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

Quality Audits

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

The Food and Drug Administration (FDA) will evaluate the effectiveness of your internal quality audits and review the corrective actions pursued as part of the overall quality audit system. If a nefarious approach to executing quality audits is pursued, the reward will be a Form 483. If the FDA feels the violation is egregious, a warning letter will be forthcoming. In monopoly speak, “do not pass go and do not collect your two hundred dollars.” Warning letter violations As you can see by the abundance o…

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

Management Responsibility

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

I begin this edition of Devine Guidance  (DG) by reinforcing the importance of DG Rule #1 – Compliance to regulations is not optional, compliance is mandatory and dictated by law. In my belief, management responsibility is what the doctor likes to call the “catch-all requirement.” What does that mean Dr. D? Simply put, if your organization fails to comply with any part of the QSR, rest assured, the reward will be in the form of a Form 483 for the specific transgression, by the agency. Additionally,…

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

Nonconforming Products

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

In a perfect world, there would never be a need to handle non-conformances from your supplier base. However, the world of medical device manufacturing is far from perfect (please do not tell the regulators). You may call it fate, destiny, or bad luck, but Dr. D. calls it problem suppliers. Rest assured some of your suppliers will eventually deliver nonconforming product and at some point in the not-so-distant future, I will address managing nonconforming products as a whole. Warning letter violation Vio…

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

Purchasing Controls

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

Over the past two months, Dr. D has focused on supplier management from a quality and regulatory perspective. However, the successful execution of a well-defined supplier-management system, and the overall organizational success within the medical device industry, is premised on a strong cross-functional approach to quality. It takes a collegium (may need to look it up) of dedicated professionals, in multi-functional roles, to ensure all aspects of the supplier management system function efficiently. In…

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Jeff Wickham, P.E. is the Principal at LifeHope Medical, Inc.
Ask the Engineer

Two Discussions on Electromagnetic Materials and Sealing Medical Gases

By Jeff Wickham, P.E.
Jeff Wickham, P.E. is the Principal at LifeHope Medical, Inc.

Q: What are the best materials for electromagnetic applications? A: This depends on the application, and on factors such as the performance, cost and specific geometry. Electromagnetic materials are commonly compared using B-H curves (B stands for induction and H for magnetizing force), which are basically a plot of how much magnetic flux a material will carry versus the intensity of the magnetic field. This can be experimentally seen by using an electromagnet and observing how strong…

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Jeff Wickham, P.E. is the Principal at LifeHope Medical, Inc.
Ask the Engineer

Two Discussions on Cantilevered Snap Fit and Calculating Max Shear Stress

By Jeff Wickham, P.E.
Jeff Wickham, P.E. is the Principal at LifeHope Medical, Inc.

Q: I designed a cantilevered snap fit that extended as a continuation of a wall, but some of the prototypes cracked at the snap finger barb. Usually, the highest stresses are at the base of the cantilever. So why did the snap finger crack where it did? A: The snap finger would likely have cracked at its base if it were extending from a flat surface rather than as a continuation of a wall.  In this case, because it was extending from a wall there was no stress concentration at the base,…

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

Supplier Maintenance Assessments

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

If a supplier scored well on their original selection assessment, or scores well on repeat maintenance assessments—say, a score of 90 percent or above for argumentative sake—and your organization is receiving 100 percent conforming product (yes, imagine a perfect world), what is the value of performing an annual or regularly scheduled maintenance assessment? Dr. D does not see any upside. Now I could write a philippic (yep, look up time again) that takes medical device organizations to task in regards t…

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Jeff Wickham, P.E. is the Principal at LifeHope Medical, Inc.
Ask the Engineer

Three Discussions on Bonding a nylon component to an SLA part, First production run of an impeller assembly, and Plastic part with bosses for screws

By Jeff Wickham, P.E.
Jeff Wickham, P.E. is the Principal at LifeHope Medical, Inc.

Q: I tried to bond a nylon component to an SLA part, but the adhesive easily peeled off of the nylon even though I used what I thought was a very good adhesive. Any recommendations on how to get these parts bonded together? A: Plastics have different characteristics based on whether their material structure is semi-crystalline or amorphous. Plastics are composed of long polymer chains. In an amorphous structure these polymer chains are tangled together like a plate of spaghetti noodles. Typical ex…

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

Supplier Metrics

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

To ensure supplier surprises are kept to a bare minimum, an organization cannot simply rely on thaumaturgy (go ahead and look it up). Supplier performance must be continuously gauged for effectiveness, and a feedback loop created to ensure suppliers are receiving accurate information in regards to their overall performance. Additionally, supplier performance metrics should be included into your management review process. Management must be informed of parlous issues that can result in the need for field…

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