Columns
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Anika Therapeutics, Caligan Tussle Over Finances
Anika is being pressured to re-evaluate its growth strategy and consider positioning itself for sale to improve shareholder value.Michael Barbella, Managing Editor 03.10.23
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The Hospital Value Analysis Committee and Orthopedic Devices
To be successful, hospitals have adopted programs using a multi-disciplinary, data-driven approach.Maria Shepherd, President and Founder, Medi-Vantage 03.10.23
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Navigating the EU MDR UDI Requirements: The Benefits and Challenges
This is not an action that should be postponed until regulatory compliance is mandatory.Bayode Adisa, Manager, Regulatory Affairs – Europe, MCRA 03.10.23
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3-D Printing/Additive Mfg.
How 3D Printing is Impacting the Orthopedic Industry
Additive manufacturing combats the fragmented supply chain and reverses outsourcing mistakes.Mahemaa Rajasekaran, R&D Engineer, EOS North America 03.10.23
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FTC’s Proposed Noncompete Ban Puts Medtech Trade Secrets In the Spotlight
Noncompete agreements are meant to prevent intentional or inadvertent misappropriation of confidential information by a departing employee.Gregory S. Bombard and David J. Dykeman, Greenberg Traurig 03.10.23
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Face Time: Why Getting Engineers Out of the Lab Is Good for Business
Employees pick up new skills, clients find new connections, and the work we do becomes more than just a job.Dawn A. Lissy, President, Empirical 03.10.23
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AdvaMed’s The MedTech Conference Makes Its In-Person Return
The global community can meet and greet new investors and partners while hearing of new ideas and innovations.Maria Shepherd, President and Founder, Medi-Vantage 02.17.23
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Materials
Material Matters: New Materials Call for New Thinking
We’re seeing a rise in new substances that improve the life, function, and recovery of patients.Dawn A. Lissy, President, Empirical 02.17.23
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Biologics
Revolutionizing Orthopedics: The Transformative Potential of Regenerative Medicine
Look to the revolution in biologic delivery as a real option for improving treatment outcomes.Dr. Luis Alvarez, CEO and Founder, Theradaptive 02.17.23
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FDA, EU MDR Updated Guidance Coming in 2023
The guidance is chock full of new measures for medtech manufacturers.Rod Mell, Executive Head – Medical Device Consulting, Regulatory Compliance Associates 02.17.23
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Large Joint
How MedTech Can Support Surgeons and Maintain High Expectations
By co-creating hip solutions alongside surgeons, the orthopedic implant industry can continue to empower them and their healthcare teams.Keith Palmer, Worldwide Vice President, Hip Reconstruction, DePuy Synthes 02.17.23
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Large Joint
Reconstructing ACL Treatment Paradigms
A few enterprising orthopedic device firms aim to improve or replace the paradigm of ACL reconstructive surgery.Sam Brusco, Associate Editor 02.17.23
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How Orthopedics Could Lead the Way Toward Healthcare Joining the Circular Economy
It is the responsibility of the medical industry to provide effective, as well as affordable, healthcare to the people.Akshat Jain, Product & Quality Engineer, Pierce AB 02.17.23
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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
