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Virtual Physical Therapy on the Move
There is a rise in the development of novel systems to provide virtual physiotherapy and telerehabilitation.Sam Brusco, Associate Editor 11.15.22
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Top 10 Health Cost Drivers for Large Employers
13% of employers report a greater number of late-stage cancers and 44% say they expect an increase in late-stage cancers.Maria Shepherd, President and Founder, Medi-Vantage 11.15.22
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Braving Change: Facing Fears in the Midst of Major Transitions
Earlier this year, we sold Empirical, the company I built from a single test frame 24 years agoDawn A. Lissy, President, Empirical 11.15.22
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Spine/Neurology
Bringing Complex Medtech Devices to Market—A Case Study
The geko device was the first bioelectronic product of its kind to receive NICE and FDA nods for blood clot prevention.Bernard Ross, Founder and CEO, Sky Medical Technology 11.15.22
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Benefits and Implications of the Breakthrough Device Designation Program
As of June 30, CDRH and CBER have granted 693 Breakthrough Device designations.Palmer Smith, Associate, Spine Regulatory Affairs, MCRA LLC 11.15.22
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Diversity and Orthopedics: Still No Change
Diversifying orthopedics is likely to take time.Michael Barbella, Managing Editor 09.16.22
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The Amazon Effect on the Orthopedics Industry
Amazon clearly sees what many of us have forgotten in our focus on orthopedic surgeons.Maria Shepherd, President and Founder, Medi-Vantage 09.16.22
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Balancing Act: Why and How I Made Major Shifts for Success
There’s a toxic ideology when it comes to the 60- to 80-hour work week and the expectations that are out there.Dawn A. Lissy , President, Empirical 09.16.22
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Materials
Why a Polymer Is Critical to Successful Orthopedic Device Performance
UHMW-PE), is uniquely suited to meet the high standards for biocompatibility and flexibility required in manufacturing orthopedic implants.Rainer Walkenhorst, Ph.D. , Senior Manager, Technology & Innovation Engineered Materials, Celanese 09.16.22
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Imaging
AI-Driven Computer Vision in Orthopedic Surgery: Opportunities and Benefits
With computer vision, orthopedic surgeons have found their driver assistance.Moshe Safran , CEO, RSIP Vision USA 09.16.22
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Large Joint
The Genetic Risk for Joint Replacement Failure
This could begin a new era where genetic testing prior to receiving medical implants becomes routine.Sam Brusco, Associate Editor 08.12.22
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The Fundamentals of Go-To-Market Strategy in Orthopedic Medical Devices
Getting the fundamentals right in go-to-market strategy, especially for disruptive products, is critical to success.Maria Shepherd, President and Founder, Medi-Vantage 08.12.22
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Minding the Gap: How Harmonizing Quality Systems Pays Off
FDA issued a proposed rule to harmonize 21 CFR 820 with ISO 13485, which could save medical device companies $439 to $533 million over a decade.Dawn A. Lissy, Founder & President, Empirical 08.12.22
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Contract Manufacturing
Four Key Considerations for OEMs Transferring a Product Program
Transferring programs can offer a variety of advantages—including with regard to streamlining resources.Todd Owens, Vice President of Engineering, Donatelle 08.12.22
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The Case for Using Historical Control in Clinical Trial Design
Historical control refers to the use of data from past studies to estimate potential response to a placebo or standard care treatment among trial patients.Michael Coladonato and Lucas Tatem, MCRA 08.12.22
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Understanding the Costs of Care in the Orthopedic OR
The cost of operating in the OR never seems to decline.Maria Shepherd, President and Founder, Medi-Vantage 05.26.22
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Sick of Being Sick: Pandemic Fatigue Flares at AAOS
So many of us seem to be over COVID-19 from a mental standpoint, but lingering symptoms remain.Dawn A. Lissy, Founder & President, Empirical 05.26.22
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Large Joint | MIS/Robotics
A Frantic Race to Combine Orthopedic Implants and Robotics
The future of orthopedic implants is inextricably linked to surgical robotics.Ali Madani, Founder and Managing Partner, Avicenne Medical 05.26.22
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Breakthrough Device Designation’s Impact on Incremental Medicare Payment
There are impactful benefits that may allow for incremental reimbursement.John McDermott and Mickayla Roan, MCRA 05.26.22
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Biocompatibility & Testing
The Problem Plaguing U.S. Antimicrobial Joint Implant Development
The regulatory landscape surrounding antimicrobial-associated implants is challenging to navigate.Dr. Mehdi Kazemzadeh-Narbat, Dr. Sherry Parker and Dr. Kim Ehman, WuXi AppTec 05.26.22
