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Volume 3 Issue No. 19
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Omar Ishark
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Omar Ishrak is a 16-year GE veteran having served as president and CEO of the $12 billion GE Healthcare Systems; announcement comes as a relief for industry watchers and analysts following months of uncertainty over Medtronic's leadership. Full Article >>
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J. Raymond Elliott
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Brought in from Zimmer Holdings two years ago, Elliott focused on paying down debt, restructuring business units and acquiring new technology like asthma treatments, heart valves and women's health products; but these efforts didn't compensate the company's sluggish sales of its two main products, defibrillators and stents. Full Article >>
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What Wrong with Wright?
Three senior executives of Wright Medical resign "without good reason;" and U.S. Attorney's Office for the District of N.J. accuses the company of breaking a deferred prosecution deal that Wright struck last year to settle charges that it ran an illegal kickbacks scheme. Full Article >> |
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Medtronic-Bayer Partner to Tackle Diabetes in U.S.
The partnership also seeks to develop next-generation diabetes management solutions and state-of-the art wireless glucose meters for global markets. Full Article >> |
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Abbott's Carotid Stent Gets FDA Approval
Abbott Laboratories wins FDA approval for expanded use of its RX Acculink carotid stent system in patients with 'standard' risks of surgical complications. Full Article >> |
 | | Dr. Devine |
Article 15 provides guidelines for device manufacturers that have product or are planning to introduce product, into an EU Member State, for the purpose of conducting a clinical investigation. Failure to comply with this will result in device manufacturers failing to obtain approval to pursue clinical investigations within the EU, and in today's increasingly complex medical device market, not performing a clinical investigation will result in device manufacturers being shut out of the European market. Full Article >>
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How to Feel Positive about a Biocompatibility Test Failure
by Thor Rollins, RM(NRCM)
Biocompatibility testing is common in the medical device industry, but with 24 categories under which a device could qualify, biocompatibility testing can be intimidating. The majority of biocompatibility failures are not catastrophic and can be solved without significant delays, cost or recalls. Having a plan in place will expedite that process and get the product to market in a timely manner. Always anticipate a failure and be prepared with options before they happen. Full Article >>
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| Cost of Quality, by Dr. Christopher Devine |
School@TheSummit - One Day Workshops
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June 21: Off-Label, Anti-Kickback, and Other Enforcement Risks in the Medical Technology Industry. Where: The Conference Center at Waltham Woods - Massachusetts Medical Society's HQ (just outside of Boston, MA) More Info
June 22: Medical Device Market Access for 2012 and Beyond. Where: The Conference Center at Waltham Woods - Massachusetts Medical Society's HQ (just outside of Boston, MA) More Info
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SummerSchool@TheSummit Upcoming Conference
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CAPA Conference: Related Processes & Best Practices
July 14 & 15, at the Georgetown University Conference Center, Washington D.C.
Confirmed Speakers:
Kim Trautman, Medical Device Quality Systems/GMP Expert, Office of Compliance CDRH/FDA
Sue Jacobs, President, QMS Consulting
Patricia Shrader, VP Corp. Regualtory Affairs, Medtronic
Lea Ann Conway, VP, Quality Operations, Johnson & Johnson MD&D Supply Chain
David Kouchoukos, Director, World Wide Quality Systems, Diabetes Care Franchise, Johnson & Johnson
Ted Wilson, Partner, Hogan Lovells
Tom Weaver, President, Weaver Consulting
Save The Date!
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From Medical Device Summit's LinkedIn Group
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