Labor Hours or Machine Hours: Which is Preferable?
A manufacturer that fails to segregate indirect and support costs driven by the operation of equipment from those driven by...
Dec 11 2013,
Competitive Landscape
Start Early: Converting Your Spinal Technical File into a Class III Design Dossier
As part of EU Commission regulatory changes, spinal implants will be reclassified from Class IIb devices to Class III devices....
Dec 11 2013,
Strategic Orthopaedic-related 510(k) Update
The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Altus Spine, Anchor Innovation, Beijing Libeier Bio-Engineering...
Dec 11 2013,
Lessons in M&A
Mergers and acquisitions require great human and capital resources. Two OEMs share how they completed transactions this year....
Nov 06 2013,
How to Build a Better Supplier Scorecard
Supplier scorecards are intended to be a simple tool to help you evaluate suppliers. These steps provide for an easier...
Nov 06 2013,
Collaborating with Suppliers in a Changing Landscape
OEMs operate with different expectations and visions, causing suppliers to react and accommodate each relationship. A supplier lends its perspective...
Nov 06 2013,
Japan: Entering an Established Market
While much emphasis has been placed on the double-digit growth in emerging markets, there are advantages to expanding business in...
Nov 06 2013,
Strategic Orthopaedic-related 510(k) Update
The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Binder Biomedical, Corentec, Jeil Medical, NovoSource, ORTHOSoft,...
Nov 06 2013,
How to Find Savings in the Excise Tax Era
There is much more to the medical device excise tax than reporting and remitting. Some manufacturers might benefit from re-evaluating...
Oct 03 2013,
Strategic Orthopaedic-related 510(k) Update
The following companies recently received strategic FDA 510(k) clearances: Advanced Interventional Technology, CoreNexus, Crosstrees Medical, Emerge Medical, Ingen Orthopedics, JG...
Oct 03 2013,
Mitigate Patent Infringement Risk with an FTO
Performing an FTO search is a critical tool when developing or getting ready to launch a new product. Here's how...
Oct 03 2013,
Risk Management: The Science of Minimizing Uncertainties
The success of a risk management process in medical device manufacture lies in an early start in design and use...
Oct 02 2013,
Measuring and Assessing the Cost of Manufacturing Cells and Lines
If a company is to understand the benefits that accrue as a result of cellularization, it cannot follow an obsolete,...
Oct 02 2013,
Consumers Union Seeks Warranties to Support Hip, Knee Implants
The Consumers Union is asking U.S. manufacturers to back products with a 20-year warranty. Other suggested requirements include the following....
Oct 02 2013,
Presenting Data to Show Product Cost Effectiveness
Shifts in the marketplace are driving a need to collect and position clinical data in order to show product effectiveness....
Oct 01 2013,