What makes Greenlight Guru unique and sets it apart from other medical device solutions? It’s Guru edge⁠—a team of medical device professionals with a ton of industry experience.

In this episode of the Global Medical Device Podcast Jon Speer talks to Maryann Mitchell, a Medical Device Guru and Solutions Engineer who has recently joined the Greenlight Guru team.

Listen as Maryann shares fascinating details about her day-to-day working with device companies who are evaluating the Greenlight Guru Medical Device Success Platform (MDSP) to better understand their product and business needs and how Greenlight Guru's MDSP solution can help them achieve ultimate success.

 

LISTEN NOW:

Like this episode? Subscribe today on iTunes or Spotify.

 

Some highlights of this episode include:

  • Maryann’s background is in quality systems initiatives, and she has extensive experience with ISO 13485. She loves being a part of audits and truly enjoys defending quality systems.
  • While Maryann has been through numerous ISO 13485 audits, she has experienced only a few FDA inspections. She explains that there’s a whole different level of terror when it comes to the FDA.
  • Maryann was attracted to joining the Greenlight Guru team because of her interest in quality system software. She wanted to help the company sell its software and connect with customers and medical device companies.
  • Maryann shares some of her favorite stories working with companies trying to evaluate their options for quality systems. The best part is customers’ positive reactions during design control matrix and risk matrix demonstrations.
  • The benefits of Greenlight’s QMS include the ability to quickly and easily find and access visually appealing information and data. Ultimately, it helps people get through audits faster and be in compliance.
  • However, Maryann explains how and why EU MDR continues to be a challenge for medical device companies. Compiling records and evidence for submission as well as interconnectivity are just some of the bigger quality issues.
  • If the FDA transitions to the 13485 standard, Maryann believes the medical device industry shouldn’t panic but anticipate it. It would be better to have a harmonized way of auditing and inspecting companies.

 

Links:

Maryann Mitchell on LinkedIn

ISO 13485 - Medical Devices

FDA Inspections

European Union’s Medical Device Regulation (EU MDR)

Meet a Guru - Sara Adams

Meet a Guru - Taylor Brown

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable quotes from Maryann Mitchell: 

“I’ve lived and breathed the 13485, 820, all those fun standards, which I love. It’s really exciting and I love being in audits.”

“There’s a whole different level of terror when it comes to the FDA, but it was really exciting to be there. Thankfully, I wasn’t in the hot seat for those, but I was in the front room to participate.”

“Not just during an audit, but for your own internal quality, it’s just so much easier when your systems are connected, and that’s exactly what Greenlight offers to our customers.”

“You should always be audit ready.”

 

Transcription:

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.

Jon Speer: Time to time, you probably have heard me talk to one of our gurus, or one of our subject matter experts at Greenlight Guru. Well, I do so again, today. Today I talked to Maryann Mitchell. Maryann is a solutions engineer, and she's part of our sales team at Greenlight Guru. She has a role of talking to companies that are evaluating the Greenlight Guru medical device success platform, and understanding what their needs and their requirements are, and explaining to them how Greenlight products and services can be a resource to help them accomplish success in their businesses. So, Maryann has a great background and quality, a lot of experience with ISO3485, and going through the whole audit process. She loves audits, and she has a lot to offer. So I hope you enjoy this episode of the Global Medical Device Podcast. Hello, and welcome to the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer. And from time to time, I have featured a Meet the Guru episode on the Global Medical Device Podcast. And joining me today is one of our gurus at Greenlight Guru, Maryann Mitchell. Maryann, welcome.

Maryann Mitchell: Thank you. I'm excited to be here.

Jon Speer: Absolutely. So your role is a little bit different than some of the other gurus that we've featured in the past. You're a solutions engineer. I guess maybe that's a good place to start. What does that mean and how do you get involved in the process?

Maryann Mitchell: Yeah, good question. Well, I'm paired up with the sales organization. So, first time for me working in sales, coming from industry. So I get to be paired up with an account executive and then use my experience to help them through the demonstration process.

