Columns
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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
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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
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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
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13 Mistakes to Avoid in a 510k Submission
The FDA 510(k) review process can broadly be divided into two steps—acceptance review and substantive review.Samradni Patil, Regulatory Consultant and Writer, Kolabtree 11.18.20
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Contract Manufacturing
A Supply Chain Strategy for Pandemic Survival
Medical device supply chain managers will likely conclude that 2020 is a year best forgotten.Tony Freeman, President, A.S. Freeman Advisors LLC 11.18.20
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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Key Factors Driving the Adoption of Digital Health Technologies
...Lauren Craig, Director, Reimbursement Strategy Execution, Musculoskeletal Clinical Regulatory Advisors LLC 08.11.20
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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
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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
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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
