Columns
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Diagnostics
A Breath of Fresh Air for COVID-19 Testing
One of the latest COVID-19 testing innovations has recently emerged from Israel’s Technion-Israel Institute of Technology—a coronavirus breath test.Sam Brusco, Associate Editor 09.01.20
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Contract Manufacturing | R&D & Design
Trends for Medtech Contract R&D and Manufacturing
Over the past 10 years, medtech manufacturers from startups to giants have grown their levels of outsourcing to contract R&D and manufacturing partners.Maria Shepherd, President and Founder, Medi-Vantage 09.01.20
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Self-Care in Business: Four Ways to Extend the Peace of Home to the Workplace
I began applying my self-care rules to the extension of myself that is the Empirical family of companies.Dawn A. Lissy, Founder & President, Empirical 09.01.20
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Facts to Ensure MDR Success
Even with the delay of the European Union’s MDR deadline until May 26, 2021, the race to reach compliance is still on for medical device manufacturers.Sherry Parker, Ph.D. and Bob Pryzgoda, Ph.D. 09.01.20
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A Market Analysis of the Siemens-Varian Deal
On Aug. 2, Siemens Healthineers announced its $16.4 billion acquisition of Varian Medical Systems Inc.Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 09.01.20
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Contract Manufacturing
Smart Sourcing: Transforming the Supply Chain Into a Value Network
The rise of globalization and outsourcing has led to increased supply chain risk and decreased predictability due to variability and complexity.Daniel R. Matlis and Sandra K. Rodriguez, Axendia Inc. 09.01.20
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Digital Health
What’s Apple Been Up To in Healthcare?
Apple is building its bench with teams of physicians and engineers creating software and hardware to address the healthcare market.Maria Shepherd, President and Founder, Medi-Vantage 07.21.20
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Rising to the Challenge: Six Innovators Win Fast-Track Support to Market
These six winning submissions reflect a keen awareness of patient needs during the unique and surprising circumstances of the COVID-19 pandemic.Dawn A. Lissy, Founder & President, Empirical 07.21.20
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Patent Marking: The Proper Method to Display Protection
Manufacturers should have an active patent marking program that aids in deterring infringement while minimizing potential liability for false marking.Douglas Portnow, Principal, Schwegman Lundberg & Woessner, P.A. 07.21.20
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Dynamic Organizational Changes to Succeed in the New Normal
Medtech executives must adapt to managing their businesses in a substantially different environment.Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 07.21.20
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COVID-19 Accelerating Remote Auditing in MedTech
The move to modernize is now reaching audit groups, which are rapidly shifting to remote auditing as a new way of working.Seth Goldenberg, Ph.D., Vice President, Vault Medical Device & Diagnostics, Veeva Systems 07.21.20
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Digital Health
The Rise of Digital Medical Devices and Implications for the Supply Chain
Over the past few decades, the medical device industry has seen waves of technological innovation. From the replacement of sterilizable glass and steel devices with disposable plastic in the 1960s to the rise of elegantly engineered minimally invasiv…Tony Freeman, President, A.S. Freeman Advisors LLC 07.21.20
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Recent Regulatory Changes and a 2020 Election Update
As COVID-19 continues to impact the country, legislators and policy makers in Washington are keenly focused on the upcoming national election on Nov. 3.Jeffrey J. Kimbell, David C. Rudloff, Caroline P. Tucker, and Matteson L. Beckis, Jeffrey J. Kimbell & Associates Inc. 07.21.20
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Diagnostics
‘Pandemic Drone’ Spots COVID-19 Symptoms
About three months ago, drone-making company Draganfly began to strategize how drones might be able to help against COVID-19.Sam Brusco, Associate Editor 06.04.20
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Digital Health
Hospital Advances in Digital Health Medical Technology
It's been stated, “What the world would have taken five years to achieve was accomplished in five weeks,” regarding virtual care and the U.S. population.Maria Shepherd, President and Founder, Medi-Vantage 06.04.20
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R&D & Design | Surgical
Sparking Innovation as We Struggle to Find the New Normal
The goal is to find the best ideas to support orthopedic patients adjusting to additional pain and immobility while they wait for elective surgeries.Dawn A. Lissy, Founder & President, Empirical 06.04.20
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ISO 13485 Remote Audits: Views from Both Sides of the Table
Remote audits have been a standard practice for low-risk suppliers or in the cases where restrictions existed in entering certain parts of the world.Jim Shore, Quality Lean Solutions, and Neel Patel, Florida Anodize System & Technologies 06.04.20
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Remote System Diagnostics: Transform Service with a Four-Phase Strategy
Manufacturers are focusing ever more closely on service strategies and excellence in system uptime as a complement to the overall efficacy of their devices.Mark Villanova, Service Operations Manager and Sustaining Engineer, Dedicated Computing 06.04.20
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Contract Manufacturing
Shopping Smart: What to Look for in a Contract Manufacturer
A contract manufacturing organization can help shoulder the workload of bringing a new device to market.Claudio Hanna and Jennifer Ponti, Web Industries Inc. 06.04.20
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R&D & Design
Disposable Design: Consider All Interfaces
The disposable component is becoming more challenging as products get smaller and more complex.Will DeMore, Mechanical Engineer, Key Technologies Inc. 06.04.20
