Columns

Trauma/Sports

‘Smart Crutches’ Help Boost Leg Injury Recovery

Based on a doctor’s weight-bearing parameters, an alert is sent if the leg is loaded incorrectly with too much or too little weight.

Sam Brusco, Associate Editor 11.17.21

COVID and Life Have Me Rethinking My Connections

Early in my career, I learned the value of following up on handshakes and intros, even if there was no obvious short-term benefit.

Dawn A. Lissy, Founder & President, Empirical 11.17.21

Packaging & Sterilization

Overcoming Packaging Challenges with Innovative Materials

At times, packaging orthopedic devices such as implants can prove to be challenging because of their size and sterility requirements.

Brian Ingraham, Senior R&D Director, Amcor Healthcare 11.17.21

3-D Printing/Additive Mfg.

Designing Orthopedic Devices for Additive Manufacturing

The opportunities to leverage AM to improve current products or production processes in the here and now is enormous.

David Krzeminski, Additive Minds Consultant, EOS 11.17.21

FDA Regulatory Challenges for Antimicrobial Orthopedic Devices

Preventing and managing orthopedic-associated infections is one of the major challenges in orthopedic surgery.

Mehdi Kazemzadeh-Narbat, Ph.D., Associate Director, Regulatory Affairs, MCRA LLC 11.17.21

3-D Printing/Additive Mfg.

Medical Device Manufacturing at the Point of Care

Additive manufacturing is a tool that can be reasonably deployed at the point of care.

Benjamin Johnson, VP, Portfolio & Regulatory, Healthcare, 3D Systems 11.17.21

EU MDR Interpretation and Understanding—Devil in the Details

While the date to conform to all transitional requirements has passed, a new wave of scrutiny will arrive as organizations seek certification under the new MDR.

Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 11.17.21

Trauma/Sports

A Better Surgical Suture: A Development Story

The EasyWhip is indicated for use in approximation and/or ligation of soft tissues, including the use of allograft tissue for orthopedic surgeries.

Michael Barbella , Managing Editor 09.14.21

Bone Cancer: The Global Burden and Medtech Opportunity

There are so many medical devices critical to the treatment of cancer.

Maria Shepherd, President and Founder, Medi-Vantage 09.14.21

3-D Printing/Additive Mfg.

3D Printing as Art Therapy

It’s a new-tech take on art therapy and art psychotherapy, which are both elements of the support Westwood Prep offers its students.

Dawn A. Lissy, Founder & President, Empirical 09.14.21

The New U.K. Conformity Assessment: 10 Checklist Items

This new divergence between EU and U.K. requirements also means different rules apply to Great Britain (England, Scotland, and Wales) and Northern Ireland.

Ed Ball, Senior Associate, RQM+ 09.14.21

Managing a Global Medtech Business Amid International Travel Challenges

Travel restrictions have made it difficult for C-Suite executives to manage a global medical technology business.

Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 09.14.21

Medical Device IP Strategy, Part II: Creating a Patent Strategy to Mitigate Risk

U.S. patent law establishes the right of a patent owner to prevent others from making, using, selling, offering for sale a product claimed in a valid patent.

Gregory Grissett, Principal and Chair, Intellectual Property Group, Offit Kurman P.A. 09.14.21

Early Regulatory Strategy: Streamlining the Path to Market

Planning for a regulatory submission entails consideration of numerous requirements beyond simply the content and required elements of the application.

Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 09.14.21

Biocompatibility & Testing

Automated Data Analysis: Making the Case

Shifting to automated data analysis for process qualification activities can improve the effort for manufacturers and their customers in several ways.

Jack Wieland, Project Manager, Lowell Inc. 09.14.21

Biocompatibility & Testing

Disinfectant Efficacy Testing: How Limiting Bioburden Keeps You Compliant

Medical devices are only effective if they can perform their intended functions safely, and safe performance starts with reducing bioburden.

Leslie Tavares, Melinda Johnson and Jessica Lawrence, WuXi AppTec 09.14.21

Bracing/Prosthetics

Liquid Metal and AI Create Artificial Sense of Touch

The fingertips of the human hand contain over 3,000 touch receptors, making them extremely responsive to pressure.

Sam Brusco, Associate Editor 08.17.21

Biocompatibility & Testing

Human Factors Usability Testing at Home

Online, remote usability testing at home for orthopedic patients has turned out to be a valuable option.

Maria Shepherd, President and Founder, Medi-Vantage 08.17.21

3-D Printing/Additive Mfg.

Back in 3D: AMUG Conference Welcomes Members in the Flesh

This was my first visit to AMUG; I spoke about the role of the FDA in regulating medical devices produced via AM.

Dawn A. Lissy, Founder & President, Empirical 08.17.21

Medical Device IP Strategy, Part I: Creating a Patent Strategy that Protects Your Revenue Model

This is the first part of a two-part series that will cover how to create an IP strategy, and in particular, a patent strategy, that stands above the rest.

Gregory Grissett, Principal and Chair, Intellectual Property Group, Offit Kurman P.A. 08.17.21