The three biggest barriers to scalable IVD development – and how innovators can overcome them

This article explores the three most common barriers in IVD development, why they occur, and how CPI’s integrated approach helps teams build investor confidence, reduce time-to-clinic, and de-risk the path to scalable manufacture.

1. Why early IVD prototypes rarely scale to manufacture

Early feasibility studies often show strong technical promise, yet many IVD innovators encounter the same issue: a functional prototype is not enough to move towards clinical use, pilot manufacture, or investment. While prototypes can demonstrate core performance, they rarely include the design rigour, documentation, and manufacturability required for GMP-aligned production. 

This gap between prototype and product is one of the biggest blockers in IVD development. Its consequences can be significant: 

• Lengthy delays as products are redesigned for real-world production environments. In some cases, this can be 19 – 24 months before progression to pilot manufacture*. 

• Higher costs due to re-engineering and repeated prototyping, which can typically be 2 – 3x higher. 

• Reduced investor confidence, particularly where manufacturing readiness is unclear. 

*A survey by MedTech Europe shows that for IVD manufacturers under the new In‑Vitro Diagnostic Regulation (IVDR; EU), the total conformity assessment timelines (QMS + Technical Documentation Assessment + certificate issuance) averaged 19.5 months for IVDs and 21.8 months for medical devices. 

This suggests nearly 2 years just for certification/​assessment, before scale-up and manufacturing transfer can be considered. The same report noted that post-market surveillance updates for IVDs under IVDR took 20+ months in ~13 % of cases. 

Common causes of product–prototype failure

Design for Manufacture (DFM) begins too late
Early-stage innovators, particularly academic spinouts, often optimise assays, hardware, or microfluidics for performance rather than manufacturability or safety. Critical details such as material compatibility, robustness, and process variability only surface later. 

Manufacturers increasingly reject unscalable designs
Contract manufacturers now expect clear documentation, validated processes, and credible scale-up paths. Designs that lack these foundations often require major rework before transfer. 

Supply chain resilience and cost of goods matter earlier
Since COVID-19, investors and acquirers scrutinise COGS, supply chain security, and production feasibility much sooner in the development cycle, especially for lateral flow, microfluidics, and cartridge-based platforms. 

How CPI helps close the prototype–product gap

CPI supports IVD innovators by embedding manufacturing considerations from the start. Teams benefit from integrated expertise across: 

• Early-stage DFM and engineering. 

• Cleanroom prototyping aligned to future commercial processes. 

• Quality-by-design frameworks and early QMS considerations. 

• Pilot-scale feasibility that enables smoother technology transfer. 

This approach reduces redesign cycles, shortens timelines, and strengthens investor and partner confidence. 

2. How to navigate evolving IVD regulatory requirements in the UK, EU, and US

The second major barrier is regulatory uncertainty. IVD innovators developing across multiple markets face shifting expectations and overlapping requirements. With IVDR implementation continuing across Europe, and with FDA QMSR harmonisation influencing the US landscape, many teams struggle to decide when and how to integrate regulatory strategy into development. 

Too often, regulatory planning begins only after technical milestones have been reached. This can slow progression, increase risk, and reduce investor confidence. 

Key pain points for innovators

Regulatory planning arrives too late
Some teams focus on assay performance or hardware optimisation without embedding quality management, risk management, or clinical strategy early on. 

Dual-market ambitions complicate sequencing
Teams often ask whether analytical validation should be aligned to FDA or CE first, how UKCA fits in, or whether market strategy should shift as regulations evolve. 

Weak regulatory strategies raise investor risk
Investors increasingly expect a clear, realistic regulatory pathway. Missing, vague, or overly optimistic roadmaps can stall fundraising. 

Consequences

• Misaligned technical, clinical, and regulatory development. 

• Rework or repeated verification and validation cycles. 

• Missed market windows due to delayed submissions. 

How CPI integrates regulatory readiness from day one

CPI’s regulatory experts help teams progress technical and compliance activities in parallel, not in competition. Support includes: 

• Early ISO 13485-aligned processes and documentation. 

• Risk management aligned to ISO 14971. 

• FDA, UKCA, and CE regulatory and clinical strategy. 

• Alignment of technology development with verification plans and evidence requirements. 

This approach ensures innovators build towards regulatory-ready products from the outset. 

3. Why biology–hardware integration remains a major IVD development barrier

IVD systems combine interdependent components: assays, microfluidics, optics, firmware, sensors, software, sample preparation, and mechanical design. When these elements develop in silos, incompatibilities often emerge later on, when fixes are slow, costly, and potentially project-threatening. 

This biology – hardware integration gap remains one of the most common points of failure for IVD organisations. 

Where projects typically fail

Assay science develops separately from instrumentation
Biology teams may optimise for sensitivity and specificity, while engineers focus on hardware architecture. Misalignment can lead to poor analytical performance or unstable workflows. 

Late integration exposes hidden failures
Issues with sample preparation, chemistry compatibility, microfluidic stability, or sensor performance often appear only during verification, when fixes are most costly. 

Multiplexing and miniaturisation increase complexity
Modern diagnostic expectations require greater precision, tighter tolerances, and more reliable sensor and fluidic behaviour. Without integrated development, these become major sources of instability. 

Impact on development

• Failed verification and validation campaigns. 

• Repeated prototyping cycles. 

• Erosion of investor confidence. 

• Slower commercial progression. 

How CPI enables integrated IVD systems engineering

CPI brings biology, chemistry, engineering, software, and data science teams together under one roof. This multidisciplinary environment enables concurrent development across: 

• Assay design and optimisation. 

• Microfluidics and digital microfluidics. 

• Biosensors and cartridge design. 

• Optics, imaging, firmware, and control algorithms. 

• Modelling, simulation, and systems engineering. 

By integrating these capabilities from the start, innovators reduce risk, accelerate timelines, and build more reliable diagnostic platforms. 

What this means for IVD innovators

Whether developing diagnostic cartridges, molecular detection platforms, wearable sample analysers, or high-throughput instruments, these three barriers shape every development journey. They influence: 

• Investor readiness.

• Cost-of-goods.

• Manufacturability.

• System reliability.

• Time-to-clinic.

• Regulatory preparedness.

• Commercial viability.

Addressing these barriers early, through integrated science, engineering, regulatory, and manufacturing approaches, is the most efficient and cost-effective way to progress towards pilot manufacture and market entry. 

How CPI helps innovators build scalable, regulatory-ready IVDs

CPI’s MedTech capabilities are designed to help IVD companies overcome these systemic barriers. Innovators gain access to: 

• Biology, chemistry, engineering, and software teams working together. 

• ISO 13485-aligned quality frameworks. 

• Cleanroom and pilot-scale manufacturing environments. 

• Microfluidics, digital microfluidics, biosensor, and cartridge development expertise. 

• Regulatory and clinical pathway support. 

• Materials science, adhesives, biocompatibility, and formulation expertise. 

This integrated ecosystem reduces development risk, accelerates progression, and ensures diagnostic platforms are both technically robust and commercially viable. 

Want to access CPI’s full IVD development roadmap?

Contact us today to explore CPI’s full IVD development roadmap, or to discuss how CPI can support you to accelerate development, strengthen regulatory readiness, improve manufacturability, increase investor confidence, or reduce failure risk through multidisciplinary design. Let’s innovate together.