It’s not often that I do book reviews. However, a book crossed my desk that has some extra appeal. Written by Mike Silverman, the book is called “How Reliable is Your Product?” The reason this book caught my attention was the familiar name associated with it. I’m involved in the MD&M East event (June 6-9 in New York City) and one of the classes I’ve penciled into my calendar is called Medical Device Reliability Testing, presented by none other than Mike Silverman.

Back to the book: a lot of the space at MD+DI is spent on reliability issues. If you’re not really careful throughout the entire design process (emphasis on “entire”), the results can be disastrous. Staying on track to develop a reliable product needn’t be a process that completely derails your design...

April 25th, 2011
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No, it doesn’t. There are requirements that our design departments need to meet that are not in 820.30 but are part of quality management. Our record and document controls pertain to our design records and documents. Our material controls (supplier controls, incoming acceptance, identification and traceability) pertain to the suppliers (including test labs, contractors and consultants) we use for design and for receipt, identification and traceability of raw materials, parts, components, sub-assemblies or final product used during design and for design verification and validation. Our corrective and preventive action (including non-conforming product) applies to actions taken during design to correct for...

April 25th, 2011
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I recently crossed paths with Jonathon Lee, now a consultant to the medical device industry. At the time, Jonathon was making the transition from working as Medtronic’s expert in the areas of regulatory and clinical (for the company’s Surgical Technologies group) to being an independent consultant. The name of his new company is Medical Device Consulting Solutions International, or MedDev CSI.

Jonathan claims that he can help device makers take their designs from conception all the way through the product lifecycle, through the end of product life. His expertise lies in the area of risk management.

Supplier management is a subset of risk management. If you look at standard 14971, which is product lifecycle, risk management as associated with medical devices, it not only looks at the risks associated and introduced with design, but also the process control, component purchase, package sterilization, and the distribution, labeling, user education, and...

April 25th, 2011
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Japan has raised the crisis rating of the Fukushima nuclear power plant to 7 on the International Nuclear and Radiological Event Scale, writes Tokyo-based UBM Canon editor Miki Anzai. That number puts the tragedy on par with Chernobyl. Manufacturers from the region surrounding the power plant fear that international markets will avoid products made in Fukushima. Known for its industrial products, Fukushima prefecture is home to more than 40 medical device makers. Not surprisingly, the region also produces a substantial amount of medical device components.

A growing number of customers fear that Japanese products have been contaminated with radioactivity. As a result, the country has begun testing the radiation levels of industrial levels.

Read more on how the crisis is affecting the Japanese medtech industry on medtechinsider.

April 22nd, 2011
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Condoms are an over-the-counter product with rare opportunities for innovation. But Futura Medical, creator of Durex, thinks it has a new spin on the old prophylactic.

The CSD500 condom is nearing regulatory approval and could be on sale in Europe by the end of 2011, according to the Wall Street Journal. It contains a compound gel, known as Zanifil, designed to help men maintain a firmer erection during intercourse. It has been clinically shown to increase local blood flow. The company also says that "a good safety and tolerability profile was reported for CSD500."

No word on when this product will be available in the United States, but the company is pursuing (or has gained) patents in 35 consumer markets, including Europe and the United States.

—Heather Thompson

April 20th, 2011
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Scientists at McGill University have introduced an intubation robot that is operated by remote control. Known as the Kepler Intubation System (KIS), the device could facilitate intubation and help prevent some complications associated with tracheal intubation. The device, which proved to be successful in considerable testing in medical dummies, is being tested in clinical trials on human patients. Earlier this month, the first robotic intubation on a patient was performed at the Montreal General Hospital. The device was developed by Dr. Thomas M. Hemmerling, a professor at McGill University who created the McSleepy automated anesthesic drug-delivery system in 2008.

Speaking of intubation, check out our recent coverage of the...

April 18th, 2011
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Yes, actually you do. If you are using a software tool or an automated test to perform design or design verification or validation then the data generated is paramount to your understanding of the design or the design verification or validation results. This requirement extends to software tools used to generate medical device software or even the writing of test software for the production environment. 21 CFR Part 820.70(i) requires all software used anywhere within the quality system to be validated for its intended use. This includes software used in design.

If you are using any test method for design verification or validation that has not been previously validated or qualified, you should ensure it...

April 18th, 2011
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Planning to attend HCI in Washington, DC on April 28? Let us know. We're looking for your opinions on the event and speakers.

Get details on HCI DC 2011. Then drop us a line in the comments space below. We want to know what ideas inspire you at this important industry event. They can come from the speakers or from casual conversations.

Select comments will be published in the June issue of MD+DI.

Speakers at the event include regulatory, technology, and M&A experts including: 

  • Donald Casey, Chief Executive Officer, West Wireless Health Institute
  • Jonathan Sackner-Bernstein, Associate Director for Technology and Innovation, CDRH, FDA
  • Jeffrey Shuren, MD, JD, Director, CDRH, FDA
  • Thomas Gunderson, Sr Research Analyst, Piper Jaffray

—Heather Thompson

April 18th, 2011
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Industry has plenty of supportive voices in Congress, voices that span both ends of the political spectrum, from Tea Partiers Rep. Michele Bachmann (R-MN) and Sen. Scott Brown (R-MA) to liberal stalwarts Sen. John Kerry (D-MA) and Sen. Al Franken (D-MN). The one thing that ties them all together: they represent states that have a heavy industry presence. And, for the most part, they've been dominating the discussion over medical device safety and the 510(k) process.

But Wednesday's Senate hearing on device safety and approval processes gave rise to some dissenting opnions, with Sen. Herb Kohl (D-WI) and Sen. Richard Blumenthal (D-CT) seeming to view industry and FDA with a skeptical eye. On Friday, Rep. Rosa DeLauro (D-CT) wrote a letter to FDA comissioner Margaret Hamburg decrying the way FDA currently handles device approvals.

"It is simply unacceptable that [patients] should continue to rely on an inadequate approval process...

April 15th, 2011
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A group of researchers at Brown University and the U.S. Department of Energy’s Argonne National Laboratory are using a supercomputer to precisely map the territory of the human circulatory system. Drawing on biophysics, the scientists hope the work will eventually translate to improved technology for treating blood-flow disorders.
 
The researchers harnessed the power of modern supercomputers that can model blood flow at the molecular level. The Blue Gene/P supercomputer can crunch 500 trillion calculations per second. Because supercomputers are custom made, the code for the machines must be customized. According to computational scientist Vitali Morozov, the Blue Gene/P system offers high efficiency but optimizing the code for the...
April 15th, 2011
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