Departments

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

Delivering Smart Kit Functionality to the Orthopedic Industry

Quest offers tracking and status information of a firm’s kits in real time.

Sean Fenske, Editor-in-Chief 02.18.20

Keeping Up to Date in an Evolving Regulatory Landscape

As the May 26 implementation for MDR quickly approaches, a sense of urgency is affecting both medical device manufacturers and Notified Bodies.

Lucas Tatem, Technical Writer, Regulatory Affairs, MCRA LLC 02.18.20

Trends and Innovation in Supplier Quality

ISO 13485:2016 states a quality management system must include criteria for evaluating, selecting, monitoring, and re-evaluating suppliers.

Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 02.18.20

Extremities

Toe Fusion Alternatives Gaining a Firm Market Foothold

Dr. Carl Hasselman, co-designer of the Arthrosurface ToeMotion Arthroplasty System, speaks about non-fusion alternatives for MTPJ osteoarthritis.

Michael Barbella, Managing Editor 12.02.19

The Cluster Effect in Orthopedics: Is It Sustainable?

For a long time, we all assumed Minnesota dominated the medical device industry worldwide, but is this true for the orthopedic surgical tools industry?

Maria Shepherd, President and Founder, Medi-Vantage 12.02.19

‘If You’re Reading This, You Need to Be at This Meeting’

The AAOS/FDA/Industry Townhall is taking place March 24, 2020, at the AAOS annual meeting in Orlando.

Dawn A. Lissy, President & Founder, Empirical 12.02.19

Turning the New EU MDR Into a Competitive Advantage

This column examines three new elements of the EU MDR that medical device manufacturers can leverage.

Dan Goldstein, Associate Director, Quality Assurance, MCRA LLC 12.02.19

Impeachment, Executive Orders, and Must-Pass Congressional Legislation: A Fall Update

The final quarter of 2019 has begun, which means Congress and the Trump Administration are hard at work finalizing healthcare initiatives before year's end.

Jeffrey J. Kimbell, David C. Rudloff, and Caroline P. Tucker, Jeffrey J. Kimbell & Associates Inc. 12.02.19

Spine/Neurology

Pediatric Orthopedics Taken Off the Back Burner

There are several different types of scoliosis, a condition that causes a sideways spinal curve, that affect children and adolescents.

Sam Brusco, Associate Editor 09.17.19

What Are Orthopedic Surgeon Salary and Employment Statistics?

The percent of employed physicians is greater than self-employed physicians.

Maria Shepherd, President and Founder, Medi-Vantage 09.17.19

U.S. May Offer a Safe Harbor from the Impending MDR Storm

There are factors that make for a more inviting environment for the medical device industry in the United States.

Dawn A. Lissy, President & Founder, Empirical 09.17.19

How Identifying Gaps in Clinical Data Can Ease the Transition to New Regulations

As of 2017, the European medical device market was estimated at $126 billion, the second largest worldwide, comprising 27 percent of the global market. The European market trails only the United States, which accounts for roughly 43 percent of…

Mike Goodson, Associate Director, Regulatory Affairs, MCRA LLC 09.17.19

What Keeps Hospital CEOs Awake at Night and How Can Medtech Help?

With the continued surge of mergers and acquisitions, vertical integrations, and no clear U.S. policy or reform direction for our $3.6 trillion annual healthcare spend,1 the healthcare ecosystem remains in a phase of dramatic disruption. What Is K…

Maria Shepherd, President and Founder, Medi-Vantage 08.14.19

Mayday: How the Upcoming MDR Implementation Forecasts Disaster for Our Industry

I’m generally an optimistic person. My outgoing voicemail greeting encourages every caller to “keep smiling!” My wardrobe is about 40 percent “Life is Good” apparel and I keep a daily gratitude journal. Despite this s…

Dawn A. Lissy, President & Founder, Empirical 08.14.19

Successful Strategies for Health Plan Medical Policy Outreach

Getting approval from the FDA can be a significant achievement for a company but a bigger challenge awaits for novel technologies: health payor acceptance and coverage. Adopting a novel technology does not occur easily due to complex commercial insur…

Chelsey Jaworski and Anabel Tapia, MCRA 08.14.19

Contract Manufacturing | Supply Chain

Contract Service Providers: Forward Thinking in Supplier Management

Virtual manufacturing is common among startups and entrepreneurs building a new company or project with a prudent fiscal approach. Intellectual property and an experienced contract manufacturer can make it a reality. Harnessing a contract manufacture…

Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 08.14.19

Extremities | Research & Development