magnifying glass

Scoping Out the Market

By Robert Kaminsky

…200 customers while developing a new product. Some of those conversations come through advisory boards and one-on-one discussions. Other interactions come through well-designed, cost-effective market research. Market Research Objectives Through…

…200 customers while developing a new product. Some of those conversations come through advisory boards and one-on-one discussions. Other interactions come through well-designed, cost-effective market research. Market Research Objectives Through…

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handcuffs, guilty

Former Lutonix Exec Pleads Guilty to Stealing Trade Secrets

By MedTech Intelligence Staff

…from the company. The Department of Justice (DOJ) announced the guilty plea on Tuesday. The case came to light following an investigation by the FBI, the criminal investigation division of…

…from the company. The Department of Justice (DOJ) announced the guilty plea on Tuesday. The case came to light following an investigation by the FBI, the criminal investigation division of…

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Ameing for Asia

Chinese Investment in U.S. Medtech Companies

By Ames Gross

…capital firm of Wuxi Pharmatech, a Chinese research and development services company, also targets investments in U.S. and Chinese healthcare companies. In 2015, Wuxi Ventures led the $42 million round…

…capital firm of Wuxi Pharmatech, a Chinese research and development services company, also targets investments in U.S. and Chinese healthcare companies. In 2015, Wuxi Ventures led the $42 million round…

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Scott Gottlieb, FDA

Scott Gottlieb Confirmed as FDA Commissioner

By MedTech Intelligence Staff

…– HHS Secretary Tom Price, M.D. AdvaMed praised the confirmation, citing Gottlieb’s qualifications due to experience at FDA and CMS. The association will work with the new commissioner on key…

…– HHS Secretary Tom Price, M.D. AdvaMed praised the confirmation, citing Gottlieb’s qualifications due to experience at FDA and CMS. The association will work with the new commissioner on key…

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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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3-D printed hip implant, electron beam melting technique

Medical Device Developmentā€™s Use of 3-D Printing: Applications and Common Processes

By Nathan MĆ¼ller

…major component of medical device development. Examples of when traditional methods of fabrication cause issues include the coolant ingress into material—take the machining of parts via CNC, for example, using…

…major component of medical device development. Examples of when traditional methods of fabrication cause issues include the coolant ingress into material—take the machining of parts via CNC, for example, using…

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Medical device recall

Modern Medicine: Managing Lithium-Ion Battery Recalls in Medical Devices

By Chris Harvey

…as well. Any time a recall crosses international boundaries, the complexity is compounded. That is especially true in the already complex case of lithium-ion batteries. Globally, organizations involved include the…

…as well. Any time a recall crosses international boundaries, the complexity is compounded. That is especially true in the already complex case of lithium-ion batteries. Globally, organizations involved include the…

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Dollar, money

North American TKR Market To Surpass $4 Billion by 2023

By MedTech Intelligence Staff

…according to a new report from GlobalData. Areas of potential development include investment in robotic technology, as it has been shown to provide consistent implant placement, it results in less…

…according to a new report from GlobalData. Areas of potential development include investment in robotic technology, as it has been shown to provide consistent implant placement, it results in less…

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Medtech question

Answers: Test Your ISO 13485 IQ Part II

By MedTech Intelligence Staff

…to ISO 13485 cannot claim conformity to ISO 9001 unless their quality management system meets all the requirements of ISO 9001. To be compliant with ISO 13485, purchased product from…

…to ISO 13485 cannot claim conformity to ISO 9001 unless their quality management system meets all the requirements of ISO 9001. To be compliant with ISO 13485, purchased product from…

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