Columns
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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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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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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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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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Software & Quality
The Path to Modernizing Medtech Regulatory Affairs
This article discusses the state of regulatory affairs and identifying opportunities for greater efficiency.Seth Goldenberg , Vice President, Veeva MedTech 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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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
