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An ACA Repeal With (Some) Appeal
The hours are finally getting to R. Blake Curd, M.D. As a doctor, he’s grown accustomed to working odd hours to care for patients. But over the last seven years, his schedule—and those of his colleagues—has increasingly become mo…Michael Barbella, Managing Editor 08.15.17
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Market Data & Trends
Changing Administrations and the Strategy for Value-Based Growth in Medtech
In 2013, the U.S. medtech business turned the corner with improving revenue trends. The roll-out of Obamacare has stimulated growth in hospital admissions and other new systems of healthcare utilization at sites of care that didn’t exist before…Maria Shepherd , President and Founder, Medi-Vantage 08.15.17
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3-D Printing/Additive Mfg. | Prototyping
Pro Tips for Prototypes: The Smart Way to Manage Device Iterations
There’s something about hitting the prototype stage of the development cycle that makes everything finally seem real. This is the point at which there is finally an object to hold in your hands—a physical representation of the vision, inv…Dawn A. Lissy, President & Founder, Empirical 08.15.17
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Regulatory & Legal
Comparing cGMP Pharma vs. Device: Subpart A – General Provisions
Since they are both part of the healthcare industry, you’d think pharmaceutical and medical device companies would have a better understanding of each other’s current Good Manufacturing Practices (cGMP) requirements. Think again. Despite…James A. Dunning, Owner, QPC Services LLC 08.15.17
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Incorporating Payer Requirements into the Development Process
With the current U.S. healthcare payer system, planning for payment during the development process is critical. Early assessment of payer requirements is key to selling a device after U.S. Food and Drug Administration (FDA) clearance. (Note, this col…Bryan Brosseau, RAC, Vice President, Quality and Regulatory Affairs, Secure BioMed Evaluations 08.15.17
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Biologics | Regulatory & Legal | 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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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 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
