Departments

An Orthopedic Giant Re-emerges: DJO to Return?

At the beginning of March, diversified tech firm Colfax Corp. proclaimed its intention to split in two.

Sam Brusco, Associate Editor 03.16.21

Actual Orthopedics Medical and Surgical Supply Costs for Care Centers

According to a 2018 clinical journal article, U.S. hospitals spent approximately $200 billion on medical devices.

Maria Shepherd, President and Founder, Medi-Vantage 03.16.21

Show Time: Here’s What a Year of No Tradeshows Meant for Small Businesses

For small businesses, trade shows are a critical part of developing new business as well as maintaining contacts.

Dawn A. Lissy, Founder & President, Empirical 03.16.21

A Summary of Key Provisions Within CMS’ Final MCIT Rule

MCIT is available not only for new breakthrough devices but also for products that received this designation within the last two years.

John D. McDermott Jr., Senior Director, Reimbursement Strategy, MCRA LLC 03.16.21

Design

A Holistic Approach to Early Product Development

Regulatory requirements and limitations have a pronounced impact on new product development in the medical device industry.

Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 03.16.21

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

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

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