Sharon Higgins is director of the Irish Medical Devices Association (IMDA), which represents the interests of medical technology companies within the Irish Business and Employers Confederation (IBEC). At a national level she represents IBEC and IMDA on the (Irish) Life Science Alliance and is currently the chair of the Irish Convergence Council. She also plays a key role on the Irish Medical Technology Code of Ethics taskforce.
 
 
MD+DI: How did you get your start in the medtech industry?
 
Sharon Higgins: I completed a degree and research masters in industrial chemistry at the...
May 1st, 2012
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The MD+DI December 2011 isssue has been awarded a Maggie for the best Medical, Dental and Related Services trade publication by the Western Publishing Association.

Per the WPA's Web site: "One of WPA‘s primary objectives is to promote the pursuit of excellence among publishing professionals... WPA believes recognition is the best way to honor achievement. For more than fifty-eight years, WPA has bestowed awards of excellence to deserving individuals and companies whose work is deemed 'The Best in the West' in a wide variety of publishing categories."

Other finalists in the category included American Journal of Critical Care, September; Critical Care Nurse, April; Dimensions of Dental Hygiene, January; IVD Technology, Nov/Dec, and MedEsthetics, May/Jun.

 MD+DI's May issue was also selected as a finalist for best cover.

The December...

May 1st, 2012
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1. Why does FDA require validation of spreadsheets and databases?

Denise DionTo put it simply, the purpose of validating any software or computerized system is to establish trust in the data or electronic record. Spreadsheets and databases are automated data processing systems under 21 CFR Part 820.70(i) and if used as part of production or the quality system, as software they need to be validated for their intended use. If used as part of the quality system, then they are also creating and maintaining electronic records required by another FDA regulation or the Food, Drug and Cosmetic Act 21 CFR Part 11.1(b) so they need to be validated per  21 CFR Part 11.10(a). 21 CFR Part 11 states that the purpose of validation is to “ensure accuracy, reliability, consistent intended...

May 1st, 2012
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While attending the China International Medicinal Equipment Fair (CMEF) in Shenzhen, CMDM Associate Editor Helen Zhang took the opportunity to gauge the pace of innovation among smaller domestic medical device manufacturers. While the government has introduced a number of positive measures to bolster healthcare, China's medtech industry suffers from an innovation deficit, concludes Zhang.

"While industry icons such as GE, Philips, the Weigao Group and Mindray impressed attendees with an array of innovative products, too many domestic medical device manufacturers are hobbled by a lack of focus on R&D and a “me-too” business strategy," she writes in an article posted on medtechinsider.com. A post-show report published by J.P.Morgan explains why, Zhang adds.

Read the ...

May 1st, 2012
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To my surprise, a previous post of mine (about the importance of integrating human factors and industrial design) generated some quite spirited objections to my use of the term usability. See what you learn by doing a blog? I never knew that anyone in the human factors community objected to the term usability

Stephen B. Wilcox, Ph.D., FIDSA

Since quite a few people who don’t have a behavioral-science background are having to struggle with human factors issues—to do validation research, for example—I thought I would use a discussion of word choices to...

April 30th, 2012
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If you are in Los Angeles between now and August 26 and have an unfolding interest in origami and medical technology—they are not mutually exclusive—you might want to pencil in a visit to the Japanese American National Museum. An exhibition titled "Folding Paper: The Infinite Possibilities of Origami" includes a fascinating glimpse into how the Japanese artform has inspired medical technology engineers. One of the exhibits shows a prototype of a collapsible cardiac stent using the water-bomb base origami technique, a rounded cube form that folds...

April 27th, 2012
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This Week in Devices [4/27/12]

 

MIT Develops Nanoscale Films to Promote Bone Growth in Implant Patients

  • Researchers at MIT have developed a nanoscale film coating for medical implants that could help better adhere them to bone and reduce the risk of premature implant failure
    Via: Medical News Today

 

Forget Hacking, Watch Out for Interference!

  • Concerns over medical device hacking are running rampant. But the proliferation of wireless signals from portable devices, and the interference they cause, could pose a much greater, and more plausible, threat.
    Via:...
April 26th, 2012
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Consumer-inspired design is not just for consumer-facing products. Vessix Vascular’s V2 Renal Denervation System shows how traditional cardiovascular device manufacturers can learn a lesson from consumer electronics companies about creating excitement through design.
 
 
In consumer design, where potential customers are faced with a wide variety of options and often make final purchase decisions based heavily on a split-second emotional reaction, aesthetics is a critical success factor. Consumer companies have made an art out of this split-second emotional reaction. Procter...
April 25th, 2012
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Beyond the unique design of the Vessix Vascular V2 Generator, the product was a success because of the design process and the partnership between the manufacturer, its engineers, and the designer. Vessix Vascular CEO Raymond Cohen shares his strategies for success that any medical device manufacturer can adopt.
 

Be Involved

Cohen believes that successful product development requires executive involvement. Companies that have made their mark on design usually did so because a designer had a strong relationship with the company’s founder. The relationship between Jonathan Ive and Steve Jobs is the most recent example of such a success story. “Steve Jobs was involved in...
April 25th, 2012
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A recent trend report published by German industry association Electrical, Electronic & Information Technologies (VDE) states that Germany continues to hold its leading position internationally in important key and cross-sectional technologies, including medical device technology. For the VDE trend report Electro- and Information Technology 2012, VDE surveyed 1300 of its member companies as well as universities. The study reports that 57% of respondents consider Germany to be the world leader in medical device technology.

The report notes that 88% of those surveyed believe Germany leads the world when it comes to innovating in production and automation...

April 25th, 2012
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