Top Procurement Strategies to Enhance Profitability

To remain competitive in today’s global marketplace, the smartest medical device manufacturers are broadening their perspectives when it comes to contract manufacturing strategies for new product introductions. They are moving…

To remain competitive in today’s global marketplace, the smartest medical device manufacturers are broadening their perspectives when it comes to contract manufacturing strategies for new product introductions. They are moving…

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Jessica Holmes, Argenta Advisors
Reimbursement Report

The Best Value Proposition. Ever.

By Jessica Holmes

Any life science company that is not actively defining or redefining its technology’s value proposition—appealing to payers’ wants while addressing customer needs—risks losing a competitive edge to companies that are…

Any life science company that is not actively defining or redefining its technology’s value proposition—appealing to payers’ wants while addressing customer needs—risks losing a competitive edge to companies that are…

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

If Hackers Can Commandeer a Car, Why not a Medical Device?

By Dr. Christopher Joseph Devine

…selection/input. (October 2012). Accessed August 3, 2015. Retrieved from http://www.fda.gov/safety/recalls/ucm326131.htm Symbiq Infusion System by Hospira: FDA safety communication – cybersecurity vulnerabilities. (July 2015). Accessed July 31, 2015. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm456832.htm…

…selection/input. (October 2012). Accessed August 3, 2015. Retrieved from http://www.fda.gov/safety/recalls/ucm326131.htm Symbiq Infusion System by Hospira: FDA safety communication – cybersecurity vulnerabilities. (July 2015). Accessed July 31, 2015. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm456832.htm…

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Alert

Hack Alert: Infusion Pump Security at Risk

By MedTech Intelligence Staff

System. On Friday FDA issued a safety communication alert related to this product and advised any healthcare facilities that are currently using it to “transition to alternative systems”. The issue:…

System. On Friday FDA issued a safety communication alert related to this product and advised any healthcare facilities that are currently using it to “transition to alternative systems”. The issue:…

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What Do FDA Investigators Look for During an Inspection?

By Maria Fontanazza

…Drayton spoke about the considerations of inspections specifically related to combination products during MedTech Intelligence’s Combination Products in June. While FDA investigators are trained to look at the big picture…

…Drayton spoke about the considerations of inspections specifically related to combination products during MedTech Intelligence’s Combination Products in June. While FDA investigators are trained to look at the big picture…

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

Silence is Not Always Golden

By Dr. Christopher Joseph Devine

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (July 2015). Accessed July 28, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm455224.htm…

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (July 2015). Accessed July 28, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm455224.htm…

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FDA: Developing Combination Products Requires Consistency, Transparency, Collaboration

By Maria Fontanazza

Combination Product Approved Under BLA, NDA, or PMA Other activities Inter-Center Consult Process Study (analysis is almost complete) Communication enhancements to Combination Product IT Database Inter-Center review and compliance procedure…

Combination Product Approved Under BLA, NDA, or PMA Other activities Inter-Center Consult Process Study (analysis is almost complete) Communication enhancements to Combination Product IT Database Inter-Center review and compliance procedure…

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

FDAā€™s Most Wanted List

By Dr. Christopher Joseph Devine

…for a cup of coffee and an inspection. Please keep in mind, the agency has no problem with foisting (look-it-up) their beliefs upon medical device companies that fail to comply…

…for a cup of coffee and an inspection. Please keep in mind, the agency has no problem with foisting (look-it-up) their beliefs upon medical device companies that fail to comply…

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How New FDA Expectations for Human Factors Affect Process and Medical Device Submissions

By James Jackson

…data rather than tangible and comfortable quantitative data. The word comfortable is used here for quantitative because development that is based on using quantifiable measurements and a process that is…

…data rather than tangible and comfortable quantitative data. The word comfortable is used here for quantitative because development that is based on using quantifiable measurements and a process that is…

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Five Important Facts About 21st Century Cures Act

…by Rep. Fred Upton (R- Mich) and co-sponsored by Rep. Diana DeGette (D-Colo) in May. It has received the support of industry and trade associations, including AdvaMed and MDMA. Five…

…by Rep. Fred Upton (R- Mich) and co-sponsored by Rep. Diana DeGette (D-Colo) in May. It has received the support of industry and trade associations, including AdvaMed and MDMA. Five…

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