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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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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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The Impact of U.S. Regulation on Medical Device Innovation
Passion, inspiration, perseverance, altruism, and need have historically been the factors driving innovators. During World War II, antibiotics were scarce and chronic osteomyelitis and bone deficiencies such as non-unions and deformities were common.…Patricia Kontoudis, Associate, Regulatory Affairs, Musculoskeletal Clinical Regulatory Advisers LLC 02.12.18
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The Use of Acceptance Criteria in a Changing Regulatory World to Support 510(k) Clearance
Successful regulatory submissions are critical for the commercialization of an orthopedic device. U.S. Food and Drug Administration (FDA) clearance on a product is not the only factor in commercial success, but it is certainly one of the key componen…Linda Braddon, Ph.D., President and CEO, Secure BioMed Evaluations 02.12.18
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Bracing/Prosthetics
Outsmarting the Laws of (Mother) Nature
There seems to be no limit to device intelligence these days. Better brainpower has permeated practically every aspect of modern life, easing such mundane tasks as vacuuming, cooking, dieting, home surveillance, and indoor climate control, among o…Michael Barbella, Managing Editor 11.21.17
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Large Joint
An Update on U.S. Obesity and Its Impact on Hip, Knee Transplants
The global obesity epidemic continues to grow. In 2016, it was estimated that greater than 39 percent of adults1 (up from 35.7 percent of adults2) are obese (Table 1). Obesity can bring a quadruple whammy of co-morbidities including cardiovascular di…Maria Shepherd, President and Founder, Medi-Vantage 11.21.17
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The Final Four: My Top Headlines for 2017
In a year of political and social discord, international conflict, and natural disasters, the big news in the medical device industry really didn’t make headlines—even within our sector. But as 2017 comes to a close, I consider fee hikes,…Dawn A. Lissy, President & Founder, Empirical 11.21.17
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Software & Quality
Managing Deviations and Adequately Recording Failures
According to the ECA Academy, managing deviations and Corrective and Preventive Actions (CAPAs) are still the focus of inspectorates. The summaries of their observations show deficiencies relating to quality systems are by far the most frequently obs…Emily Ysaguirre, Content Marketing Writer, EtQ 11.21.17
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A Risk-Based Approach to QMS: ISO 13485:2016 Requirements
Among numerous major changes contained within the revised ISO 13485:2016 standard, a risk-based approach is perhaps the most notable alteration affecting all areas of the quality system. The 2003 version of the standard addressed risk management in r…Bryan Brosseau, RAC, Vice President, Quality and Regulatory Affairs, Secure BioMed Evaluations 11.21.17
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Spine/Neurology
Mind Over Matter: Brain-Controlled Physical Rehabilitation
It’s usually not a promising prognosis for patients once the connection between the brain and muscles becomes severed or disrupted in some way. Whether through spinal cord injury, a stroke, or a gait disability, mobility suffers once the brain…Sam Brusco, Associate Editor 10.02.17
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Orthopedic Device Price Strategies: Who Is Going to Pay for It?
Orthopedic device product innovation and pricing strategy must be closely linked. In orthopedic product development, the most important three questions are: Is there an unmet need that can be answered with an orthopedic device and what is i…Maria Shepherd, President and Founder, Medi-Vantage 10.02.17
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So We’re All on the Same Page: You Need a Test Plan
I’m a huge fan of lists. Covering every base with an organized way to track everything from my companies’ financial progress to whether the Doritos made it into the car for the drive home from school keeps me functioning. I note things on…Dawn A. Lissy, President & Founder, Empirical 10.02.17
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Comparing CGMP Pharma vs. Device: Subpart A—General Provisions (Part II)
Despite maintaining a somewhat close professional relationship, the pharmaceutical and medical device industries are complete strangers in many ways. Between product development timelines, innovation, and outsourcing, the two sides lead mostly separa…James A. Dunning, Owner, QPC Services LLC 10.02.17
