Columns

Extremities | Large Joint | Spine/Neurology

Electing a Path Back to Operational Normalcy

In deciding whether to allow elective surgeries to resume, states must balance patient needs with safety and equipment requirements.

Michael Barbella, Managing Editor 05.20.20

Illusion of Choice in Orthopedics in a COVID World

The Permanente Medical Groups represent a behemoth compared to the rest of the medical groups in the U.S. Kaiser employs more than three times the number of physicians as the second largest group—Fresenius Medical Care Holdings. The Permanente…

Maria Shepherd, President and Founder, Medi-Vantage 05.20.20

Winning from the Sidelines: What Can We Do Now to Mitigate Pandemic Fallout?

Discover a contest to determine the top 10 ideas, technologies, software systems, or other processes that will best serve orthopedic patients.

Dawn A. Lissy, Founder & President, Empirical 05.20.20

Software & Quality

The 5 Steps Toward Machine Learning

Many want to use AI/ML applications, but few have the means to do so; the process is a long one, so the best approach is to just take one step at a time.

Sue Marchant, Director of Product, Machine Learning and Artificial Intelligence, MasterControl 05.20.20

Biocompatibility & Testing

Conducting Chemical Characterization/Risk Assessment for FDA Submissions

Chemical characterization/risk assessment is a powerful methodology for addressing select biocompatibility endpoints.

Robert A. Allen, Ph.D., Senior Associate, Regulatory Affairs, MCRA LLC 05.20.20

Design

Design Intent Strategy Brings Clarity to Device Development

Communicating clear design intent is an important indicator for success in medical device development.

Philip Allen, VP Sales and Marketing, Lowell Inc. 05.20.20

COVID Strategy for Regulatory and Quality Professionals and Their Leaders

Great challenges and changes are being wrought by the SARS-CoV-2 virus and mitigation efforts to control its spread. The changes have been relatively sudden and impact every aspect of personal and professional life. While these changes seem abrupt an…

Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 05.20.20

Biologics

Made-to-Order Muscles Could Be Served in a Hospital Near You

Dr. Ali Tamayol recently developed a handheld bioprinter pen that could significantly change the way musculoskeletal procedures are performed.

Sam Brusco, Associate Editor 03.13.20

Design

The Importance of Usability/Human Factors Testing

When is the work of human factors over, and how does your team know they are prepared for summative testing?

Maria Shepherd, President and Founder, Medi-Vantage 03.13.20

Large Joint

Particle Particulars: Why this Analysis Is Foundational for Successful Devices

In the mid-2000s, medical device experts were hopeful they’d found one solution to longer-lasting implants.

Dawn A. Lissy, President & Founder, Empirical 03.13.20

Large Joint

All Knee Implants Are Not Created Equally

Despite knee replacement being one of the most successful orthopedic procedures, up to 20 percent of patients are dissatisfied with their implant.

Rajit Kamal, Vice President and Global Franchise Leader, Knees, DePuy Synthes 03.13.20

The ABCs of Reimbursement for Breakthrough Devices

At the cross-section of BDD status are device reimbursement strategy considerations.

Tonya Dowd, MPH and Simran Madhani, MCRA 03.13.20

Design | Instruments

A Case Study of Design Controls and Orthopedic Instruments

Most orthopedic instruments are Class I so manufacturers aren’t required to apply formal design controls, but recently, attitudes are changing.

Victoria Trafka, President & Principal Engineer, Engineering & Quality Solutions Inc. 03.13.20

Large Joint

Joint Replacement Trends Takeaways

In 2019, the American Joint Replacement Registry Annual Report reported aggregate procedural growth of 28.5 percent over 2018.

Maria Shepherd, President and Founder, Medi-Vantage 02.18.20

Recalibrating for 2020: Tips for a Better New Year

In 2019, I had to take a long, hard look at both my businesses and my industry to find balance and a way forward through the ripple effects of big changes.

Dawn A. Lissy, President & Founder, Empirical 02.18.20

Instruments | Instruments, Cases & Trays