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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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 09.07.18
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Maintaining Compliance in the Digital Age
I’ve spent much of my professional life assessing regulatory compliance in the life sciences industry. In the past, there was always a clear difference between compliance and continuous improvement, but times have changed. The old (i.e., out of…James A. Dunning, Principal, QPC Services LLC 09.07.18
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Five Strategies to Gain New Business During Global Trade Tensions
This has been an exciting year for OEM medtech suppliers, though at times, it’s been a little too exciting. Companies have had to carefully navigate a slow-boiling, transatlantic trade war, careful to avoid crashing their profits and losses in…Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 09.07.18
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Software & IT
How to Choose the Right Quality Management System
Beyond the requirement for medical device companies, having a quality management system (QMS) provides a framework to deliver consistency and efficiency in a business. The two main regulations requiring a QMS are FDA 21 CFR 820 (U.S.) and ISO 13485 (…Chuck Cimalore and Rasean Hamilton, Omnify Software and EarLens 09.07.18
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R&D & Design
Building a Strategic Patent Portfolio that Doesn’t Break the Bank
A strategic patent portfolio is crucial to a medical technology company’s growth and survival, and also provides numerous business advantages. Patent portfolios are often the driving force in mergers and acquisitions (M&A), public offerings…David J. Dykeman, Co-chair, Global Life Sciences & Medical Technology Group, Greenberg Traurig LLP 09.07.18
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R&D & Design
The Impact of Changing Healthcare Economics on Device Design
As the world’s largest and most profitable medical device market, the United States is economically essential for the launch of new products. OEMs must be successful in America to fund global marketing and R&D. Yet the U.S. is topping out i…Tony Freeman, President, A.S. Freeman Advisors, LLC 09.07.18
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R&D & Design
Finding Balance by Design
Every team developing a new product sets out determined to design the best product possible, but the word “best” isn’t precise enough. Products are subject to business realities and constraints, often comprised of many attributes th…David C. Robson, Principal, Robson Advisors 09.07.18
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AI and Healthcare’s Promising Future
Artificial intelligence (AI) has the potential to truly augment human activity through medtech. In their most simple form, AI applications in healthcare consist of a collection of technologies that enable machines to sense, comprehend, predict, act,…Maria Shepherd, President and Founder, Medi-Vantage 07.26.18
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Packaging & Sterilization | Testing
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 07.26.18
