Columns
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Extremities
Toe Fusion Alternatives Gaining a Firm Market Foothold
Dr. Carl Hasselman, co-designer of the Arthrosurface ToeMotion Arthroplasty System, speaks about non-fusion alternatives for MTPJ osteoarthritis.Michael Barbella, Managing Editor 12.02.19
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The Cluster Effect in Orthopedics: Is It Sustainable?
For a long time, we all assumed Minnesota dominated the medical device industry worldwide, but is this true for the orthopedic surgical tools industry?Maria Shepherd, President and Founder, Medi-Vantage 12.02.19
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‘If You’re Reading This, You Need to Be at This Meeting’
The AAOS/FDA/Industry Townhall is taking place March 24, 2020, at the AAOS annual meeting in Orlando.Dawn A. Lissy, President & Founder, Empirical 12.02.19
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Turning the New EU MDR Into a Competitive Advantage
This column examines three new elements of the EU MDR that medical device manufacturers can leverage.Dan Goldstein, Associate Director, Quality Assurance, MCRA LLC 12.02.19
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Design | Large Joint | Spine/Neurology
Five Reasons for the Small World of Orthopedic Product Development
Why do product development people tend to stay within the orthopedic and spine industry and not cross over into other medtech sectors?Victoria Trafka, BSME, MSME, President and Lead Engineer, Engineering & Quality Solutions Inc. 12.02.19
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Impeachment, Executive Orders, and Must-Pass Congressional Legislation: A Fall Update
The final quarter of 2019 has begun, which means Congress and the Trump Administration are hard at work finalizing healthcare initiatives before year's end.Jeffrey J. Kimbell, David C. Rudloff, and Caroline P. Tucker, Jeffrey J. Kimbell & Associates Inc. 12.02.19
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Spine/Neurology
Pediatric Orthopedics Taken Off the Back Burner
There are several different types of scoliosis, a condition that causes a sideways spinal curve, that affect children and adolescents.Sam Brusco, Associate Editor 09.17.19
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What Are Orthopedic Surgeon Salary and Employment Statistics?
The percent of employed physicians is greater than self-employed physicians.Maria Shepherd, President and Founder, Medi-Vantage 09.17.19
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U.S. May Offer a Safe Harbor from the Impending MDR Storm
There are factors that make for a more inviting environment for the medical device industry in the United States.Dawn A. Lissy, President & Founder, Empirical 09.17.19
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How Identifying Gaps in Clinical Data Can Ease the Transition to New Regulations
As of 2017, the European medical device market was estimated at $126 billion, the second largest worldwide, comprising 27 percent of the global market. The European market trails only the United States, which accounts for roughly 43 percent of…Mike Goodson, Associate Director, Regulatory Affairs, MCRA LLC 09.17.19
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Software & Quality
Benefiting from Paperless Production Records: A Case Study
EpiBone discovered how eliminating paper with digital production records can help ensure data integrity, reduce errors, and increase efficiency.Terrance Holbrook, Director of Product, MasterControl 09.17.19
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Connecting the Dots in Medical Device Outsourcing
San Francisco is globally renowned for many things: The Golden Gate Bridge (its color, international orange, was actually a primer used to protect the steel during transit), Ghirardelli chocolate, the TransAmerica pyramid building, and the “Pai…ODT Staff 08.14.19
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What Keeps Hospital CEOs Awake at Night and How Can Medtech Help?
With the continued surge of mergers and acquisitions, vertical integrations, and no clear U.S. policy or reform direction for our $3.6 trillion annual healthcare spend,1 the healthcare ecosystem remains in a phase of dramatic disruption. What Is K…Maria Shepherd, President and Founder, Medi-Vantage 08.14.19
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Mayday: How the Upcoming MDR Implementation Forecasts Disaster for Our Industry
I’m generally an optimistic person. My outgoing voicemail greeting encourages every caller to “keep smiling!” My wardrobe is about 40 percent “Life is Good” apparel and I keep a daily gratitude journal. Despite this s…Dawn A. Lissy, President & Founder, Empirical 08.14.19
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Successful Strategies for Health Plan Medical Policy Outreach
Getting approval from the FDA can be a significant achievement for a company but a bigger challenge awaits for novel technologies: health payor acceptance and coverage. Adopting a novel technology does not occur easily due to complex commercial insur…Chelsey Jaworski and Anabel Tapia, MCRA 08.14.19
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Design
Why and How Good Design Matters to the Bottom Line
There should be no confusion: good design pays dividends. Literally. Many highly successful medical products that substantively improve the delivery of healthcare also significantly increase market share and revenue. But just what is the elusive good…Bryce G. Rutter, Ph.D., Founder and CEO, Metaphase Design Group Inc. 08.14.19
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Contract Manufacturing | Supply Chain
Contract Service Providers: Forward Thinking in Supplier Management
Virtual manufacturing is common among startups and entrepreneurs building a new company or project with a prudent fiscal approach. Intellectual property and an experienced contract manufacturer can make it a reality. Harnessing a contract manufacture…Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 08.14.19
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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
