Columns
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Software & IT | Surgical
Extolling the Virtues of Surgical Simulation
Gaining surgical competence for a new technique has a drastic learning curve. When surgeons are trained to perform a new procedure, however, the curriculum appears remarkably straightforward. Typically, the surgeon will attend a one- or two-day cours…Sam Brusco, Associate Editor 04.03.18
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Will Medtech M&A Mania Continue?
There are many opinions about the scope and scale of future medtech mergers after the M&A boom seen in 2016 and 2017. By June 2017, medical device M&A value rose 178 percent,1 propelled by the strategic imperative for medical device companies…Maria Shepherd, President and Founder, Medi-Vantage 04.03.18
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Learn from My Mistakes: Why You Need a Quality System
I’ve made my share of stupid mistakes. When I was younger, most of them stemmed from just not thinking things through. I still cringe to admit I had some really big hair in the 1980s, one of many reasons I’ll be forever grateful my younge…Dawn A. Lissy, President & Founder, Empirical 04.03.18
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Brexit: D-Day or the Y2K for Global Supply Chains?
On the same day Britons went to the polls to determine their country’s future with the European Union (EU), the Irish Business & Employers Confederation (IBEC) held a manufacturing conference in Dublin. IBEC represents the policy interests…Dan O’Mahony, Lifesciences Manager, Exertis Supply Chain Services Limited 04.03.18
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Planning for Brexit
Are you ISO 13485 certified by a United Kingdom Notified Body? Perhaps you’re a contract manufacturer serving OEM customers who are certified by a U.K. Notified Body. Either way, medical device companies must start preparing now to mollify the…James A. Dunning, Principal, QPC Services LLC 04.03.18
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ISO 13485 2016: Upgrading to the New Edition (Part 1)
For the first time in 13 years, the International Organization for Standardization (ISO) has updated ISO 13485, the medical device industry’s framework for quality management systems (QMS). With an emphasis on risk management in the quality sys…Maria Fagan, President and Co-Founder, Regulatory and Quality Solutions LLC (R&Q) 04.03.18
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Trade Wars—How Are You Impacted?
Early last month, President Donald J. Trump ignited a firestorm on Twitter by expressing confidence that America would prevail in an international trade war on steel and aluminum. “When a country (USA) is losing many billions of dollars on trad…Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 04.03.18
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Contract Manufacturing
How Do I Serve Thee? Let Me Count the Ways
Perhaps it is obvious to most readers these days that using outsourced service providers (OSPs) can be a benefit to a client company. Historically, however, it has not been obvious. Back in the 80s and for much of the 90s, the idea of using outside r…David C. Robson, Principal, Robson Advisors 04.03.18
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Funding New Ideas or Innovation
Everyone has the next big new idea, and in medtech, they don’t come cheap. But companies also don’t have to be valued in the billions of dollars to make an impact or get an idea moving forward. The funding environment is hi…Marissa Fayer, President, Fayer Consulting LLC; CEO, HERHealthEQ; and Partner, LLEX Partners 04.03.18
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The Not-So-Sweet Road to C-Suite Symmetry
Women have made great strides in the past half-century to end workplace gender disparity. They’ve gained legal safeguards (FMLA, Equal Pay Act, Pregnancy Discrimination Act), boosted their earnings potential, and gradually siphoned job market s…Michael Barbella, Managing Editor 03.15.18
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Neurological
The Development of New Medtech Markets Through Neurostimulation
The number of new disease states that can be addressed with implantable neurostimulation devices continues to grow. The most common currently indicated use for these technologies is for the treatment of chronic pain—an enormous market tha…Maria Shepherd, President and Founder, Medi-Vantage 03.15.18
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A Plan for Better Planning
Planning is one of four business management functions (the others encompass organizing, leading, and controlling). Over the last several decades, the planning process has become a well-accepted tool in corporate America, especially for regulatory dep…James A. Dunning, Principal, QPC Services LLC 03.15.18
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Software & IT
How an Automated QMS Helps to Keep Up with Regulatory Changes
Medical device regulations are changing rapidly, and companies have limited time to comply. The deadline for ISO 13485:2016 is March 1, 2019, so organizations have just over a year to comply. Up until February 2018, organizations were able to be a…Alexa Sussman, Content Marketing Writer, EtQ 03.15.18
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The Importance of Asking the Right Questions
As M&A advisors that focus in healthcare (medical device, medical technology, dental, OEM, and biotechnology companies), we spend a lot of time talking to the “C-suite” among our clients, their acquirers, and their suppliers. We enjoy…Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 03.15.18
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Materials
Material World: Is Titanium the New PEEK?
The fanny pack is back. Give that a minute to sink in. According to Harper’s Bazaar, that’s one of 12 trends we all need to know about for 2018. I don’t spend much time thumbing through fashion tomes, but the occasional doctor&rs…Dawn A. Lissy, President & Founder, Empirical 03.14.18
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Contract Manufacturing
‘Wait, What’s My Motivation?’ Keeping a Clear Eye on Priorities
A project manager’s job is never easy. Much of their job is related to figuring out a plan, foreseeing and mitigating risks, and keeping all various resources focused and working in sync with each other. They often carry all the project’s…David C. Robson, Principal, Robson Advisors 03.14.18
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Manufacturing’s Great Opportunity
Twelve months ago, Johnson & Johnson subsidiary Ethicon Inc. announced plans to close a surgical suture plant in Livingston, Scotland, and transfer production to facilities in Texas, Mexico, and Brazil. The closure—Ethicon’s second of…Bryan Hughes, Director, P&M Corporate Finance 03.14.18
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Autism Treatment Options Reach Fever Pitch
The AVACEN 100 (Advanced VAscular Circulation ENhancement) is an FDA-cleared, over-the-counter, non-invasive heat therapy device indicated for temporary relief of minor muscle and joint pain stiffness, joint pain associated with arthritis, muscle spa…Sam Brusco, Associate Editor 01.30.18
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Cardiovascular | Digital Health
Feeding the Medtech Innovation Pipeline
MassMEDIC is the largest regional medical device association in the United States, with member companies ranging from the largest to the smallest medical technology innovators. The MassMEDIC Medtech Showcase, held in October every year, is a meeting…Maria Shepherd, President and Founder, Medi-Vantage 01.30.18
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R&D & Design
Shop Smart: How to Make the Most of the Prototype Phase
There are two basic types of people: Those who make sweeping generalizations, and those who don’t. (Actually, there’s a third type—one who opens columns with corny jokes and strains to hear the laugh track over the lonely cricket in…Dawn A. Lissy, President & Founder, Empirical 01.30.18
