Challenges in the Supply Chain
We queried OEMs for thoughts on their biggest challenges in the supply chain....
Dec 13 2011,
Competitive Landscape
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,
Sales & Operations Planning: Beyond the Basics
Companies that have learned how to implement sales & operations planning will realize increased profitability....
Oct 11 2011,
The CMS/FDA Proposed Parallel Review Process: Can One Clinical Trial Really Satisfy Two Agencies?
Medically necessary vs. safe and effective. Can clinical trials, by design, realistically satisfy the needs of two Federal agencies with...
Oct 11 2011,
Thoughts on Low-Cost Orthopaedic Device Companies
Industry responds to thoughts/opinions on small firms offering discounted orthopaedic products...
Oct 11 2011,
The View from Washington: What Device Makers Need to Know about FDA’s Latest Strategic Priorities and Initiatives
Continuously hammered by Congress, news media and the international health community, the U.S. FDA has responded with a five-year plan...
Aug 31 2011,
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,
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,
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,