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,
Competitive Landscape
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,
Spotlight on Titanium: An Interview with C. Jeffrey Wise
We posed two questions to C. Jeffrey Wise of Titanium Industries to gain knowledge on titanium from a supplier’s perspective....
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,
The State of American Medicine – Orthopaedics and the Vampire Economy
Individuals and private corporations, not the government, make the world better. Dr. Lee Hieb has studied economics and history, and...
Aug 09 2012,
Market Growth Rates in Orthopaedics – OMTEC 2012 Opening Panel Discussion
OMTEC 2012 Opening Panel Discussion addressed multiple topics, including trends in innovation and R&D investment in orthopedics....
Aug 09 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,
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...
Aug 02 2012,
Building a Basic Good Clinical Practice Foundation to Weather the Storm
OMTEC 2012 opening panel presenters, consisting of David Floyd, Bill Plovanic, Bill Kolter and Brian Moore, painted a compelling picture...
Aug 01 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,