Achieving Operational Readiness through Good Project Management

April 27, 2022

256 GMDP-header

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.



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Some 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.


Patrick Hayes on LinkedIn


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


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.”



Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Etienne Nichols: Hey, everyone. Today, we have something a little bit different. We recorded at the South Carolina Bio Conference. The subject we're talking about today is project management and how to achieve operational readiness in the manufacturing setting. Today, we're going to be talking with Patrick Hayes, who's the Associate Director of Program and Project Management at CAI. CAI is a company that works to help medical devices, or medical device companies get to market and have their operational readiness. That's the phrase that we hear a couple times, but essentially, it's making sure that all of the products, all of the lean manufacturing, supply chain management, the planning, the international training, all of those sustaining items are in place so that when you get to market, you can be confident that you have a quality product. It's an interesting conversation. What you'll notice, though, is we have a lot of background noise. We have some different things going on. So curious what you guys think as far as this format, this style. It's a little bit different than what we have done. But I'll quit rambling and let you get to the episode. Hey, everyone. Welcome back to the Global Medical Device Podcast. This is an episode coming from South Carolina, the SCBIO Conference. And with me today is Patrick Hayes. He is the Associate Director of the Program and Project Management portion of CAI. And maybe we could talk a little bit about what CAI is. Do you want to give us a spiel as to what you guys do?

Patrick Hayes: Yeah, absolutely. Thank you, and thanks for having me.

Etienne Nichols: Yeah.

Patrick Hayes: I appreciate the opportunity to speak. CAI, we are a professional engineering operations quality. We call ourselves a professional service provider. We specialize in everything from... Say, if you look at the concept from breaking ground on a new facility, all the way to product out the door. We can provide expertise for speed of the patient, to get the product out and qualified in a safe, effective, and cost efficient manner.

Etienne Nichols: So I attended one of your, well, I guess you are... Well, I keep wanting to say episode, but it's not episode. It was a session.

Patrick Hayes: The speaking session, the presentation. Yeah. Right on.

Etienne Nichols: On operational excellence.

Patrick Hayes: Yes.

Etienne Nichols: And from what I gathered, it looks like, and please correct me if I'm wrong, fill in gaps, but you guys provide project management, but not just project management, you fill in any gaps that a manufacturer may have.

Patrick Hayes: Yes.

Etienne Nichols: Staffing.

Patrick Hayes: We use-

Etienne Nichols: Go ahead.

Patrick Hayes: Absolutely. We use the term integrated services. So as we identify client, the first thing in layman's terms, I'd say," Okay, well, what are your needs? What is keeping you from achieving operational readiness?" Which can't be confused with operational excellence, because that's the final goal. If you look at the Olympics, operational readiness is the silver. Operational excellence is getting the gold. So everybody strives for operational excellence, but a strong package with operational readiness is the key. You mentioned project management. As you lay out the needs, as you create the project charter, and you do the needs assessment of the client, we can tailor that to say," Hey, if it's regulatory within quality to where you're looking to do a FDA filing and you just don't have it, or if you go from a paper based to electronic based quality system, we could help validate that. Or if you just need to bring in a new line of equipment, we can validate and commission that equipment." So basically, we are a tailored service to a client, and we've been doing it for about 20, 25 years now.

Etienne Nichols: Awesome. So you probably know what you're doing by now, I'm guessing

Patrick Hayes: I'd like to think so. We have a great team. And the beauty in CAI, and CAI stands for Commissioning Agents. In the beginning, we started with commissioning quality and validation. And that's still a good portion of our business, but now we're, like I said, we're branching in operational readiness and going into large emphasis program and project management.

Etienne Nichols: Yeah. So the majority of our audience is medical device professionals. There may be early stage companies that are working towards, like you said, that regulatory filing or trying to get their products scaled up to manufacturability and so forth, commercialization. You guys can help them from a lot of different facets. So I just want to put that out there just to connect the dots there. But one other thing that I wanted to talk to you about, maybe we can get a little bit more specific, is about the actual project management, the actual program management. Because as I said, these are a lot of times early stage companies that maybe they don't have a PMO and maybe they can't afford a PMO. What advice can you give them and what are your thoughts?

