Columns
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Diagnostics
Theranos Fraud Trial, Part II: The Blame Game Continues
Theranos whistleblowers, an FDA investigation, and a Wall Street Journal expose revealed the truth behind the company’s proprietary innovation.Michael Barbella, Managing Editor 06.01.22
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Surgical
An Update on Surgical Robotics
Intuitive is still the 800-pound gorilla in the room, but the entire market segment struggles to prove its value and justify its high cost.Maria Shepherd, President and Founder, Medi-Vantage 06.01.22
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Testing
Letting the Light In: How Failure Analysis is the Cornerstone of Success
Failure analysis is a vital part of the process of developing medical devices that function safely and efficiently.Dawn A. Lissy, Founder & President, Empirical 06.01.22
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Three Talent Strategies to Attract High-Demand Skills
As many people already know, STEM skills have been in short supply for a long time.Tania de Decker, Managing Director—Global Strategic Accounts, Randstad Enterprise Group 06.01.22
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Packaging & Sterilization
The Advantages of Bioburden Screening for Sterilization Validation
Bioburden can be introduced at several stages throughout the manufacturing process.Shelley Zimmerman and Cathy Leckwart, WuXi AppTec 06.01.22
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The Impacts of SPACs, M&A, and Divestitures on OEM Suppliers
Medtech companies have orchestrated many noteworthy portfolio moves in recent years, creating interesting market dynamics.Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 06.01.22
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Software & IT
Redefining Quality Audits for a Digital World
Quality audits help ensure effectiveness and compliance within the quality system, but today’s digital world requires a different approach.Zillery Fortner, Product Advisor, QA/RA Life Sciences, Sparta Systems, a Honeywell company 06.01.22
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Contract Manufacturing
Dominant Supply Chain Strategies—Integrated Contract Manufacturer and Specialist
Like any strategy, specialization has its advantages and disadvantages.Tony Freeman, President, A.S. Freeman Advisors, LLC 06.01.22
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R&D & Design
4 Ways to Align Product Development with Investor Milestones
Aligning all technical activities around the investor gates typically means, the whole company must be aligned around lean startup milestones.Scott Phillips, Founder and CEO, StarFish Medical 06.01.22
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Financing Healthcare Deals: The Many Factors to Consider
Despite challenges, 2021 was a banner year for healthcare sector investment activity, and early indications suggest that 2022 will be equally busy.Stephanie S. McCann, Partner, McDermott Will & Emery 06.01.22
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Neurological
Injecting Neurostimulators into Blood Vessels (We Swear, It’s Not Sci-Fi)
Houston’s Rice University believes PNS technology could be reduced to about the size of a grain of rice.Sam Brusco, Associate Editor 05.02.22
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Surgical
Understanding the Costs of Care in the OR
Somehow, the cost of operating in the OR never seems to decline.Maria Shepherd, President and Founder, Medi-Vantage 05.02.22
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Surgical
Sick of Being Sick: Pandemic Fatigue Flares at AAOS
For the second time in less than a year, I surveyed the exhibit hall of the American Academy of Orthopedic Surgeons’ biggest event.Dawn A. Lissy, Founder & President, Empirical 05.02.22
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Managing Critical Healthcare Supply Chains in Turbulent Times
Our interconnected global economy has been disrupted, and remains vulnerable.Chris Qualters, CEO, TekniPlex Healthcare 05.02.22
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To Drive Value, Human Capital Leaders Turn to Outsourced Solutions
With the growth of talent scarcity in the labor market, interest in outsourced HR services is rising.Tania de Decker, Managing Director—Global Strategic Accounts, Randstad Enterprise Group 05.02.22
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Testing
Outsourcing vs. In-House Chemical Characterization Testing
Outsourcing pre-clinical safety testing or keeping it in-house is a nuanced and multi-factored decision.Mark Cabonce, MS, DABT and Kim Ehman, Ph.D., DABT, WuXi AppTec 05.02.22
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M&A in Turbulent Times—Bullish or Bearish?
M&A deal volume in the medical device contract manufacturing market rebounded dramatically last year.Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 05.02.22
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Software & IT
Preparing for a More Digital Future in Medtech Clinical Trials
The length of the medtech product development lifecycle drives the industry to find ways to accelerate clinical trials.Ami Dudzinski Mehr, VP of CDMS Strategy, Veeva MedTech 05.02.22
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Software & IT
Is a Quality Management System Really Necessary?
The technical answer lies in the details of exactly what you’re doing, for whom you are doing it, and for what geography.Nathan Dowd, Co-Owner, med-sherpa Inc. 05.02.22
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Software & IT
The Impact of Digital Transformation on the Healthcare Supply Chain
Even before the COVID-19 pandemic, the healthcare industry was undergoing significant changes.Chris Luoma, Senior Vice President, Product Management, Global Healthcare Exchange 05.02.22
