Ask the Engineer

Micro Molding – It’s Not Just About the Size

By Sangita Viswanathan

Micro molding is has been debated over last number of years, and while size certainly plays a part in defining what it is, other aspects like precision, complexity and details involved are more the drivers for micromolding techniques.

Micro molding is has been debated over last number of years, and while size certainly plays a part in defining what it is, other aspects like precision, complexity and details involved are more the drivers for micromolding techniques.

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

Who Wants Clean Air and Water?

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

The QSR does not dictate how to execute a Receiving Inspection program; it only stipulates that purchased materials must be assessed for their suitability to be used in the manufacture of medical devices that are safe and effective in their intended use. It is up to the establishment to define their approach to RI.

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Ask the Engineer

Accelerating Device Development Against Current Product Development, Regulatory Landscape

By Sangita Viswanathan

“If you are doing a wound care dressing, what is unique about the product, what are you doing differently than what is already in the market, what is it intended to be used for, who is using it, and where is it being used… All of these pieces of information help you decide how to proceed.” – Jeff Kaminski , President of MBK Tape Solutions. Excerpts from an interview.

“If you are doing a wound care dressing, what is unique about the product, what are you doing differently than what is already in the market, what is it intended to be used for, who is using it, and where is it being used… All of these pieces of information help you decide how to proceed.” – Jeff Kaminski , President of MBK Tape Solutions. Excerpts from an interview.

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Reimbursement Report

The Appeals Process

By Elizabeth Brown, MD

Presenting clinical evidence to payers is the most efficient method of gaining coverage. But when this strategy is unsuccessful or hits a wall, a ground-up approach is required, relying on consistent and steady support from local physician champions that demonstrates broad acceptance of a technology.

Presenting clinical evidence to payers is the most efficient method of gaining coverage. But when this strategy is unsuccessful or hits a wall, a ground-up approach is required, relying on consistent and steady support from local physician champions that demonstrates broad acceptance of a technology.

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

The Training Tradeoff – Trained Employees that Leave versus Untrained Employees that Remain

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

One concern we frequently hear is absorbing the expense associated with training and then key employees departing the organization for greener pastures after their training has been completed. But what about the costs associated with mistakes and errors employees make, when employees are not properly trained and decide to stick around?

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Tom Weaver, President, Weaver Consulting
CAPA Corner

Mistake Proofing

By Tom Weaver, Rob Weaver
Tom Weaver, President, Weaver Consulting

Mistake proofing is used in product, process, and service design and development as well as in ongoing operations and improvement applications. The goal with mistake-proofing is to find and correct mistakes, errors, or omissions as close to the source as possible, when the mistakes cost less to correct than if found later.

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