Lessons Learned From Metal-on-Metal Implants
The FDA is only the latest regulatory body to take investigative action on metal-on-metal implants. What follows is a two-part...
Mar 05 2013,
DePuy Synthes to Co-Promote Ortho Development’s KASM Knee Spacer
The Future of Additive Manufacturing in Orthopaedic Implants
Additive manufacturing is expected to be a $3.5 billion industry by 2017. Orthopaedic device manufacturing has the ability to grow...
Mar 05 2013,
FDA Releases New Requirements for Combination Products
FDA's final rule on cGMP for combination products provides a definition of these products and the new requirements....
Mar 05 2013,
ASTM Names New Standard for Raw Materials
ASTM added a PEKK raw material standard for medical device implants that if met, will reduce the testing needed to...
Mar 05 2013,
Polygon Solutions is 2013 Transformation Award Finalist
The Southwest Florida Regional Technology Partnership announced finalists today for its Transformation and Savvis Direct Innovention Awards to be presented...
Feb 25 2013,
Strategic Alliance between Arcam and DiSanto Technology to offer EBM-designed and Manufactured Medical Implants
Arcam signed a strategic alliance agreement with DiSanto Technology (DTI). The companies will offer customers, including industry-leading orthopedic and spinal...
Feb 22 2013,
Spotlight on Argentina
Argentina’s orthopaedic device market faces the same challenges as those experienced around the world: pricing pressure and increasing productivity while...
Feb 14 2013,
Entering the Market in Argentina
Argentina’s medical device industry has strengthened along with the country’s economy over the last decade, making it an attractive emerging...
Feb 14 2013,
Hammill Manufacturing Completes Recent FDA Inspection
Hammill Manufacturing announced that on December 7, 2012, they received an Establishment Inspection Report from FDA confirming the results of their...
Feb 13 2013,
Develop Orthopaedic Implants Faster Through Auditing
Do your auditing techniques actually improve product development? These three techniques—one simple, one advanced and one new—will shorten the cycle....
Feb 13 2013,
Breakthrough in NiTiNOL Use in Implants
The use of nickel titanium or NiTiNOL in large orthopaedic devices has been limited in basic materials and devices. MedShape...
Feb 13 2013,
Trademarks vs. Domain Names, Part II: There is a BIG Difference
What happens if your trademark or company brand becomes a victim of cybersquatting? Part II on trademarks vs. domain names...
Feb 13 2013,
Rethinking the Role of Clinical Affairs
“Clinical” has become virtually synonymous with Investigational Device Exemption and Premarket Approval. Really, clinical affairs should be viewed as a...
Feb 13 2013,
Strategic Orthopaedic-related 510(k) Update
The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Camber Spine, Eleven Blade Solutions, K7, LSK...
Feb 13 2013,
C5 Medical Werks Launches Rapid Prototyping Capability for Ceramic Medical Device Components
C5 Medical Werks has launched a fast track service for next-generation ceramic device component developers, to provide manufacturers with quick...
Feb 13 2013,