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,
Competitive Landscape
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...
Jun 09 2012,
The Dangers of Direct Labor-Based Costing at Orthopaedic Device Manufacturers
As we begin the second decade of the 21st Century – over a quarter-century into the “cost measurement and management...
Jun 08 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,
Sharp Rise in Use of Bone Growth Factor for Spinal Fusion Surgery
Studies suggest that the use of bone morphogenetic protein (BMP) for spinal fusion has risen sharply over the past decade,...
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,
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...
Mar 12 2012,
Executive Interview: Michael E. Miller, Chief Executive Officer, Orchid Orthopedic Solutions
Mike Miller shares Orchid's growth story....
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,
Sector Snapshot: The Orthopaedic OEM and Supplier Markets
Slowing growth in the orthopaedic OEM sector was reflected in the supplier side, though competition remained high and consolidation/collaborations continued...
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,
Strategic Orthopaedic-related 510(k) Update
The following companies recently received strategic FDA 510(k) clearances for devices in the orthopaedic space. For certain companies, this represents...
Dec 13 2011,
Quality, Speed, Price: Pick Three
The challenge is to adapt to the changing times and find the best new ways of doing things. That’s only...
Dec 13 2011,