FDA Publishes Q&A on UDIs
The deadline for Unique Device Identifier (UDI) implementation for medical devices is September 24, 2014. FDA has issued a 14-page...
Sep 10 2014,
Competitive Landscape
Customer Profitability: The Why and How of SG&A Costs
Many costs that separate desirable customers from less-desirable customers lie hidden in that great “blob” of costs christened as SG&A....
Sep 09 2014,
Experts Offer Strategies for Clinical Trial Execution and Outsourcing
Experts share their insights on best practices and strategies for conducting clinical trials inside and outside of the U.S., as...
Sep 09 2014,
FDA Clarifies Substantial Equivalence Requirements for 510(k) Submissions
FDA attempts to clarify substantial equivalence requirements in its latest 510(k) guidance. What do these changes mean for your next...
Sep 09 2014,
Choosing Materials in a Shifting Global Regulatory Environment
Orthopaedic device manufacturers face increasing pressures related to the safety of raw materials used in implants and instruments. Consider these...
Aug 05 2014,
Strategic Orthopaedic-related 510(k) Update
The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. An asterisk denotes those companies receiving first...
Aug 05 2014,
The “Cost to Serve” Customer Fulfillment
Manufacturers can gain critical insight on customer and product profitability when “cost to serve” activities are measured and assigned....
Aug 05 2014,
Greater Memphis Medical Device Council Forms to Support Industry Health
Seventeen medical device manufacturers have formed the GMMDC to address issues critical to the local medical device industry. GMMDC will...
Jul 22 2014,
Suppliers Speak to Economic and Regulatory Challenges in Global Expansion
New market entry presents logistical hurdles for every company. Suppliers provide insight based on their own experience of opening overseas...
Jul 09 2014,
Effective Tools for Patent Searches
Management has given the go-ahead to design a new device. As an engineer, you’ll now conduct a patent search to...
Jul 09 2014,
The Starting Line: Turning the Corner with a Device Concept
New orthopaedic device concepts from surgeon entrepreneurs and novice inventors often hit snags when facing the reality of the regulated...
Jul 08 2014,
What to Consider When Converting Parts from Machined to Molded
Reduce cost AND increase quality: these requirements have device companies rethinking the manufacturing process. Discuss these factors when choosing between...
Jul 08 2014,
Protecting Inventions and Brands: IP Due Diligence in the Product Development Process
The importance of IP due diligence is often overlooked when bringing an orthopaedic device through each of the eight stages...
Jun 03 2014,
Survey Finds Half of Surgeons Worldwide Unwilling to Use Generics
A recent survey found 52 percent of orthopaedic surgeons worldwide would not be willing to use generic implants. A greater...
Jun 03 2014,
Six Ways to Prevent Supplier Quality Problems
The root cause of defective product from suppliers is often inadequacies of your own supplier controls. The methods described in...
Jun 03 2014,