Jon Speer: Sure. You're talking to, I mean, you're newer to the team, but I'm guessing by now you've probably talked to at least dozens, probably quickly approaching hundreds of medical device companies from all over the globe, and your role is really to understand what that company is going through, what their needs are, what their challenges are, and explain to them how Greenlight products and services might be a resource, right?

Maryann Mitchell: Exactly.

Jon Speer: Yeah. So, let's go back in time a little bit in your career. Talk to us a little bit about your upbringing in the medical device industry, some of the things that you've done along the way prior to Greenlight.

Maryann Mitchell: Well it started back in 2003. I got a job as a receptionist at an alternative medicine, medical manufacturing company, and I was just curious what everybody was doing back there. I didn't want to just be answering phones. So, the quality manager reached out to me because he needed a quality system for them. So I got to be on the ground to help them establish 13485 and learn all about that process. So ever since 2003, I've been in the medical device space. I took a couple of years off working in a blood bank, still in quality, but on blood bank side. But then the good last 12, almost 13 years, I spent at a small- Not small, actually fairly large, medical manufacturing company, but we were component manufacturers for x- ray tubes and flat panel imaging detectors. So I was the global compliance manager, responsible for quality system for Salt Lake City that had over 1000 employees and then a few sites around the world too. So, it was really exciting.

Jon Speer: Wow. So, a lot of your experiences today have been all about quality system initiatives.

Maryann Mitchell: Exactly. I've lived and breathed the 13485, 820, all those fun standards, which I love it. It's really exciting. And I love being in audits, which was another reason I think I got thrown into it. Nobody else really wanted to be in audit. So I enjoyed it. I like defending our quality stuff.

Jon Speer: I was going to ask you about that, because I've talked to a couple of our other gurus, Sarah Adams and Taylor Brown, specifically.

Maryann Mitchell: Yeah, we've bonded.

Jon Speer: Yeah. They get so excited when talking about audits, and it doesn't matter what type of audit, they're super excited about it. What is it to you that is so exciting about the audit experience?

Maryann Mitchell: I don't know. Sitting in front of that auditor and anticipating the next question. It turns into a game in my mind. I want to be ready with the answer before they even ask the question. But really, I live and breathe all these processes, and being able to defend it and being that defendant for the company was really exciting for me.

Jon Speer: Yeah. I know a lot of people are terrified to even think about an audit. You've certainly been through the ISO side of things. I'm guessing you'd probably have also been through your fair share of FDA inspections too.

Maryann Mitchell: Only a couple at a couple of our other sites, but yeah, there's a whole different level of terror when it comes to the FDA, but it was really exciting to be there. Thankfully I wasn't in the hot seat for those, but I got to still be in the front room to participate.

Jon Speer: Absolutely. And so, I mean, obviously Greenlight has products and services to help companies with their quality system initiatives. What was the allure, the attraction, to joining the Greenlight team? I mean, I'm guessing the product had something to do with it, but I guess elaborate a little bit more on that. What did you find refreshing or interesting about the Greenlight experience so far?

Maryann Mitchell: When I was doing research on it, I used ETQ in a past life and that was my whole day was inside of a policy system software. So I just started looking at what other software programs were out there, and just like," This is what I'm used to, this is what I think I'm good at." So instead of working in industry, I started to think of, maybe I can help work at a company that sells this software. And when I met with a few people from Greenlight, immediately... Because I feel like interview is not the company interviewing you, but it's you interviewing them, and I just felt that it was a connection right away. And I loved how positive everybody was during the interview process. It's just not another person that they had to interview and go through, and yeah, the energy was amazing. The reviews online were amazing. So it really made me think, this is somewhere that I can see myself.

Jon Speer: Absolutely. So, folks listening out there, I want to remind you all that Greenlight is always looking to add to our team of gurus and subject matter experts. There's often opportunities to join either a sales team or to work directly with customers. In fact, I think as we're chatting, Maryann and I are chatting today, I think we have a couple of positions that are open. So if this sounds like something you'd like to learn more about, I would encourage you to go to the Greenlight Guru website, www.greenlight.guru, look at our careers page and see if there's opportunities there. And even if there's not something currently posted, shoot me a note. Because like I said, we're always looking to add expertise and great team members to the company as we continue to grow, the need for that guru expertise continues to grow with that. So I would encourage you to check that out. And if you know, a friend or a colleague or somebody that might be interested, send that information along to them as well. All right. So Maryann, so far, you've been at Greenlight now for a few months. I honestly forget when you started, but...

