Asia

Don’t Ignore Statistical Trends In Asia

By Ames Gross

…demand from China, India, and ASEAN countries will more than compensate for this decrease in demand. Medical device companies should take note of these statistics as they look to expand…

…demand from China, India, and ASEAN countries will more than compensate for this decrease in demand. Medical device companies should take note of these statistics as they look to expand…

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The Devil Is in the Due Diligence

By Thomas Maeder

companies. Here are five reasons you need to come to the program in Boston: Meet top level speakers who have been through it all Identify the hidden areas where problems…

companies. Here are five reasons you need to come to the program in Boston: Meet top level speakers who have been through it all Identify the hidden areas where problems…

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Eric Luyer, Axendia
MEDdesign

Augmented Reality in Today’s Operating Rooms

By Eric M. Luyer

…the procedure and why, and for checking compliance with regulations and to help settle any complaints. In line with the examples described above, virtual reality is another technology that can…

…the procedure and why, and for checking compliance with regulations and to help settle any complaints. In line with the examples described above, virtual reality is another technology that can…

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Diving into Product Development: Who Are Your Users?

By Maria Fontanazza

…is something that isn’t necessarily required,” said Baird. Having the time and the resources to do good research. “I emphasize the word ‘research’,” said Baird. “We are a research and…

…is something that isn’t necessarily required,” said Baird. Having the time and the resources to do good research. “I emphasize the word ‘research’,” said Baird. “We are a research and…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

The FDA Loves Stats

By Dr. Christopher Joseph Devine

…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (May 2016). Inspections, Compliance, Enforcement, and…

…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (May 2016). Inspections, Compliance, Enforcement, and…

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Cybersecurity

New Cybersecurity Project Supports Safety of Veteran Patient Data

By MedTech Intelligence Staff

A new program established by the U.S. Department of Veteran Affairs and UL aims to address the current gap for cybersecurity standards and practical certification approaches for connected medical devices…

A new program established by the U.S. Department of Veteran Affairs and UL aims to address the current gap for cybersecurity standards and practical certification approaches for connected medical devices…

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Maria Fontanazza, Editor-in-Chief, MedTechIntelligence.com
From The Editor's Desk

From Digital Health to ‘Digital Snake Oil’

By Maria Fontanazza

companies struggle to identify user needs. Attend the MedTech Product Development Conference to learn how to navigate the process. | September 29-30, 2016 | 3M Innovation Center | St. Paul,…

companies struggle to identify user needs. Attend the MedTech Product Development Conference to learn how to navigate the process. | September 29-30, 2016 | 3M Innovation Center | St. Paul,…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

The FDA and Risk, It Matters

By Dr. Christopher Joseph Devine

…use. Complaint data, MDRs, vigilance reports, literature, performance of similar devices (such as a competitors) and production / manufacturing information are excellent sources for obtaining post-market surveillance data. Takeaways For

…use. Complaint data, MDRs, vigilance reports, literature, performance of similar devices (such as a competitors) and production / manufacturing information are excellent sources for obtaining post-market surveillance data. Takeaways For

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Medtronic, IBM Unveil SugarWise Diabetes App

By MedTech Intelligence Staff

…behavior and their glucose levels, all in real time. According to an IBM release, the companies also released results from a hypoglycemia prediction data study of 10,000 patients that showed…

…behavior and their glucose levels, all in real time. According to an IBM release, the companies also released results from a hypoglycemia prediction data study of 10,000 patients that showed…

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Ameing for Asia

Minimize Acquisition Risk in Asia

By Ames Gross

company was also paying the general manager at the newly acquired company about $400,000 annually. When I asked the medtech company executive why they had not paid the $20 million…

company was also paying the general manager at the newly acquired company about $400,000 annually. When I asked the medtech company executive why they had not paid the $20 million…

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