An Interview with Gilero’s Vice President of Technical Operations

Eli Nichols is the VP of Technical Operations at Gilero, where he uses his extensive engineering background and breadth of medical device knowledge to oversee Gilero’s design transfer team. Learn more about why Gilero has a dedicated team for transferring designs into manufacturing, and Eli’s role in ensuring the success of that team.

You were recently promoted from Director of Design & Engineering to Vice President of Technical Operations. How has your role at Gilero changed with this recent development?

“The goal with creating this role was to put more focus and accountability around Gilero’s manufacturing transfer process. We’re working to bridge the gap between the product design & development process and manufacturing. In my previous roles at Gilero, I’ve worked in all phases of the design process, but now I focus on the completion of that process and what comes after when it’s time for manufacturing. Design for manufacturing (DFM) plays a vital role in this too. Our design and product development engineers always try to integrate manufacturing considerations as early as possible in the design process. Having a go-to design transfer team that can be called on to help promote manufacturability early in design & development helps to create a more efficient pathway for transferring a design into manufacturing. The design transfer team understands both the design & development and manufacturing sides of our business, helping to make manufacturing transfers as smooth as possible.”

The newly formed design transfer team, which you head, is responsible for transferring designs into manufacturing. Why is it important to have a team dedicated to this?

“As Gilero established ourselves as leaders in medical device design & development, we found our customers repeatedly requesting manufacturing support following their product design completion. This led us to the natural next step in building out our manufacturing capabilities and opening our facility in Pittsboro. As Gilero’s manufacturing business expanded alongside our engineering services, we began to notice that we had a lot of individuals specializing in either manufacturing or product development, but not many team members working routinely within both areas of the business. We recognized an opportunity to add a dedicated design transfer team in order to strengthen communication between the two groups. So, I proposed this technical operations role and built out a team to have formal accountability and responsibility for the design transfer to manufacturing process. The team has proven that they can understand and effectively connect both sides.”

What do you think is the single most important thing to ensuring a successful design transfer?

“Open communication and feedback throughout the development lifecycle. Starting the design transfer process early and keeping tabs on it all the way through the end of the project is extremely valuable. Being very open and getting the feedback in both directions throughout the design process helps to make the transition as smooth as possible when the time comes for manufacturing.”

How do you see Gilero’s manufacturing capabilities growing over the next few years?

“I think they’ll change quite a bit. With plans to expand into Mexico, coupled with our focus on providing more services for our pharmaceutical customers and gaining 21 CFR Part 211 compliance for drug handling and kitting, our manufacturing service offerings will grow significantly. The Tijuana facility will expand our footprint in North America and support our core domestic manufacturing operations in Pittsboro as well as our partner facility in Shenzhen.”

What is the advantage of having design and manufacturing experts under the same roof?

“Design transfer is something that we’ve found to be a major pain point for many of our customers in the past. Sometimes designers tend to “throw things over the wall” to manufacturing and there’s a lack of information and knowledge transfer. This results in several inefficiencies, setbacks, and frustrations from both sides of the process. By having the design and manufacturing experts under the same roof working in collaboration, we are able to remove many of these inefficiencies allowing for a smoother process.”

You’ve been with Gilero for 8 years. What is the biggest difference between the company now and when you started?

“The biggest change is probably the overall size of the company and everything that comes with it. When I started, I was one of about 12 billable engineers in a company of about 18 people total, all working in one office. Then a few years ago we moved to a bigger office to accommodate our larger Morrisville team, opened an office in California in 2019, added Medacys as our partner in China, opened our plant in Pittsboro, and we have all this future growth planned that will position us as a strong international organization. Once COVID hit, the dynamic of how we work together as a team changed drastically, and we’ve actually been able to improve collaboration and communication while adding some more remote and distributed team members.”

Is there a specific device you worked on at Gilero that you are really proud of? What was your role in that project?

“The buffered anesthetic delivery system that we worked on for Anutra Medical. We truly developed it from the ground up, through design, development, and the entire regulatory process. The objective was to create a system that would allow lidocaine to be buffered at the point of use, speeding up the onset of local anesthetic and reducing the pain of injection. We ended up designing and developing three products that work together as a system: The Anutra Dispenser, which measures out a precise dose of buffered anesthetic, The Anutra Cassette, designed to precisely mix lidocaine with epinephrine and sodium bicarbonate to effectively buffer local anesthetic, and The Anutra Syringe, offering multiple dose delivery and providing haptic feedback to tell the user how much volume has been delivered. I was the project manager up until the point where we started getting close to readying the device for DV&V builds, at which point I continued on as the technical lead while our in-house regulatory expert, Kristin Benokraitis, took over as the project manager to get the device through DV&V and regulatory clearance. I think the coolest thing about this project is that it really touched on every piece of what we can do at Gilero, outside of our electromechanical capabilities. Today, the Anutra Local Anesthetic Delivery System exists as a combination of Class I and II sterile and non-sterile devices, used by dentists to prepare and deliver buffered lidocaine prior to dental procedures.”

You were once a member of Duke University’s football team. Are there any lessons you learned on the field that you’ve transitioned into your work life?

“Time management and efficiency are big ones. Being a varsity college athlete is demanding, so those were critical. There are also inherent leadership traits learned through athletics that help me to be successful in my professional endeavors. Understanding the value of a team is important as well because football is the ultimate team sport. There are a lot of specialized individuals that are required to make a successful team. This is similar to Gilero and how we structure our project teams in ways that allow each member to make unique contributions to the project’s development.”

What’s your favorite thing about working for Gilero?

“The diversity of products and fast-paced nature of the work is what used to be my number one, but I’ve grown to appreciate the culture and management style the most. There’s a lot of support without micromanaging, people are allowed to have the space to fail and grow, and there is a very entrepreneurial spirit with an emphasis on improvement and professional growth.”

Posted in: Contract Manufacturing, Design & Development, Gilero News