Maryann Mitchell: I'm beginning my seventh week.

Jon Speer: Seventh week, okay. So we're approaching month number two. Do you have any favorite stories that you want to share so far about the working with companies who are trying to evaluate their options for their quality systems? Any stories that come to mind so far?

Maryann Mitchell: A couple of stories that really stood out were, that I have heard, I've been listening to a lot of recorded demos too, in preparation. And I love hearing how people's voices change and sometimes there's even video turned on when I can see their faces light up when we show them the design control matrix and the risk control, our risk matrix. And I know from personal experience, those are really hard to compile. Like myself in demos when the account executive is showing it, I have to hold myself back from going," That's so cool." Because it's so easily created where I've been in audits and we had many electronic systems and it was really hard to pull all that together. So the fact that it's all in one location and easy to access and visually appealing is definitely one of the stories that I like hearing. Another one is the fact that people are getting through audits faster, because audits are obviously close to my heart. So if you can get through them faster and with zero non- conformances, that's amazing.

Jon Speer: Yeah. I think I just saw someone from our customer success team shared some feedback from a customer that they had a four day, I think it was an ISO audit, scheduled and it only took a couple of- Or no, actually, I take that back. It was a supplier audit of some sort and it was scheduled for four days and it only took two days. And the reason for that is the efficiency of the Greenlight system, having that single source of truth and everything at your fingertips, essentially, to be able to easily find information. Because I think that's one of the, going back to one of the things you said a moment ago, when you're in an audit situation, you're trying to anticipate where this is going. So that in your mind, you're like," Okay, where is that? Is it in a file cabinet somewhere? Is it on somebody's desk? Is it in a certain folder on a server? Where am I going to find it?" Because you want to get through this audit as efficiently as you can, right?

Maryann Mitchell: Yes. So it's all about perception in audits. And if you can give a good perception and then show that you're compliant, it wraps it up much faster.

Jon Speer: Yeah. A lot of things happening in our industry right now. I think probably the most current thing that a lot of companies are still trying to navigate and then struggling with, from what I'm hearing, is EU MDR. It sounds like that's still a big challenge. And then lo and behold here, in about a year or so, the EU IVDR will be theoretically live too. But you're in the trenches. You're talking to companies every day, again, all over the world who have some sort of challenge or objective or something that they're trying to accomplish. What are some of the themes that you're hearing from companies? What is the biggest issues that they're dealing with these days?

Maryann Mitchell: Definitely the road to submission, and of course, that road, you're compiling all of the records and evidence that you need for that submission. So having all of their information in one place, I think is a big issue. Another theme is definitely interconnectivity. So, I may have a CAPA looking at your post- market health and then if you don't have all those railroad tracks in place to go to the next spot, not just during an audit but for your own internal quality, it's just so much easier when your systems are connected, and that's exactly what Greenlight offers to our customers.

Jon Speer: Yeah, absolutely. There's always going to be something on the horizon that's going to change. I mean, I've read recently that FDA has been talking about transitioning to 13485 for a couple of years now, and I think that those discussions are starting to ramp up quite a bit too. So, where do you see that going? I mean, imagine FDA moves towards 13485. How do you think the industry is going to respond to that?

Maryann Mitchell: I mean, it would be nice to just have a harmonized way of auditing and inspecting companies, but yeah, I think it's definitely been something that the industry has been talking about for quite some time. And personally, I've always followed more 13485 only because it was the more stringent of the two. So I knew that if I had 13485 covered, I had most of FDA as well. So, I've got my 13485 at all times ready to go.

Jon Speer: And I think part of that is, you know, when you go through the 13485 path, the certification path, you're essentially signing up your company for the routine surveillance and inspection. So it keeps you on your toes and in a rhythm. Not to say FDA wouldn't show up for an inspection, but it's just different.

