8 Design Control Issues Found During FDA Inspections
Involvement with numerous FDA inspections over the years has given me, I think, a unique perspective on design control trends—specifically,...
Nov 11 2015,
Competitive Landscape
Outsource Innovation by Tapping into Supplier Expertise
When it comes to outsourcing, the traditional role of suppliers is based upon their core competencies in manufacturing or specialty...
Nov 11 2015,
Big Data Tops FDA’s 2016 Priorities
FDA’s Center for Devices and Radiological Health (CDRH) plans to embrace the use of big data and patient reported outcomes...
Nov 10 2015,
3D Printing, Cybersecurity Emerging Concerns for Device Manufacturers
Additive manufacturing and the domination of digital communication and information transfer pose new concerns for manufacturers....
Nov 10 2015,
Supplier Consolidation Continues with Greatbatch’s Acquisition of Lake Region
Greatbatch purchased Lake Region for ~$1.73 billion, allowing the company to scale parallel to its main customers–Johnson & Johnson, Medtronic...
Oct 29 2015,
Manufacturing or Selling Medical Devices in Mexico: A Regulatory Conundrum
Mexico is making significant steps on in-roads into the medical device industry and is ready for success. Industry analysts predict...
Oct 01 2015,
Brazil Remains Among Top Ten Markets, Despite Economic Downturn
Claiming the 7th largest economy in the world and the largest in South America, Brazil is a force in the...
Oct 01 2015,
International and Domestic Manufacturers Compete to Serve Growing Asian Population
Orthopaedics remains an attractive and growing market, especially in Asia. Multiple factors contribute to the growth of the orthopaedic market...
Oct 01 2015,
The Fundamentals of a Human Factors Program
Prudent manufacturers already know that the deployment of human factors and usability engineering go beyond meeting regulatory requirements. Manufacturers can...
Oct 01 2015,
4 Questions to Answer Before Outsourcing
Companies jump into supplier selection and contract negotiation without proper preparation and due diligence. This often results in uncovering issues...
Oct 01 2015,
Product Development and IP Considerations: A Marriage Made in Heaven?
This article outlines the stages of the R&D process and the corresponding parallel issues that the legal department would want...
Sep 30 2015,
FDA Outlines Critical Quality Measures
FDA’s Director of the Division of Manufacturing and Quality discussed recent Agency initiatives that emphasize quality over compliance....
Sep 11 2015,
Wright Medical’s AUGMENT Bone Graft Approved by FDA
Wright Medical's AUGMENT receives long-awaited FDA approval for ankle/hindfoot indication....
Sep 10 2015,
Three Spine Companies Implement New Manufacturing Strategies
Alphatec Spine, Globus Medical and NuVasive, the three largest pure-play spine companies, announced revised manufacturing strategies during 2Q15 earnings calls....
Sep 09 2015,
NASS Preparation: Suppliers to Meet on the Exhibit Floor
Of the 321 exhibitors at this year’s NASS Annual Meeting, 21 are suppliers and service providers listed in the ORTHOWORLD/BONEZONE...
Sep 09 2015,