Columns

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

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

Contract Manufacturing

Three Steps to Improve the Manufacturing Process with Pre-Production Meetings

To meet today’s expectations and paperwork requirements, customers and manufacturers should go beyond a simple design review.

Thomas Van Wilpe, Manufacturing Process Engineer, Lowell 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

Design | Large Joint | Spine/Neurology

Five Reasons for the Small World of Orthopedic Product Development

Why do product development people tend to stay within the orthopedic and spine industry and not cross over into other medtech sectors?

Victoria Trafka, BSME, MSME, President and Lead Engineer, Engineering & Quality Solutions Inc. 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