Columns
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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
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Selling Regulatory Compliance
Does the title of this column strike a nerve? Does it seem crass or disrespectful to combine “selling” with “regulatory compliance”? I ask these rhetorical questions because I have found that many regulatory professionals feel…James A. Dunning, Principal, QPC Services LLC 07.26.18
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Managing the China Supply Chain: One CEO’s Experience
It’s a good time to reflect on changes in supply chain activities, with MPO celebrating its 15th anniversary this year. This month’s column will focus on China, as no other country has impacted the medtech supply chain as much as the Midd…Dave Sheppard and Scott Hayden, MedWorld Advisors 07.26.18
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Potential Sunshine Act Changes & A 2018 Midterm Elections Update
Of particular interest to the life sciences industry are a series of recent efforts by the U.S. Congress to expand the scope of the Physician Payments Sunshine Act—a 2010 law that requires transactional transparency between drug and device manu…Jeffrey J. Kimbell and David C. Rudloff , Jeffrey J. Kimbell & Associates Inc. 07.26.18
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The Tax Man Cometh for the Healthcare Industry—Again
For the last few years now, I have begged the Obama administration, Trump administration, and Congress to adopt Lee Iacocca’s motto of “lead, follow, or get the hell out of the way” regarding Obamacare. Unfortunately, other than eli…Chris Oleksy, Founder and CEO, Oleksy Enterprises and Next Life Medical CEO, Emergent Respiratory 07.26.18
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R&D & Design
Second-Generation Products—Pressing the “Re-Do” Button
Introducing a product involves myriad best guesses and estimations. There is often no way to adequately know everything in advance of release. A design team can conduct research and user evaluations and follow best practices to anticipate user needs,…David C. Robson, Principal, Robson Advisors 07.26.18
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Stoking the Corner Office Compensation Controversy
If only the real world functioned as it does in academia. Or in human imagination. Consider the possibilities: world peace, racial/gender harmony, financial security, and perfect health are just a few that come to mind. Even eternal youth wouldn&r…Michael Barbella, Managing Editor 07.26.18
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Cardiovascular
15 Years of Consi-stent Medtech Progress
Though merely 15 years ago, given the breakneck pace of innovation these days, 2003 seems a world away in terms of science and technology. It was the year the Concorde supersonic jet made its final flight; the year Kodak released the first digital ca…Sam Brusco, Associate Editor 06.04.18
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Digital Health
What a Long, Strange Trip It’s Been…
Who could have predicted all the changes we have seen in medtech in the 15 years since 2003? In 2003, pacemakers were only used in cardiology. Since then, modifications of early pacemaker technology have erupted into the neurostimulation market. In M…Maria Shepherd, President and Founder, Medi-Vantage 06.04.18
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3D/Additive Manufacturing | Surgical
Top 5 of the Past 15: Moments that Shifted, Shaped, or Shook the Medical Device Industry
You don’t have to be a Greek philosopher to understand the only constant is change; we see it every day in our personal and professional lives. The medical device business is driven by disruptive change fueled by our commitment to continually d…Dawn A. Lissy, President & Founder, Empirical 06.04.18
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Diagnostics | Materials | Patient Monitoring
Diabetes Management and the Role of Adhesives
Diabetes management has come a long way over the past few decades. The disease that used to require patients to visit their doctor’s office on a weekly basis for glucose readings can now be continuously monitored on-the-go in the office or at h…Del R. Lawson, Ph.D., R&D manager, Critical and Chronic Care Solutions Division, 3M 06.04.18
