An Interview with Gilero’s Vice President of Manufacturing
Wade Stauffer is the Vice President of Manufacturing at Gilero. Working out of our contract manufacturing facility in Pittsboro, North Carolina, Wade makes sure that all areas of the plant run smoothly while overseeing the manufacturing growth operations across the entire company.
What does a typical day at work look like for you?
“I spend about 60% of my day being hands-on. At this point of our growth, it’s imperative the systems we are building are challenged now to avoid future issues. That hands-on work could be walking through a process with the team, understanding machining capabilities, conducting training, enhancing QMS processes, working on continuous improvement, or helping out with anything that needs to be done around the plant. I appreciate that I can walk the floor and see what’s actually happening instead of looking at something on paper or theoretically.”
What are Gilero’s manufacturing capabilities in the Pittsboro facility?
“Assembly, packaging, and kitting are the primary manufacturing services we offer in Pittsboro. Currently our main focus is medical devices, but groundwork is being laid and implemented on both infrastructure and quality systems to enter the drug handling aspect of manufacturing too. In terms of our services, there are a variety of different assembly methods that we can provide, including manual and fully automated assembly, for both low and high volume runs. We have an array of packaging schemes and equipment which allow us to provide primary and secondary packaging for finished devices. We also offer kitting for things like combination products or customized thermoformed trays, which will be a service offering we expand greatly in the near future. In addition to these services, Gilero has a dedicated design transfer team that oversees the process of transferring product designs into manufacturing. This team is based primarily in Pittsboro and allows our design and manufacturing experts to collaborate with one another, ensuring that production gets off to a smooth start.”
How many cleanrooms does the Pittsboro facility have? What are they used for?
“There are 10 cleanrooms in Pittsboro. One of these is controlled and monitored to ISO Class 7 standards, while the rest are monitored and maintained to ISO Class 8 specifications. At the moment, most are being used for assembly and packaging of Class I and Class II medical devices. We have various types of packaging equipment that we keep inside the cleanrooms, from form fill seal machines to very highly customized semi-automated packaging machines.”
What are some recent or upcoming changes happening in Pittsboro that you are most excited about?
“We’re working toward 21 CFR Part 211 compliance in order to be able to handle finished drug products in the Pittsboro facility. This will really expand Gilero’s capabilities and allow us to enter into more complex manufacturing landscape with increased production of combination devices and drug delivery systems. I’m excited to add this capability to our manufacturing business and solve the technical challenges that come with it.”
How will our capabilities change once we are fully compliant with 21 CFR Part 211?
“The ability to handle drugs means that we will be able to better serve our customers in the pharmaceutical industry. We will still provide the same services that we do today, but I anticipate a growth of Gilero’s kitting capabilities and a rise in the number of drug/device combination products that we manufacture.”
Will you be involved with the opening of Gilero’s manufacturing facility in Mexico? How?
“Yes. The plant in Mexico will be a part of our manufacturing business, so I will ultimately be responsible for it. I anticipate being down there quite a bit to get the plant up and running. We’re still in the process of site selection, but the great thing about this location is that it will be just over the US-Mexico border, about a 45-minute drive from our design office in Carlsbad. We have already seen the benefits in Pittsboro of having our Morrisville design office nearby. If there is an issue at the Mexico facility, we can have one of our California-based design or product development engineers down there the same day to address it.”
Can you tell me a little bit about your background?
“I have a Bachelor of Science in Manufacturing, so even before my professional career began, I was learning about quality, automation, and all of the things that go into the process of manufacturing. My entire career, 24 years, has been spent working in regulated markets, including the last 17 years that I’ve been working in medical device manufacturing. Half of my medical device career was on the quality and regulatory side of the business, and the other in operational management. I am a 25-year member of ASQ where I am certified as a Six Sigma Black Belt, Quality Engineer and Quality Auditor. I hold my Master Black Belt from Villanova and am certified as an RJG Master Molder.”
Why did you decide to pursue a career in manufacturing, and why medical manufacturing in particular?
“Ever since I was a child, I have liked being hands-on, loved business, and appreciated the ability to transform raw materials into something of value. I found that with the medical device industry specifically, I enjoy the overarching regulatory component that goes into it. I feel that quality and regulatory systems create more compliance and ultimately lead to a better product. Standardizing a process is the only way to create real consistency, which ultimately delivers value to the company.”
What’s your favorite thing about working at Gilero?
“I get to see a lot of different things and am not caught up doing the same work every day. Many of the devices we work on are novel, so we get to see firsthand the innovation that’s happening in medtech. But my favorite thing, without a doubt, is knowing that the work we do and the products we make will be used to improve the lives of people and patients around the globe. We are truly making a difference.”