Cutting medical device manufacturing costs without cutting corners

In the medical device industry, bringing a new product to market is expensive and time consuming. Often, it takes too long and costs too much. While safety, efficacy, and regulatory compliance are essential, the leadership team at Trident Manufacturing believes there is a smarter path forward. They contend it’s possible to meet all required standards while also reducing costs, improving quality, and accelerating time to market.

President John Sapiente began his career in automotive manufacturing at Elgin Die Mold, a company specializing in injection molding and assembly for Tier 1 automotive suppliers and OEMs. The company focused on safety-critical parts and assemblies. Following the 2009 economic downturn, Sapiente sought to diversify and came across Trident Manufacturing, a company with strong medical device capabilities but in financial distress.

After acquiring Trident, Sapiente integrated its production lines into the existing automotive facility in Pingree Grove, Illinois. The move brought the teams together under one roof, enabling collaboration and shared access to lean manufacturing systems and personnel trained in operational discipline. With the help of a unified and highly capable team, Trident significantly reduced overhead and began transforming its processes.

Lessons from automotive manufacturing

By exposing Trident’s operations to lean principles and proven automotive methodologies, the team quickly identified areas for improvement. The results were significant: waste was eliminated, processes were streamlined, and total cost reductions reached as much as 25%. More important than any single metric, however, was the cultural shift that followed – a shift that continues to define the company’s operations today.

Still, even well-intentioned improvements can meet resistance. When the team presented its proposed cost savings to a major medical OEM, it encountered a familiar challenge: revalidation. Even a small change that increases efficiency can trigger a regulatory process consuming both time and resources – resources that many OEMs struggle to free up mid-program.

“It actually created more work for them,” Sapiente recalls. “Because of the stringent requirements in the medical device industry, it’s difficult to optimize a product once it’s already in production.”

The key, the Trident team found, is to engage early – well before final designs are locked. To support this, Trident has invested in engineering capabilities allowing the company to partner with customers from day one, helping to design smarter, more efficient, and more cost-effective solutions from the ground up.

The automotive industry has long operated under a zero-defect mindset. With strict safety requirements and a deep focus on efficiency, it emphasizes flawless execution and the systematic elimination of failure at every stage. When Sapiente and his team brought this philosophy to medical manufacturing, they expected to find similar alignment. While safety and quality are rightly top priorities in the medical space, they observed opportunities to embed more process efficiency and root-cause thinking.

“The medical industry often relies on repeated inspection and testing to ensure quality,” Sapiente explains. “But in automotive, if you’re scrapping a part at the end of the line, that’s not zero defects. That’s just containment.”

At Trident, the focus is on prevention. Rather than accepting late-stage testing as the gatekeeper of quality, the team concentrates on building quality into the process. They identify root causes, design around failure modes, and trace problems upstream. “If a device fails inspection at the end of the line, the team asks why,” Sapiente says. “Where did the failure mode originate? How do we eliminate it so we’re not throwing away a seventy-five or one-hundred-dollar device? That’s what true zero-defect thinking looks like.”

That mindset is embedded throughout the organization. It’s not just a manufacturing strategy – it’s a company-wide culture. From order entry to shipping, from front office to back dock, every department operates with a shared mission: deliver the highest quality product through continuous improvement, creative problem solving, and lean execution. Whether engineering is designing for manufacturability, purchasing is identifying cost-effective materials, or shipping is optimizing fulfillment workflows, every corner of the business is aligned.

“It’s constantly about asking what could go wrong, how to prevent it, or how to respond if it does,” Sapiente says. “And ultimately, that lens ties back to cost, quality, and timing.”

Low-volume automation

One of the most unique challenges in medical manufacturing is scale. In automotive, high volumes justify investment in automation. In medical, where production runs may consist of only a few thousand units, manufacturers often respond to capital constraints by relying on added labor. While understandable, this workaround introduces variability, cost, and potential risk.

The Trident team approached this challenge with creative solutions. Drawing from their automotive background, they implemented low-cost automation and lean tooling strategies such as custom fixtures with integrated poka-yokes reducing human error and ensuring repeatable outcomes without requiring major capital outlay. The result is consistent quality, even in low-volume environments.

Managing variability doesn’t stop at the workstation. Trident employs a ‘manage by exception’ model to help employees identify, rather than chase, problems. Integrated systems flag discrepancies automatically, whether it’s a customer order mismatch, a pricing issue, or an inventory concern. “No one can deliver perfect quality every time,” Sapiente says. “But with the right systems, you can catch what matters, early. It allows our people to spend their time solving problems, not searching for them.”

A mountain-moving mindset

Sapiente also believes many of the delays and inefficiencies in medical manufacturing are self-inflicted. He points to the early days of the COVID-19 pandemic, when ventilators were developed and delivered with unprecedented speed. The urgency cut through the usual bureaucracy, and the industry proved it could move quickly when it needed to. Since then, that urgency has faded – and with it, efficiency. Projects now get bogged down in slow decision-making, sometimes with dozens of stakeholders debating issues that have little impact on quality or safety.

By contrast, in the automotive world, the expectation is different from the outset. Entire project launches are governed by immovable deadlines. Model year rollouts, supplier integration, tooling readiness, and regulatory approvals all have to align, often down to the week. Automotive teams are hardwired to treat the launch date as sacred. The mentality isn’t “we’ll get there when it’s ready.” It’s “we don’t move the date. We move mountains to meet it.”

Sapiente, who spent years overseeing safety-critical automotive components such as the locking mechanism in seatbelts and rollover valves, brings that mindset to his work at Trident Manufacturing. “In auto, there’s no option to miss a launch date. You figure it out,” he says. “In medical device, I see incredible teams, great ideas, and strong engineering, but too often, there’s no urgency around launching on time.”

To be clear, Sapiente isn’t advocating cutting corners. He understands the regulatory rigor required in healthcare. After all, a failing medical device carries just as much risk as a defective seatbelt. But what he challenges is the culture of endless refinement, the lack of schedule discipline, and the overreliance on drawn-out processes that can choke innovation and drain resources.

He believes by applying the same executional discipline found in automotive, aligning cross-functional teams around a hard launch date, engineering toward manufacturability from day one, and designing compliance into the process, medical device firms can get to market faster without compromising safety or quality.

“We’re not trying to race to the bottom,” Sapiente notes. “We’re trying to lower health care costs and time to market while guaranteeing patient safety.”

Leading change in a mature, heavily regulated industry is not easy. But with the right structure, tools, and mindset, Trident is helping its partners navigate the complexities with confidence. “We are a true one-stop solution,” Sapiente says. “Our team engages early, helps optimize the product, supports prototyping and validation, and manages everything through to full-scale production and sterilization.”

Trident’s tagline says it all: Make it better for less. And by infusing lean, automotive-style discipline into every step of the medical manufacturing process, they are showing that zero defects and zero waste are not only possible – they can become the industry standard.

About the author: Clare Scott is managing editor of GIE Media’s Manufacturing Group of publications. She can be reached at CScott@gie.net.

Trident Manufacturing
https://tridentmfg.com