Columns
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R&D & Design
Charting a Course in Medical Innovation
Something obviously was lost in translation. For more than 60 years, the West has found inspiration in the Chinese symbol for crisis. Conventional wisdom avows that the word’s Mandarin translation consists of two characters—one symboli…Michael Barbella, Managing Editor 09.01.17
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R&D & Design
Medtech Price Strategies: Who Is Going to Pay for It?
Medical device product innovation and pricing strategy must be closely linked. In medtech product development, the three most important questions are: Is there an unmet need that can be answered with a medical device and what is it? I…Maria Shepherd, Medi-Vantage 09.01.17
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Testing
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, Empirical 09.01.17
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Comparing cGMP Pharma vs. Device: Subpart B—Organization and Personnel
The medtech and pharmaceutical sectors are both essential to health, and while they have long maintained a symbiotic relationship, the two have never really understood each other. Certainly, there are some common threads connecting the pair—bot…James A. Dunning, QPC Services LLC 09.01.17
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Software & IT
Six Document Control Problems for Medical Device Firms to Avoid
Homegrown systems and paper-based processes can create unnecessary risk for medical device companies when it comes to document management. From policies to manuals, regulatory reports to standard operating procedures (SOPs), these companies deal with…Rachel Beavins Tracy, EtQ 09.01.17
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Contract Manufacturing
Nine Critical Considerations When Selecting a Contract Manufacturing Partner
Once deciding it’s time to outsource device manufacturing—as more original equipment manufacturers (OEMs) are doing these days—how does one choose the right partner? Start by considering the OEM’s priorities. Is the goal to…Mike Treleaven, Tegra Medical 09.01.17
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Contract Manufacturing
Supply Chain 2020: What Can We Learn From a Wise Banker?
Most people are familiar with the popular adage “History repeats itself.” I have found this axiom to be true more often than not and I’m willing to bet a good portion of the general population has, too. Faithful MPO readers will als…Chris Oleksy, Emergent Respiratory 09.01.17
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Cardiovascular | Surgical
Age of Innovation for Valves
By the time one reaches age 75, each of his or her four heart valves will have opened and closed approximately 3 billion times. But aging and illness cause some heart valves to stiffen or flop. Although mild valve damage may be treated with medicatio…David Novotny, Novella Clinical 09.01.17
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R&D & Design
The Value Creation Roadmap for Medical Technology Innovation
Translating clinical research and medical technology innovation into a sustainable company is a complex and far-reaching process. First-time entrepreneurs, clinicians, and engineers often don’t appreciate the importance of the many factors invo…Steve Maylish, Fusion Biotec, and Scott Hutchinson, StoneCreek Capital 09.01.17
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Diagnostics | Surgical
Crash Test Dummies with Synthetic Beating Hearts
Tampa, Fla.-based SynDaver Labs is in the business of manufacturing humans. But before you grab your torch and pitchfork and race off to rally the townspeople, they’re not live humans and are most certainly not harvested from graveyards by a ma…Sam Brusco, Associate Editor 07.26.17
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Cardiovascular | Diagnostics
Changing Administrations and the Strategy for Value-Based Growth in Medtech
In 2013, the U.S. medtech business turned the corner with improving revenue trends. The roll-out of Obamacare has stimulated growth in hospital admissions and other new systems of healthcare utilization at sites of care that didn’t exist before…Maria Shepherd, Medi-Vantage 07.26.17
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3D/Additive Manufacturing | R&D & Design | Testing
Pro Tips for Prototypes: The Smart Way to Manage Device Iterations
There’s something about hitting the prototype stage of the development cycle that makes everything finally seem real. This is the point at which there is finally an object to hold in your hands—a physical representation of the vision, inv…Dawn A. Lissy, Empirical 07.26.17
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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, QPC Services LLC 07.26.17
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A Look into ISO 14971: Risk Management and Quality System Integration
“People generally prefer present benefits over future benefits, and prefer future harms over present harms, so time-preference may need to be captured when risks and benefits occur at different times,” stated an Association for the Advanc…Emily Ysaguirre, VERSE Solutions 07.26.17
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Contract Manufacturing
The Everlasting Life of Legacy Medical Products
Large medical device companies are mostly publicly traded firms that are obliged to meet consistently high levels of market returns. Analysts not only expect robust revenue growth and healthy profits, but also strong margins. Satisfying these demands…Dan O’Mahony, Lifesciences Manager, Exertis Supply Chain Services Limited 07.26.17
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Paying It Forward: Mentoring the Next Generation of Design Professionals
As we progress in our careers, it’s interesting to reflect on the times that made a real difference. For us, it was three mentors: one when my career was just beginning, and two when our careers were shifting gears. These highly intelligent peo…Steve Maylish and Mike White, Fusion Biotec 07.26.17
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Diagnostics | Digital Health | Patient Monitoring
Medical Auto-Pilot: Medtech’s Focus on Digital Therapeutics
Necessity is the mother of invention. Although often attributed to Plato and appearing in certain translations of his Republic, this well-known proverb more likely evolved from an early 1500s Latin textbook of everyday sayings that included the phras…Bryan Hughes, Director, P&M Corporate Finance 07.26.17
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Digital Health | Software & IT | Testing
Recent Cyber Attack Enough to Make Medtech WannaCry
It was the U.S. Food and Drug Administration’s (FDA) worst nightmare come true. On May 12, the WannaCry ransomware cryptoworm slithered its way into computers worldwide, infecting as many as 200,000 Microsoft Windows systems in 150 countries…Michael Barbella, Managing Editor 06.06.17
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The Business of Medtech
Boston, Mass., was the place to be in the first week of May 2017 for people interested in the business of medtech. The World Medical Innovation Forum kicked off the week for a three-day meeting that maintained a focus on cardiovascular disease and te…Maria Shepherd, President and Founder, Medi-Vantage 06.06.17
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Class III Devices from 10,000 Feet: The Big Picture on Getting Premarket Approval
It takes a certain level of passion and perseverance to break new ground. For the innovator introducing a disruptive technology to improve patient outcomes and lives, the creativity fueling the process of getting a Class III device to market is rival…Dawn A. Lissy, President & Founder, Empirical 06.06.17
