Combination product, human factors

Optimize Combination Products: Select a Drug Delivery Device that Meets User Needs

By Allison Strochlic, Erin Davis

company’s ability to get an important drug to market. Given this pattern, pharmaceutical companies are well-served to select a device that is not only compatible with the drug, but that…

company’s ability to get an important drug to market. Given this pattern, pharmaceutical companies are well-served to select a device that is not only compatible with the drug, but that…

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MEDICA

Wanted: Innovative Medical Mobile Solutions for Competition

By MedTech Intelligence Staff

…home €2000, second place wins €1000 and third place takes home €500. To submit a medical mobile solution for the competition, go to http://www.medica.de/mac2. View last year’s winners: https://medtechintelligence.com/news_article/medicas-medical-mobile-app-competition-winners-announced/  …

…home €2000, second place wins €1000 and third place takes home €500. To submit a medical mobile solution for the competition, go to http://www.medica.de/mac2. View last year’s winners: https://medtechintelligence.com/news_article/medicas-medical-mobile-app-competition-winners-announced/  …

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

What, No Inspection Results?

By Dr. Christopher Joseph Devine

…as required by 21 CFR 820.80(a). For example, a review of acceptance testing performed at your facility revealed the following inconsistencies: Material inspection reports for three components were reviewed during…

…as required by 21 CFR 820.80(a). For example, a review of acceptance testing performed at your facility revealed the following inconsistencies: Material inspection reports for three components were reviewed during…

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Abbott

Abbott Initiates Voluntary Recall of Coronary Catheters

By MedTech Intelligence Staff

…the protective balloon sheath. This issue can cause problems in inflating or deflating the balloon, potentially leading to complications that include air embolism, additional intervention, thrombosis and myocardial infarction. According…

…the protective balloon sheath. This issue can cause problems in inflating or deflating the balloon, potentially leading to complications that include air embolism, additional intervention, thrombosis and myocardial infarction. According…

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magnifying glass

Scoping Out the Market

By Robert Kaminsky

…medical device company also sought to determine how its corporate brand compared to that of its competitors as perceived by hospital-based value analysis committees. A market research-based analysis yielded the…

…medical device company also sought to determine how its corporate brand compared to that of its competitors as perceived by hospital-based value analysis committees. A market research-based analysis yielded the…

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handcuffs, guilty

Former Lutonix Exec Pleads Guilty to Stealing Trade Secrets

By MedTech Intelligence Staff

…numerous trade secret files belonging to the company so that he could utilize the proprietary information in connection with his next job. During his employment with Urotronic, Barry transferred the…

…numerous trade secret files belonging to the company so that he could utilize the proprietary information in connection with his next job. During his employment with Urotronic, Barry transferred the…

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Ameing for Asia

Chinese Investment in U.S. Medtech Companies

By Ames Gross

…between Chinese investors and U.S. healthcare companies, including more than 20 in 2016. There are several reasons for the high amounts of Chinese investment in U.S. companies, particularly medical device…

…between Chinese investors and U.S. healthcare companies, including more than 20 in 2016. There are several reasons for the high amounts of Chinese investment in U.S. companies, particularly medical device…

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Scott Gottlieb, FDA

Scott Gottlieb Confirmed as FDA Commissioner

By MedTech Intelligence Staff

Yesterday Scott Gottlieb, M.D., President Trump’s nominee who has been criticized for his ties to the pharmaceutical industry, was confirmed by the Senate to lead FDA as its next commissioner….

Yesterday Scott Gottlieb, M.D., President Trump’s nominee who has been criticized for his ties to the pharmaceutical industry, was confirmed by the Senate to lead FDA as its next commissioner….

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Hospitals, recalls

How Do Providers Handle Device Recalls?

By Maria Fontanazza

When a product recall occurs, the communication between the device company and the hospital needs to be prompt, well structured and involve all the relevant stakeholders. Hospitals are generally notified…

When a product recall occurs, the communication between the device company and the hospital needs to be prompt, well structured and involve all the relevant stakeholders. Hospitals are generally notified…

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

Customer Complaints: 1,385 and Counting!

By Dr. Christopher Joseph Devine

…agency warning letter. Obviously, having a great complaint management system is not a panacea(look-it-up) for all that ails a less than compliant quality management system (QMS). However, effective complaint management…

…agency warning letter. Obviously, having a great complaint management system is not a panacea(look-it-up) for all that ails a less than compliant quality management system (QMS). However, effective complaint management…

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