Randy Myers, Sr. VP of Global Manufacturing & Quality with Luminex discusses COVID-19 testing

MFG Austin: Randy Myers of Luminex on quickly scaling COVID tests and working with the FDA, and the need to build cross department relationships.

November, 2020

We've gone from [making] 600,000 [COVID] tests last year in our Aries product line to finishing this year with over 3 million and that's all happened in 9 months, and I’m scaling that again next year.

Randy Myers is senior vice president with Luminex, a manufacturer and developer of biological technologies in support of the life science industries.

Making COVID tests (0:36)
We went from a very minor portion of our portfolio dedicated to this kind of a test for this particular virus obviously and we have quadrupled our output in the last nine months and that's been everything from the supply chain to people, automation, plastics, molding. When they say it takes a village it really does and we have added space, people, equipment and supply chain at a rate that's just unheard of in that amount of time especially in an FDA regulated environment. So very proud of the team. One of the things that is always frustrating for us is we're going absolutely fast as we can and it's just not fast enough. I've kind of utilized the phrase lately with folks, “It's not the race you run; it's the race you're in.” This is a race that we just need to run as fast as we can.
What are you paying attention to daily? (1:40)
It's interesting, I'm not a person who has this huge wall of metrics outside my office. I tend to rely on my leaders to execute to the best of their ability everywhere they are. We're in Seattle, Madison, Wisconsin, Toronto, Chicago and here, and I can't be in every single spot. I depend on that leadership, but my job is to remove every barrier that they have. Knitting all this together across the corporation is my challenge and my leaders challenge. You got to come up and see the surface and look around but then you got to dive deep to make changes happen. Just as an example, on Friday we had a plastics company that three levels deep in the supply chain said, “Oops, we put in 3% of a different resin.” Well, that spins everybody into understanding impacts and what did that do. All of our leaders come together to make that happen and when I say all, I want to make sure I express that it's not just manufacturing. My peer and good friend Chuck Collins, whose the senior vice president of R&D, he and I work incredibly close together, our field service teams, we don’t recognize our organizational boundaries when it comes to this kind of scaling effort.
Building Cross Department Relationships (3:14)
It's the difference between being a manufacturing operation and being an operations organization. In operations, we touch everything. It's not just about what we made on the line today or what went into a box, it's about the quality of the product, how it fits in the portfolio, and what customer needs are. We are responsible for design transfer and scaling of products as it comes in from R&D; our marketing team as they go into new markets, they need to understand how we can support that; and field service, obviously we’re well integrated with those teams. So, our ability to engage and be seamless in all topics is really the difference between being a manufacturing group and an operations group. I do think that's foundational. If you draw the Venn diagram of a company, operations sits right in the middle and everything touches it at some point or another. It also lets our people move. I mean if they want to grow their careers they can move into ancillary spaces because they're familiar with it as opposed to, “Hey look dude I just make something each day.” It's really important—super important.
When is automation appropriate? (4:56)
I think people can get in love with those tools a little too quick. I’m going to be honest. We have multiple product lines that we build every day on automated equipment. We just landed another $1.9 million piece of equipment literally Friday night and in the back door. It went into the clean room Saturday morning. The source is here today setting it up. So certainly, where it is appropriate and applicable, it's about can I drive consistency of execution and volume of execution with automation? But there are a lot of things that don't lend itself to automation: the electromechanical box build of all of our instruments. We have a lot of chemistry formulations and those types of things that just require really smart people doing their job and helping them to do it consistently every day. Where automation is appropriate, go for it, where it's not, don't try and force fit it. That's kind of where we've landed.
What’s it like to work in an FDA regulated environment during COVID? (6:16)
Before semiconductors, I was actually in aircraft engines for 10 years and so I had the FAA. Then a whole lot of folks in the SEC talking about what to do in semiconductors and now the FDA on this molecular diagnostics and devices. Back when I was in aircraft engines and with the FAA, if you screwed up, people fell a long way and so there was a lot of structure, a lot of testing, a lot of surety that was required because people could get hurt. The FDA is no different than that. Their job is to ensure the health and safety and efficacy of things that go into the general population. Now this pandemic time has stressed the FDA beyond their imaginable limits. Things that would normally take years, people are trying to get it done in months and with that always comes some error bar associated with that. I think a lot of our agencies have taken a black eye and perhaps undeservedly. You look at the first CDC test that came out that didn't work real well in the hands of people in Seattle or New York and had to change when you move at this speed and things that cross an entire population, the error bar gets very wide. I think the FDA has done a pretty decent job of trying to deal with that.
When you oversee mission-critical products, what keeps you up at night? (8:12)
So, several things. I tell people I used to be 6’4” and good looking and this is all that's left! But one thing is that we are an organization of about 550 people strong across five different sites and it's keeping my people here every day. For a variety of reasons, we have been lucky in that over the course of the last nine months, we've had very few corona positives and none inter-office transmissions. We mask up, we try to maintain distance where appropriate and possible, but you always worry about that call that says, “Johnny, Suzy, Billy, Bobby and Sally are all out today.” I have not gotten that so that certainly keeps me up. There's always the challenge of keeping your best. We talk about people not necessarily as invested perhaps as they used to be. When you have leadership change and people moving, then you've got to react to all that and if you don't stay focused on keeping your leadership coffers full, then it really starts to unravel on you—that keeps me awake at night. Right now, is our ability to scale to meet the demand. We've gone from like 600,000 tests last year in our Aries product line to we will finish this year over 3 million. That's all happened in nine months so and I’m scaling that again next year. Having all that happen and not break when you scale, keeps me awake at night. It's funny, it's product, it's people, it's the standard stuff, but when you move at the pace that we're moving at right now, things can get a little wonky and you just have to keep the car on the road.