Patrick Hayes: So my thoughts are, first, I come from medical device. I was Vice President of Operations at a medical device plant in Auburn, Alabama. I was one of the guys that you're talking about, you're referring to. And like I said, it's a host of things. So some companies don't have a lot of PMO office. Some people treat it as it's a collateral duty. Because you're running the plant, or idled equipment. You're at a presentation today. Idled equipment is not beneficial to anyone. So a lot of people focus on that, and you have all these hurdles and you have these challenges. And especially with startups, you're trying to get the most for the time. And most of the time, it's like you're drinking out of a fire hose. So my advice for my recommendation, what I've seen in the past is have a conversation. And the sooner we can have that, we would be able to have that conversation and do an assessment to identify your needs. You might not need everything, but usually, if you can get ahead of it, speed to patient, and what we call vertical startups. So in the beginning with startups, you go from a slow walk to maybe a faster walk. Or sometimes, you go from a walk to a run. And with that, you climb significantly to where... And that's fine if you can have the predictive steps along the way to get you to where you're not having to go backwards. So my advice is everything, we follow a PMI, we're a partner with them.

Etienne Nichols: And just so people know, Project Management-

Patrick Hayes: Project Management Institute. A lot of our agents, a lot of our project managers are PMP qualified, which is a course in a professional qualification within PMI. The training is great, because it's a very integrated approach, step- by- step approach to where you can tailor it to your needs. And it just enhances your degree of success.

Etienne Nichols: Well, let's talk about that. I actually have a PMP certification myself.

Patrick Hayes: Not an easy process, right?

Etienne Nichols: No, it's not easy.

Patrick Hayes: It is not an easy process.

Etienne Nichols: That 4, 500 hours or depending on what route you take, project management is tough. Now, I'm a little bit embarrassed to admit this, but some of the real things that they teach might have drained out my ears a little bit. So what does that process look like? A good, solid project management process?

Patrick Hayes: And there's steps to it. And I don't want to take up all the time. But it's pretty much planning, integration, and then execution. Getting a solid planning for it here at the voice of the customer, come up with a project charter, called a RACI. And it means, reportable, accountable, or even just informed.

Etienne Nichols: Yeah. The RACI being who-

Patrick Hayes: Who are your critical team players? And who just needs to be informed? And all it is communication and a hierarchy of, who would the project manager go to get the end result? So if you start out with your project charter, identify the scope of work, identify what your client needs and expectations, and have buy- in from the client or the stakeholder, which is huge, and then come up with a RACI and come up with a thorough action plan, which with any project, it's going to change. People come, people go, then some things go faster. Some things go slower. I mean, right now with some supply chain, it's a lot of issues. But if you follow the steps, you follow a strong project charter, strong RACI and a communication plant. And then what I tell people, I just wrote a white paper on communications and then also sphere of influence within the project manager. If you go in and... I say overcommunicate, I mean, a lot of people don't like to bother people. In a project, especially with startups, I'd say there's no such thing as overcommunicate. So I think that's... I know I'm rambling, but-

Etienne Nichols: No, this is good.

Patrick Hayes: I believe in the PMP process if you come in with the fundamentals. And that's what we do, we bring that to market where we are, I'd say we're experts in coming in and making a package to where, even if the project manager's not there, a designant could follow the step- by- step process to go forward and within efficient, and also what we call earned value. Meaning every action item that we do within our project, we show a direct correlation to the amount of money or budget to where we actually show the amount of money that we put towards it. And if we're in a positive, negative to where we can assess within our budget to show. And that's what's earned value, where we show it's pretty much getting more or equal to what you pay for.

Etienne Nichols: Yeah. That earned value calculation can trip some people up, but it really is worth looking at. So I'll try to link something in our show notes so you can maybe get a little bit more information there, but you mentioned something that made me think about communication. The project manager really is a hub of communication. That's who and what that person should be. Now, that being said, some of the people listening that maybe you're a company of two people, five people, or whatever, and you think," Eh, do we need to formalize this process?" So what I want to ask you, maybe a company's not ready to use, whether financially or resource, whatever. They're not there yet. And obviously, maybe down the road, they're going to utilize you guys. But what about right now? What would you say to a company that's only two to five people that can prepare them in the future to not have to have that remediation process?

