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Articles Tagged "data"

3 OMTEC Takeaways: Personalized Medicine, Data and ASCs

by BONEZONE | Jun 2019

During OMTEC’s opening keynote panel, executives spoke to the questions: How will technology personalize the patient’s experience? What role will data play in surgeon and device company decision making? Will companies’ strategies for implant design and the supply chain change to meet the needs... Read more »

Orthopaedic Companies Collaborate with NESTcc on Real-World Evidence Considerations

by BONEZONE | Jan 2019

The National Evaluation System for health Technology Coordinating Center launched its first round of Real-World Evidence Test-Cases, which include a focus on postmarket surveillance in orthopaedics. NESTcc's Deputy Director discusses what manufacturers should know about Real-World Data and Real-Worl... Read more »

AM Case Study Shows Potential to Double Production of Implants

by BONEZONE | Jan 2019

Additive manufacturing software company Betatype significantly increased the production of 3D-printed metal orthopaedic implants using its technology platform and Renishaw’s RenAM 500Q powder bed fusion printer.... Read more »

Smart Devices, Robotics, Sensors: Tools to Improve Patient Outcomes

by BONEZONE | Oct 2018

Dr. Martin Roche explains how these technologies are shaping the future of orthopaedic surgery: "A surgeon needs data to make objective decisions intra-operatively. The subjective Art of Surgery is poorly translatable ... Through all this rapid evolution, the clinician must take a leadership role."... Read more »

AIRO Focuses on Robotic, Artificial Intelligence Application for Joint Reconstruction

by BONEZONE | Sep 2018

Brett Robertson, Managing Director for the Australian Institute of Robotic Orthopaedics, explains how AIRO is leveraging decades of orthopaedic expertise to deliver a platform technology that unites lasers, robot-assisted motion, computational modeling, AI, digital sensing and real-time responses.... Read more »

Finding Your Way in a Post-Lean/Six-Sigma World Using Operations Science

by BONEZONE | Jul 2018

This alternative approach to Lean and Six Sigma allows executives to build business success by making decisions guided by practical, scientific principles.... Read more »

Optimizing Your Supply Chain with Science, Data and People

by BONEZONE | May 2018

It is recommended to implement your optimal management of inventory, capacity and response time buffers to get the best possible solution for your unique challenges.... Read more »

Ceramics Expo 2018: Three Takeaways for Orthopaedic Engineers

by BONEZONE | May 2018

Topics of interest included a deep dive into the role of advanced data analytics in manufacturing and the future of ceramics in the spine space.... Read more »

Making the Most of UDI

by Chris Mosby | Aug 2016

UDI regulations have altered your business. Gaining solid ROI from your compliance efforts comes down to internal efficiency, capturing your own master data and learning how to use that data for product development, marketing and logistics.... Read more »

Applying Supply Chain Best Practices From Other Industries

by Chris Mosby | May 2016

OEMs are now more willing to leverage best practices and solutions from other industries. Those sources of inspiration are as diverse as high-tech, e-commerce and retail. While the highly-regulated nature of the industry presents obstacles to adopting new supply chain practices, increasing pric... Read more »

Big Data Tops FDA’s 2016 Priorities

by Carolyn LaWell | Nov 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

3D Printing, Cybersecurity Emerging Concerns for Device Manufacturers

by Hannah Corcoran | Nov 2015

Additive manufacturing and the domination of digital communication and information transfer pose new concerns for manufacturers.... Read more »

Regulatory Expert Builds Web Tool to Assist Companies with 510(k)s

by Hannah Corcoran | Jul 2015

Frustrated with FDA’s 510(k) search function, Eric Eggers created kBLASTER to help companies simplify and speed their 510(k) submissions.... Read more »

Mobile Medical Apps Attract OEM, FDA Attention

by Prithul Bom, MBA, RAC | Jun 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

U.S. Registry Offers New TJR Data

by BONEZONE | May 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

ACL Injuries More Common after Reconstruction

by BONEZONE | Aug 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Lessons Learned From Metal-on-Metal Implants

by Robert Packard | Mar 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Medicare: Trends in Beneficiaries Served and Hospital Resources Used in Implantable Medical Device Procedures

by BONEZONE | Aug 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Imaging Analytics: Optimizing Time Efficiencies

by BONEZONE | Dec 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The CMS/FDA Proposed Parallel Review Process: Can One Clinical Trial Really Satisfy Two Agencies?

by BONEZONE | Sep 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Regulatory, Reimbursement & Clinical Challenges in the Orthopaedic Marketplace

by BONEZONE | Jun 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Outcome Measures in Joint Replacement by Physical Activity Monitoring: Pre-pilot Study

by BONEZONE | Dec 2010

Success rate figures for total joint arthroplasty are typically based on revision rates, and do not reflect patients’ satisfaction or quality of life. Neither do they take into account the patient’s physical mobility after a surgical procedure.1 In order to reduce the need for revision, many stu... Read more »

The Benefits of Capturing Product Data Are High - The Costs of Doing So Don’t Have to Be

by BONEZONE | Dec 2010

Co-authored by Keith Kennedy Perhaps more than at any other time in recent years, we are witnessing rapid changes in the way products and procedures are developed and measured in orthopaedics. In addition to innovative product advancements, there is a groundswell of interest in tracking product and... Read more »