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Low-volume PCB manufacturing vs. COTS: Which is less risky at scale?
Reading time 15 mins
Key Points
- Transitioning from an IoT prototype to a scalable product with commercial off-the-shelf (COTS) components is a risk, as generic parts may fail to meet reliability, availability, or regulatory compliance standards.
- Low-volume PCB manufacturing enables tight design control, early testing, and iteration before mass production, supporting product customisation and quality assurance.
- COTS components can introduce supply chain vulnerabilities, end-of-life issues, and limited long-term support.
- Generic hardware often compromises performance, efficiency, miniaturisation, and environmental resilience.
- Custom PCB design reduces total cost of ownership by optimising BOM, assembly, testability, and lifecycle stability.
- Compliance and certification are easier with bespoke PCBs that embed safety, EMC, and regulatory standards from the start.
- Low-volume runs act as a bridge to mass production by validating manufacturing processes, field performance, and quality control protocols.
- Partnering with a full-service consultancy like Ignitec de-risks scale-up by integrating design and low-volume production with supply chain management and compliance expertise.
Want to build smarter, scale faster, and reduce risk without compromising flexibility or quality? Schedule a free consultation with an expert to plan your custom manufacturing roadmap.
Ben Mazur
Managing Director
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Do you know why the journey from a functional IoT prototype or Proof of Concept (PoC) to a commercially viable product is often referred to as the “Valley of Death”? This is because it is the stage where many hardware ventures fail. Sometimes, due to funding and certification hurdles, and at other times, due to limitations in the commercial off-the-shelf (COTS) components used during early development.
While COTS parts are ideal for rapid experimentation, they often fail to deliver the robustness, reliability, or long-term availability required when a product needs to scale. For new product launches, specialised electronics, IoT devices, or AI hardware, producing printed circuit boards (PCBs) in small quantities helps teams navigate the route to market more effectively. By enabling tighter control and flexibility over product design and performance, low-volume PCB manufacturing reduces risk, supports customisation, and improves quality assurance – ultimately reducing the time-to-market.
Ironically, it’s often the pressure to accelerate development and prove feasibility that prompts product managers and CTOs to turn to COTS solutions and generic manufacturing partners in the first place. This approach can work in early prototypes, but as soon as a product enters regulated or mission-critical environments, relying on COTS becomes a strategic gamble. Issues such as supply chain volatility, performance limitations, certification mismatches, or unexpected part end-of-life (EoL) events can introduce significant risk—leading to redesigns, delays, and the erosion of stakeholder trust.
Why are commercial off-the-shelf (COTS) solutions risky?
The primary appeal of COTS is its speed and initial savings, which result from lower upfront product development costs. However, these benefits diminish and become risks-to-be-assessed as soon as the product moves towards certification, scaling, or long-term deployment.
Supply chain vulnerability and obsolescence
COTS components are tied to their vendor’s roadmap, not to your product’s lifecycle. If a key module or chip goes EoL, you are forced into an expensive, unplanned redesign, which can stop production entirely. Even if replacements exist, even minor differences in electrical characteristics, firmware, or packaging can trigger compatibility issues.
This dependence becomes problematic when subsequently transitioning to low-volume PCB manufacturing and then scaling, as you’ll lack control over availability, future revisions, or long-term supply stability. And while no partner can guarantee, for example, a 10-year supply for every component, a lifecycle-aware team can manage the risk associated with the Bill of Materials (BoM) from the outset and source stable parts, plan for alternatives, and design with longevity in mind.
Performance and customisation limitations
COTS hardware is, by nature, generic. For commercial products and those deployed in challenging environments, this leads to devices that are:
- Inefficient: Off-the-shelf often include unnecessary features, older chipsets, or power-hungry components that drastically reduce battery life. This is a critical failure point and non-starter for wearables and IoT devices in remote sites (e.g., agricultural fields), offshore platforms, sealed enclosures, or hazardous zones.
- Oversized: The mechanical design is dictated by the COTS module’s footprint, not by your product requirements. This limits enclosure design, ergonomics, weight distribution, ruggedisation, and the ability to create compact or discreet devices.
- Inaccurate: Especially in health tech and environmental monitoring, COTS sensors may lack the precision, signal integrity, noise control, or calibration required to meet professional or regulatory data standards.
- Thermal management issues: COTS boards frequently run hotter than custom boards and are not thermally optimised for your enclosure, increasing the risk of failure over time.
- RF constraints: With fixed antennas, filters, and power profiles, COTS wireless modules limit range optimisation, interfere unpredictably with other components, and may fail regional RF compliance.
