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,
Regulations
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,
FDA Draft Guidance: Refuse to Accept 510(k) Policy
On August 13, 2012, FDA issued a draft guidance, “Refuse to Accept Policy for 510(k)s.” This guidance explains procedures and...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 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,
Unique Device Identification: From Compliance to Value
FDA issued a proposed Unique Device Identification rule requiring manufacturers of medical devices to uniquely identify their products....
Oct 04 2012,
Medical Device Excise Tax: Achieving Compliance with Confidence
Complying with indirect taxes is a legal mandate that is not core to a business, yet the operational outlay is...
Oct 04 2012,
Complaints: A Second Chance to “Make it Right”
Customer complaints can give medical device companies a wake-up call when they're not achieving their fundamental purpose: that is, meeting...
Oct 04 2012,
Quality by Design: Incoming Acceptance Activities of Purchased Materials
All manufacturers of orthopaedic medical devices must establish and maintain procedures to verify that all products meet their specifications and...
Aug 16 2012,
The IP License Agreement: A View from 5,000 Feet
License agreements may look very similar, they are not created equal. Great care must be taken by both the licensee...
Aug 15 2012,
Medicare: Trends in Beneficiaries Served and Hospital Resources Used in Implantable Medical Device Procedures
Results from a U.S. government agency report summarize data on average length of stay, patient characteristics, discharges, etc. Highlights include: ...
Aug 03 2012,
FDA to Guide Device Makers on Marketing Application
FDA launched a program to help device makers identify regulatory requirements early in the device development process....
Aug 02 2012,
The Post-Market Imperative: Understanding the requirements for effective post-market clinical follow-up
In my previous BONEZONE article, “Basic Anatomy of a Design Dossier” (BONEZONE March 2011), I presented an overview of the...
Aug 02 2012,
The Anatomy of a Warning Letter, Part Two: Excerpts and Response Strategies
This is the second of two articles dealing with the FDA Warning Letter, in which we’ll look at actual letter...
Jun 09 2012,
Trademark Searches and Availability Opinions
Branding of products and services is the key to success for almost any medical device company. For example, the NexGen®...
Jun 09 2012,
The Orthopaedic Regulatory and Clinical Affairs Program at Grace College: A Joint Partnership
Grace College shares an address with a $38 billion global industry in Warsaw, Indiana, the orthopaedic capital of the world....
Jun 09 2012,