect’ from Medical Devices
May 16, 2013 12:19 pm | by Bob Frostholm, Director of Sales and Marketing, JVD Inc. | CommentsNowhere is the concept of developing a system with ‘point-products’ more hazardous than in medical devices. It is here that the performance of every aspect of the system is critical to the long-term behavior of the end product. Interoperability between components takes on a whole new meaning in the context of critical care. Like Shelley’s monster, multiple devices from multiple suppliers will perform differently under identical conditions.
Changing the Status Quo for Implantable Devices
May 15, 2013 3:15 pm | by Derek Smith, Chief Commercial Officer, GHX | CommentsOn average, implantable devices account for 30 percent of total hospital supply spend, and make up 50 to 80 percent of the total cost for some procedures. Despite these large numbers, processes around managing and tracking these devices are rife with inefficiencies and revenue leakage.
Where Has All the Training Gone?
May 14, 2013 11:41 am | by Kathy Bellemare, Director of Human Resources, and Robert Allen, Director of Engineering, Tooling, and Metal Form, Connecticut Spring & Stamping | Connecticut Spring & Stamping | CommentsTraining is extremely important to the future of manufacturing in the United States, yet in many states, it has fallen by the wayside. Training for skilled manufacturing positions has been hit by a perfect storm of budget cuts and the mistaken idea that all young workers should go to college. What training exists has a near-exclusive focus on non-manufacturing skills.
Why Medtech Startups Are Moving to Ireland
May 13, 2013 2:33 pm | by Eddie Goodwin, Manager, Boston Office, Enterprise Ireland | CommentsIt’s no secret that getting a medical device to market can be a lengthy, frustrating process. Facing the new medical device excise tax and lack of clarity from the FDA around regulatory policies, medtech startups are now starting to rethink launching in the U.S.
Managing Medical Product Development Effectively: A Systems Engineering Approach
May 10, 2013 3:24 pm | by Jennifer Vondran and Richard Moroney, PA Consulting Group | CommentsFor companies involved in designing and developing medical devices and diagnostic instruments, adhering to design control principles at every stage is critical. This begins with the identification of user requirements (voice of the customer) and continues through verification and validation testing.
5 Ways to Turn a Medical Supply Chain into a Competitive Advantage
May 9, 2013 2:25 pm | by Greg Thompson, Vice President of Engineering, Sanmina | CommentsDesign engineers are charged with creating reliable, high quality, safe medical devices that easily (and quickly) pass U.S. FDA and other geographies’ regulatory requirements. Because of the unique challenges that a medical device OEM must overcome to stay competitive, more and more OEMs are choosing to outsource manufacturing.
From Wireless Age to Consumer Age
May 8, 2013 11:54 am | by Sean Fenske, Editor-in-Chief, MDT | CommentsWireless healthcare is upon us. Each day, it seems more devices and technology are becoming untethered or new capabilities are being added to wireless devices. No longer are the applications of wireless devices limited to patient monitoring, but rather an array of therapies are now available for treating patients at home or even on the go.
Much Ado About Nothing: The Impact of the Medical Device Excise Tax
May 7, 2013 3:19 pm | by Michael Lewis, Writer, Money Crashers Personal Finance | CommentsCritics of the new 2.3% medical device excise tax are hitting new heights with their claims of dire consequences. Conservative blogger and attorney Johnathan Emord blogged that the tax will "wipe out an entire industry," and further asserts that the tax is "one of the most draconian tax burdens in history." What are the facts? Is the industry overreacting?
The Future of Energy-Based Surgical Systems
May 6, 2013 2:43 pm | by Steven Walsh, Ph.D., VP of R&D, and Nikolay Suslov, Ph.D., EVP and CTO, Plasma Surgical | CommentsUnique energy-based surgical devices afford broad clinical use in the cutting, coagulation, and ablation of tissues using a high velocity jet of thermal plasma, and the PlasmaJet surgical system is one example of this medical device evolution. Plasma is formed when sufficient energy is added to remove outer electrons from a gas to form ions.
Error-Free Labeling—Accuracy, Traceability, and Compliance
May 3, 2013 11:43 am | by Warren Ward-Stacey, SVP of Global Sales, PRISYM ID | CommentsIn an era of intense media pressure, growing patient power, and escalating litigation, it is extraordinary that so many medical device recalls are due to labeling errors. After years of robust, highly compliant medical research and product design, ensuring the correct information is included with each device should be a given.
Laser-Structured, High-Performance Polymers are Ideal Combination for Miniaturization
May 2, 2013 3:12 pm | by Anthony Verrocchi, Technical Marketing Engineer, Ticona Engineering Polymers | Ticona Engineering Polymers | CommentsMiniaturization of medical devices is dependent upon the reliability of their assembled components, which is crucial for proper functioning devices. Miniaturization creates material challenges—especially in electronic medical device applications such as implantable cardiac devices.
Beyond 'Glocalization': Securing the Future for Medical Technology Innovation
May 1, 2013 3:08 pm | by Milind Purandare, Industry Principal, Medical Devices, Infosys | CommentsIt is a well-known fact that innovation is the true lifeblood of a medical device company. In an industry where approximately 80 percent of revenue for a medical device company comes from products introduced in the last five years, strategic growth requires continuous and efficient innovation.