- Firmware and security dependency: Many COTS modules run proprietary firmware. You cannot inspect, modify, or patch it, meaning vulnerabilities or vendor updates can break your system or invalidate certification.
- Licensing/IP limitations: Some modules are subject to redistribution restrictions, unclear licensing terms, or contain closed-source components, which can complicate global deployment.
Regulatory and certification roadblocks
This is the most critical failure point. When a product must adhere to stringent standards (e.g., ATEX for hazardous environments, or IEC 60601 for medical devices), every component and trace must be documented and controlled. You simply cannot certify a product built on a COTS module whose internal design and software you do not fully control. Certification failure means project failure.
Why choose a custom design for low-volume PCB manufacturing?
Choosing bespoke design is a direct investment in long-term stability, longevity, and product fit, but it’s not an automatic guarantee of superiority. A custom PCB gives you the levers to optimise performance, reliability, regulatory compliance, and long-term cost in ways COTS does not. For teams moving from prototype to product, custom boards shorten the path to a stable, certifiable, and commercially competitive offering.
Optimal BOM and Total Cost of Ownership (TCO)
While the initial engineering costs are higher, custom PCB design reduces the TCO across the product’s lifecycle. This allows you to:
- Eliminate bloat: Removes unused circuitry and unnecessary components to optimise the component count, reduce the power draw, and lower the per-unit cost.
- Design for manufacturing (DfM) and assembly (DfA): Layout can be optimised for automated assembly, reducing assembly time, yield loss, and manual rework. Including Design for Test (DFT) features — such as test points, boundary-scan access, and fixture-friendly pads — reduces production test time and enhances field reliability.
- Secure the supply chain: Choose parts with predictable lifecycles, industry-standard footprints, and dual-sourcing options where possible. While no one can promise a perfect 10-year supply for every part, lifecycle-aware selection and approved alternates dramatically reduce the risk of unplanned redesigns during low-volume runs and scale-up.
Compliance and Certification Security: Design for Regulation
Custom PCBs enable you to bake compliance into the design, from schematic to layout. Examples include:
- Intrinsic safety & hazardous environments: At Ignitec, we design segregation (separating circuits for safety), safety barriers (protective circuits), current/voltage limiting, and fault containment directly onto the PCB to meet ATEX (a European directive for equipment used in explosive atmospheres) and IECEx (international certification for equipment in explosive environments) requirements.
- Medical device pathways: Aligning development with an ISO 13485-compliant quality management system (QMS—a system for consistent product quality) and design principles from standards such as IEC 60601 (an international standard for medical electrical equipment) ensures traceability, risk management, and documentation practices that simplify regulatory submissions.
- EMC/EMI control: Controlled stack-up, ground plane strategy, proper decoupling, and shielding are all far easier to implement in a custom design — and these choices materially reduce the chance of EMC failures during certification.
Superior Performance and IP Protection
A custom PCB is the most effective way to protect your Intellectual Property (IP). Unlike COTS solutions that are easily reverse-engineered, a bespoke board houses your proprietary firmware and design architecture, ensuring your intellectual property remains protected. Furthermore, it enables maximum miniaturisation, power efficiency, and signal integrity—essential advantages in highly competitive markets such as wearables.
How is low-volume manufacturing the ideal bridge to mass production?
Moving from a final prototype to a mass-produced product shouldn’t be done in one giant leap. It requires a controlled, iterative phase where assumptions are tested, risks are surfaced, and the design matures under production conditions. Low-volume PCB manufacturing provides that bridge.
This phase — typically manufacturing 50 to 5,000 units — is the essential proving ground where both your team and your manufacturing partner can:
Validate and refine the manufacturing process
Low-volume runs expose issues that are invisible in prototyping but become costly at scale. This phase allows you to:
- Identify defects, soldering inconsistencies, and assembly bottlenecks before committing to high-volume tooling to ensure optimal performance.
- Fine-tune DFM and DFA features such as component spacing, panelisation strategy, fiducials, pick-and-place orientation, thermal reliefs, and solder mask tuning.
- Produce golden samples and reference assemblies that become the standard for mass production.
- Confirm supplier capabilities and verify that the full production workflow performs reliably at scale.
Conduct meaningful field trials, compliance checks, and beta testing
Low-volume manufacturing gives you units built under near-production conditions — not hand-soldered or lab-assembled prototypes. These units provide credible real-world data needed for:
- Environmental and durability validation: temperature extremes, vibration, ingress protection (IP ratings), drop testing, and long-term power performance.
- Wearable and health-tech trials: clinical data, ergonomics, human factors engineering, biocompatibility, and sensor accuracy validation.
