Columns
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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 comp…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
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R&D & Design
Taking the Waste Out of Product Development
We have supported the medical industry for nearly 40 years, both in product development and production of precision sheet metal products. These include sterilization cases and trays, pharmaceutical trays, medical furniture, patient handling products,…Ron Estes , VP Operations, Estes Design and Manufacturing 05.01.19
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Cardiovascular | Diagnostics | Digital Health | Patient Monitoring
Cardiac Care on the Can
Transitioning from reactive to proactive/preventive care could work wonders for the healthcare system. A proactive strategy is important for cardiovascular disease, the leading cause of death across the globe. According to a 2017 American Heart Asso…Sam Brusco, Associate Editor 04.03.19
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Cardiovascular
What’s New with TAVR?
Transcatheter aortic valve replacement (TAVR), once the last resort for patients so sick or elderly they were deemed unable to outlive surgical aortic valve replacement performed via open-heart surgery, has now been proven to offer benefits for young…Maria Shepherd, President and Founder, Medi-Vantage 04.03.19
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Software & IT
Quality Systems: It’s All Greek to Us
I admire people who love what they do. There’s a lot of truth to the oft-quoted Mark Twain observation: “Find a job you enjoy doing, and you will never have to work a day in your life.” For the most part, that applies to me. But…Dawn A. Lissy, President & Founder, Empirical 04.03.19
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Software & IT
Five Questions to Improve Your Requirements Management
Medical device developers spend years designing devices that help improve patient outcomes, which leads to millions of dollars invested in product development. If risk and requirements are not managed properly during development, it could result in a…Kevin Steigerwald, VP of Product & UX, Jama Software 04.03.19
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CAPA’s Impact on Compliance
You might be wondering why I’m writing about Corrective and Preventive Action (CAPA) in a regulatory column. What else, after all, can be said about CAPA that hasn’t already been articulated? Not much, but there is one thing: how importan…James A. Dunning, Principal, QPC Services LLC 04.03.19
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Digital Health | Patient Monitoring
Converging Goals: How a Focus on the Patient Drives Stronger Healthcare Partnerships
The foundation of healthcare is shifting from a provider-based to a patient-centric—or value-based—model. With aging populations, better-informed patients, and emerging technologies, the responsibilities and roles of every stakeholder in…Vicki Anastasi, VP and Global Head—Medical Device and Diagnostics Research & Real World Evidence Late Phase Research, ICON 04.03.19
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Overcoming Global Challenges for Successs
There is no denying the innovative and disruptive nature of the medtech industry, or its constant evolution. Success in this space has long depended largely on flexibility and a commitment to change, as reformation can help companies avoid obsolescen…Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 04.03.19
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Software & IT
Digital Transformation: Seven Considerations for Your QMS
Increasing numbers of companies are investing in digital transformation to gain a competitive edge, with digitization set to more than double among manufacturers since 2016 according to Forbes. It’s all part of a rapid technological acceleratio…Tony Parise, Product Strategist—Life Sciences, ETQ 04.03.19
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Pain in the (Supply) Chain: Tariffs and U.S.-China Medtech Trade
Over the past two years, medical devices have been implicated in a volley of trade actions between the United States and China. To better understand the potential implications of these trade actions, this article first provides an overview of U.S-Chi…Mihir Torsekar, Analyst, U.S. International Trade Commission 04.03.19
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Improvements to Medicare’s NTAP for New, Innovative Medical Devices
The new technology add-on payment (NTAP) program is a payment system designed by Congress to encourage the uptake of new and costly medical technologies1 in the hospital setting under the Hospital Inpatient Prospective Payment System (IPPS) in Medica…Jeffrey J. Kimbell and Caroline P. Tucker, Jeffrey J. Kimbell & Associates Inc. 04.03.19
