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,
Regulations
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,
FDA and Industry Reach Agreement in Principle on Medical Device User Fees
Under a user fee program, industry agrees to pay fees to help fund a portion of the FDA’s device review...
Mar 12 2012,
The Anatomy of a Warning Letter, Part One: A Primer
This is the first of two articles dealing with the dreaded Food & Drug Administration (FDA) Warning Letter. This first...
Mar 12 2012,
An Introduction to Patent Opinions
Whenever a medical device company develops a new product, process or technology, the topic of getting an “opinion” inevitably arises....
Mar 12 2012,
510(k) Clinical Data Requirements: Current Status and Considerations for Clinical Studies
In an effort to promote innovation while protecting the population at large, the US Food and Drug Administration (FDA) has...
Mar 12 2012,
IP Portfolio Management Strategies for Medical Device Manufacturers
Management of a company’s intellectual property (IP) is all about two things: controlling the innovation produced by the Research and...
Dec 14 2011,
Planning for the Unpredictability of Change
...and it Begins Change, defined: The act, process, or result of altering or modifying Change is inevitable and sometimes even predictable but,...
Dec 13 2011,
Final Office Action Rejections for Patent Applications: It Ain’t Over until the Fat Lady Sings…Usually
The patent process can be a long and, at times, tedious process. Many inventors assume that once you file your...
Oct 11 2011,