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

Maybe 13 is an Unlucky Number

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

In the United States, to manufacture and/or enter devices into commerce, device establishments are expected to have written procedures that are fully implemented and in compliance with the QSR and subsidiary regulations. Do not be that organization that receives 13 Form 483 observations because procedures have not been established.

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Reimbursement Report

Minimally Invasive Procedures

By Elizabeth Brown, MD

Ever since the advent of laparoscopic surgery some 25 years ago, payers have become wary of minimally invasive surgery. What should device manufacturers do?

Ever since the advent of laparoscopic surgery some 25 years ago, payers have become wary of minimally invasive surgery. What should device manufacturers do?

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Reimbursement Report

Let’s Start at the Very Beginning

No matter how tortuous the path to durable coverage and adequate payment for a new technology, the bedrock of the entire reimbursement process relies on the clinical evidence of safety and effectiveness. This inaugural blog post is the first in a series focused on the key reimbursement issues in this fluid health care environment.

No matter how tortuous the path to durable coverage and adequate payment for a new technology, the bedrock of the entire reimbursement process relies on the clinical evidence of safety and effectiveness. This inaugural blog post is the first in a series focused on the key reimbursement issues in this fluid health care environment.

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

Data Falsification

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

Whenever phrases such as “data falsification” are referenced by FDA in a warning, the offending organization will probably become familiar with the acronym DOJ, as in investigation. Falsifying data that may have resulted in the overall compromising of product safety and efficacy is a serious accusation.

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