Columns

MIS/Robotics

Orthopedics is Slowly Wising Up to AI Tech

Medtronic conducted several tuck-in acquisitions to enhance its capabilities in robotic surgery, data analytics, and artificial intelligence.

Michael Barbella, Managing Editor 05.17.21

IVF, Exercise Science, and Sports Medicine

There could be a strong link between infertility and regular exercise for women.

Maria Shepherd, President and Founder, Medi-Vantage 05.17.21

Paying it Forward: How Mentorship Pushes Us to Success

The right people can build us up, push us to excel, and persevere when we think we can’t go on.

Dawn A. Lissy, Founder & President, Empirical 05.17.21

A Paradigm Shift—Third-Party Immersive Execution

A reputable firm will provide a thorough and unbiased review of all portions of your business and supply fractional leadership where you may have gaps.

Kevin Haines, Partner, Factor 7 Medical 05.17.21

When Is Digital Health Technology Regulated?

Whether you’re a startup or a well-established manufacturer, it can be challenging to determine if the software you’re developing needs FDA oversight.

Nikki Batista, Director, Digital Health Regulatory Affairs, MCRA LLC 05.17.21

Materials

Nitinol and FDA Guidance: Key Insights to Consider for Medical Devices

Manufacturers using at least one nitinol device component must consider recent FDA guidance and protect end users from nickel-ion release.

Dr. Sherry Parker and Dr. Kimberly Ehman, WuXi AppTec Medical Device Testing 05.17.21

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

Prototyping

Intelligent Iteration: The Benefits of Prototyping Rapidly

You don’t need to make a full prototype with all features, finishes, and functions included in order to evaluate the design and gain valuable information.

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

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