Maryann Mitchell: They just don't have the time or the manpower.

Jon Speer: Yeah. I also think it's interesting too, that when a company hears or gets the call from FDA and says," Oh, we're coming out next week." Then all of a sudden there's this panic attack. What do you think about that? When a company is like," Oh, crap, the FDA is coming out next week." Should they be panicking, or do you have some other mindset do you think they should be in for that type of event?

Maryann Mitchell: The mindset that I was taught and that I try to, as a leader is, you should always be audit ready. There shouldn't be a panic. Your quality systems health should always be at a good place. So I mean, the FDA, like I said, can be scary. So, just the fact that they're coming in, but yes, you should always be audit ready. And a system like Greenlight, because it's so strong and robust, it gives you that audit readiness.

Jon Speer: All right. So you've been in the industry now since 2003.

Maryann Mitchell: A good 15 years, yeah.

Jon Speer: I'm sure the time has flown and you've probably seen and experienced quite a few things in your career. For those listening who are maybe, we'll say newer, medical device companies, do you have any tips or pointers, suggestions, things that can put them on the path of success?

Maryann Mitchell: I have this quote that is from a Brazilian footballer named Pelé. I'm sure my Brazilian's are going to like this quote. It says," Success is no accident. It is hard work, perseverance, learning, studying, sacrifice, and most of all, love of what you are doing or learning to do." And that's how I feel about quality. It's not something that you can just expect to happen. You have to work at it. Yeah. It's in your products or processes. It has to stem across both. And just because you have a quality system and maybe you pass your inspections or your audits with the notified body, you may not have a quality product. So the company and the individuals within that company have to work really hard for that success to be there. You can't just have a CAPA process and it's not effective, then it's a pointless CAPA. Or have an internal audit performances. You may not be anybody's friend at the end of the internal audit, but you don't have many friends in quality. We're not there to make friends, we're there to help the organization. And it's better that we catch those rather than the FDA or the notified body.

Jon Speer: Yeah, I totally agree. And I hope we get to a point in this industry here soon where we can look at internal audit and audits and the quality team as our friends, or at least respect the role that quality plays in the process. Because to your point, if you have good quality and your products and processes, it's not accidental. It just doesn't happen by serendipity. It takes some intention to make those things happen. Now, the converse though is, if you don't have intention on your quality and focus on ensuring the highest and best quality of your products and processes, you can almost guarantee you're going to have poor quality as an outcome. So, if you ignore it, it's going to be a bad result.

Maryann Mitchell: Yeah, so it's great to be at a company in a job that I get to talk about what I love, and teach other people how to be better. So, this just seems like a dream job. I'm getting paid to talk about what I love.

Jon Speer: That's great to hear. Well, Maryann, do you have any other final tips, pointers, suggestions, before we wrap up our discussion today?

Maryann Mitchell: Nope. But, thank you so much.

Jon Speer: All right. Folks, Maryann Mitchell, solutions engineer at Greenlight Guru. And if you're a company that's interested in learning more about the Greenlight Guru Medical Device Success Platform, the only software platform designed specifically and exclusively for the medical device industry, then I want to encourage you to go to www.greenlight.guru, someone from our team will reach out to you. We would like to understand your needs, your requirements, things that you're trying to do. And there's a good chance that if you do connect with us, you might get a chance to talk with Maryann and she can share some of her pro tips and the things that she's saying that goes well, some of the things that she's saying that maybe it didn't go so well, and really help you understand how the Greenlight platform might be a great solution for you to implement at your company. So check it out. As always, thank you for listening to the Global Medical Device Podcast, the number one podcast in the medical device industry, and that is because of you. You keep tuning in, you keep sharing with your friends, with your colleagues, that this podcast exists. So thank you for doing so. And as always, this is your host and founder at Greenlight Guru, Jon Speer, and you have been listening to the Global Medical Device Podcast.


ABOUT THE GLOBAL MEDICAL DEVICE PODCAST:

medical_device_podcast

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.

Like this episode? Subscribe today on iTunes or Spotify.