Posts Tagged ‘device’
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New York, US (PRWEB) July 19, 2012
The primary reason for translating packaging for medical devices and diagnostics to be sold overseas is to ensure that the products can be used safely and as intended. Many medical devices and diagnostics businesses are now embarking upon translation projects to take advantage of the huge demand in regions such as Asia, South America and Africa.
Datamonitor predicts that by 2015, the global healthcare equipment and supplies market will be worth $ 370.7 billion, which is up 13.4 percent from the industrys value in 2010. Although the US still accounts for 45 percent of this market, there are several growing markets in emerging economies such as the BRIC nations and Africa. Therefore, it makes economic sense for healthcare and medical device firms to carefully translate the packaging and documentation of their products to a range of languages whether it is Portuguese, French, Cantonese or Hindi.
Proper translation is a vital part of the process of bringing medical products into foreign markets. Whether it is a consumer buying a device such as a hearing aid, a nurse administering an infusion pump or a surgeon implanting a stent, they preferably need to be able to read the packaging and directions in their own language. Medical device firms cannot afford mistakes in terminology in the translation process and the same can be said for medical diagnostics companies. Accurate translation is essential and cannot be compromised.
Medical device firms entering new markets do find that they are faced with growing regulatory pressures and this is where working with a qualified language services provider can help. The US Food and Drug Administration is keen to stress the importance of accurate and high-quality translation of medical device packaging. It states that medical device firms should work on, establishing and maintaining design transfer procedures that insure that the package design is correctly translated into production specifications.
It also asserts that manufacturers of other Class I devices should establish and maintain procedures for ensuring that their device design is correctly translated into production specifications.
In light of the regulatory demands and the pressure to constantly accelerate time-to-market for medical devices and diagnostics products, working with a language services provider with expertise in the medical device field can help. Translating medical device and diagnostics packaging is a high-risk activity that requires a huge level of expertise and experience to ensure best practice is observed. With short product-development cycles and increasing time pressures, medical technologies manufacturers cant risk putting speed above quality. Inaccurate and faulty translation could lead to expensive product recalls or liability cases.
Working with a qualified language service provider that holds internationally recognized quality standards, including ISO 13485:2003 and 14971:2007 certifications, is an effective way to reduce exposure when embarking upon a medical device, diagnostics and related services translation project. Merrill Brinks medical devices and diagnostics translation services offer a world-class, end-to-end solution that ensures medical device firms can get their products to new markets accurately and within budget.
Merrill Brinks translation professionals are subject matter experts with experience in translating medical device and diagnostics packaging. They have linguists with expertise in diverse subjects such as vision care, orthopaedics, neurology, urology, vascular surgery and cardiology – equipping them with the background knowledge necessary to produce accurate translations of even the most complex and technical medical terminology.
About Merrill Brink International
Merrill Brink International (http://www.merrillbrink.com) is a leading provider of complete translation and language solutions for global companies and law firms, with special expertise in serving the legal, financial, life sciences, software, heavy machinery and corporate markets. A proven leader with more than 30 years of experience, Merrill Brink offers a wide range of language solutions including translation, localisation, desktop publishing and globalisation services.
Merrill Brink is recognised in the industry for its commitment to quality and its pioneering approach of leveraging technology to reduce costs, eliminate redundant processes and accelerate translation life cycles. Merrill Brink is certified to ISO 9001:2008; ISO 27001:2005 and ISO 13485:2003, and registered to EN 15038:2006 and ISO 14971:2007. Together, these standards provide assurance that the most stringent process and quality standards for translation are followed. Merrill Brink International is a wholly owned subsidiary of Merrill Corporation.
For more information, please contact Merrill Brink at eurosales(at)merrillbrink(dot)com or in Europe, call 353-(0)91-393000 or in the U.S., call 800-688-4400; Web: http://www.merrillbrink.com
For full text: http://www.merrillbrink.com/packaging-translation-for-the-medical-device-and-diagnostics-07162012.htm
Follow us on Twitter: @merrillbrink
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A Covidien device for rare malformed blood vessels can get stuck in the brain and has been linked to nine patient deaths, U.S. regulators warned.
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North Chelmsford, MA (PRWEB) May 21, 2012
Bleck Design Group, an award-winning industrial design and engineering firm, will showcase examples of its medical product design and development capabilities at MD&M East expo booth 427 during May 22-24, 2012. There will be innovative home health products, minimally invasive surgical instruments, and patient monitors designed by Bleck Design Group as well as examples of business equipment and consumer electronic product design.
Bleck Design Group, founded by James Bleck in 1983, designs products for clients in a wide range of industries: including medical devices, business equipment, computer/telecom, and consumer products. Its team of industrial designers and mechanical engineers has earned over twenty international awards for design excellence, including two prestigious Design of the Decade Awards from BusinessWeek/IDSA.
