Protecting Your Design with Patents
A smart legal strategy is to develop a comprehensive intellectual property portfolio of the various diverse–but related–IP rights associated with...
May 04 2018,
Competitive Landscape
Successful Medical Device Design Transfers Hinge on Advance Planning
Elements of a well-constructed plan include an understanding of regulatory requirements, a comprehensive review of all documentation and a thorough...
Apr 23 2018,
Start Simple: Advice to Effectively Use Statistical Methods in Process Validation
Thorough process development, optimization and control using appropriate statistical methods and tools is recommended to show that processes are stable...
Apr 23 2018,
Acquisitions Position NN, Inc. as Major Orthopaedic Supplier
The recent acquisition of Paragon Medical, coupled with purchases of several other household names during the past three years, means...
Apr 11 2018,
Smith & Nephew Names CEO with Acquisition, Turnaround Experience
Mr. Namal Nawana's experience includes 15+ years with Johnson & Johnson, primarily in the Medical Devices & Diagnostics segment and...
Apr 06 2018,
FDA and Customs Monitoring of International Purchasing: What You Need to Know
The ultimate goal is to ensure that all medical device products manufactured or distributed in the U.S. are both safe...
Apr 06 2018,
Extremities Players Seek to Bolster Shoulder Revenue with Stemless Implants
Exactech’s FDA-cleared Equinoxe is competition for Wright Medical and Zimmer Biomet’s offerings. The three are the only FDA-cleared stemless shoulders...
Apr 06 2018,
Knee and Hip Manufacturers Focus on Additive, Materials, Robotics
Among our takeaways from the American Academy of Orthopaedic Surgeons Annual Meeting include the trend that products must correlate to better...
Mar 19 2018,
Globus Medical Making Sizable Push Into Trauma Market
The company debuted its suite of FDA-510(k)-cleared trauma products in four families at the 2018 American Academy of Orthopaedic Surgeons...
Mar 19 2018,
Vital Validation Considerations for Your Company’s Next Packaging Project
Common problems that OEMs face during packaging validation include determining what validations are actually necessary, understanding all timelines and costs...
Feb 27 2018,
Medical Device Packaging is Shaped by Increased Regulations
Global unique device identification (UDI) and ISO updates are among the regulations and standards that companies must monitor in the...
Feb 27 2018,
Spine, Trauma Companies Continue a Focus on Sterile Packaging
Infection rates, regulatory implications and the efforts of hospitals to cut costs have driven sterilization changes in device packaging. ...
Feb 27 2018,
Precision, Accuracy Among Swiss Machining Benefits
"Because of the technology," one supplier says, "you’re able to drop off parts to the customer complete and don’t have...
Feb 23 2018,
The Contribution of Biomaterials to the Dawning of the Age of the Forgotten Hip
Primary total hip arthroplasty (THA) has undergone 25 years of product development, thanks to contributions from a host of materials...
Feb 22 2018,
The Medical Device Labelling Process Needs to Start Early in Design Controls
Mislabeled and misbranded medical devices are one of the top three causes for recalls in the United States. Companies can...
Feb 21 2018,