Big-picture context
IVD success is no longer a purely biological challenge. While companies remain strongly rooted in scientific excellence, many are hitting a capability ceiling: their expertise in assay performance hasn’t yet been matched by the specialized systems engineering required for decentralized adoption. Diagnostics now need to function across fragmented healthcare settings, from central labs to point-of-care environments and even patient-facing use cases. That means usability, connectivity and workflow integration are just as critical as analytical accuracy. On top of that, regulatory expectations around traceability and real-world performance have intensified, while cost and operational pressures continue to grow. These combined pressures are redefining success in diagnostics, shifting the focus from isolated analytical performance to end-to-end ecosystem effectiveness in complex healthcare environments.
Trend 1: Decentralized testing needs robust usability
In vitro diagnostics have always been designed for trained lab techs working in controlled lab environments. That model doesn’t really work anymore. Testing is steadily shifting out of central labs and into clinics, hospital wards, pharmacies, and even patients’ homes. That means what used to be a very technical process now has to be simple, intuitive and robust in real-world conditions.
For IVD system design, this shift is profound: Usability now effectively defines the product. Devices must be small enough to fit into constrained clinical spaces, but also simple enough that there is only one way to run the test: the correct one. Every extra step increases the risk of error. At the same time, workflows need to be managed and streamlined end-to-end, including how patients register, how samples are collected, and where results are integrated.
Cartridge and consumable design are also changing, since tests are no longer performed in clean lab environments. Contamination risks must be engineered out at the design stage. All of this must be achieved while using lower-cost materials and supporting less specialized users, without compromising reliability or consistency.
Trend 2: Connected traceability changes system architecture
With stricter frameworks such as EUDAMED and tighter post-market surveillance rules, manufacturers are now expected to continuously generate, structure and report performance data across the entire product lifecycle. The old model of building a device and releasing it is giving way to one of ongoing accountability.
This shift matters more than ever because diagnostics are moving into higher-stakes clinical areas. Tests that once supported relatively simple decisions, such as pregnancy confirmation, are now being used in complex and sensitive domains like neurodegenerative diseases and long-term condition management. As clinical impact increases, so does the demand for traceable, reliable and auditable data.
Connectivity enables this transition, turning what was once sporadic data collection into a continuous flow of structured information. Yet, it also changes the fundamentals of system design. Devices must now be built as data-generating platforms from the outset, with storage, parameters and data streams considered at the architecture level, rather than added later.
The consequences for existing offline systems are significant. Companies must either re-engineer legacy products or phase them out, both of which can divert valuable engineering capacity from new innovation. This shift is particularly challenging for mid-sized and niche players, because larger companies are more likely to leverage existing software capabilities across business units. As a result, regulatory compliance demands strong in-house expertise to ensure systems are registered and data streams are correctly structured and maintained.
Trend 3: Scalability starts earlier, in cartridge and platform design
Scalability in IVD is often treated as a manufacturing or supply chain challenge, but in reality, it starts much earlier, in the architecture of cartridges, consumables and platforms. As diagnostics move closer to patients and away from centralized labs, manufacturers are being pushed toward smaller, simpler devices that can operate in clinics, pharmacies and other decentralized settings. Paradoxically, this miniaturization often increases technical complexity inside the system.
In the past, devices were developed primarily for trained laboratory professionals, which reduced the pressure around usability, volume scaling and cost sensitivity. Today, that is no longer the case. Products must be designed from the outset for high-volume use and non-expert users, making early design decisions far more consequential. Usability considerations just can’t be postponed without risking expensive redesigns later in the cycle.
Cost of goods has also become a defining constraint. Unlike central labs, which can absorb higher per-test costs, general practitioners and point-of-care settings operate under tighter budgets. This forces manufacturers to make manufacturability and cost trade-offs much earlier in development. At the same time, they need to shift toward system-level thinking and modular platform designs capable of running multiple tests on a single system, rather than single-disease instruments. Many R&D teams are still adapting to this way of working.
What you can learn from other industries
Luckily, IVD’s current transformation is not happening in isolation. FMCG and aerospace, in particular, offer clear lessons in how to design for miniaturization, modularity, and tight system integration without losing control over cost and complexity. In FMCG, high-volume product development has long depended on breaking systems into modular, interchangeable parts that can be rapidly iterated and optimized. Aerospace and space applications, on the other hand, have pushed miniaturization and reliability under extreme constraints, where every gram, component choice, and interface matters.
In practice, this translates into a more structured cost-down approach early in development, screening architectures faster and eliminating non-viable options before heavy R&D investment. In some of our projects, such as for Hippo Diagnostics and Fujirebio, applying this discipline helped reduce bill of materials costs by up to 50%, mainly by simplifying subsystem choices and improving component alignment.
Another transferable capability is holistic gap assessment: mapping the current system state, identifying regulatory and technical gaps, and translating them into a clear product roadmap. While we don’t replace regulatory expertise, this approach helps you turn complex requirements into actionable engineering decisions.
Finally, FMCG and industrial sectors also provide mature models for cybersecurity and system robustness, including proven approaches to risk management, layered security architecture, and continuous monitoring. These practices are increasingly relevant as IVD platforms become more connected, data-driven, and exposed to external systems and networks.