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Biologics | MIS/Robotics | Trauma/Sports
Global Prospects in Orthopedics
Camil Moldoveanu was fully prepared for the challenge. Or so he thought. The four-time Brazilian jiu-jitsu world champion knew he would need significant rehabilitation for his knee injury. He also knew the recovery process would be difficult, and…Michael Barbella, Managing Editor 11.30.18
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Spine/Neurology
Leveraging Innovation to Address the Opioid Crisis
The news has been devastating; according to the National Institute on Drug Abuse (NIDA) website, “every day, more than 115 people in the United States die after overdosing on opioids…including prescription pain relievers, heroin, and syn…Maria Shepherd, President and Founder, Medi-Vantage 11.30.18
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Design | Research & Development
MPO Summit: The View from the Top
It started with a wintry dusting of snow and ended in a blaze of autumnal glory. On top of a mini tour of Colorado’s best seasons, the two-day MPO Summit in Broomfield on Oct. 11-12 offered forecasts and insights into what it takes to weather c…Dawn A. Lissy, President & Founder, Empirical 11.30.18
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Data Monitoring Committees: Making DMCs Work for Your Study
The use of independent data monitoring committees is becoming increasingly prevalent in the U.S. medtech industry. The FDA outlines these groups and their operation in a 12-year-old guidance due to expire at the end of this year. However, the composi…Margeaux Rogers, Senior Associate, Regulatory Affairs, Musculoskeletal Clinical Regulatory Advisers LLC 11.30.18
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Top 10 Findings from a Warning Letter Analysis
When I first started out in medtech, I did not have a good appreciation for quality systems. I was working as an engineer at the time, and I found quality systems quite a nuisance because any change I proposed was either restricted or not allowed due…Linda Braddon, Ph.D., President and CEO, Secure BioMed Evaluations 11.30.18
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Extremities | Large Joint | Materials | Spine/Neurology
Recycling Implanted Metals From Beyond the Grave
Ever wonder what happens to devices implanted in the body after their users pass away? Probably not, because the thought of it tends to make most people who aren’t ODT editors cringe. But as medical implants become more common, people are dy…Sam Brusco, Associate Editor 09.19.18
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MIS/Robotics
Premium Medtech Price Stategies for the Orthopedic Robotics Segment
Growth in the market for surgical robots used in hip and knee orthopedic procedures was forecasted at $222 million in 2015 with anticipated growth to reach $5 billion by 20221 (Table 1). A substantial number of next- generation robotic devices, syste…Maria Shepherd, President and Founder, Medi-Vantage 09.19.18
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A Different Class of Engineer: How to Connect with Rising Medtech Talent
My grandfather—a World War II veteran who worked at GE in my native Cleveland—was one of my most beloved family members. When I told him I wanted to study engineering in college, he told me to find a university where I could get real, on-…Dawn A. Lissy, President & Founder, Empirical 09.19.18
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Getting Started on the Right Foot: Initiating Orthopedic Clinical Trials
Initiating an orthopedic clinical trial (OCT) is an exciting milestone for companies as years of pre-clinical testing and conversations with the U.S. Food and Drug Administration (FDA) finally come to fruition. Focusing on specific elements of the st…Bhavana Shivakumar , Clinical Research Associate, Musculoskeletal Clinical Regulatory Advisers LLC 09.19.18
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Design
Coming Clean: Developing Standards for Cleaning Reusable Devices and Instruments
Five years ago, I shuddered to read the headlines about “dirty” endoscopes being used in colonoscopies and the speculation that followed. Are colonoscopies really safe? Is this what’s creating new superbugs? Why weren’t hospit…Dawn A. Lissy, President & Founder, Empirical 08.15.18
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Innovation in the 510(k) Space: A Case for Incrementalism
Although the term “innovative technology” often evokes images of a breakthrough, radical discovery, or inventive cure-all, the certainty associated with incremental improvements to established, higher-risk technologies such as implantable…Samuel Pollard, Senior Regulatory Associate, Musculoskeletal Clinical Regulatory Advisors 08.15.18
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FDA’s Educational Opportunities Abound
As a former U.S. Food and Drug Administration (FDA) reviewer, I have spent a considerable amount of time learning the system from the “inside.” There are many avenues of training offered by the FDA, and if you know where to look, you may…Elizabeth O’Keeffe, Ph.D., Director, Engineering and Technical Services, Secure BioMed Evaluations 08.15.18
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Imaging | MIS/Robotics
The Promising Future for AI in Orthopedics
In their most simple form, AI applications in healthcare consist of a collection of technologies that will enable machines to sense, comprehend, predict, act, and learn. The first application for AI-based machines, as discussed at the World Medical I…Maria Shepherd, President and Founder, Medi-Vantage 08.15.18
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Stoking the Corner Office Compensation Controversy
If only the real world functioned as it does in academia. Or in human imagination. Consider the possibilities: world peace, racial/gender harmony, financial security, and perfect health are just a few that come to mind. Even eternal youth wouldn&r…Michael Barbella, Managing Editor 08.15.18
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Extremities | Spine/Neurology
Bioelectronic Medicine Gets on Arthritis’ Last Nerve
According to Northwell Health, as of 2016 rheumatoid arthritis (RA) affects 1.3 million adults in the U.S. And despite billions of dollars spent annually treating the disease, there has yet to be a therapeutic agent able to universally relieve the jo…Sam Brusco, Associate Editor 05.29.18
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How Do We Make Orthopedic Surgery Easier for Our Physicians?
The practice of orthopedic surgery is still going through a significant transformation. Practice shifts from private to hospital employees and back to private again. This level of turbulence creates ambiguity, questions, threats, and opportunities.…Maria Shepherd, President and Founder, Medi-Vantage 05.29.18
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Assembly & Automation | Coatings/Surface Modification | Contract Manufacturing | Design | Extrusion | Machining & Tooling | Molding | Prototyping
The Right Vendors Foster Growth: Why Firms of All Sizes Need to Outsource
I was working as a product development engineer at AcroMed (a spinal implants manufacturer that was acquired by DePuy in 1998), when I noticed a gap in the medical device industry. There were plenty of companies coming up with great ideas for d…Dawn A. Lissy, President & Founder, Empirical 05.29.18
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Design | Research & Development
The Hidden Costs of Clinical Trial Agreement Negotiations
Negotiating can be a daunting task, often inducing anxiety in those without much practice. For many, it’s not a skill that develops naturally or easily. Graduate programs offer numerous courses aimed at preparing students for the necessary evil…Megan Florez, Compliance and Reimbursement Associate, Musculoskeletal Clinical Regulatory Advisors 05.29.18
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Modifications to a Cleared Device: Letter to File or New 510(k)?
Change is good, right? Most orthopedic manufacturers have been working under the ISO 13485 umbrella, which stresses the need for continuous improvement. Once a device is in commercial distribution, there are valuable lessons to be learned. Shouldn&rs…Linda Braddon, Ph.D., President and CEO, Secure BioMed Evaluations 05.29.18
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3-D Printing/Additive Mfg.
Will Additive Manufacturing Revolutionize Orthopedic Product Manufacture?
Additive manufacturing is a disruptive fabrication process impacting an array of industry sectors, including healthcare. As such, members of this industry have made bold claims and predictions on the potential for this innovation. How much of this, h…Ali Madani, CEO, Avicenne Medical 05.29.18
