Departments

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

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

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

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

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

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

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