Columns
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Digital Health | Neurological
A Breakthrough for the Nightmarish Effects of PTSD
Though I am not a particularly strong supporter of Apple—and you’re welcome to contact me to find out why—I have to admit the Apple Watch could be a useful tool for proactive health monitoring. The Apple Watch Series 4, released…Sam Brusco, Associate Editor 06.13.19
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Digital Health
AI in Healthcare: Where Are We Now?
At the 5th Annual World Medical Innovation Forum (WMIF), hosted by Partners HealthCare, three days of panels and presentations highlighted new applications of artificial intelligence (AI) machine learning and natural language processing technologies…Maria Shepherd, President and Founder, Medi-Vantage 06.13.19
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Profiting from Philanthropy: The Business Case for Supporting Nonprofits
I’m extremely proud that I know the elastic properties of Tootsie Rolls and jaw breakers for two reasons: Should Willy Wonka ever decide to venture into the medical device industry, I will have my testing and regulatory support estimate…Dawn A. Lissy, President & Founder, Empirical 06.13.19
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Contract Manufacturing
Outsourcing and Trade Policies: Navigating a Complex Issue
The goals for medical contract manufacturing run the gamut from simply finding a lower cost source for building products to finding a partner capable of supporting entry into markets where a device manufacturer has no physical presence. To best deter…Walter Tarca, President, Forefront Medical Technology 06.13.19
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Medtech M&A: Advice for Buyers and Sellers
Studies show firms actively engaged in M&A increase their shareholder returns an average 25 percent to 100 percent more than their non-acquisitive counterparts over time. There are several key reasons for this additional shareholder value:…Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 06.13.19
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Software & IT
Connected Quality Systems Reduce Risks
For the best outcome in medical design innovation with highly outsourced teams, having a rock-solid approach to quality is a prerequisite. As regulatory standards, market requirements, and device complexities have evolved, so too has the weight of th…Scott Reedy, Senior Director of Marketing, Arena Solutions 06.13.19
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Packaging & Sterilization
Package Testing and Validation: Interplay Between ISO 11607 Updates and MDR
With recent updates to ISO 11607, Part 1 and Part 2, and the Medical Device Regulation (MDR) on track to replace Europe’s current Medical Device Directive (MDD) in 2020, medical device manufacturers are working hard to ensure their package desi…Britt Jones, Manager of Package Testing Services, WuXi AppTec 06.13.19
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Collaboration and Control Are Key to a Successful Global Supplier Network
Note: This is the second in a two-part series. Read the first part by clicking here. Supply chain dynamics are prompting life science companies to seek innovative approaches that improve product safety while also enhancing clinical outcomes, redu…Daniel R. Matlis, President, Axendia Inc. 06.13.19
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Medical Device Legislative and Regulatory Policy: A Spring Update
As the temperature begins to rise here in Washington, D.C., Congress continues to focus its heat on healthcare as a top priority. Looking closely at prices, lawmakers from both sides of the aisle are determined to achieve solutions to lower healthcar…Jeffrey J. Kimbell, David C. Rudloff, and Caroline P. Tucker, Jeffrey J. Kimbell & Associates Inc. 06.13.19
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R&D & Design
Designing for a Seamless UX
Everyone has experienced the difference between a product that works the way a user thinks, feels, and behaves and one that is irritating, hard to interpret, and inhibits a positive experience. All medical product and service providers must consid…Dr. Bryce Rutter, Founder and CEO, Metaphase Design Group Inc. 06.13.19
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Medtech Due Diligence: Proactive Steps to Successful Transactions
The bar for due diligence in life sciences transactions is high and inching higher. Although today’s competitive deal landscape puts pressure on buyers and investors to move quickly, a strategic due diligence process that takes into account end…Robert H. Underwood, Ph.D., Partner, McDermott Will & Emery 06.13.19
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Packaging & Sterilization
Sterilization Facility Shutdown Sparks Device Shortage
Matt Haller put up a good fight. But he was no match for the cancer that sprouted in his stomach and ravaged his entire body, eventually reducing him to a skeletal 100 pounds. In his final days on Earth, Haller found joy in the simple things: travel…Michael Barbella , Managing Editor 05.01.19
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A Snapshot of the Hottest U.S. Medical Device Regions
For a long time, we all assumed Minnesota dominated the medical device industry worldwide, but is this still true? And, which other clusters lead in their contributions to the medtech industry? Why This Is Important When an industry cluster&rsquo…Maria Shepherd, President and Founder, Medi-Vantage 05.01.19
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3D/Additive Manufacturing
What’s ‘In’ for Manufacturing? (Hint: It’s Not Neon)
It seems the only time I catch up on the latest clothing fashions is when I seek inspiration online for columns I write pertaining to trends. Each time I do, I’m reminded why I read magazines like MPO and ODT instead of something in the checkou…Dawn A. Lissy , President & Founder, Empirical 05.01.19
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The First 510(k)
This column is directed at the small medical device company hoping to obtain its first U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification. While such an undertaking can be nerve-racking, it also can be quite rewarding, provided the…James A. Dunning, Principal, QPC Services LLC 05.01.19
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Contract Manufacturing
Understanding the Competitive Advantages of Full Service Outsourcing in the Make vs. Buy Decision
Across industries, managers and leaders often struggle to determine whether handling capabilities in-house or outsourcing them is financially and operationally advantageous for their companies. Put more simply, this struggle can be expressed as: &ldq…Tom Williams, General Manager, Millstone Medical Outsourcing 05.01.19
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Developing Market Access Strategies
Clearly, innovation is one of the keys to success for medtech OEMs and their suppliers. But it’s not the only key—market access is equally as important to long-term growth, as it helps drive immediate sales and generate a return on invest…Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 05.01.19
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Software & IT
Using Digitization to Get Ahead in Medtech
Companies developing cutting-edge medical devices need cutting-edge technology for their business processes. Whether a company focuses on finding new device materials, designing non-invasive monitors, or tackling the regulatory process, medtech is ad…Bryant Headley, Customer Success Executive, MasterControl 05.01.19
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Supply Chain Visibility: A Regulatory Necessity and Business Imperative
The globalization of life science products has created unique opportunities and demanding challenges for both industry and regulators. The globalization and outsourcing of life science products began in the late 1990s. At the time, life science co…Daniel R. Matlis, President, Axendia Inc. 05.01.19
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Medicare for All: Choice and Affordability for None
The term “Medicare for All” has increasingly become a rallying cry in the Democratic Party. The motto has become even more resounding as Republicans struggle to reach a consensus on what free-market healthcare reforms may look like. While…Jeffrey J. Kimbell, David C. Rudloff, Caroline P. Tucker, Jeffrey J. Kimbell & Associates Inc. 05.01.19
