Columns

A Wrinkle in the COVID-19 Financial Recovery

A British Journal of Surgery study projected the global pandemic would postpone or outright cancel 6.3 million orthopedic procedures.

Michael Barbella, Managing Editor 09.15.20

Research & Development

Trends for Orthopedic Contract R&D and Manufacturing

Over the past 10 years, medtech manufacturers from startups to giants have grown their levels of outsourcing to contract R&D and manufacturing partners.

Maria Shepherd, President and Founder, Medi-Vantage 09.15.20

Self-Care in Business: Four Ways to Extend the Peace of Home to the Workplace

Like so many small business owners, the lines between work and home often blur in the Lissy household.

Dawn A. Lissy, Founder & President, Empirical 09.15.20

When to Submit a 510(k)

When are design and manufacturing changes considered significant enough to surpass the threshold of submitting a new 510(k)?

Tom McDougal, MS, Associate, Regulatory Affairs, Musculoskeletal Clinical Regulatory Advisers LLC 09.15.20

Assembly & Automation

Behind the Scenes, Automation Drives Manufacturing Results

This article offers a closer look at how automation may work behind the scenes to improve quality, delivery, and cost.

Jim Stertz, Vice President of Automation/Technology, Lowell Inc. 09.15.20

Experiments in Remote Orthopedic Care

In an effort to protect patients amid the COVID-19 pandemic, many doctors are relying on telemedicine to “see” their patients through video chats.

Sam Brusco, Associate Editor 08.11.20

What’s Apple Been Up To?

Apple is building its bench with teams of physicians and engineers creating software and hardware to address the healthcare market.

Maria Shepherd, President and Founder, Medi-Vantage 08.11.20

Design

Rising to the Challenge: Six Innovators Win Fast-Track Support to Market

These six winning submissions reflect a keen awareness of patient needs during the unique and surprising circumstances of the COVID-19 pandemic.

Dawn A. Lissy, Founder & President, Empirical 08.11.20

Biocompatibility & Testing

Avoiding Contradictions: Testing Advice for Manufacturers

Manufacturers need to evaluate their approach to preclinical testing. Avoiding contradictory study design is the most effective path forward for study sponsors.

Mark R. Cunningham, Ph.D., Senior Director of Science and Technology, Technical Services, WuXi AppTec 08.11.20

Key Factors Driving the Adoption of Digital Health Technologies

As COVID-19 presented an immediate need for novel therapies and treatments to combat the disease, diagnosing the virus and managing patient symptoms from afar drove the adoption of telemedicine, telehealth, and remote patient monitoring devices. Like…

Lauren Craig, Director, Reimbursement Strategy Execution, Musculoskeletal Clinical Regulatory Advisors LLC 08.11.20

Recent Regulatory Changes and a 2020 Election Update

Legislators in Washington are keenly focused on both the upcoming national election on Nov. 3 and addressing the healthcare challenges during a pandemic.

Jeffrey J. Kimbell, David C. Rudloff, Caroline P. Tucker and Matteson L. Beckis, Jeffrey J. Kimbell & Associates Inc. 08.11.20

Trauma/Sports

A Spectrum of Value and Its Importance in Orthopedic Trauma

Three orthopedic surgeons speak with the founder of The Orthopaedic Implant Company on value-based healthcare.

Peter Althausen, M.D., Orthopedic Surgeon; Co-Founder, The Orthopaedic Implant Company 08.11.20

Extremities | Large Joint | Spine/Neurology

Electing a Path Back to Operational Normalcy

In deciding whether to allow elective surgeries to resume, states must balance patient needs with safety and equipment requirements.

Michael Barbella, Managing Editor 05.20.20

Illusion of Choice in Orthopedics in a COVID World

The Permanente Medical Groups represent a behemoth compared to the rest of the medical groups in the U.S. Kaiser employs more than three times the number of physicians as the second largest group—Fresenius Medical Care Holdings. The Permanente…

Maria Shepherd, President and Founder, Medi-Vantage 05.20.20

Winning from the Sidelines: What Can We Do Now to Mitigate Pandemic Fallout?

Discover a contest to determine the top 10 ideas, technologies, software systems, or other processes that will best serve orthopedic patients.

Dawn A. Lissy, Founder & President, Empirical 05.20.20

Software & Quality

The 5 Steps Toward Machine Learning

Many want to use AI/ML applications, but few have the means to do so; the process is a long one, so the best approach is to just take one step at a time.

Sue Marchant, Director of Product, Machine Learning and Artificial Intelligence, MasterControl 05.20.20

Biocompatibility & Testing

Conducting Chemical Characterization/Risk Assessment for FDA Submissions

Chemical characterization/risk assessment is a powerful methodology for addressing select biocompatibility endpoints.

Robert A. Allen, Ph.D., Senior Associate, Regulatory Affairs, MCRA LLC 05.20.20

Design

Design Intent Strategy Brings Clarity to Device Development

Communicating clear design intent is an important indicator for success in medical device development.

Philip Allen, VP Sales and Marketing, Lowell Inc. 05.20.20

COVID Strategy for Regulatory and Quality Professionals and Their Leaders

Great challenges and changes are being wrought by the SARS-CoV-2 virus and mitigation efforts to control its spread. The changes have been relatively sudden and impact every aspect of personal and professional life. While these changes seem abrupt an…

Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 05.20.20

Biologics