Columns

Striving to Attain a Gain on the Pain

A growing number of orthopedic patients are wrestling with fear, perhaps fueled in part by variant virus strains believed to be more contagious.

Michael Barbella, Managing Editor 02.08.21

Rethink Your Orthopedic ASC Strategy, Part 1

ASCs have adopted a strategy to focus on predictable, low-risk procedures with lower complication rates in an out-of-hospital setting.

Maria Shepherd, President and Founder, Medi-Vantage 02.08.21

Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

Pandemic restrictions may have diminished certain advantages large companies hold over small and mid-sized competitors.

Dawn A. Lissy, Founder & President, Empirical 02.08.21

Tips for Reigniting Your MDR/IVDR Preparation

To get the MDR/IVDR preparation ball rolling again, here are four processes to help refocus on achieving compliance with the updated regulations.

Nicolle Cannon, Founder and CEO, Cannon Quality Group LLC 02.08.21

Biologics

An FDA Regulatory Perspective on Bone Grafts

There are various bone grafts with different composition, source, mechanical strength, and functional biological mechanisms.

Mehdi Kazemzadeh-Narbat, Ph.D., Senior Associate, Regulatory Affairs, MCRA LLC 02.08.21

Packaging & Sterilization

Building a More Transparent Healthcare Supply Chain with UDI

The FDA’s 2013 Unique Device Identification (UDI) Rule sets specific requirements for medical device labeling to improve traceability and patient safety.

Beth Wells, Senior Director, Community Engagement, Healthcare, GS1 US 02.08.21

Stryker Strikes Back After Pandemic Slump

Late last year, Stryker announced it would snap up Wright Medical to fortify its position in the trauma and extremities markets.

Sam Brusco, Associate Editor 11.18.20

Large Joint

Obesity and the Impact on Hip and Knee Implants

Obesity causes multiple health issues, and the COVID-19 pandemic is only adding to the problem.

Maria Shepherd, President and Founder, Medi-Vantage 11.18.20

Virtually the Same? The Challenges of Online Conferences

Like everyone else on the planet, I’m turning increasingly to virtual solutions to our physical challenges in the midst of a pandemic.

Dawn A. Lissy, Founder & President, Empirical 11.18.20

13 Mistakes to Avoid in a 510k Submission

The FDA 510(k) review process can broadly be divided into two steps—acceptance review and substantive review.

Samradni Patil, Regulatory Consultant and Writer, Kolabtree 11.18.20

Contract Manufacturing

A Supply Chain Strategy for Pandemic Survival

Medical device supply chain managers will likely conclude that 2020 is a year best forgotten.

Tony Freeman, President, A.S. Freeman Advisors LLC 11.18.20

Medical Device Equivalence Requirements Strengthened under the EU MDR

This column focuses on the directive under EU 2017/745 on medical devices (MDR), highlighting some of the changes in claiming and demonstrating equivalence.

Cindy Boyer, Senior Manager, International Regulatory Affairs, MCRA LLC 11.18.20

Solid Footing During Shaky Times: Current Compliance Considerations

The changes and challenges wrought by COVID-19 have significantly impacted the medtech industry.

Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 11.18.20

A Wrinkle in the COVID-19 Financial Recovery

A British Journal of Surgery study projected the global pandemic would postpone or outright cancel 6.3 million orthopedic procedures.

Michael Barbella, Managing Editor 09.15.20

Research & Development

Trends for Orthopedic Contract R&D and Manufacturing

Over the past 10 years, medtech manufacturers from startups to giants have grown their levels of outsourcing to contract R&D and manufacturing partners.

Maria Shepherd, President and Founder, Medi-Vantage 09.15.20