Patrick Hayes: Okay. So yeah. So just in general, say, if I go out and I want to start up a company, entrepreneurial, and I have no background in project management, which in my turn would be like," I need you to draw engineering designs for construction." That would be what it would be equal to. I don't have a lot of background in that. But what you can do, one, invest in a little bit of education. A lot of the education is free. Not everyone has to go through PMP, but a lot of the training and a lot of the offerings out there are very similar within it. So LinkedIn Learning's an amazing training platform, their LMS site. A lot of project management. You can get a thorough understanding of how to run a project by LinkedIn Learning. And honestly, I've got, this is about 25 years I've been involved in it. I still find good takeaways from just refreshing. Because like you said, if you don't use it, you lose it. Or you probably remember a lot of it, but it's got to have something to jog your memory. So LinkedIn Learning's good. Even if you're not a member PMI, you can go on to pmi. org and you can get a lot of their white papers where you can read material. And a lot of it will link directly to what you're trying to do. I guarantee you can find something that tailors to your situation. But I will say, don't go it alone. Don't just go off," Hey, you know what? I'm in it and I'll fake it until I make it." It doesn't work.

Etienne Nichols: So, and while we're at it, while we're talking about some of those different ways of learning things, I definitely recommend you all listen and check out the Greenlight Guru Academy. So we actually do have a paid course for project management for medical devices.

Patrick Hayes: That's awesome right there. That's something I'm going to be looking at.

Etienne Nichols: Yeah. We'll put a link in the notes as well. What are some challenges? Maybe you've seen medical devices, it's a regulated industry, heavily regulated. A lot of complexity. What are some challenges, or can you think of any specific challenges that we would need to overcome as medical device professionals with project management?

Patrick Hayes: I think, and I'm looking back to my time working in med device. Everyone's in a hurry to bring that to market. Everyone's in a hurry to get a speed to patient because, face it. In med device, anything in a medical device industry directly affects, correlates, and supports of the public. So it's a huge market and it's a very important market, in my opinion. Most of my life takeaways to where I really felt accomplished to where I felt like I was really contributing to society was in the medical device field. I do that now still, because I'm dealing with a host of clients, but I really felt like a tribute because I was fighting that fight during COVID when it was an unknown and ramping up. I would say that the challenges are, one, never make any shortcuts to your quality. Meaning, I know speed to market is huge. Getting it to the patient's huge, and the orders come in and you have to provide it. Because customers' people are waiting on the vial, they're waiting on the syringe, they're waiting on the tube to go into the device. That's always a big thing. I would never shortcut your initial qualifications, your performance qualifications. You need to follow the processes with that. Secondly, I would say that positions. You hear about their great resignation right now. And based on what you read, I'm still not fully understanding that one. But oftentimes, I think right now, we're trying to place people in positions. And sometimes, it's by necessity. Meaning you have an engineer that now, you do the cross." Hey, you're now my project manager." And you know what? Some people rallied. They like the challenge. They like the pressure and they do great. I come from a family of engineers. So my firm belief is my father, which was in engineering for 40 years, I believe the man could do anything. He could probably be an astronaut if he wanted to be. But understand the audience. Understand what the job and what you're asking people to do. And if you're going to ask them to do something outside of their normal job duties, provide them the chance to digest it and provide them the chance to get some training. And then I think at the end, I'd say the main thing is I think we fall short, and when I say" we," it's just based on my, including me, in the past and other customers, I think we fall short on our manufacturing process, meaning we don't provide a lot of time for training. We don't provide a lot of time for SO to make sure our SOPs are up to date and make sure then our job are on the job training documents, our job checklists are matching the SOPs. Are we doing our revisions? Are we doing our updates? Are we communicating it down? So one thing in project management that's also huge is getting it all the way down to the operator level, to where the operators, hey, they fully understand. So I mean, you have a case," Hey, here's the SOP. Make sure everybody's trained on it." You got to make sure all across that line, people are familiar with it. It's kind of like you tell, you do it, and then you discuss it. So I think looking back, some lessons learned from myself, I think I would invest more in making sure my operators had everything they needed, as in changes, deviations, stock control, everything like that. Because we assume, but-

Etienne Nichols: That's a good point.

Patrick Hayes: But until you actually make sure and you run it down, that's when you scrap. That's when everything... You don't want the boomerang effect.

