Integrating Internal Strategies to Impact a Successful Product Launch
As companies face daily challenges of bringing new products to market, they continuously seek ways to drive efficiency, reduce internal...
Aug 31 2011,
Start Simple: Advice to Effectively Use Statistical Methods in Process Validation
Vested Outsourcing: A New Business Model
Companies often fall prey to 10 Ailments that result in poor outsourcing agreements. We break down the elements. ...
Aug 31 2011,
The Internal Quality Audit Process for Orthopaedic Medical Device Companies: Risk Indicators and Uncertainties
FDA analysis of factory inspections has shown that manufacturers who do not have an adequate quality audit system usually do...
Aug 31 2011,
How (Not) to Fail as an Entrepreneur (or R&D Engineer, Buyer, Product Manager…)
What follows is a list of things that I have personally seen lead to entrepreneurial failure in the medical device...
Aug 31 2011,
The Reimbursement Top Ten Checklist: Understanding How Coverage, Codes and Payment Impact the Success of a New Medical Technology
The product design is flawless. The clinical trial endpoints were met. FDA has given the green light to begin marketing....
Jun 30 2011,
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,
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,