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Articles written by Rob Meyer

Start Simple: Advice to Effectively Use Statistical Methods in Process Validation

by Rob Meyer | Apr 2018

Thorough process development, optimization and control using appropriate statistical methods and tools is recommended to show that processes are stable and capable. ... Read more »

Acquisitions Position NN, Inc. as Major Orthopaedic Supplier

by Rob Meyer | Apr 2018

The recent acquisition of Paragon Medical, coupled with purchases of several other household names during the past three years, means that NN has positioned itself as a top-five contract manufacturing player.  ... Read more »

Extremities Players Seek to Bolster Shoulder Revenue with Stemless Implants

by Rob Meyer | Apr 2018

Exactech’s FDA-cleared Equinoxe is competition for Wright Medical and Zimmer Biomet’s offerings. The three are the only FDA-cleared stemless shoulders in the U.S. ... Read more »

Scientists Successfully Test New Titanium Plate for Bone Tissue Repair

by Rob Meyer | Apr 2018

In animal testing, the patented titanium fiber plates did not demonstrate bone embrittlement after close contact for prolonged periods. ... Read more »

Rapid + TCT Additive Conference Ramps up Medical Presence with MMI Series

by Rob Meyer | Mar 2018

This year’s event, April 23-26 in Fort Worth, Texas, features several educational sessions and topics of interest for orthopaedic medical device professionals. ... Read more »

Globus Medical Making Sizable Push Into Trauma Market

by Rob Meyer | Mar 2018

The company debuted its suite of FDA-510(k)-cleared trauma products in four families at the 2018 American Academy of Orthopaedic Surgeons annual meeting. ... Read more »

TKRs, Associated Products Among Strategic Announcements, Launches at AAOS 2018

by Rob Meyer | Mar 2018

In addition, companies including Stryker, Smith & Nephew and DePuy Synthes have launched some of their latest technologies in hip, biologics, spine and more. ... Read more »

Vital Validation Considerations for Your Company's Next Packaging Project

by Rob Meyer | Feb 2018

Common problems that OEMs face during packaging validation include determining what validations are actually necessary, understanding all timelines and costs associated with each validation type and re-executing if validation fails.  ... Read more »

Medical Device Packaging is Shaped by Increased Regulations

by Rob Meyer | Feb 2018

Global unique device identification (UDI) and ISO updates are among the regulations and standards that companies must monitor in the coming years. ... Read more »

Supplier Talks: Precision, Accuracy Among Swiss Machining Benefits

by Rob Meyer | Feb 2018

"Because of the technology," one supplier says, "you’re able to drop off parts to the customer complete and don’t have to go to secondary operations, which costs money and time. Swiss-type screw machines are so complete, in terms of capabilities." ... Read more »

Smith & Nephew’s eCAP Shows 97% Decrease in Readmission Rates

by Rob Meyer | Feb 2018

The initiative is designed to mitigate risk associated with readmissions in value-based healthcare reimbursement models. ... Read more »

FDA Issues Direct Final Rule to Alter Outdated Requirements on Biologics Inspections

by Rob Meyer | Feb 2018

The rule amends that inspections will be risk-based, not biennial. ... Read more »

Augmedics Bringing X-Ray Vision to Surgery with X-VISION Visualization System

by Rob Meyer | Jan 2018

With its first application in minimally invasive spine procedures, X-VISION technology is designed to save time during surgery, reduce radiation exposure and reduce the number of repeat operations and hospitalizations. ... Read more »

FDA Releases Priorities for 2018

by Rob Meyer | Jan 2018

Among the Agency’s 2018 priorities is an alternative, fast-track 510(k) pathway for certain devices. ... Read more »

CMS Finalizes Joint Bundled Payment, Outpatient Payment Changes

by Rob Meyer | Dec 2017

The Centers for Medicare & Medicaid Services (CMS) made changes to the bundled payment model for Comprehensive Care for Joint Replacement, and finalized cancellation of the mandatory hip fracture and cardiac bundled payment models. ... Read more »

Sanford Health Stem Cell Therapy Trial First in U.S. for Shoulder Injuries

by Rob Meyer | Dec 2017

The hospital system is attempting fat-based stem cell treatments on orthopaedic patients, using the cells to heal small/partial thickness rotator cuff tears. It's the first trial in the U.S. to gain FDA approval for the use of adipose stems cells to treat the injury. ... Read more »

UDI Direct Marking Guidance Finalized by FDA

by Rob Meyer | Nov 2017

FDA did not offer device companies new direction on methods to direct mark, as it would be difficult to account for the wide variety of existing devices, use conditions and reprocessing methods. ... Read more »

Smith & Nephew Adds to Sports Medicine Portfolio with Rotation Medical Acquisition

by Rob Meyer | Nov 2017

Rotation Medical’s collagen-based bioinductive implant for rotator cuff repair boosts Smith & Nephew’s arthroscopy/soft tissue portfolio and focus on regenerative medicine. ... Read more »

AAOS to Launch Orthopaedic Registries, Integrate With AJRR

by Rob Meyer | Nov 2017

As data plays an increasingly important role in orthopaedics, the American Academy of Orthopaedic Surgeons announced plans to create registries for a broad range of conditions and procedures. ... Read more »