Etienne Nichols: Yeah. That's a good point. I can remember, I'm trying to remember the specifics about this situation. We had an operator quit. Well I think he may have retired. It wasn't a bad situation, but he was gone and someone else took over his spot. Well, he was the only one who ever ran this one machine. Turns out, like 15 years prior when he started running this, he tweaked something. He said," Well, this isn't right. This paperwork isn't right." So he tweaked it and he's ran it that way ever since. And everything was fine. This new operator came on the machine and started running the part and looked at it and said," Well, this isn't matching to print." And the parts started failing. And that was a miscommunication between the floor and maybe engineering, and just one of the examples that-

Patrick Hayes: It's not uncommon. I would bet anyone listening a lunch if somebody didn't experience something like that. I mean, it might be a different product, might be a different position, but somebody's experienced like," Wow, I didn't think about that." And it is often times you get wrapped up and you get so many competing demands. And you face like," Wow, I should have caught that." And I'm not trying to go back and sell what I love to do, is the project management piece. The project manager should have a sense of that. Yeah. Military. I was a career military officer, and I could tell you one thing the military stressed was, every person knew the position above you and everybody knew the position below you because you have people leave. You have people fall sick. You have people that can't go on the job. And that was one beauty, and it is a very simplistic approach to it. And you're taught that from the day you indoctrinate and you're standing on that line in bootcamp to the time you're in your position. And I'm not saying that medical device should be ran like the Ranger battalion. But I'm saying there's some good correlations there.

Etienne Nichols: Yeah. Yeah. You bring out a good point there too. Like you said, some people may leave the company. Hopefully, some companies will gain new employees. Sometimes, when we're two to five, 10 employees, even a little bit bigger, maybe even 100 employees, you might get to the point where you have a project, and I know I've seen this, where the project managers say," Well, what does the project charter really matter? Nobody reads it." Or what about the scope, these different documents? Somebody else may be taken on that project. And so whatever you have in your head really needs to be written down.

Patrick Hayes: Right. And that's one thing with us. Within our company, of course we have a lot of guidelines, we have a lot of policies, to where we are required to... We call it our project folder. And it has everything. It has our communications, it has our reports. It has our safety, it has our schedules. It has our scope of work. It's a very systematic approach to it. But what we do I think is a great concept is we keep it electronically. We keep it on the cloud. We also keep it backup. And we provide that to our home office once the project's closed out, but we also provide it to the customer too, to the client. So, but yes, you're absolutely right. A lot of people think," Well, nobody reads the comms log. Nobody cares who is in charge of the incubator or who is the point of contact for an autoclave." Nobody really thinks about that." Or my molding machine." But you never know. And here's the thing. If you keep things accurate, you have the sense of security that, when it does happen, and it's not if, it's when, when it does happen, you'll have everything you need. And like you said, what if I decide one day, say," Hey, I'm going to retire." And you know what? One day, I hope that happens. Somebody's going to have to take my spot. And I'm not awesome. I mean, I'm an average guy, but you know what? I want the next guy coming in, I want to have everything to where my pride would be to where I can do a turnover with that individual to where it's seamless.

Etienne Nichols: That's my dream. If you ever leave a company that they don't talk bad about you.

Patrick Hayes: Leave it better than you left it.

Etienne Nichols: Right. Exactly.

Patrick Hayes: Absolutely.

Etienne Nichols: One other thing I was going to mention, we could go into project management, all the details. There's a lot we could talk about, but one of the other benefits of following a regimented process and a thorough process is it's going to increase your value if a company understands and sees that you care about your process.

Patrick Hayes: Right. Right. And I believe that's where CAI has that. We have the repeat business. We have the reputation to where everything within program manage... We picked PMI. It's a globally accredited source. Wealth of training. And it's something that the average person can adapt to. You went through the course. It's a very step- by- step systematic process. Now, I mean, don't get me wrong. You still have to use it, and you have to implement it, and you have to practice it. It's a craft. But we found that at any point of any project or any need of a client, you can reference it there.

Etienne Nichols: So you're somewhat associated with PMI. That right?

Patrick Hayes: Right. So I'm a member and I contribute to the PMI North Alabama Chapter, which is in Huntsville, Alabama. And I'm also in the Georgia Chapter, which is in Columbus, Georgia. So I live in Auburn, Alabama, and Columbus is about 30 minutes from me and Huntsville across the state. But I live in Alabama, so I have to contribute to my state. But it's great individuals. And it's networking. And they have a bunch of leadership development, learning development, it's networking with other partners. And you know what? Honestly, I don't have a lot with business related clients because most of Huntsville's aerospace. But when you join a network with project management and you volunteer and you take on roles like the board or any other council or just, I call them collateral duties, just where you contribute, I think it's beneficial to speak with other colleagues, even outside of your business. You get good takeaways.

