July 10th, 2012
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In today’s manufacturing environment, ergonomics and preventing repetitive motion injuries are major challenges that every business must address. Doing so ensures that production levels remain at expected levels and employee injuries remain as infrequent as possible. Although many of the hand assembly processes have been replaced with automated equipment over the past 20 years, there is still a surprising number of manual operations still required for many applications.

Jim Norton is president of Custom Products & Services Inc. located in Inver Grove Heights, MN. Contact him at www.custom-products.com. or call 888-444...
July 10th, 2012
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This Week In Devices [7/6/2012]:

FDA Proposes Identification System for Medical Devices

  • Today, FDA proposed a unique identification system for medical devices. Such a system would allow FDA to better track problem devices and recalls.
    Source: FDA

FDA Approves HIV Home Test

  • Tuesday FDA announced it has approved the OraQuick In-Home HIV Test from Orasure Technologies making it the first testing kit for HIV that will be available over-the-counter.
    Source: Medical News Today

DIYers are Hacking Their Own Hearing Aids

  • Tech-savvy people are taking...
July 6th, 2012
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In doing some reporting for MD+DI's upcoming Guide to Outsourcing supplement (look for it coming out in August), I came across Capital Partners' Q2 2012 report on medical device outsourcing, which contains a preliminary mergers and acquisitions assessment for medical device outsourcers.

Though the form is meant to be a self-assessment tool for contract manufacturers, it struck me that some of the traits that make a contract manufacturer attractive to corporate and private equity group buyers also make it a good outsource partner for OEMs. Some examples include:

 

  1. "Trusted, highly integrated...
July 5th, 2012
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When talk turns to China's medical device industry, the focus invariably is on mainland China. But the island of Taiwan, which is located approximately 180 km off the southeastern coast, also has an illustrious past and robust future as a hub of medical innovation. This was made abundantly clear during my visit to Medicare Taiwan 2012 and the co-located SenCare, which features healthcare products targeting the elderly, in Taipei in June.

Taiwan has long been recognized as a leading force in innovation, technology and the development and manufacture of cost-effective ICT and medical products. At the beginning of the 21st century, the government identified the medtech and biotech industries as pillars of opportunity that could set Taiwan apart from other nations. It instituted initiatives not only to drive expansion of these two sectors...

July 2nd, 2012
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Larry Spears is director, Health Sciences Industry, Deloitte and Touche, LLP and former CDRH Deputy Director for Regulatory Affairs. We asked him to draw on his 30 years of experience to explain exactly what role managers take in the regulatory process.

Larry Spears

What is the role of the management representative in an effective quality system?

The representative should be a key player in developing the firm’s quality policy and in assuring that it is followed.  That individual should participate regularly in management reviews.  The management representative also needs to have sufficient delegated authority and responsibility for ensuring the following:
 

  • Adequate  resources are available
  • All employees are appropriately trained
  • Operations are...
July 2nd, 2012
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This is a story about usability that has nothing to do with regulation and nothing to do, at least initially, with human factors professionals. The story begins with a patient—Cari Ugent, who was in the unenviable position of spending a few weeks in the hospital connected to an IV pole. If you’re ambulatory in the hospital, which Cari was, and if you’re on an IV, which she also was, then it’s not just a matter of lying there next to the pole; you have to bring it along with you wherever you go. During her ordeal, Cari, being a writer and journalist, and a naturally curious person, began to wonder why her new intimate friend, the IV pole, was so terrible—for example, why she kept injuring her feet on the legs of the pole, why the wheels got hung up on door thresholds, why it was so awkward and top-heavy, why the lines and cords kept getting entangled in the wheels, and why it was so ugly and intimidating-looking.

...
June 29th, 2012
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 This Week in Medical Devices [6/29/12]

Supreme Court Upholds Affordable Care Act

  • The Supreme Court laid down its decision on the Affordable Care Act and particularly the constitutionality of the individual mandate requiring all U.S. Citizens to purchase health coverage. The act passed the Supreme Court, but the medical device tax remains a huge concern for those in the medical device industry.
    Source: MD+DI

A Software Engineer Creates a Breakthrough Medical Device for Cancer Treatment

  • The inspiring story of Robert Goldman, a software engineer by trade, whose mission to save his sister resulted in the development of a new type of catheter...
June 29th, 2012
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Uncertainty abounds in today's medical device industry. While the world’s aging population is spurring demand for medical technology, the industry is also facing a number of hurdles. The supply chain is becoming ever more complex; the pressure to slash healthcare costs is intense; operational costs are up; navigating the regulatory climate—both in the United States and abroad—is often an exercise in frustration. And, domestically, there are concerns about how healthcare reform will ultimately affect the medical device industry.

Outsourcing can be used to help device companies meet these challenges as it can help them cut costs and redirect energy into adapting to the rapidly changing business climate. As Nancy Duarte-Lonnroth, director of quality and regulatory affairs for Celestica HealthTech, explains, "a strategic partner can offer a current and broad surveillance of the...

June 28th, 2012
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A healthcare stimulus designed to benefit domestic medical technology companies and public hospitals (and, ostensibly, patients) was unveiled by Brazil on June 27. As the country struggles to regain star status among emerging economies—growth is forecast by the government to reach approximately 2.5% this year, but many independent economists find that overly optimistic—President Dilma Rousseff has initiated an array of stimulus measures and tax incentives to revive the sputtering economy. The healthcare stimulus is part of the larger 6.6 billion reais ($3.2 billion) stimulus package that boosts government spending in multiple sectors and lowers subsidized lending rates. Medical technology is one of the industries identified by the government as a present and future economic performer. Anyone attending the MD&M Brazil tradeshow and conference, which ended a successful two-day...

June 28th, 2012
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