- Pre-certification tests: early EMC/EMI checks, RF pre-scans, power safety evaluations, and mechanical compliance reviews.
- Market testing: collecting user behaviour data, reliability metrics, and performance logs that drive final firmware and hardware tuning.
This step dramatically reduces the risk of regulatory failure or late-stage design reversals during mass production.
Finalise Quality Control (QC) and Quality Assurance (QA) protocols
Effective mass production depends on having reproducible, well-documented quality systems. Low-volume runs allow you to:
- Define and refine test coverage.
- Establish traceability methods.
- Validate statistical quality metrics needed for stable, high-volume production.
- Identify failure modes early and correct them before volume-based cost amplification sets in.
Once finalised, these processes are automated and scaled — ensuring every unit meets the target specification.
Why having an experienced low-volume manufacturing partner matters
This intermediate stage is where a specialised manufacturing partner adds enormous value. They combine the agility of a startup — quick iterations, rapid feedback loops, flexible tooling — with the discipline of a mature manufacturer, including rigorous QC, traceability systems, and structured process control.
How can a full-service consultancy help de-risk the manufacturing scale-up process?
Partnering with a consultancy that handles both custom design and low-volume PCB manufacturing is one of the most effective strategies to de-risk product scale-up. At Ignitec, we don’t just design your circuit boards; we manage the transition from prototype to production, ensuring continuity in design intent, knowledge transfer, and quality control throughout the process.
- Integrated Design-to-Manufacture: From the outset, our engineers incorporate DfM and DfA principles into your PCB design. Component selection balances electrical fit with market availability, lifecycle stability, and dual-source options — ensuring low-volume PCB manufacturing runs reliably and smoothly as you scale.
- Supply Chain Vetting and Management: We leverage trusted global suppliers and specialist low-volume assembly houses, managing component sourcing, verification, and logistics to ensure seamless operations. This mitigates risks such as counterfeit or end-of-life components, ensures competitive pricing, and guarantees that your Bill of Materials (BOM) is consistent and production-ready.
- Compliance Engineering Expertise: Regulatory and certification requirements are embedded early in the design and manufacturing process. Whether it’s intrinsic safety for hazardous environments or medical device standards, our team ensures audit-ready traceability, robust quality management systems, and alignment with certification frameworks, reducing the risk of costly redesigns or delays.
By combining custom design, low-volume production, and compliance expertise, a full-service partner like Ignitec provides the structured, data-driven bridge between prototype and mass production. The result is a safer, faster, and more predictable scale-up — with fewer surprises, fewer redesigns, and a higher probability of commercial success.
Final thoughts & next steps
For innovative companies in high-risk, high-reward sectors, relying solely on COTS components and fragmented manufacturing processes introduces unnecessary risk and uncertainty. Custom design paired with strategic low-volume PCB manufacturing isn’t a luxury — it’s a safeguard against regulatory setbacks, supply chain disruption, and costly redesigns.
You’ve proven your concept. Now it’s time to protect your product’s future. Stop working within the constraints of generic COTS solutions and start building a foundation designed for scale, compliance, and reliability.
If you’re ready to secure your supply chain, optimise performance, and scale your certified product with a fully integrated, risk-managed process, speak with our engineering team today about a custom PCB review and manufacturing roadmap.
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FAQ’s
Why is low-volume PCB manufacturing important for IoT products?
Low-volume PCB manufacturing allows teams to validate designs and manufacturing processes before committing to mass production. It helps identify assembly issues, component limitations, and potential regulatory gaps. This reduces risk, improves quality, and shortens the path to market for IoT devices.
How does low-volume PCB manufacturing reduce supply chain risk?
Low-volume manufacturing lets engineers select components with stable lifecycles and dual sourcing options. It reduces reliance on end-of-life or proprietary modules often found in COTS solutions. This ensures more predictable production and fewer unplanned redesigns during scaling.
What are the main differences between COTS and custom PCBs?
COTS modules are off-the-shelf components designed for general use, offering speed and lower initial cost. Custom PCBs are designed specifically for the product, optimising performance, manufacturability, and regulatory compliance. Custom designs allow better control over supply, power efficiency, and IP protection.
Why is regulatory compliance critical in low-volume PCB manufacturing?
Regulatory compliance ensures that your device meets safety, environmental, and performance standards before it reaches the market. It reduces the risk of recalls, legal penalties, and reputational damage. Low-volume runs allow you to test compliance measures early in the production process.
How do low-volume PCB runs benefit the development of wearable technology?