Etienne Nichols: Yeah. That makes sense. People may not even be aware of the project management certifications if you're coming into the medical device industry and you never worked with project management. So that's helpful to know.

Patrick Hayes: Right. And PMI is one, I mean there's others. There's a Management Strategy Institute. I've been through a few other courses. It's mostly online. Well, PMI is online too. If you're looking Agile or a faster pace project management, and what you're talking about, like startups, really have to get speed to a patient. There's Agile mindset where you're doing the sprints, you're doing the, hey, you're cutting out all the fodder and what's important.

Etienne Nichols: And PMI has Agile.

Patrick Hayes: They do. They have Agile, but mean, there's a lot of resources out there.

Etienne Nichols: Oh, sure. Yeah. Yeah. Yeah. That's very cool. I'm trying to think. We've covered a lot of ground. I know there's a lot more we could cover.

Patrick Hayes: I could talk all day, I guess.

Etienne Nichols: Any recommendations or thoughts or other pieces of advice for medical device professionals who, I know qualification, validation, we could talk those subjects, but just in general, any parting thoughts?

Patrick Hayes: Parting thoughts would be, in the medical device industry, any day you wake up, never underestimate your value of what you're bringing to the average public, to the customer. I have seen personally where my product has benefited the average public. I'm not going to go into companies that were my customers. But I can tell you that one time, I was making a small syringe with a twist plunger. Well, you know what? From a manufacturing point of view, you look at the plunger, you look at the vial, you look at the syringe that you mold, you look at the needle, what have you. And you look at it as parts. But when you put it together and it passes quality control, it goes through sterilization. And then for the most people in manufacturing, just goes into the abyss. Well, you know what? That was actually contributing to treatment for premature babies for ophthalmic eyes. So we was providing eye drop medication to premature babies to help them develop. Huge. Also, when the rapid test, with COVID rapid test, we're trying to get tests out there to where to keep the workforce going to keep that. Well, we took on initial project within 90 days, we're up in manufacturing, the break off for the Q- tips that you did, the nasal swab. Nobody really thought about that. I was pushing out like 80,000 a week. Well, guess what though? That could contribute it to getting people back into the workforce. So I'm just saying, my thoughts are I think it's an honorable industry. I think a lot of people underestimate the impact that they have. So I would say, you know what? Any medical device that anyone makes, any engineer designs, anything, put your heart into it. Because you know what? That may say somebody's life. And oftentimes, it will. I mean, it's a direct impact to your mother, my grandfather, whoever. Your family, your loved ones, your colleagues.

Etienne Nichols: Yeah. That's something that we tout at Greenlight Guru. It's one of our core values. We improve the quality of life. That's the goal. And I know that's the goal of a lot of our listeners, so yeah. Appreciate you working to help others achieve that goal as well.

Patrick Hayes: I tell you, I wake up every day and I love my job, so I can't complain. I can't complain.

Etienne Nichols: Oh, that is good to hear. You don't always hear people say that. So that's-

Patrick Hayes: Yeah. Yeah. You're right. And I can't say I've always said that in my life. But yeah, no. It's a great company. It's a great job. Great industry.

Etienne Nichols: Yeah. Well, I appreciate it. So those of you who want to learn more about CAI or Patrick Hayes, we'll put his information in the show notes. I'm sure they can look you up on LinkedIn?

Patrick Hayes: Yep. I'm on LinkedIn. You've got my contact information. I'd be happy to speak with anyone.

Etienne Nichols: All right. Great. For those of you've been listening, you've been listening to the Global Medical Device podcast. We are at a conference right now. So Patrick and I are actually sitting at a table. So if you hear this background noise or you hear somebody say," Hey-"

Patrick Hayes: There was some music going on earlier.

Etienne Nichols: Yeah. I'm actually really curious. What's going on?

Patrick Hayes: I don't know what that was about. Yeah.

Etienne Nichols: Yeah. Thank you for listening. Be sure and check out Greenlight Guru, We are the only medical device success platform that is specifically for medical devices. So be sure and check that out. And we'll put a few other links in the show notes. We talked about a lot of different things, but thank you for listening and we'll see you next time.



The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

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