Ask the Engineer

Ask the Expert: Home Use Devices and Sterilization

The way in which we deliver healthcare is changing rapidly. Technology and rapid adoption is enabling device and tech manufacturers to develop products that move the delivery of care away from the clinical environment. Having the option to stay out of hospitals could be extremely important from both a financial standpoint as well as a health perspective, and could essentially help low-risk patients avoid exposure to viruses. Our experts today provide information regarding the regulatory requirements for …

The way in which we deliver healthcare is changing rapidly. Technology and rapid adoption is enabling device and tech manufacturers to develop products that move the delivery of care away from the clinical environment. Having the option to stay out of hospitals could be extremely important from both a financial standpoint as well as a health perspective, and could essentially help low-risk patients avoid exposure to viruses. Our experts today provide information regarding the regulatory requirements for …

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Reimbursement Report

HCT/P Regulation and Third-Party Reimbursement

By Elizabeth Brown, MD

Comprehensive and unwieldy payer policies for wound care, the tiered system of FDA regulation of human cells, tissues, and cellular and tissue-based products, and the use of brand specific names in HCPCS coding have created a challenging reimbursement environment.

Comprehensive and unwieldy payer policies for wound care, the tiered system of FDA regulation of human cells, tissues, and cellular and tissue-based products, and the use of brand specific names in HCPCS coding have created a challenging reimbursement environment.

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Tips to Consider When Selecting a Contract Manufacturer

To ensure that you are choosing the contracting partner that will help carry both parties into the earning margins desired – it is essential that a set of criteria is used to establish the perimeters for how to choose that partner, including the specifics of what things to look for.

To ensure that you are choosing the contracting partner that will help carry both parties into the earning margins desired – it is essential that a set of criteria is used to establish the perimeters for how to choose that partner, including the specifics of what things to look for.

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Ask the Engineer

Ask the Expert: Device Electrical and Mechanical Safety

With the publication of IEC 60601 3rd edition, manufacturers have been scrambling to meet EU and Canadian deadlines and formally incorporate a risk management process in the quality management systems. Device electrical and mechanical safety continues to be a critical path on the road to regulatory approvals and ongoing compliance.

With the publication of IEC 60601 3rd edition, manufacturers have been scrambling to meet EU and Canadian deadlines and formally incorporate a risk management process in the quality management systems. Device electrical and mechanical safety continues to be a critical path on the road to regulatory approvals and ongoing compliance.

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4 QFD Tips for Emerging Medical Device Technology

Defiant minds can conceptualize embodiment that customers actually want. But determining methods to best define what the customer wants with novel technologies can be challenging as many of the methods published just don’t fit early stage work. How can we then manage the process of quality function deployment?

Defiant minds can conceptualize embodiment that customers actually want. But determining methods to best define what the customer wants with novel technologies can be challenging as many of the methods published just don’t fit early stage work. How can we then manage the process of quality function deployment?

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Ameing for Asia

3 Tips for Building Strong Business Relationships in Asia

By Ames Gross

A good understanding of and appreciation for Asian cultural traits is essential to building strong relationships with Asian executives. Business in Asia will be more likely to thrive if a Western medical device executive is able to overcome these challenges.

A good understanding of and appreciation for Asian cultural traits is essential to building strong relationships with Asian executives. Business in Asia will be more likely to thrive if a Western medical device executive is able to overcome these challenges.

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