In this episode of the Global Medical Device Podcast Etienne Nichols talks to Patrick Hayes, Associate Director of Program and Project Management at Commissioning Agents (CAI), about how to achieve operational readiness in a manufacturing setting.

CAI is a professional service provider that helps medical device companies get their quality products to market through operational readiness. The company provides expertise to get products out the door and qualified in a safe, effective, and cost-efficient manner.

Some of the highlights of this episode include:

CAI utilizes integrative services to identify clients’ needs to achieve operational readiness. Then, operational excellence is the end goal.
Most CAI agents are Project Management Professional (PMP) qualified through Project Management Institute (PMI). Patrick encourages and recommends people to attain PMP certification to enhance their degree of success.
Patrick describes the steps of a solid project management process. It includes planning, integration, and execution.
The earned value calculation is where every action item is shown a direct correlation to the amount of money spent. Basically, you are getting more or equal to what you paid.
If a small company with 2-5 employees is not ready to use or formalize a project management process, Patrick advises people to invest in education and training.
The project manager is a hub of communication. Always keep everything accurate to create a sense of security for having everything that will be needed.

Memorable quotes from Patrick Hayes:

“Everybody strives for operational excellence, but yes, a strong package with operational readiness is the key.”

“In a project, especially with startups, I’d say there’s no such thing as over communicating.”

“Anything in the medical device industry directly affects, correlates, and supports the public. It’s a huge market and it’s a very important market.”

“Never make any shortcuts to your quality.”

Links:

Patrick Hayes on LinkedIn

CAI

South Carolina Bio Conference (SCBio)

FDA - Medical Device Overview

Project Management Institute (PMI)

PMP Certification

PMI - Roles, Responsibilities, and Resources (Responsible, Accountable, Consulted, and Informed - RACI Chart)

Earned Value Calculation

LinkedIn Learning

True Quality 2022

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru Academy

Greenlight Guru

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