Columns
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Biologics | Trauma/Sports
Seeing Pain Relief in a New (Infrared) Light
Welcome to another installment of technology-based opioid alternatives to treat orthopedic pain. This one’s a bit on the lighter side (joke to be explained in due course), and features some empirical evidence, as I was able to test this device…Sam Brusco, Associate Editor 05.19.17
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Market Data & Trends | Trauma/Sports
What’s New in Orthopedics in the ED?
Perhaps it’s due to the traditionally long wait times in the emergency department (ED) and the fact that no one wants to return to wait again. A problem for orthopedic care in the ED is the high rate of “no-show events” following an…Maria Shepherd, President and Founder, Medi-Vantage 05.19.17
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Quality, Recalls & Risk | Regulatory & Legal
Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel
For a company navigating a Class III medical device’s path to market, the U.S. Food and Drug Administration (FDA) panel presentation is the make-or-break point. That’s the day to present a case to convince the FDA the device—for whi…Dawn A. Lissy, President & Founder, Empirical 05.19.17
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Quality, Recalls & Risk | Software & Quality
The Importance of an Integrated QMS Within Regulatory Industries
The life sciences market is constantly evolving, and automated quality and compliance solutions must follow suit. The ability to interact, collaborate, and coordinate across the board is key to uncovering gaps in processes and creates visibility betw…Emily Ysaguirre, Content Marketing Writer, VERSE Solutions 05.19.17
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Regulatory & Legal
Current Good Manufacturing Practices: Pharma vs. Device
After years of working in and consulting for pharmaceutical and medical device companies on quality and regulatory matters, I am still somewhat surprised by the difficulty both industries have in understanding the other’s Current Good Manufactu…James A. Dunning, Owner, QPC Services LLC 05.19.17
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Regulatory & Legal
Enhanced CE Mark Requirements for Clinical Evaluation Reports
The European Union’s requirements for CE marking significantly changed with last summer’s fourth official revision of MEDDEV 2.7/1. From the standpoint of those who ensure a project’s documents are compliant and properly submitted f…Linda Braddon, Ph.D., President and CEO, Secure BioMed Evaluations 05.19.17
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Extremities | Large Joint
The ABCs of ASC Cost Savings
Rick E. Parsons, M.D., isn’t a big fan of hospitals. His aversion is quite paradoxical, however, considering he’s a self-professed “adventure junkie” and orthopedic surgeon who’s worked at four different hospitals in…Michael Barbella, Managing Editor 03.22.17
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Extremities | Instruments | Large Joint | MIS/Robotics
HACs and How Orthopedic Surgical Devices Can Help Reduce Medical Error
After a 30-year effort, data collected in 2014 and published in 20161 illustrated that there has been a 17 percent decline in hospital-acquired conditions (HACs) since 2010. This data is impressive, as it represents a 2.1 million case decline in prev…Maria Shepherd, President and Founder, Medi-Vantage 03.22.17
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Software & Quality
Three Places for Risk Management in Life Science Organizations
By now, the concept of risk probably isn’t a brand new one—it has entered into many regulations, standards, and best practices. Risk-based thinking has become a cornerstone in many industries, especially those as critical as the life scie…Alexa Sussman, Content Marketing Writer, EtQ 03.22.17
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Biocompatibility & Testing
Testing…Testing…Is This Thing On? Should You Outsource Device Testing or Keep it In-House?
When people ask me what I do, I often reply, “I break things for a living.” Yes, I say it with tongue firmly in cheek. That’s a gross oversimplification of a business I’ve been in for almost 20 years: mechanical testing for…Dawn A. Lissy, President & Founder, Empirical 03.22.17
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Quality, Recalls & Risk
Risk Management Lessons Beyond ISO 14971
Risk management used to be simple. Much simpler than it is now, if my memory serves me correctly. I’m not dreaming, am I? Risk management was simpler back in the day, wasn’t it? Alas, maybe it was never simple, and I’ve just forg…James A. Dunning, Owner, QPC Services, LLC 03.22.17
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Financial & Deals
Pace of Medtech M&A Activity Not Likely to Abate in 2017
Predicting the future can be risky and fraught with difficulty, especially in the healthcare sector. A myriad of unforeseen factors can affect outcomes, botching even the most conservative of forecasts. Some prophecies have better odds than others…Mark Bonifacio, Founder and President, Bonifacio Consulting Services 03.22.17
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Spine/Neurology | Trauma/Sports
Debunking the Skepticism of the ‘Good Vibes’ Treatment
I expect readers will tire of hearing this from me in due time, but the opioid addiction crisis has, ironically, become a rather painful burden on the healthcare system. The scary reality of this crisis is that it’s not junkies abusing the syst…Sam Brusco, Associate Editor 02.23.17
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AdvaMed and MassMEDIC: Two Meetings You Should Attend in 2017
MassMEDIC and AdvaMed are two trade associations that lead the effort to advance medical technology around the world. These organizations act as a common voice for medical device, orthopedics, diagnostics, and health information technology companies.…Maria Shepherd, President and Founder, Medi-Vantage 02.23.17
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Contract Manufacturing
Smart Outsourcing: Hiring the Team to Get Your Class III Device to Market
When Cartiva Inc. successfully sped through its Class III device premarket panel in less than half the average time—71 days instead of 159—that caught my attention. For more than 18 years, the Empirical family of companies has partnered w…Dawn A. Lissy, President & Founder, Empirical 02.23.17
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Software & Quality
The Benefits of Electronic Medical Device Reporting
Most tend to think of safety and quality in two separate spheres. In truth, these two are closely linked—having a total safety mindset often means having a quality mindset. Someone consistently acting in a high-risk manner will likely create pr…Emily Ysaguirre, Content Marketing Writer, VERSE Solutions 02.23.17
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Software & Quality
The Form, Fit, and Function of the Quality Role
I think a lot about role of quality in companies today. This may seem odd, given my vast experience in quality and regulatory compliance, but there are still situations that are new to me. I have not, nor will I ever, “see it all.” Qualit…James A. Dunning, Owner, QPC Services, LLC 02.23.17
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Trump’s 100-Day (Plus) Plan for Medtech M&A
Amid much pomp and circumstance, Donald J. Trump has been officially sworn in as the 45th U.S. president, bringing an end to the most inconceivable election cycle in modern history. As Trump’s reign begins, pundits, economists, and ordinary Ame…Bryan Hughes, Director, P&M Corporate Finance 02.23.17
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A Peek at the Future of Orthopedics
Looking back is much easier than looking forward. Winston Churchill, despite his talent as a futurist (he foretold of compact engines, wireless telephones, synthetic biology, and material 30 times stronger than steel), was not very fond of prognostic…Michael Barbella, Managing Editor 11.22.16
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Trauma/Sports
Trends in Sports Medicine
Value-based care and hospital consolidation are having an impact on the practice of medicine. However, it is important to recognize that sports medicine surgeons are still some of the most highly paid in the U.S. Family medicine physicians on av…Maria Shepherd, President and Founder, Medi-Vantage 11.22.16
