Columns
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Reflections on 2022 and What’s Ahead for Medtech: MPO Sounding Board
Several members of the MPO editorial advisory board share their thoughts on the headlines of 2022 and what’s coming in 2023.Sean Fenske, Editor-in-Chief 12.02.22
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Software & IT
3 Ways to Prepare for ISO 13485/Part 820 Harmonization
Once finalized, the FDA is proposing a one-year transition period from the publication of the final rule for device manufacturers to adapt.Nate Henriod, Senior Product Manager, MasterControl 11.16.22
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A New Home for Theranos' Elizabeth Holmes?
From prologue to main plot, Elizabeth Holmes' tale has had more incredulous chapters than a “Ripley’s Believe It or Not!” guide.Michael Barbella, Managing Editor 11.09.22
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Health Cost Drivers for Large Employers
Despite the headwinds of healthcare, the medical device market has strong momentum headed into 2023.Maria Shepherd, President and Founder, Medi-Vantage 11.09.22
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Braving Change: Facing Fears in the Midst of Major Transitions
Earlier this year when we sold Empirical, I understood how my team felt.Dawn A. Lissy, President, Empirical 11.09.22
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Upskilling in the Rapidly Evolving Age of Digitalization
The skills gap in the medtech sector will not diminish anytime soon.Tania de Decker, Managing Director—Global Strategic Accounts, Randstad Enterprise Group 11.09.22
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MedTech M&A in 2023: Will It Remain a Seller’s Market?
Compared to past years, 2022 investments are at historically average levels.Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 11.09.22
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Software & IT
Transforming Complaints in a Digital World
Management of complaint files continues to be one of the top 483 observations given by the FDA.Zillery Fortner, Product Advisor, QA/RA Life Sciences, Sparta Systems, a Honeywell company 11.09.22
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Developing a Readiness Game Plan for Future Supply Chain Swans
Supply chains must be reactive to both known events and the occasional curveball in order to be successful.Chris Oleksy, Founder and CEO, Oleksy Enterprises and SCHAIN101 11.09.22
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Testing
Addressing Myths About Extractables/Leachables Testing of Medical Devices
A thorough, thoughtful approach to E/L testing is becoming increasingly important.Sandi Schaible and Peter Steen, WuXi AppTec Medical Device Testing 11.09.22
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A Blueprint for Navigating Economic Growth Challenges
Each day has the potential to bring a maelstrom of supply chain, pricing, and pandemic-related obstacles.Craig Ackerman, Doug Beveridge and Mike White, The Alexander Group Inc. 11.09.22
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Getting More Value Out of a Contract Manufacturing Partnership
Today’s smart OEMs are engaging in deeper contract manufacturing and development partnerships.James Porter , Vice President of Sales and Business Development, Beacon MedTech Solutions 10.17.22
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Neurological
Treating Lupus with Light
A novel 3D-printed light-sensing medical device placed on the skin generates real-time feedback.Sam Brusco, Associate Editor 10.03.22
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Digital Health
It’s Time for Healthcare to Accelerate its Digital Vision
Technology and retail companies are stepping into place to power a new generation of care delivery models.Lisa Mazur and Ed Zacharias, McDermott Will & Emery 10.03.22
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R&D & Design
Taking the Pulse: Human Factors Engineering and Its Application to Medical Devices
The key is to integrate HFE into the entire product development process.Michael Wiklund, GM, Human Factors Research & Design, Emergo by UL; Professor of the Practice, Tufts University 10.03.22
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Inflation is Eyeing Medtech’s Margins
The great challenge of inflation to medtech managers will be defending margins as the volatile components of their costs reprice.Tony Freeman, President, A.S. Freeman Advisors 10.03.22
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Creating Value for Medtech Partnerships
The most important points to consider in developing an early-stage company.Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 10.03.22
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Testing
Following the Test Article: Timelines, Expectations for E/L Testing
Complete chemical characterization is a highly technical process that requires collaboration and communication.Zachary Remillard and Sandi Schaible , WuXi AppTec 10.03.22
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Surgical
Electromagnetics in Surgical Navigation: Accurate Object Tracking
Enables minimally invasive and robotic techniques to be applied to more types of procedures.Garrett Plank and Andrew Brown, TT Electronics and Radwave Technologies Inc. 10.03.22
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Software & IT
Want to Supercharge Training? Look to Digital Assistants
These assistants simultaneously supplement and enhance the natural talents and capabilities of humans.Prasad Akella , Founder and Chairman, Drishti 10.03.22
