Columns
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Effects of MEDDEV Revision 4 on Clinical Evaluation Reports (Part 2)
Whether writing a clinical evaluation report (CER) for a new device or updating one for an existing device, compliance with MEDDEV 2.7/1 Revision 4 requirements is integral. As part of the general planning associated with CERs, first perform a gap as…Jonathan Gimbel, Director, Regulatory and Quality Solutions LLC (R&Q) 08.15.18
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Design
Coming Clean: Developing Standards for Cleaning Reusable Devices and Instruments
Five years ago, I shuddered to read the headlines about “dirty” endoscopes being used in colonoscopies and the speculation that followed. Are colonoscopies really safe? Is this what’s creating new superbugs? Why weren’t hospit…Dawn A. Lissy, President & Founder, Empirical 08.15.18
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Innovation in the 510(k) Space: A Case for Incrementalism
Although the term “innovative technology” often evokes images of a breakthrough, radical discovery, or inventive cure-all, the certainty associated with incremental improvements to established, higher-risk technologies such as implantable…Samuel Pollard, Senior Regulatory Associate, Musculoskeletal Clinical Regulatory Advisors 08.15.18
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Design | Research & Development
Tips to Help Ensure a Successful Surgeon Design Team
Design surgeons and surgeon design times have been at the core of the significant advances that have occurred in the medical device market in the last few decades. Working with surgeon design teams is inspirational, mentally demanding, and exciting.…David C. Kelman, President, Kelman & Company Consulting LLC 08.15.18
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FDA’s Educational Opportunities Abound
As a former U.S. Food and Drug Administration (FDA) reviewer, I have spent a considerable amount of time learning the system from the “inside.” There are many avenues of training offered by the FDA, and if you know where to look, you may…Elizabeth O’Keeffe, Ph.D., Director, Engineering and Technical Services, Secure BioMed Evaluations 08.15.18
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Imaging | MIS/Robotics
The Promising Future for AI in Orthopedics
In their most simple form, AI applications in healthcare consist of a collection of technologies that will enable machines to sense, comprehend, predict, act, and learn. The first application for AI-based machines, as discussed at the World Medical I…Maria Shepherd, President and Founder, Medi-Vantage 08.15.18
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Stoking the Corner Office Compensation Controversy
If only the real world functioned as it does in academia. Or in human imagination. Consider the possibilities: world peace, racial/gender harmony, financial security, and perfect health are just a few that come to mind. Even eternal youth wouldn&r…Michael Barbella, Managing Editor 08.15.18
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Extremities | Spine/Neurology
Bioelectronic Medicine Gets on Arthritis’ Last Nerve
According to Northwell Health, as of 2016 rheumatoid arthritis (RA) affects 1.3 million adults in the U.S. And despite billions of dollars spent annually treating the disease, there has yet to be a therapeutic agent able to universally relieve the jo…Sam Brusco, Associate Editor 05.29.18
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How Do We Make Orthopedic Surgery Easier for Our Physicians?
The practice of orthopedic surgery is still going through a significant transformation. Practice shifts from private to hospital employees and back to private again. This level of turbulence creates ambiguity, questions, threats, and opportunities.…Maria Shepherd, President and Founder, Medi-Vantage 05.29.18
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Assembly & Automation | Coatings/Surface Modification | Contract Manufacturing | Design | Extrusion | Machining & Tooling | Molding | Prototyping
The Right Vendors Foster Growth: Why Firms of All Sizes Need to Outsource
I was working as a product development engineer at AcroMed (a spinal implants manufacturer that was acquired by DePuy in 1998), when I noticed a gap in the medical device industry. There were plenty of companies coming up with great ideas for d…Dawn A. Lissy, President & Founder, Empirical 05.29.18
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Extremities | Materials | Spine/Neurology
In Situ Cured Silicone Could Enable Personalized Implants
Medical-grade silicone is a highly valued, versatile biomaterial widely used for medical implants. Often associated with applications such as cardiovascular pacemakers, cochlear implants, hydrocephalus shunts, implantable infusion pumps, and even int…Brian Reilly and Jim Lambert, Ph.D., NuSil, an Avantor brand 05.29.18
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Effects of MEDDEV Revision 4 on Clinical Evaluation Reports (Part 1)
The latest revision of MEDDEV 2.7/1 was published June 2016 and calls for substantial changes from revision 3. Updating clinical evaluation reports (CER) to meet the new requirements will require a major effort for most manufacturers selling in the E…Jonathan Gimbel, Director, Regulatory and Quality Solutions LLC (R&Q) 05.29.18
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Design | Research & Development
The Hidden Costs of Clinical Trial Agreement Negotiations
Negotiating can be a daunting task, often inducing anxiety in those without much practice. For many, it’s not a skill that develops naturally or easily. Graduate programs offer numerous courses aimed at preparing students for the necessary evil…Megan Florez, Compliance and Reimbursement Associate, Musculoskeletal Clinical Regulatory Advisors 05.29.18
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Modifications to a Cleared Device: Letter to File or New 510(k)?
Change is good, right? Most orthopedic manufacturers have been working under the ISO 13485 umbrella, which stresses the need for continuous improvement. Once a device is in commercial distribution, there are valuable lessons to be learned. Shouldn&rs…Linda Braddon, Ph.D., President and CEO, Secure BioMed Evaluations 05.29.18
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Design | Research & Development
Product Development in the Changing Healthcare Environment
The healthcare market has been changing over the past 30 years and the speed of change is increasing significantly. During this timeframe, great advances have been made to patient care through new surgical interventions and medical devices. Early on…David C. Kelman, President, Kelman & Company Consulting LLC 05.29.18
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3-D Printing/Additive Mfg.
Will Additive Manufacturing Revolutionize Orthopedic Product Manufacture?
Additive manufacturing is a disruptive fabrication process impacting an array of industry sectors, including healthcare. As such, members of this industry have made bold claims and predictions on the potential for this innovation. How much of this, h…Ali Madani, CEO, Avicenne Medical 05.29.18
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Hospital and Orthopedic Service Line Trends
What a difference eight years makes. The massive changes in economic, regulatory, and consumer mandates have altered healthcare delivery across the United States. Compare 2018 to 2010. While we still haven’t seen an aggregate reduction in healt…Maria Shepherd, President and Founder, Medi-Vantage 03.21.18
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Large Joint
The Ins and Outs of TKA Reimbursement
Ira Kirschenbaum, M.D., never really gave much thought to his professional habitat. He’s spent more than two decades fixing broken or damaged knees, carefully drilling into bone, reattaching ligaments, and cementing new joints in place. Each…Michael Barbella, Managing Editor 03.21.18
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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 03.21.18
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Packaging & Sterilization
The Role of Purified Water in Critical Cleaning Applications
High purity water is an absolute essential ingredient to a medical device and biases surgical outcomes toward success.James Dwyer, VP of Technical Operations, Millstone Medical Outsourcing LLC 03.21.18
