Columns
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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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Considerations in Heading East: A Beginner’s Guide to Japan and PMDA
Manufacturers should be aware of the unique characteristics of the Japanese regulatory process.Samuel Pollard, General Manager, Vorpal Technologies - a MCRA company 09.16.22
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Biocompatibility & Testing
How Statistics Can Reduce Medical Device Inspection Time
Highlighting three statistical methods that can help CMs and OEMs work together to reduce inspection time.Jack Wieland , Project Manager, Lowell Inc. 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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Trouble Finding Talent? Three People-Centric Measures to Edge Out Competitors
A growing skills gap is a significant concern for CEOs everywhere. In fact, for the Fortune 500, talent is their biggest worry.Tania de Decker, Managing Director—Global Strategic Accounts, Randstad Enterprise Group 08.12.22
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Supply Chain
The Interdependence of Supply Chain Stability and World Peace
Supply chains and world peace are codependent—one cannot exist without the other.Chris Oleksy, Founder and CEO, Oleksy Enterprises and Co-Founder/CEO, Next Life Medical; CEO, Emergent Respiratory; Founder, SCHAIN101.COM 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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Software & Quality
Bridging the Intelligence Divide in Medical Device Commercialization
A 2021 analysis showed an unprecedented 45 percent increase in AI-driven omnichannel actions.Alan Kalton, SVP of Global Sales, Aktana 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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Design | Research & Development
Seeking Production Time Savings? Consider De-Automating Dimensioning
Manually dimensioning drawings can be a better option when working with a contract manufacturer.Thomas Van Wilpe, Manufacturing Engineer, Lowell Inc 05.26.22
