PCBs for medical devices – where the real supply chain risk hides

For procurement and supply chain leaders in MedTech, reliability and compliance aren’t optional, they’re the foundation of everything. Yet one of the most critical components in your design, the printed circuit board, often sits several tiers deep in the supply chain, hidden behind your contract manufacturer.

Most contract manufacturers (CMs) are exceptional at what they do, managing components, logistics, and assembly with precision. But PCBs are different. They’re not catalogue parts. Every board is unique, and small process variations can have huge implications. When sourcing decisions are left entirely in someone else’s hands, your risk profile can quietly change, often without you realizing it.

Why PCB sourcing is different

For a reliable PCB, all details matter. Material choice, stack-up design, copper thickness, via structures, plating quality, and quality assurance strategy all directly affect long-term reliability. These aren’t minor manufacturing details; they’re performance and compliance drivers. Even small variations, for example in lamination pressure, copper adhesion, or plating integrity can cause failures that only appear months or years later, when your device is already in the field. Managing that risk demands an understanding of both the intent of the PCB design, and manufacturing reality.

Convenience can create blind spots

Relying on your CM to choose the PCB producer may seem logical — one supplier, one invoice, less admin. But that convenience can also be misleading:

• Qualification depth: CMs may not qualify PCB factories to the same depth an OEM operating in a regulated environment would expect.
• Commercial pressures: lead-time priorities or existing relationships can influence sourcing decisions.
• Limited visibility: PCBs often sit two or three steps removed from the OEM, making traceability harder.

The result? A board that looks correct, passes early testing, but may not meet the stringent requirements of your product or its regulatory environment.

Risks starts with data

Risk doesn’t begin in the factory, it starts much earlier, with the data used to build the board. Across the industry, around 40% of PCB data packs arrive incomplete or unclear. Missing material details, incomplete stack-ups, or undefined test criteria leave room for assumptions, and assumptions lead to variation. When manufacturers must “fill in the blanks,” even with the best intentions, small deviations from the design intent can slip through. Those gaps may not show up until late in the process, or worse, after the product is in the field. In a medical device, that’s a risk no one can afford. Small documentation errors can quickly snowball into lost time, rework, or compliance issues. Recognising that vulnerability early is the first step toward real control.

Design disconnects: the third-party challenge

Another often-overlooked source of risk lies in how designs are created. Many MedTech companies outsource PCB layout to external design houses. These designers are skilled, but may not fully understand the manufacturing capabilities of the factories that will build the boards. The result? Data sets with features that can’t be produced using standard processes. We’ve seen track and gap as fine as 1.5 mil, or via structures that simply can’t be manufactured. When that happens, the data must go back to the designer for correction which delays builds and creates room for error.

Early collaboration between the design team and a PCB partner who understands their approved factories´ capabilities closes that gap and prevents costly surprises.

Auditing a PCB factory once isn’t enough

A single audit doesn’t secure long-term quality. To maintain true control, you need regular audits over time, including on-site visits, continuous performance monitoring, and full access to quality data and traceability systems.

NCAB´s model is built around continuous factory management. We have local Production Quality Engineers (PQEs) and Quality Control technicians (QCs) working on site at our approved factories. Our PQEs are working proactively to achieve improvements and are responsible for the factories’ performance, as well as for building relationships. Our QCs confirm that the PCBs are manufactured and verified according to our specifications.

The real cost of a hidden failure

When PCB issues occur, they rarely show up in prototypes. They surface months later as intermittent test failures or field returns, often traced back to subtle process variations. Typical root causes include contamination during lamination, poor microvia plating, track repairs, unapproved material substitutions, or weaknesses in quality assurance processes. By the time the issue is discovered, the cost of investigation, re-qualification, and lost confidence can dwarf the original price difference between suppliers – not to mention potential recall or liability risks.

To be sure to minimize those failures, we use our own PCB Specification. It is a comprehensive document listing over 100 different requirements, all of which must be met while manufacturing PCBs for our customers. The specification either complements or goes beyond the established industry standard of IPC class 2. Part of it is our qualification and release process where we have strict inspection standards regarding compliance, materials, dimensions, reliability tests, and more. The final product is inspected according to our standard and delivered with a first article report, including a microsection, to ensure the product meets our standards for a reliable and durable PCB.

Sustainability: the next dimension of control

Sustainability has become a board-level topic for most MedTech companies, and rightly so. PCB manufacturing is energy-intensive, and environmental performance varies significantly from factory to factory.

We strive to be a catalyst for a more sustainable PCB and manufacturing, and our goal is to ensure that our PCBs are produced in a way that minimizes the total environmental impact.

Choosing the right factory from a sustainability perspective

A major global MedTech company recently asked us to help reduce CO₂ emissions at board level. By reviewing production across our approved network, we moved their product to a site powered by over 80% renewable energy — cutting CO₂emissions per board by 60% without any design or quality compromise.

Collaboration, not confrontation

This isn’t about taking control away from your CM. They play a vital role in assembly, logistics, and component sourcing. But PCBs deserve a different approach — one based on shared responsibility and transparency.

The best outcomes happen when OEMs, CMs, and PCB partners work together:

• The CM manages assembly and logistics.
• The OEM defines clear specifications and maintains oversight.
• The PCB partner ensures those requirements are built into the board from the start by translating standards into practical manufacturing steps, guiding documentation, and maintaining full traceability through every stage of production.

Working this way creates a supply chain that’s resilient, transparent, and built for reliability. A supply chain that keeps surprises to a minimum and quality consistent from first build to full production.

Taking control where it matters

Hidden risks live where visibility is low. In today’s regulated and sustainability-driven environment, that risk increasingly sits within the PCB supply chain. By tightening documentation, engaging your PCB partner early in design, maintaining continuous oversight of your factories, and integrating sustainability into sourcing decisions, you build a supply chain that’s stronger, cleaner, and more compliant from the design through the whole production process to the final product.

Do you have questions regarding PCBs for medical applications?

Contact Sam Thompson, Global Sales Director Medtech at NCAB Group.