This MD&M event is a particularly great venue for connecting with contacts in the medical device industry, said Jim Bleck, president of Bleck Design Group. I look forward to discussing new projects, our medical product design capabilities, and current product development trends. We are excited to share how we apply our business equipment design experience to create easy-to-use electronic home healthcare products, as well as discuss the advantages of using Android tablet and phone technology in new product development.
For additional information about Bleck Design Groups product design capabilities contact Jim Bleck at 978-251-7474 x223 or 508-932-4233 or visit http://www.bleckdesigngroup.com.
About Bleck Design Group:
Bleck Design Group is an award-winning product design and development firm based in North Chelmsford Massachusetts. For over 25 years, their industrial designers and mechanical engineers have created iconic designs for visionary leaders at both small and large medical device, business equipment and consumer product companies. They have a proven track record of working with clients to provide seamless product development from concept to production.
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Los Angeles, CA (PRWEB) April 15, 2012
The Medical Device Manufacturing industry has enjoyed strong revenue growth recently and is forecast to continue expanding in the years ahead. Since 2007, revenue increased at an average annual rate of 12.8%, and sales are expected to grow 7.4% in 2012 alone, to $ 64.7 billion. The US economic downturn did little to deter hospitals and other customers from purchasing medical devices, according to IBISWorld industry analyst Nima Samadi. In fact, more industry companies gained sales in 2008 and 2009 than lost them. The aging US population is a major factor driving demand, as the occurrence of health issues that require medical devices is higher in the elderly population. This demographic is forecast to expand further as a percentage of the total population during the five years to 2017, which will help maintain industry growth.
But revenue in the Medical Device Manufacturing industry will not grow as quickly over the five years to 2017. The changing regulatory environment will be the main hindrance, Samadi said. For example, the Patient Protection and Affordable Care Act of 2010 will place an excise tax on medical devices, eating into revenue and reducing profit. Also, potential reform to the approval process for new devices will likely hamper innovation and encourage more companies to shift functions overseas.
Foreign outsourcing of manufacturing, research and development and other operations, combined with industry consolidation, is forecast to decrease the number of industry operators during the next five years. This industry has traditionally had a low level of industry concentration, with no one firm dominating. Small operators are common in this type of industry, and typically specialize in developing technology and products for a niche area. Larger players frequently seek to acquire these firms to expand their product range or gain access to a particular technology. But during the five years to 2012, consolidation has swept the industry, with the number of companies decreasing at an average annual rate of 5.5% to total 828. Meanwhile, emerging markets like China and Brazil will attract medical device manufacturers, as US customers face more stringent Medicare reimbursement requirements and other cost-cutting pressures. For more information, visit IBISWorlds Medical Device Manufacturing report in the US industry page.
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IBISWorld industry Report Key Topics
This industry includes manufacturers of electromedical and electrotherapeutic apparatus, such as magnetic resonance imaging equipment, medical ultrasound equipment, pacemakers, hearing aids, electrocardiographs and electromedical endoscopic equipment. The industry also manufactures irradiation apparatus and tubes for applications such as medical diagnostic, medical therapeutic, industrial, research and scientific evaluation.
Key External Drivers
Industry Life Cycle
Products & Markets
Products & Services
Globalization & Trade
Market Share Concentration
Key Success Factors
Cost Structure Benchmarks
Barriers to Entry
About IBISWorld Inc.
Recognized as the nations most trusted independent source of industry and market research, IBISWorld offers a comprehensive database of unique information and analysis on every US industry. With an extensive online portfolio, valued for its depth and scope, the company equips clients with the insight necessary to make better business decisions. Headquartered in Los Angeles, IBISWorld serves a range of business, professional service and government organizations through more than 10 locations worldwide. For more information, visit http://www.ibisworld.com or call 1-800-330-3772.
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New York, NY (PRWEB) March 27, 2012
Bernstein Liebhard LLP reports on new legislation proposed by Representative Edward Markey (D-MA) which will alleviate concerns and reform the 510(k) loophole in the U.S. Food and Drug Administrations (FDA) approval process for medical devices.* Currently, medical device manufacturers can utilize the 510(k) process to receive market approval for devices such as surgical mesh without having to undergo rigorous clinical testing by claiming that the devices are substantially similar to prior versions, even if the prior versions have been recalled.** The new bill, Safety of Untested and New Devices (SOUND) Act, would give the FDA authority to request documentation from manufactures to demonstrate that a new products design has addressed and fixed potential problems if it is based on a prior version with safety issues. During a press conference on March 22, 2012, Representative Markey cited vaginal mesh complications stemming from transvaginal surgical mesh devices, which were approved under the current system, to support his calls for reform. According to the Boston Globe, Markey said in an interview following the briefing that he hoped the legislation would be added to a larger bill about medical devices that Congress is set to vote on at the end of May. [The] loophole in our current law actually requires the FDA to approve certain kinds of medical devices even if they have reason to believe [the devices] may harm or even kill patients, Markey said.
