FDA Finalizes UDI Requirements
Final rule does not mandate direct part marking for implantable devices, provides manufacturers of Class III implants one year to...
Sep 24 2013,
Competitive Landscape
How to Choose a Notified Body
The right Notified Body will support device manufacturers in accomplishing current and long-term goals. Here are questions to ask and...
Sep 10 2013,
Ten Elements of a Successful Supplier Agreement
Developing an agreement using these steps enables progressive companies to establish dynamic, collaborative and modern business relationships....
Sep 09 2013,
A Supplier’s View on the Indian Market
One supplier discusses the opportunities and challenges it has experienced working in India’s growing orthopaedic device market....
Sep 09 2013,
Postmarket Studies in Lieu of Clinical Trials
A strategic combination of premarket and postmarket clinical studies proactively establishes a process to identify design problems and generate revenue...
Sep 03 2013,
Strategic Orthopaedic-related 510(k) Update
The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Pantheon Spinal, Pinnacle Spine, Spine Wave, Synergy...
Aug 05 2013,
India Considering New Device Regulations
With an evolving regulatory situation, medical device companies must stay up-to-date in order to achieve success in India. Orthopaedic OEMs...
Aug 05 2013,
Spotlight on Asia
The Asian population is quickly aging and accumulating wealth, ripening conditions for the orthopaedic industry to grow 15 to 18...
Aug 05 2013,
Looking Back at INFUSE: 2002 to Today
In mid-June, two independent research groups released a long-awaited review of trial data regarding the use of Medtronic’s INFUSE. The...
Aug 05 2013,
Need for Data in Unproven Implants
A review of data found registry reports are accurate in providing information about hip and knee arthroplasty devices, though researchers...
Aug 05 2013,
Industry’s Achilles Heel: The Supply Chain
The implantable device supply chain is ripe with more than $5 billion in inefficiencies in the U.S. alone. This knowledge...
Aug 05 2013,
Unique Challenges in Instrument Manufacturing
What challenges are unique to the manufacture of orthopaedic instruments? We ask a supplier for perspective....
Jul 10 2013,
China Becomes Vastly Improved Player
China’s medical device market is growing fast and the competition is fierce. Companies looking to enter the market or expand...
Jul 10 2013,
Cutting Instruments: Safe and Effective Design
Cutting tools can look similar, but they don’t all perform alike. Consider these design and manufacturing processes for the best...
Jul 10 2013,
How to Avoid Major FDA Inspection Mistakes
Don’t let these details get lost in the preparation and follow up for FDA inspections....
Jul 10 2013,