Passing Brazil’s Inspections to Take Product to Market
Over the past few years, I have had the opportunity to help orthopaedic medical device companies prepare for and logistically...
Jan 16 2013,
Competitive Landscape
Spotlight on Brazil
The World Bank ranks Brazil as the sixth largest country in the world in terms of gross domestic product at...
Jan 16 2013,
Strategic Orthopaedic-related 510(k) Update
The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: B2B Spine, Brainlab, Christopher D. Endara, Emerge...
Jan 16 2013,
Making Smarter Product Recall Decisions: 4 Critical Steps to Meeting FDA’s Expectations
FDA’s multi-layered rules for product recalls can resemble a double-edged sword. Have you under-reported your recall? Over-reported? How can you...
Dec 17 2012,
The Quality Review Board: A Conduit for Success
Your Quality Review Board exists to ensure continual improvement to your Quality Management System. How do they stack up as...
Dec 17 2012,
Strategic Orthopaedic-related 510(k) Update
The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Alliance Spine, Aston Medical, Iconacy Orthopedic, Implanet,...
Dec 17 2012,
Trademarks vs. Domain Names, Part I: There is a BIG Difference
What happens if there is a dispute over the use of your domain name, or if someone is using your...
Dec 14 2012,
Strategic Planning for Regulatory Compliance
Will you wait until your company has an unannounced audit by a Notified Body? Or will you develop a Quality...
Dec 13 2012,
Staffing Solutions: CNC Machinists in Training
BONEZONE presents a short list of schools and programs in the U.S. that provide CNC operator education, in response to...
Dec 12 2012,
Purac Acquires Fiberlive Technology from Vivoxid
Purac Biomaterials acquired FiberLive™, Vivoxid’s composite technology comprising resorbable glass fibers and polymers. FiberLive boasts strength reportedly up to 6...
Oct 05 2012,
FDA Draft Guidance: Refuse to Accept 510(k) Policy
On August 13, 2012, FDA issued a draft guidance, “Refuse to Accept Policy for 510(k)s.” This guidance explains procedures and...
Oct 04 2012,
The Ohio State University, Cleveland Clinic Form Alliance To Focus On Accelerated Commercialization
Cleveland Clinic Innovations and The Ohio State University's Technology Commercialization and Knowledge Transfer Office entered into an alliance to accelerate...
Oct 04 2012,
The IPXI® – An Alternative to the License Agreement? Maybe!
Monetizing intellectual property is the process of deriving tangible value from the IP or the technology that is protected by...
Oct 04 2012,
Is Depreciation Expense a Misleading Illusion?
“Sunk costs are irrelevant" is a principle stated in Shlomo Maital’s book "Executive Economics" and in almost every book on...
Oct 04 2012,
Strategic Orthopaedic-related 510(k) Update
The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first...
Oct 04 2012,