Columns
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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
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Your EU Medical Devices Regulation (MDR) Questions, Answered
The upcoming EU Medical Devices Regulation (MDR) changes are significant, potentially impacting device classification and the need for clinical data. It’s imperative organizations act now to meet these requirements in 2020 and beyond. Portfolio…Nancy Morrison, Director of Regulatory Affairs, Regulatory and Quality Solutions LLC (R&Q) 03.21.18
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Software & Quality
Medical Device Quality: Why Software Is More Challenging Than Hardware
The U.S. Food and Drug Administration’s (FDA) Quality System Regulation 21 CFR Part 820.30(g) states, “Design validation shall include software validation and risk analysis, where appropriate.” The words, “where appropriate,&r…Dan Goldstein, Manager, Quality Assurance, Musculoskeletal Clinical Regulatory Advisors 03.21.18
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Design | Research & Development
Innovation and the Development Engineer
Developing new products is not an easy task to accomplish. It takes a tremendous amount of creativity, fortitude, and sheer dogged determination. And that is just to travel from concept to a final form for commercial sale. Then the true gut wrenching…David C. Kelman, President, Kelman & Company Consulting LLC 03.21.18
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Biologics | Large Joint
We Can Rebuild Him; We Have the (Bio)technology
If a roadway is cracked and full of potholes, it’s fixed by repaving. If an edifice is damaged, it’s fixed by rebuilding. But if a joint in the body is damaged, repair isn’t quite so simple. The meniscus, for example—the ca…Sam Brusco, Associate Editor 02.12.18
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Spine/Neurology
Jump-Starting Disease Management Through Neurostimulation
Jump-starting disease management through neurostimulation.Maria Shepherd, President and Founder, Medi-Vantage 02.12.18
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Design | Prototyping
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 02.12.18
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Large Joint
Considerations for the Anterior Approach to Hip Replacement
The posterior approach has been and still is a widely used technique for hip replacement surgery. The industry, however, has seen a shift as more surgeons and their patients are turning to the anterior approach, a tissue-sparing method proven to resu…Scott Zellner, Senior Director of U.S. Joint Reconstruction and Outpatient Marketing, DePuy Synthes 02.12.18
