Departments

Stryker Strikes Back After Pandemic Slump

Late last year, Stryker announced it would snap up Wright Medical to fortify its position in the trauma and extremities markets.

Sam Brusco, Associate Editor 11.18.20

Large Joint

Obesity and the Impact on Hip and Knee Implants

Obesity causes multiple health issues, and the COVID-19 pandemic is only adding to the problem.

Maria Shepherd, President and Founder, Medi-Vantage 11.18.20

Virtually the Same? The Challenges of Online Conferences

Like everyone else on the planet, I’m turning increasingly to virtual solutions to our physical challenges in the midst of a pandemic.

Dawn A. Lissy, Founder & President, Empirical 11.18.20

Medical Device Equivalence Requirements Strengthened under the EU MDR

This column focuses on the directive under EU 2017/745 on medical devices (MDR), highlighting some of the changes in claiming and demonstrating equivalence.

Cindy Boyer, Senior Manager, International Regulatory Affairs, MCRA LLC 11.18.20

Solid Footing During Shaky Times: Current Compliance Considerations

The changes and challenges wrought by COVID-19 have significantly impacted the medtech industry.

Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 11.18.20

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

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

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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