Columns
-
Foregoing the Rainbow for the Pot of Gold
Humans are groomed from a very early age to revere happy endings. From preschool-age fairy tales with magical kingdoms and creatures to classic teen fiction and grownup television sitcoms, the species has repeatedly turned to the arts for the clas…Michael Barbella, Managing Editor 11.26.18
-
Treating Global Obesity with Medical Device Innovation
The problem is enormous (no pun intended). According to the CDC, the obesity epidemic is increasing, with estimates placing the prevalence of obesity at 39.8 percent (93.3 million American adults during the study period covering 2015-2016).1 Obesity…Maria Shepherd, President and Founder, Medi-Vantage 11.26.18
-
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 11.26.18
-
The Regulatory Outlook for 2019
Time seems to have passed more quickly for me this year than at any other period in my life. I’m still not sure why, but one contributing factor could be the volume and gravity of regulatory changes that have been looming on the horizon. This i…James A. Dunning, Principal, QPC Services LLC 11.26.18
-
Exit Strategies: Beginning with the End in Mind
Recent U.S. tax cuts and the growth of available capital has kept the spotlight focused on M&A in almost every industry, including medical technology. Although 2018 has not seen the multi-billion-dollar blockbuster deals of recent years (i.e., Me…Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 11.26.18
-
Software & IT
Organizational and Regulatory Influences on Creating and Sustaining an Effective QMS
A quality management system (QMS) is a fundamental regulatory requirement for any medical device company that needs to sell or introduce medical devices to the market. The risks associated with not having a robust QMS include making a non-conforming…Annette Schaps, Schaps Consulting, and Chuck Cimalore, Arena Solutions 11.26.18
-
Contract Manufacturing | R&D & Design
The Future of Medical Device Design Companies
Device design and regulatory services companies are of growing significance in the medical device supply chain. As recently as 10 years ago, device design was the near-exclusive realm of medtech OEMs. Once considered core to product success, design w…Tony Freeman, President, A.S. Freeman Advisors, LLC 11.26.18
-
R&D & Design
Secret Confessions of a Service Provider
Most medical device OEMs, large and small, develop new products only occasionally. Their teams often split time between new product initiatives and sustaining business. As a result, these teams aren’t necessarily well-versed in the product desi…David C. Robson, Principal, Robson Advisors 11.26.18
-
With Trump’s Space Force Idea Gaining Steam, Could a U.S. Health Force Be Far Behind?
Over the summer, the Trump administration expressed its desire to form a U.S. Space Force—a new military branch that would be different from the unit (Air Force Space Command) already tasked with overseeing much of America’s defense asset…Chris Oleksy, Emergent Respiratory 10.16.18
-
Medtech Funding: Emerging from the Valley of Death?
The number of conferences focused on finding funding in the life sciences and medtech space continues to increase. Two of them—the RESI meeting (Redefining Early Stage Investments, held in Boston, Mass., on Sept. 6) and the McDermott Life Scien…Maria Shepherd, President and Founder, Medi-Vantage 10.16.18
-
Professional Development for the Quality/Regulatory Professional
Recently, someone asked me if colleges offer degrees in quality. I replied that many schools do indeed offer undergraduate programs in quality management or other quality focus areas, but such diplomas are rare among quality or regulatory professiona…James A. Dunning, Principal, QPC Services LLC 10.16.18
-
Contract Manufacturing | Electronics | Neurological
Aligning Innovation and Unmet Clinical Needs in Neuromodulation
For physicians and care providers treating neurological disorders, the use of neuromodulation devices represents a potential solution for their patients. As this technology has evolved and advanced, its therapy applications continue to expand. Wit…Mark Hjelle, Senior Product Line Manager, Heraeus Medical Components 10.16.18
-
Spotlight on Recent Legislation and the 2018 Midterm Elections
With the second session of the 115th Congress winding down, legislators are considering several noteworthy pieces of legislation of interest to the healthcare and medical device industry. One measure, H.R. 184, which passed the U.S. House of Represen…Jeffrey J. Kimbell and David C. Rudloff, Jeffrey J. Kimbell & Associates Inc. 10.16.18
-
Supply Chain 2020—How Are You Trending?
Since the dawn of the 21st century, prognosticators have been looking ahead to the year 2020 and predicting what life might be like for various industries, markets, and professions. As that target year quickly approaches (14 months out), it’s w…Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 10.16.18
-
R&D & Design
DNA of a Successful and Innovative Product Development Program
There are many ways to successfully develop new and innovative product solutions. Projects can be oriented to meet a clinical need via a new technical approach or better satisfy a business opportunity. They can make previously unavailable treatments…David C. Robson, Principal, Robson Advisors 10.16.18
-
Making Sense of Medtech M&A and Trade Wars
It’s time for some retrospection. As we slide into the home stretch of 2018, I thought I’d share my thoughts about the events that have already transpired within the medical device industry and the issues likely to impact the sector be…Mark Bonifacio, President, BCS LLC 10.16.18
-
From Battlefield to Boardroom: Military Service & MedTech
The MedTech Conference (powered by AdvaMed) is one of my favorite events to attend. Hosted at the Pennsylvania Convention Center in Philadelphia this year, the four-day conference features panel sessions with industry veterans, showcases of innovativ…Sam Brusco, Associate Editor 10.16.18
-
Biocompatibility Pulse Check: How FDA’s New Requirements Affect Our Industry
We all knew it was coming—new regulations regarding biologics. The U.S. Food and Drug Administration (FDA) issued guidance in 2016 for ISO 10993-1, partially in response to a number of articles that found post-surgery infection rates in the Uni…Dawn A. Lissy, President & Founder, Empirical 10.16.18
-
Surgical
Premium Medtech Price Strategies for the Robotics Segment
First, Intuitive Surgical (IS) was developing procedures in laparoscopy, prostatectomy, and hysterectomy. Many of us who had presented other, non-robotic medical devices to the Value Analysis Committee said it couldn’t be done; robots and their…Maria Shepherd, President and Founder, Medi-Vantage 09.07.18
-
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 09.07.18
