Columns
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Large Joint
AJRR Struggling to Find PROM Dates
Timothy Mojonnier owes his sanity to a walk around the block. The greater Chicago-area management consultant had been inching closer to the breaking point for years prior to that walk, courtesy of his steadily deteriorating knee. But each time Mojonn…Michael Barbella, Managing Editor 05.23.19
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U.S. Healthcare Spending in Orthopedics
While total 2017 U.S. healthcare spending grew by 3.9 percent to $3.5 trillion,1 it was at a lower rate than the 4.8 percent increase reported by the U.S. Department of Health and Human Services in 2016. The 2017 growth rate correlates to the lower i…Maria Shepherd, President and Founder, Medi-Vantage 05.23.19
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3-D Printing/Additive Mfg. | Assembly & Automation | Machining & Tooling | Materials
What’s ‘In’ for Manufacturing? (Hint: It’s Not Neon)
It seems the only time I catch up on the latest clothing fashions is when I seek inspiration online for columns I write pertaining to trends. Each time I do, I’m reminded why I read magazines like MPO and ODT instead of something in the checkou…Dawn A. Lissy, President & Founder, Empirical 05.23.19
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Developing Market Access Strategies
Clearly, innovation is one of the keys to success for medtech OEMs and their suppliers. But it’s not the only key—market access is equally as important to long-term growth, as it helps drive immediate sales and generate a return on invest…Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 05.23.19
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Medicare for All: Choice and Affordability for None
The term “Medicare for All” has increasingly become a rallying cry in the Democratic Party. The motto has become even more resounding as Republicans struggle to reach a consensus on what free-market healthcare reforms may look like. While…Jeffrey J. Kimbell, David C. Rudloff, Caroline P. Tucker, Jeffrey J. Kimbell & Associates Inc. 05.23.19
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Design | Software & Quality
Dominating the Competition with Digitization
Companies developing cutting-edge orthopedic devices need cutting-edge technology for their business processes. Whether a company focuses on finding new materials for implants, manufacturing better surgical instruments, or getting a new device throug…Bryant Headley, Customer Success Executive, MasterControl 05.23.19
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MIS/Robotics
Justifying the Hype of Robotic Orthopedic Surgery
The robots are coming. But they’re not yet seeking subjugation of the human race. Instead, they want to perform surgery on our joints and spine. Last year’s “Top 10 Global Orthopedic Device Firms” reports made it clear roboti…Sam Brusco, Associate Editor 03.29.19
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Spine/Neurology
2019 Update on Surgical Management of Vertebral Compression Fracture: The Comeback Kid
Ten years ago—2009—was a controversial time for spine surgeons. This was the year the outcomes of two randomized controlled trials were published in The New England Journal of Medicine (NEJM).1,2 The results? The outcomes for vertebral co…Maria Shepherd, President and Founder, Medi-Vantage 03.29.19
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Biocompatibility & Testing
Why Big Companies With Internal Labs Should Outsource Testing
Most of us know when we’ve hit that line signaling we’ve left our cutting edge and officially spread ourselves too thin. Pushing to do and be more is often a half-step from maxing out and dropping all those balls we’re juggling.…Dawn A. Lissy, President & Founder, Empirical 03.29.19
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ISO 14971 Update: What Changes Can Medical Device Manufacturers Expect?
ISO 14971 for medical device risk management is in the final stages of an important update slated for publication this year. While ISO has specifically said the intent of the revision isn’t to rework the risk management process, subtle changes…Tony Parise, Product Strategist—Life Sciences, ETQ 03.29.19
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7 Steps Toward a Successful Orthopedic Product Launch
We have a common goal in the medical device industry to implement innovative, fast, and cost-effective designs and solutions. Design engineers also know that being proactive by focusing on the upfront work prior to freezing the design will save time…Arley Perez, Senior Product Development Engineer, Orchid Design 03.29.19
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Design
Regulatory Perspectives: Anatomy of a Medical Policy
Health insurance is a contract between a third party payer (insurer) and an individual to help cover medical and surgical expenses. The insured party pays a premium to the health insurer for this benefit. The rights and obligations of the insured and…Bonnie Clothier and Simran Madhani, MCRA 03.29.19
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An Industry on the Defensive
It’s been a rough six months for the medtech industry. Nearly 200 days after it was first blindsided by a one-two punch of bad publicity from the damning Netflix documentary “The Bleeding Edge,” the sector remains firmly immersed…Michael Barbella, Managing Editor 02.13.19
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Medtech and The Management Top 250
Developed by the Drucker Institute and publicized by The Wall Street Journal, The Management Top 250 Ranking measures and ranks corporate competencies from 1-250 by scrutinizing operations in five areas: customer satisfaction, employee engagement and…Maria Shepherd, President and Founder, Medi-Vantage 02.13.19
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3-D Printing/Additive Mfg.
The Gawky Teenage Phase: 3D Printing Enters Adolescence
As the mom of a young teen, I get a daily, real-time view of the of the challenges of a human doing his best to grow up. There are a lot of false starts, half-baked ideas, and epic fails, but there’s also tremendous potential and frequent victo…Dawn A. Lissy, President & Founder, Empirical 02.13.19
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3-D Printing/Additive Mfg. | Biologics | MIS/Robotics
Getting a Clinical Viewpoint
Last year, at the North American Spine Society’s (NASS) 33rd Annual Meeting, held in Los Angeles, Jeffrey C. Wang, M.D., professor of orthopaedic surgery and neurological surgery (clinical scholar) at the Keck Medical Center at the University o…Sean Fenske, Editor-in-Chief 02.13.19
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Design | Research & Development
Trial Master File: Paper or Electronic?
The Trial Master File (TMF) is the central location for all clinical trial documents. From the start of a clinical trial through its conclusion, the TMF contains and secures a variety of information such as signature pages, study logs, ethics committ…Anuradha Nagulapati, Clinical Research Associate, Musculoskeletal Clinical Regulatory Advisers 02.13.19
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Software & Quality
2019: The Year to Enhance Quality in Orthopedic Product Development
The world has gone digital, and now it’s time for orthopedic product developers and manufacturers to catch up. According to LNS Research, 60 percent of all organizations are investing in industrial transformation—otherwise known as digita…Anthony Parise, Product Strategist—Life Sciences, ETQ 02.13.19
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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
