Elevate Solutions Group Shares Leadership Discussions Regarding its Medical Device Injection Molding Initiatives
A Three-Part Series: Part One: Manufacturing
Part Two: Tooling
Part Three: Quality and Compliance
In this segment: What OEMs should expect from a molding partner
Austell, GA | April 2026
Interviewer: Chris Gardner, VP of Sales & Marketing
Interviewee: Fred Howery, Senior VP of Manufacturing
In this first installment of our leadership Q&A series, we spoke with Fred Howery, Senior VP of Manufacturing at Elevate Solutions Group, about what medical device OEMs should look for in a manufacturing partner.
Gardner: You’ve spent a significant portion of your career in medical device manufacturing. Can you share a bit about your background and how you got started in this space?
Howery: I began my career in medical devices at Terumo Medical. I started with syringe and test tube manufacturing and worked my way up to managing their two Cardiovascular Device plants in the United States.
Gardner: At our recent strategic planning summit, you and I discussed how medical injection molding raises the bar in most areas – process validation, documentation, consistency. How is Elevate Solutions Group positioned to meet these demands and what actions are you taking to ensure we are performing at the highest levels?
SVP of Manufacturing: We have initiated IQ, OQ, and PQ validation processes. This ensures that our molds, machines, and assembly equipment have robust and repeatable processes.
We have also invested in formal injection molding process training for our team members as well as testing and measurement equipment such as a CMM with .0001” repeatability.
Gardner: How does ISO 13485 influence day-to-day manufacturing operations and why is it so important to medical device manufacturers?
Howery: ISO 13485 is critical to medical device OEMs who must have a formal process that guides traceability from raw material to finished device. It is natural for a contract manufacturer to migrate from ISO 9001. To achieve this next level of quality, we performed a formal gap analysis to give us a clear and logical path forward, and it has helped accelerate the process.
Gardner: The tariff situation in 2025 challenged many industries including our own. Now that some of the dust has settled, where do you see our industry heading and what do you think the OEMs will value most going forward as they seek to establish manufacturing partnerships?
Howery: It has challenged us to be as efficient as possible to lessen the impact to our customer and end user. Mold prices saw dramatic increases and we have been fortunate to be able to find alternate suppliers to try and maintain the customers’ budgets while continuing to meet demanding quality requirements. Manufacturers who can present meaningful solutions for OEMs navigating these kinds of challenges are highly valued and more likely to remain loyal customers.
Gardner: How does your medical manufacturing experience influence how you lead your team at Elevate Solutions Group today?
Howery: By definition, medical manufacturing demands achieving the highest levels of quality, while also meeting the customer’s business needs. We take the same approach with all our customers, whether they are medical or not, and our entire staff understands the high bar and expectations we have established and committed to through our certifications.
Gardner: Validation is often a concern for medical OEMs. How do you approach validated manufacturing processes?
Howery: We begin with the initial concept and work with our customers to make sure their product is designed for manufacturability. Some of our customers have amazing concepts, but if the end product cannot be consistently produced it is of little value.
We start with the mold design process and work with our customers throughout manufacturing down to shipping. At each step and each piece of equipment we have IQ, OQ, and PQ validation steps to keep the process robust and repeatable.
Gardner: What role does cleanroom molding play in medical manufacturing programs? How has it influenced the responsibility of our Quality lab and personnel?
Howery: We work with our customer to understand the application of the finished product and what is required. Whether it is a standard white room or a Class 8 clean room, it is often a tailored solution designed specifically to the customer’s needs that will drive the final outcome. Our Quality team documents the entire process, dictated by the formality of our 13485 directives.
Gardner: Our big pharma customers have leveraged the IT team here. We wrote more than two million lines of custom code that allows us to collect and share data for a complex assembly operation. Connecting machines, processes and business systems creates opportunities to make smarter operational decisions. Data and traceability are becoming increasingly important for medical manufacturers. How can we help other customers understand the significance of this powerful capability?
Howery: Our IT team has worked with some of the biggest names in pharma to eliminate the paper trail that was so common in our industry years ago. In many cases our customers can see process and manufacturing data in real time. When customized for a specific customer/product, it can support better informed decisions that can greatly increase efficiency and transparency.
Gardner: Since coming to Elevate Solutions Group last year, you have hired a full-time automation engineer, traveled to China, and led the installation of fully automated assembly lines. Whereas a team of 12 operators struggled to complete 6,000 to 8,000 units per eight-hour shift, the new equipment produces 1,200 units/hr. all day long. What is your vision for more automation and what criteria do customers need to know before exploring those options?
Howery: The new technology around automation equipment is amazing. With built-in vision systems, defect logs and OEE tracking we consistently produce a higher quality and quantity of devices. This is not being done to replace our associates. Rather, it increases their skill set and eliminates repetitive low-value tasks. We now have a full-time Automation Engineer on staff, which I highly recommend when OEMs evaluate a contract manufacturer who is expected to ramp their programs quickly to high volumes.
Gardner: Elevate Solutions Group is recognized as one the industry’s fastest-growing companies in Georgia. What are some of your observations that have contributed to our success?
Howery: Because we are privately owned, we can be very nimble. When an existing or new customer presents us with an opportunity, we evaluate quickly to be sure it is aligned with our strategic goals and whether we bring value. Capital investments at less well-funded companies, or companies whose approval process can drag on for a long time, can feel discouraging. We typically try to make decisions in days, not weeks or months. Much of our success has evolved from treating customers as partners – and I highly encourage any OEM who may be seeking a manufacturing solution to look first at the leadership team and how they treat their customers.
In Closing
“Medical device manufacturing demands discipline, consistency, and trust. Those principles guide how we build processes, lead teams, and support our customers every day. Elevate Solutions Group has made strategic hires like Fred to bring deep industry experience to the table. This series is designed to share insights from some of those key individuals.”
Chris Gardner, VP of Sales & Marketing
About Elevate Solutions Group
Elevate Solutions Group is a rapidly growing, vertically integrated contract manufacturer serving medical, telecommunications, consumer, and industrial markets from its modern campus just outside Atlanta in Austell, Georgia. With more than 30 injection molding presses ranging from 80–950 tons and 240,000+ square feet of ISO 9001-certified, FDA-registered operations, ESG delivers customer-centric focus in precision molding, packaging & assembly, kitting, warehousing, and full 3PL services. Elevate’s capabilities include designing, engineering, producing, and assembling complex products as well as holding stock and shipping globally through a data-driven distribution center. https://esgworks.com/