What are the shortcomings, obstacles, and challenges when it comes to quality? Are there opportunities for improvement (OFIs) for quality? The regulatory and quality landscapes within the medical device industry can always do better through continuous improvement.

In this episode of the Global Medical Device Podcast host Jon Speer talks to Mike Drues with Vascular Sciences about quality. Practice what they preach!

Jon and Mike share tips on what you can do to improve upon your medical device company’s quality philosophy to ensure that true quality becomes a part of your company’s culture.

Some of the highlights of this episode include:

Quality is an ambiguous and esoteric word. To most, it means how good or bad something is, which leads to oversimplification and subjectivity.
If you cannot measure quality, then you cannot improve it. For quality to be meaningful, it must be defined in less subjective terms, made to be objective, and needs to be measured.
In the regulatory and FDA space, quality is not about good or bad, but about consistency. A company can make a consistently good or bad product.
The difference between product and process quality depends on understanding acceptance criteria, levels, and specifications involved that need to be followed.
Not whom but what is ultimately responsible for quality? Consistency. Appreciate what the word ‘quality’ means and whether what you’re doing is good or bad.
Quality management systems (QMS) shouldn’t emphasize checking all boxes to be in compliance, but describe how business is done and how KPIs, objectives, and criteria are measured to demonstrate quality at process/product levels.

Memorable quotes from this episode:

“The problem I have with that simple explanation is there’s subjectivity involved to that, right? What you think is good or bad, might be completely different to what I think is good or bad.” Jon Speer

“For quality to be meaningful, it’s something we have to define in as least subjective terms as we possibly can. We need to make it as objective as we can, but I think we need to measure it to determine whether or not we are actually meeting our definition of quality, whatever that might be.” Jon Speer

“Quality is not about good or bad. Quality in the regulatory sense is about consistency.” Mike Drues

“From the product perspective, does it work or not? Does it perform as expected? That may be a little bit outside the domain of the quality professional.” Jon Speer

“You have culpability and responsibility for quality at some level. It sounds cliche, but I think everyone in the organization should have that opportunity to influence or be a part of quality and influence the decisions that are made.” Jon Speer

Links:

A Regulatory Gap Analysis of FDA's Systems & Policies

Ultimate Guide to 21 CFR Part 820

ISO 13485

FDA - Classify Your Medical Device

FDA - Premarket Notification 510(k)

FDA - De Novo...

What are the Opportunities for Improvement (OFI) for Quality?

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