Columns
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Diagnostics | Digital Health
Google’s Search for Direction in Healthcare
Fake news, begone: Reports of Alphabet’s healthcare struggles have not been greatly exaggerated. That bears repeating: Not been greatly exaggerated. Indeed, Google’s parent company is foundering a bit in its attempt to claim a signi…Michael Barbella, Managing Editor 03.07.19
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The Other Side of the Socialized Medicine Story
It’s not called socialized medicine over here. The more radical proposal? A U.S. single-payer healthcare system called “Medicare for all.” Even former president Barack Obama, who long opposed a single-payer system for the United Sta…Maria Shepherd, President and Founder, Medi-Vantage 03.07.19
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Testing
Why Big Companies With Internal Labs Should Outsource Testing
Most of us know when we’ve hit that line signaling we’ve left our cutting edge and officially spread ourselves too thin. Pushing to do and be more is often a half-step from maxing out and dropping all those balls we’re juggling.…Dawn A. Lissy, President & Founder, Empirical 03.07.19
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Contract Manufacturing | R&D & Design
Patent Law: How OEMs and CMs Can Work Together
It is often more cost effective for a medical device company to outsource product development , component manufacturing, or assembly work to a contract manufacturer (CM) since the CM often has the proper equipment, technical expertise, and experience…Megha Manjunath and Doug Portnow, Schwegman, Lundberg & Woessner 03.07.19
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Survival Tips for Third-Party Verification
I have spent much of my career helping companies resolve significant regulatory issues, mostly those emanating from the U.S. Food and Drug Administration (FDA). I’m not really sure why I’m drawn to these administrative struggles; perhaps…James A. Dunning, Principal, QPC Services LLC 03.07.19
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Keeping the Positive Momentum in Your Medtech Business in 2019
The medtech industry is in a state of disruption. Global industry dynamics and technology trends are creating both opportunity and confusion in the marketplace. This dichotomy naturally can lead to concerns over maintaining positive business momen…Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 03.07.19
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Software & IT
Three Questions to Master Continual MDSAP Conformity
Product recalls frequently make headlines and tarnish brand reputations as a result. In today’s digital world, one bad customer experience with quality can be broadcast in seconds, giving brands little time to react. Not prioritizing quality is…Tony Parise, Product Strategist—Life Sciences, ETQ 03.07.19
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Contract Manufacturing
Evolving Players in the Medical Device Supply Chain
Today’s medical device supply chain was shaped by two far-reaching trends: A realization among OEMs over the last 20 years about outsourcing’s ability to reduce manufacturing costs while producing safe, reliable products; and OEMs’…Tony Freeman, President, A.S. Freeman Advisors LLC 03.07.19
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Contract Manufacturing | R&D & Design
Structuring Successful Outsourced R&D Programs
Have you ever asked a consultant, “We need to outsource regularly but were burned very badly the last time—how will it be any different with your team?” Consider outsourcing as part of your human resource strategy if: You ne…Philip Remedios, Principal, Director of Design & Development, BlackHägen Design 03.07.19
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The Benefits of Private Equity Partnerships
For an entrepreneurial life sciences company, partnership with an investment firm can be a smart option for business expansion and growth. While venture capital funds offer an attractive capital boost for startups, partnering with a private equity (P…Stephanie S. McCann, Partner, McDermott Will & Emery 03.07.19
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3D/Additive Manufacturing | Digital Health
Discerning Medtech’s Path in 2019
It’s the dawn of another year, and that means it’s time to engage in the unavoidable pastime of prognostication. Predicting the future isn’t easy, but it can be fun and oftentimes insightful. One of the most rewarding aspects of pro…Mark Bonifacio, President, BCS LLC 01.31.19
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R&D & Design | Software & IT
Disrupting the Outsourcing Model
The rise and relative success of companies dealing in cloud-based systems has revolutionized how we handle data. This is prompting a shift away from traditional software, hardware, and legacy systems, and enabling companies in new and unexpected ways…Steve Maylish and Shannon White, Fusion Biotec 01.31.19
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Election Impact and the Beginning of the 116th Congress
Much has transpired in Washington since the last column that is sure to affect the political landscape as well as manufacturers of medical products. On Nov. 6, over 113 million people voted in elections for all 435 members of the U.S. House of Repres…Jeffrey J. Kimbell and David C. Rudloff, Jeffrey J. Kimbell & Associates Inc. 01.31.19
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Packaging & Sterilization
Is Your Packaging Provider Prepared If Disaster Strikes?
The onslaught of devastating hurricanes, wildfires, floods, and other natural disasters the world suffered in 2018 have accentuated the need for business continuity planning (BCP) in medical device manufacturing. Although many companies develop plans…Wilfredo Mercado, Vice President of Operations, Latin America, Prent Thermoforming 01.31.19
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Digital Health
A Primer for Manufacturers Adjusting to Value-Based Healthcare
Value-based healthcare (VBHC) models are poised to transform everything from how patient care is delivered to how treatments are priced. A 2016 analysis by UnitedHealthcare estimated that at the end of 2018, more than $65 billion would be tied to val…Vicki Anastasi, VP and Global Head, Medical Device and Diagnostics Research, ICON 01.31.19
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Digital Health
2019 Preview: Predicting the Trends and Their Potential Impact on Business Plans
The prognosticators are at it again. With 2019 well underway, industry pundits are deeply ensconced in a longstanding New Year’s tradition—predicting the trends and developments likely to impact medtech over the next 12 months (and beyond…Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 01.30.19
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The Impact of Change on Regulatory Compliance
It’s that time of year again. Time for a calendar change. Out with the old and in with the new. Time for another 12-month journey into the unknown. It’s also time for new beginnings—a period that can be simultaneously fun, exh…James A. Dunning, Principal, QPC Services LLC 01.30.19
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Software & IT
4 Ways to Prepare for the European Medical Device Regulation (MDR)
The new Medical Device Regulation (MDR) is changing the rules for medical device manufacturers and distributors selling and marketing in Europe. The MDR replaces the current Medical Devices Directive (MDD) and goes into effect in less than 18 months.…Melonie Warfel, Vice President, Medical Device & Diagnostics, Veeva Systems 01.30.19
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3D/Additive Manufacturing
The Gawky Teenage Phase: 3D Printing Enters Adolescence
As the mom of a young teen, I get a daily, real-time view of the of the challenges of a human doing his best to grow up. There are a lot of false starts, half-baked ideas, and epic fails, but there’s also tremendous potential and frequent victo…Dawn A. Lissy, President & Founder, Empirical 01.30.19
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Medtech and The Management Top 250
Developed by the Drucker Institute and publicized by The Wall Street Journal, The Management Top 250 Ranking measures and ranks corporate competencies from 1-250 by scrutinizing operations in five areas: customer satisfaction, employee engagement and…Maria Shepherd, President and Founder, Medi-Vantage 01.30.19
