The biggest hub of medical device manufacturing on this continent is… Tijuana. Well, maybe. Considering that this claim comes from a promotional white paper published by the Tijuana Economic Development Council, there may be some grounds for skepticism here. Nevertheless, it is undeniable that San Diego’s neighbor to the south has been growing rapidly in recent years. The report cites that the region's medtech sector has seen an annual growth of 8.7% in employment since 2004.The device industry there now employees 30,000 workers. More than 40 medical manufacturing companies operate facilities in the area including Care Fusion, Medtronic, DJO Global, and GreatBatch.
—Brian Buntz
May 17th, 2011
0

Two UK media outlets, The Guardian and The Telegraph, have released stories that question the safety of medical devices.

The Guardian focuses on the rising levels of medical device recalls, and the lack of clinical data that medical device companies are required to provide for safety and efficacy.

Using recall analysis from the British Medical Journal, the publication says that there were 62 recalls in 2006 and 757 in 2010. The author also attests that medical manufacturers were unwilling to provide clinical data. "Of 192 manufactures we contacted, only 53% (101/192) replied, and only four (2%) provided any clinical data," says Carl Heneghan, director of the Centre for Evidence-Based Medicine and author of the Guardian story.

Heneghan also points to comments made several months ago by...

May 16th, 2011
0

 As we head into the weekend, here's something to get the Trekkies among you excited: X-Prize and Qualcomm have announced a competition to develop a real-life "Tricorder," with a $10 million prize. According to the press release, the device will be "a mobile solution that can diagnose patients better than or equal to a panel of board certified physicians." From the release:

The winning tool will enable consumers in any location to quickly and effectively assess health conditions, determine if they need professional help and answer the question, "What do I do next?"

Combining everybody's favorite buzzy...

May 13th, 2011
0

While publishing a book review a little while back (that book was called How Reliable is Your Product?), I mentioned that I rarely do book reviews, simply because I don’t have enough time to read the books thoroughly. A couple of days after posting that review, another book showed up on my doorstep, and this one merits coverage as well.

I admit that the book—Usability Testing of Medical Devices—caught my attention because I am familiar with one of the authors, Michael Wiklund. Michael has written lots of articles for MDDI, and they are often are highest rated articles.

One of the best things about the book is that it’s not written like a traditional text book. It’s written using language that makes it an easy read, breaking down complex concepts, making them much more understandable. It starts with the basics of medical...

May 13th, 2011
0

Silicon Valley is being honored with another nickname this week: the most expensive place to manufacture a medical device in the country, according to the Silicon Valley / San Jose Business Journal

A paper examines a study by The Boyd Company, Inc. (pdf) which examined 55 locations in North and Latin America to compare device manufacturing costs.The San Jose/Palo Alto area topped the list, with total operating costs at more than $30 million. It had the highest overall costs in labor, power, land, taxes and shipping for an average 325-employee production plant.

The study, released on May 9 also lists several other manufacturing sites. Here, I'll provide just the five most expensive, followed by the five least expensive.

MOST ...

May 13th, 2011
0

8/31/11 An update on the decisions made to RoHS Recast was provided by Christine Ruther of Eisner Safety Consultants

+++++++++++++

Medical device manufacturers should be aware that the RoHS Directive that regulates hazardous substances in electrical and electronic equipment (EEE) in the EU is being repealed. The change means that medical devices, which have been exempt, will now be included in the directive—with no grandfathering.

Using the EU’s New Approach and New Legislative Framework, the directive moves specification of restricted substances and covered EEE to the Annexes so that they can be easily “adapted to technical progress” (ATP), as follows:

  • A CE mark will be needed for compliance.
  • Procedures for conformity...
May 12th, 2011
0

French research organization CEA-Leti is spearheading the development of a pacemaker that is eight times smaller than contemporary models. The product of the Heart-Beat Scavenger (HBS) Consortium, which also includes Sorin Group, TIMA, Cedrat Technologies, Tronics, and EASII IC, the device harvests mechanical energy directly from the heart, which enables the pacemaker to forego the need for batteries and the surgeries required to change periodically change them. Not only would doing away with pacemaker batteries improve patient comfort, it would save the healthcare system a significant amount of cash. Treating heart disease is currently one of the biggest healthcare-related costs in both the United States and Europe. One of the most impressive aspects of the research is the device's anticipated size. The researchers expect the finish product to measure 1 cm3.

May 11th, 2011
0

 The CEO news is flying fast and furious this week. Less than a day after Boston Scientific announced that its CEO was stepping down, Medtronic announced that it had found one to step up: Omar Ishrak, an executive from GE's health division, will become the company's chairman and CEO as of June 13, according to a report in the Minneapolis Star Tribune. The announcement ends a search process that officially began in December 2010, when then-CEO Bill Hawkins announced that he would be retiring. 

The 55-year-old Ishrak's background—he has a successful track record at GE Healthcare Systems, where he'd been for 16 years, including the last five as president and CEO—is in line with what one would expect for a high-profile position like this. He seems like someone who is going to inspire confidence in shareholders, or at least won't make them nervous.

There is one indicator, though, that Ishrak may shake things up. Back in January, he...

May 11th, 2011
0

It looks like the minor kerfuffle that Boston Scientific CEO Ray Elliott caused last week by pooh-poohing the competition was just practice for this week's major kablooie. On Tuesday it was announced that, after less than two years on the job, the 61-year-old is stepping down as head of the company, sparking a flurry of speculation and sending the stock price into a steep dive.

Elliott was supposed to bring Boston Scientific back from the brink after taking over in 2009. But since then, things haven't gone quite as swimmingly as some might have hoped, leading some to question whether it was all just too much for the former head of Zimmer Holdings. As portfolio manager with Gabelli Health and Wellness Trust Mutual told Reuters:

“I think this was a tougher job than he thought. I don’t see him up and quitting out of short-term frustration. Ray is very well respected on Wall Street and he has done a decent job stabilizing the company. He was dealt a...

May 10th, 2011
0

Medtronic has let go of hundreds of employees in its diabetes unit, according to diabetes industry analyst David Kliff on his blog Diabetic Investor (registration required). The company also has recently announced that it will expand its partnership with Bayer HealthCare. The international alliance between the two companies will now include the United States. The two firms will work together to develop novel technologies for diabetes management. The companies initially began collaborating in 2007, using Medtronic’s insulin-pump technology and Bayer’s blood-glucose meters and strip technology. According to a press release issued by Medtronic, the two companies will work together to develop technologies that offer increased convenience and ease of use.
In a similar development, Medtronic recently announced a parnership with Eli Lilly to develop a treatment for Parkinson’s.
—Brian Buntz

May 10th, 2011
0