Medical Device & Diagnostic Industry
November 2008
Vol. 30, Number 11
COVER STORY
Manufacturer of the Year
After being buried under an avalanche of bad
publicity and underperformance, Cyberonics
springs back to life. By Erik Swain
50
FEATURES
Orthopedic Implants:
This Time It’s Personal
Changes in the industry’s landscape have enabled
orthopedic manufacturers to explore customized
implants with short lead times. By Andy Christensen and David Chen
54
Embracing Change with Electronic
Medical Device Reports
Industry should plan on getting acquainted with
electronic regulatory systems—whether they
want to or not. By Peter Hyman
60
Exploring Opportunities in India
for Device Manufacturing
Increased regulation, rising income levels, and an
increase in healthcare spending make India an
attractive place to set up shop. By Ames Gross and Momoko Hirose
66
COLUMNS
R&D Digest
Researchers create a prosthetic vein valve,
and biodegradable polymers deliver drugs.
26
Washington Wrap-Up 30
Some people in the industry scratch their heads at
CDRH’s disclosures—or lack thereof.
By James G. Dickinson
p. 50
p. 54
p. 66
On the cover: Cyberonics (Houston) is named
MD&DI’s Manufacturer of the Year. Images
courtesy of Cyberonics. Illustration by 3D4Medical.