Mauricio Arellano, President, Greatbatch Medical
As the leader of Greatbatch Medical, Mauricio Arellano is responsible for driving the design and manufacture of critical technologies for...
Jun 30 2011,
Vital Validation Considerations for Your Company’s Next Packaging Project
Regulatory, Reimbursement & Clinical Challenges in the Orthopaedic Marketplace
The medical device industry faces a number of significant challenges. Federal health care reform, unpredictable U.S. regulatory pathways and an...
Jun 30 2011,
Got GD&T? Exploring the Importance of Advanced Mechanical Inspection
Advanced mechanical inspection, such as geometric dimensioning and tolerancing, is important in the medical device industry...
Jun 30 2011,
Forecasting: It’s Getting Better
My business career started back in the industrial “Dark Ages”—the 1960s. One of my first promotions was to head up...
Jun 30 2011,
Patent Reform is On the Way…Maybe
For the past several years, Congress has debated several bills that would change the way that patent laws are currently...
Jun 30 2011,
Basic Anatomy of a Design Dossier
This article summarizes key elements required for technical documentation of medical devices provided by manufacturers in order to demonstrate conformity...
Mar 31 2011,
Engineering Plastics Deliver Cost/Performance Advantages as Metal-Replacement Option
Numerous trends in the healthcare industry favor the use of high-performance thermoplastics in a range of applications including instruments and...
Mar 31 2011,
Corrective and Preventive Action: What Does FDA Look For During Inspection?
The orthopaedic industry faces strong pressure from regulatory bodies as well as from the industry to maintain the quality of...
Mar 31 2011,
A New Inspection Paradigm
The device industry has been abuzz with discussion of non-contact inspection methods like White Light Scanning and Computer Aided Inspection....
Mar 31 2011,
Beware of the Falsely Patent Marking Boogey Man
Within the past 18 months, a cottage industry has started to emerge. This disruptive industry exists to sue companies for...
Mar 31 2011,
You May Own a Copyright and Not Know It!
Copyrights are rampant in the world of orthopaedics and are, most of the time, ignored or forgotten. Copyrights can be...
Dec 31 2010,
Design Controls: Design Transfer, Changes and the Design History File
Introduction and Review As you may recall from the first and second articles in this series, each manufacturer of orthopaedic medical...
Dec 31 2010,
The Benefits of Capturing Product Data Are High – The Costs of Doing So Don’t Have to Be
Choosing the right data collection partner and process can help device companies differentiate themselves in the minds of surgeons....
Dec 31 2010,
Selective Retention: The Key to Keeping the People You Want
When you lose a “clutch player,” it hurts! Not only is it demoralizing to you, but it can have a...
Dec 31 2010,
3D Technology Improves Surgical Implants and Procedures
3D for improving orthopaedic implant design and surgical procedures has been hindered by the need for more accurate and usable...
Dec 31 2010,