Diving into Product Development: Who Are Your Users?

By Maria Fontanazza

…is a challenge. “Having management sometimes believe they already know what the user needs are can be a problem. We see that mostly at smaller companies; larger companies seem to…

…is a challenge. “Having management sometimes believe they already know what the user needs are can be a problem. We see that mostly at smaller companies; larger companies seem to…

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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

…Program Prepares Companies for Medtech Cyberattacks”. Patching and reconfiguring medical devices has opened the vulnerability door, creating vulnerable software and thus significant challenges related to protecting devices against cybersecurity attacks….

…Program Prepares Companies for Medtech Cyberattacks”. Patching and reconfiguring medical devices has opened the vulnerability door, creating vulnerable software and thus significant challenges related to protecting devices against cybersecurity attacks….

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

From Digital Health to ā€˜Digital Snake Oilā€™

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

On occasion, Dr. D hears some device establishments make silly comments such as, “We are just a specification developer and do not have to comply with the Quality System Regulation…

On occasion, Dr. D hears some device establishments make silly comments such as, “We are just a specification developer and do not have to comply with the Quality System Regulation…

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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

…executive started by telling me his company had recently bought a Chinese device component manufacturer, but that the general manager of the company was no longer answering his calls or…

…executive started by telling me his company had recently bought a Chinese device component manufacturer, but that the general manager of the company was no longer answering his calls or…

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FDA

FDA Gives Guidance on Sharing Patient Information from Devices

By MedTech Intelligence Staff

As patients continue to demand increasing control over their healthcare, with this comes a desire for more information generated from devices that they use. In recognition of this changing landscape,…

As patients continue to demand increasing control over their healthcare, with this comes a desire for more information generated from devices that they use. In recognition of this changing landscape,…

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Boston Scientific

Boston Scientific Restructures, Expects to Reduce Headcount

By MedTech Intelligence Staff

…this also comes anticipated employee turnover and “targeted” headcount reduction, but the company also concurrently expects new job creation in certain growth areas. “We are taking these steps to build…

…this also comes anticipated employee turnover and “targeted” headcount reduction, but the company also concurrently expects new job creation in certain growth areas. “We are taking these steps to build…

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Gordon Schatz
Reimbursement Report

Reimbursement Coding Systems and Innovative Medical Devices

By Gordon B. Schatz, J.D.

Reimbursement billing codes are an essential component of a comprehensive medical device reimbursement strategy. In today’s world of device sales, customers regularly ask, “Will I get reimbursed for this product?”…

Reimbursement billing codes are an essential component of a comprehensive medical device reimbursement strategy. In today’s world of device sales, customers regularly ask, “Will I get reimbursed for this product?”…

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