3D Inspection Solutions

Evolve achieves ‘extraordinary’ result in FDA’s MDDAP

Evolve Manufacturing Technologies has scored a near-perfect score on the FDA’s Medical Device Discovery Appraisal Program (MDDAP).

Evolve Manufacturing has scored an incredible 89 out of 90 on the FDA’s Medical Device Discovery Appraisal Program. This is “extraordinary,” according to independent Lead Appraiser, Michael West. Evolve will now receive a guaranteed five-day turnaround for on-site change submissions – a significant calendar saving for product delivery.

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What is the FDA’s MDDAP?

Essentially, the FDA found that it’s traditional means of auditing was not effective enough.  So, it developed a model where companies adopt best practices into their processes to create higher quality medical devices. The Medical Device Discovery Appraisal Program (MDDAP) helps medical device manufacturers better understand, measure, and improve their capabilities.

Evolve Manufacturing – ‘Extraordinary’

It (Evolve’s score) was extraordinary because they didn’t really have that much knowledge of what the CMMI was or what the practices were. So, what that tells you is that they were naturally and continuously improving their processes.

Michael West

I’ve done many, many appraisals. That was the very first in Year One in this program that I’ve seen a score that high.

Michael West

In addition to the criteria Michael was appraising, he made a special note about Evolve’s culture. The team exemplified the values that proudly sit on the walls of the facility. It was apparent that Evolve always had a culture for continuous improvement and that was reflective of Noreen King (CEO) and Matt Pawluk’s (Sr Director of Operations) leadership.

What does Evolve do so well?

One example that impressed Michael was in the Materials Inspection area. Where Evolve’s team are intaking new sub-components or parts coming from a vendor or a supplier, it can take a human being days many days to measure down to the micron level and make sure that part is meeting the specifications. However, Evolve invested in a sixty thousand dollar machine that, in seconds, can take hundreds of three-dimensional measurements – shortening a three-day receiving inspection down to just seconds.

Why is the MDDAP so important?

There are a number of real-world benefits of adopting the Capability Maturity Model Integration (CMMI). For Evolve, participation in this program ensures they can use the framework of the CMMI to continually evaluate processes, technology, skill-sets and continuously improve using this globally proven model of best practices.

Organizations that are not part of the program can expect a 30-day turnaround on the approval when they do a site change submission to the FDA. Under this program Evolve receives a guaranteed five-day turnaround on chain site change submissions, which is a significant calendar saving.

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