They enable realistic assembly, power, and sensor testing under expected environmental conditions. Field trials can assess comfort, ergonomics, and durability before mass production. This ensures the final wearable is reliable, efficient, and compliant with industry standards.
When should a company choose low-volume PCB manufacturing?
Low-volume PCB manufacturing is ideal when transitioning from prototype to production, particularly for testing the market or verifying performance. It is particularly useful for specialised electronics, wearables, health tech, or IoT devices in challenging environments. This stage ensures quality, regulatory compliance, and production readiness before scaling.
Which industries benefit most from low-volume PCB manufacturing?
Industries such as IoT, wearable technology, health tech, industrial automation, and AI hardware gain the most benefit. These sectors require high reliability, regulatory compliance, and customised performance. Low-volume runs allow them to validate designs without committing to high-volume production upfront.
Who should be involved in low-volume PCB manufacturing planning?
Engineers, product managers, and supply chain specialists should collaborate from the start. Compliance and regulatory experts can incorporate certification requirements early in the design process. Engaging manufacturing partners ensures design, testing, and production processes are aligned with scaling goals.
Why is low-volume PCB manufacturing considered a bridge to mass production?
It provides a controlled phase where manufacturing processes, quality controls, and performance can be tested at near-production conditions. This reduces the risk of defects, recalls, or redesigns when moving to full-scale production. It also enables field testing and regulatory validation before mass production.
How can low-volume PCB runs improve product quality?
By producing smaller batches under realistic assembly conditions, potential defects and design flaws are identified early. Test procedures, QA protocols, and reliability metrics can be refined and automated to enhance efficiency. This ensures that mass-produced units consistently meet quality and performance standards.
What are the limitations of using COTS components in IoT devices?
COTS components are generic and may not meet specialised power, size, or precision requirements. They are tied to vendor roadmaps, making long-term supply unpredictable. Regulatory and certification compliance is harder because internal designs and firmware are often inaccessible.
When is custom PCB design more cost-effective than COTS?
Custom PCB design becomes more cost-effective over the product lifecycle when COTS solutions create redesign, supply, or compliance risks. Optimising the BOM, assembly, and test procedures reduces the total cost of ownership. Long-term reliability, regulatory success, and IP protection justify the initial investment.
Which aspects of a PCB can be optimised in low-volume manufacturing?
Component placement, trace routing, power management, thermal design, and signal integrity can all be refined. Assembly processes, test points, and design-for-test features can be incorporated to enhance the overall quality of the product. These optimisations improve manufacturability, reliability, and regulatory compliance.
Who benefits from early regulatory and certification planning in PCB design?
Medical device companies, industrial IoT manufacturers, and teams working in hazardous environments benefit the most. Early planning reduces the risk of certification failure or redesign. It ensures traceability, compliance, and faster time-to-market.
Why is testing during low-volume PCB manufacturing critical?
Testing reveals defects, assembly challenges, and environmental vulnerabilities that prototypes may not show. It validates field performance, reliability, and adherence to regulatory requirements. This ensures that mass-produced units meet functional and safety standards.
How does low-volume PCB manufacturing protect intellectual property?
Custom PCBs house proprietary circuitry, firmware, and layouts that are difficult to reverse-engineer. Unlike COTS modules, they prevent exposure of your design architecture. This safeguards competitive advantage in highly competitive markets.
What role do DFM and DFA play in low-volume PCB manufacturing?
Design for Manufacturability (DFM) and Design for Assembly (DFA) optimise board layout for efficient assembly and testing. They reduce errors, assembly time, and yield loss. Incorporating these principles early improves reliability and lowers production costs during scaling.
When can low-volume PCB manufacturing help with firmware integration?
It provides real-world boards to test firmware, communication protocols, and sensor calibration under production conditions. This ensures compatibility and performance before mass deployment. Early integration reduces the risk of software issues delaying scale-up.
Which testing methods are most useful in low-volume PCB production?
Methods such as Automated Optical Inspection (AOI), in-circuit testing (ICT), boundary-scan, and functional testing are essential. Environmental stress testing validates temperature, vibration, and durability. These methods ensure high reliability and readiness for mass production.
Why is supply chain vetting important for low-volume PCB runs?
Selecting reliable component suppliers reduces the risks of counterfeit or obsolete parts. It ensures dual sourcing and predictable availability during scale-up. Effective vetting avoids costly redesigns, delays, and quality failures.
How can low-volume manufacturing accelerate time-to-market?
By allowing early design validation, regulatory checks, and field testing, issues are resolved before mass production. Iterations can happen quickly without committing to large volumes. This controlled approach reduces delays and streamlines the path from prototype to launch.
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