In light of this latest development, Bernstein Liebhard LLP partner Jeffrey S. Grand, who is serving as co-liaison counsel in the New Jersey transvaginal surgical mesh lawsuits against Johnson & Johnson and C.R. Bard, another medical device manufacturer, commented The problems with transvaginal mesh have become a serious public health issue and are indicative that the FDA approval process needs reform. While we believe further reform is needed, this bill is a step in the right direction.
Vaginal Mesh Complications and Mounting Litigation Supports Need For New Legislation
According to the Boston Globe, an FDA spokesperson, Karen Riley, while not officially endorsing the bill, said that the agency has raised the issue of the loophole of the 510(k) process to members of Congress and believes that the new legislation would provide appropriate protections for public health. As Riley told the Boston Globe, a new device is five times as likely to be recalled with a design flaw if it is based on an older device that was itself pulled for safety problems.
Markey appeared at the briefing for the bill with Jay Nevarez, a woman from Colorado who experienced transvaginal mesh complications after receiving a vaginal mesh implant that was based on a previously recalled device. Nevarez is just one of many individuals involved in pelvic mesh litigation litigation against Johnson & Johnson/Ethicon. The Gynecare TVT vaginal mesh implant Nevarez received was approved by the FDA based on its similar design to Boston Scientifics ProtoGen, which was recalled nearly a decade earlier due to the post-surgical complications it caused. As a result of the vaginal mesh complications, Nevarez told the Boston Globe, I lost my job and my health, and am in the process of losing my home.
The lawyers at Bernstein Liebhard are actively filing cases in In re Pelvic Mesh/Gynecare Litigation, No. 6341-10 (N.J. Super Ct.), and In re Pelvic Mesh Litigation/Bard No. L-6339-10 (N.J. Super. Ct.), which are two consolidated actions of all the vaginal surgical mesh lawsuits filed in New Jersey state court.
Scottsdale, AZ (PRWEB) March 25, 2012
QualityStocks would like to highlight CNS Response, a publicly traded company providing reference data and analytic tools for clinicians and researchers in psychiatry. The company offers an online registry, developed by physicians, that enables qualified medical professionals to exchange objective, statistical neurophysiology-based data on individual patient medication response and outcomes.
In the companys news last week,
CNS Response announced that the U.S. Food and Drug Administration (FDA) has responded to the companys proposal for a clinical trial of an investigational device, PEER Interactive, designed to help physicians identify the best treatments for certain mental illnesses.
PEER Interactive, a Web service based on a standard electroencephalogram (EEG), records a patients brain function much like an electrocardiogram (EKG) does for the heart. The Psychiatric EEG Evaluation Registry (PEER) was developed by physicians as a quality assurance tool to determine which psychiatric medications are effective and which are not.
In its response, the FDA acknowledged that PEER Interactive would require pre-market approval, though the agency indicated that under certain circumstances the product could shift to the 510(k) pathway.
In regards to the FDAs additional comments and suggestions, CNS said it will revise its protocol to implement the FDAs suggestions, and that it will launch a clinical trial with Walter Reed National Military Medical Center (WRNMMC) and several other sites to establish partnerships with military physicians to diagnose mental health conditions such as depression, post-traumatic stress disorder (PTSD), mild traumatic brain injury (mTBI), and several other disorders.
The WRNMMC has indicated that it will lead the study upon approval of the final protocol.
The company also highlighted the following studies conducted within the last year:
INSURANCE STUDY: An audit of commercial health plan enrollees which found a 71 percent improvement in outcomes for physicians using PEER; an 85 percent reduction in suicidality; and successful prediction of severe adverse events in 55 percent of cases.
DEPRESSION STUDY: A 12-week study of treatment-resistant depression, in which physicians achieved a 65 percent success rate in treating patients with depression, compared to a 39 percent success rate in the control group.
EATING DISORDERS: A retrospective study of eating disorder patients with comorbid major depression or bipolar disorder. Physicians demonstrated that using PEER data helped reduce trial and error medication selection, and significantly decreased patient symptoms of depression, and reduced overall hospitalization days by 53 percent.
ADHD: Recent studies demonstrate a dramatic increase in medication use for ADHD, without corresponding improvements in outcomes. A Michigan State study demonstrated that 1 million children of the 4.5 million currently diagnosed with ADHD may be misdiagnosed.
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