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An Industry on the Defensive
It’s been a rough six months for the medtech industry. Nearly 200 days after it was first blindsided by a one-two punch of bad publicity from the damning Netflix documentary “The Bleeding Edge,” the sector remains firmly immersed…Michael Barbella, Managing Editor 02.13.19
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Medtech and The Management Top 250
Developed by the Drucker Institute and publicized by The Wall Street Journal, The Management Top 250 Ranking measures and ranks corporate competencies from 1-250 by scrutinizing operations in five areas: customer satisfaction, employee engagement and…Maria Shepherd, President and Founder, Medi-Vantage 02.13.19
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3-D Printing/Additive Mfg.
The Gawky Teenage Phase: 3D Printing Enters Adolescence
As the mom of a young teen, I get a daily, real-time view of the of the challenges of a human doing his best to grow up. There are a lot of false starts, half-baked ideas, and epic fails, but there’s also tremendous potential and frequent victo…Dawn A. Lissy, President & Founder, Empirical 02.13.19
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3-D Printing/Additive Mfg. | Biologics | MIS/Robotics
Getting a Clinical Viewpoint
Last year, at the North American Spine Society’s (NASS) 33rd Annual Meeting, held in Los Angeles, Jeffrey C. Wang, M.D., professor of orthopaedic surgery and neurological surgery (clinical scholar) at the Keck Medical Center at the University o…Sean Fenske, Editor-in-Chief 02.13.19
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Design | Research & Development
Trial Master File: Paper or Electronic?
The Trial Master File (TMF) is the central location for all clinical trial documents. From the start of a clinical trial through its conclusion, the TMF contains and secures a variety of information such as signature pages, study logs, ethics committ…Anuradha Nagulapati, Clinical Research Associate, Musculoskeletal Clinical Regulatory Advisers 02.13.19
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Software & Quality
2019: The Year to Enhance Quality in Orthopedic Product Development
The world has gone digital, and now it’s time for orthopedic product developers and manufacturers to catch up. According to LNS Research, 60 percent of all organizations are investing in industrial transformation—otherwise known as digita…Anthony Parise, Product Strategist—Life Sciences, ETQ 02.13.19
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Biologics | MIS/Robotics | Trauma/Sports
Global Prospects in Orthopedics
Camil Moldoveanu was fully prepared for the challenge. Or so he thought. The four-time Brazilian jiu-jitsu world champion knew he would need significant rehabilitation for his knee injury. He also knew the recovery process would be difficult, and…Michael Barbella, Managing Editor 11.30.18
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Spine/Neurology
Leveraging Innovation to Address the Opioid Crisis
The news has been devastating; according to the National Institute on Drug Abuse (NIDA) website, “every day, more than 115 people in the United States die after overdosing on opioids…including prescription pain relievers, heroin, and syn…Maria Shepherd, President and Founder, Medi-Vantage 11.30.18
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Design | Research & Development
MPO Summit: The View from the Top
It started with a wintry dusting of snow and ended in a blaze of autumnal glory. On top of a mini tour of Colorado’s best seasons, the two-day MPO Summit in Broomfield on Oct. 11-12 offered forecasts and insights into what it takes to weather c…Dawn A. Lissy, President & Founder, Empirical 11.30.18
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MDSAP Audits Update: Progress, Challenges, and a Cost Reduction Case Study
The Medical Device Single Audit Program (MDSAP) is growing fast, with 3,629 sites now participating, as compared to just 788 at the end of 2017. Part of this explosive growth stems from the fact that Canada will require manufacturers to comply wit…Anthony Parise, Product Strategist—Life Sciences, ETQ 11.30.18
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Data Monitoring Committees: Making DMCs Work for Your Study
The use of independent data monitoring committees is becoming increasingly prevalent in the U.S. medtech industry. The FDA outlines these groups and their operation in a 12-year-old guidance due to expire at the end of this year. However, the composi…Margeaux Rogers, Senior Associate, Regulatory Affairs, Musculoskeletal Clinical Regulatory Advisers LLC 11.30.18
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Top 10 Findings from a Warning Letter Analysis
When I first started out in medtech, I did not have a good appreciation for quality systems. I was working as an engineer at the time, and I found quality systems quite a nuisance because any change I proposed was either restricted or not allowed due…Linda Braddon, Ph.D., President and CEO, Secure BioMed Evaluations 11.30.18
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Extremities | Large Joint | Materials | Spine/Neurology
Recycling Implanted Metals From Beyond the Grave
Ever wonder what happens to devices implanted in the body after their users pass away? Probably not, because the thought of it tends to make most people who aren’t ODT editors cringe. But as medical implants become more common, people are dy…Sam Brusco, Associate Editor 09.19.18
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MIS/Robotics
Premium Medtech Price Stategies for the Orthopedic Robotics Segment
Growth in the market for surgical robots used in hip and knee orthopedic procedures was forecasted at $222 million in 2015 with anticipated growth to reach $5 billion by 20221 (Table 1). A substantial number of next- generation robotic devices, syste…Maria Shepherd, President and Founder, Medi-Vantage 09.19.18
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A Different Class of Engineer: How to Connect with Rising Medtech Talent
My grandfather—a World War II veteran who worked at GE in my native Cleveland—was one of my most beloved family members. When I told him I wanted to study engineering in college, he told me to find a university where I could get real, on-…Dawn A. Lissy, President & Founder, Empirical 09.19.18
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Getting Started on the Right Foot: Initiating Orthopedic Clinical Trials
Initiating an orthopedic clinical trial (OCT) is an exciting milestone for companies as years of pre-clinical testing and conversations with the U.S. Food and Drug Administration (FDA) finally come to fruition. Focusing on specific elements of the st…Bhavana Shivakumar , Clinical Research Associate, Musculoskeletal Clinical Regulatory Advisers LLC 09.19.18
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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
