Companies Expected to Invest Device Tax Benefit in R&D
Even if it’s small, research and development budgets are expected to get a boost in 2016 and 2017 as companies...
Mar 04 2016,
Competitive Landscape
New Guidance for UHMWPE Submissions
FDA recently released draft guidance outlining new information companies must include when submitting devices with Ultra High Molecular Weight Polyethylene...
Feb 23 2016,
Handling Disruption: The Need for Proprietary Business Models
The economic and regulatory environment for medical devices is changing. OMTEC Keynote Speaker Bill Tribe, Partner at consulting firm AT...
Feb 09 2016,
Identifiable and Sterile: Trends Driving Device Packaging
Unique Device Identification (UDI) and sterilization could be driving influences for the orthopaedic device packaging industry in 2016 and beyond....
Feb 08 2016,
The Revitalized ISO 13485: Ready for Business
The ISO 13485:2016 Standard is slated for publication in March 2016. Consider these eight changes when updating your certification. The...
Feb 08 2016,
A Look at FDA’s 2016 Priorities, Status of 2015 Priorities
FDA released its annual priority list for the new year, as well as previously-issued final guidance documents, on which CDRH...
Jan 12 2016,
UDI Update: Trays and Kits
FDA released draft guidance for its Convenience Kit exemption, offering orthopaedic device manufacturers more direction on labeling device trays and...
Jan 11 2016,
AAOS 2016: What to Expect, Suppliers to Meet
Of the ~700 companies set to exhibit at this year’s AAOS Annual Meeting, here’s a look at select suppliers who...
Jan 11 2016,
Congress Suspends Medical Device Tax
The medical device tax, fought by industry since its inception, was suspended as part of the $1.8 trillion spending and...
Jan 04 2016,
Adaptive Designs Provide Clinical Trial Flexibility
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time...
Dec 04 2015,
UDI Ruled a Requirement for EHRs
A final rule issued by the Office of the National Coordinator for Health IT of the U.S. Department of Health...
Dec 03 2015,
Zoning In with Orthopaedic Surgeon Entrepreneurs
BONEZONE looked back on some of the orthopaedic surgeon interviews conducted throughout the year to see what they had to...
Dec 02 2015,
A Look into Trauma Trends: Surgeon and Industry Perspective
According to surgeons and industry interviewed by BONEZONE, trends in trauma center on the rise in hip fractures, challenges of...
Dec 02 2015,
Harvesting Engineers’ Ideas through Invention Disclosure
The key precursor to the development step is the “harvesting effort.” Answering specific questions allows inventors to organize their thoughts...
Dec 02 2015,
NASS Recap: Surface-treated, 3D-printed Cages among New Launches in Interbody Space
Spine companies continue to focus on surface treatments and new manufacturing processes to support more solid fusions....
Nov 11 2015,