Ask the Engineer

Ask the Expert : Overcoming Barriers to Improvement

As medical device complexity grows, the product development process often needs to improve in order to maintain device quality and safety, foster innovation, and reduce costs. Yet teams looking to make improvements often encounter resistance from management. This Ask the Expert focuses on how you can overcome barriers to improving the medical device development process.

As medical device complexity grows, the product development process often needs to improve in order to maintain device quality and safety, foster innovation, and reduce costs. Yet teams looking to make improvements often encounter resistance from management. This Ask the Expert focuses on how you can overcome barriers to improving the medical device development process.

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

Reprocessing Warning

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

As FDA recommended in its comments to healthcare, it is imperative that providers inform their patients of all risks. However, it is incumbent upon patients to become knowledgeable consumers and ask questions about any procedure they are being exposed to, including the use of instruments that may have been reprocessed.

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MEDdesign

Design Considerations for Multi-Material Molding of Thermoplastic Elastomers

By Terri Marion

Multi-material molding, a process whereby at least one melt processible material is bonded with at least one other material to produce a single, molded component, allows designers to optimize material properties and costs, eliminate assembly processes, and even invent ground-breaking products that could not be manufactured otherwise.

Multi-material molding, a process whereby at least one melt processible material is bonded with at least one other material to produce a single, molded component, allows designers to optimize material properties and costs, eliminate assembly processes, and even invent ground-breaking products that could not be manufactured otherwise.

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Reimbursement Report

A Major National Health Plan Medical Director Shares Insights on How Coverage Decisions are Made

By Jessica Holmes

This Q&A session, with an active Regional Medical Director involved in traditional health plan policy and payment development, as well as emerging value-based models, reveals important information and attitudes toward coverage of new/existing technologies and standards of evidence.

This Q&A session, with an active Regional Medical Director involved in traditional health plan policy and payment development, as well as emerging value-based models, reveals important information and attitudes toward coverage of new/existing technologies and standards of evidence.

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How Good is Good Enough? The Importance of Medical Device Performance Specifications

Telling the parent their child has a temperature of 38.674 °C may be an impressive engineering feat, but the last two digits have no real value and any time spent in development getting there was misspent.

Telling the parent their child has a temperature of 38.674 °C may be an impressive engineering feat, but the last two digits have no real value and any time spent in development getting there was misspent.

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Ameing for Asia

Understanding Asian Cultural Issues is Essential to Success in Asia

By Ames Gross

While a better understanding of Asian cultural issues is crucial, it is also important to realize that in the end, people are people, and everyone around the world shares common goals and desires such as job promotions, higher salaries, and a happy family life. If Western executives keep this point in mind, and have a good grasp of Asian cultural issues, their businesses in Asia will be much more likely to succeed.

While a better understanding of Asian cultural issues is crucial, it is also important to realize that in the end, people are people, and everyone around the world shares common goals and desires such as job promotions, higher salaries, and a happy family life. If Western executives keep this point in mind, and have a good grasp of Asian cultural issues, their businesses in Asia will be much more likely to succeed.

Continue reading →