Frequently asked questions

In detail

The analytics itself runs stably and reliably in most labs. The real burden comes from the sum of many small friction losses around the process: information is spread across LIS, device software, QC tools, Excel lists, emails and paper; the same data is transferred several times; shift handovers are often informal; and decisions — why a QC was accepted, a repeat ordered or a result released — frequently stay “in people's heads”. As a result, a growing share of highly qualified staff time goes into coordination, providing context, QC review and documentation rather than expert work. Individually each friction is harmless; together they tie up significant management capacity. This burden grows gradually and is therefore often accepted as “normal lab routine” — even though it usually grows disproportionately as sample volumes rise, because organisational complexity grows faster than volume.

In detail

A classic LIS follows sample-oriented logic — one sample, one order, one result. PCR, by contrast, works in plates and batches with several consecutive steps: extraction, PCR setup, measurement, interpretation, repeats. Where these two logics meet, a structural gap appears: plate layouts are kept in Excel, data is transferred manually between systems, the same operations are documented twice, and there is no continuous view from sample intake to validated result. This gap is not a flaw of the LIS — it simply lies outside its design. Mobiolink closes exactly this batch-oriented space between intake and result return, and hands the result back to the LIS in a structured way at the end, without replacing it.

In detail

Powerful automation — especially full automation that integrates sample registration, extraction, setup, measurement, repeats and parts of QC — reduces manual work, standardises processes and relieves the team in routine steps very effectively. Within its own closed process space it solves many classic problems largely; in larger labs that is often sensible or even necessary and should not be downplayed. The open flank usually arises not inside the automated system but above and between systems: as soon as several instruments, vendors, assays, reagent lots, user roles, raw-data sources and audit trails come together, traceability, data and organisational responsibility get spread across many systems. Semi-automation and multi-instrument environments amplify this further. Mobiolink does not attack automation; it acts precisely at this overarching level: the value of existing automation systems is only fully realised when the organisation and data structure above them grows with them — Mobiolink amplifies those investments.

In detail

A lot of communication happens precisely because the system state is not visible. PCR processes are strongly state-dependent: runs are in progress, QC is open, repeats are pending, samples are waiting, instruments are blocked. If these states are not structurally visible, the team has to ask for them actively — via short conversations, sticky notes, whiteboards, emails and personal memory. Shift handovers thus become a source of error, critical knowledge stays on “information islands”, and managers become a permanent source of context. Visible states noticeably reduce queries, alignment and status emails. Put pointedly: many PCR departments do not have a communication problem — they have a transparency problem. Mobiolink makes exactly these states and decisions systemically visible, instead of having to compensate for them through meetings.

In detail

The effort is not the audit itself, but gathering the evidence beforehand. Typically, for one run, QC, raw data, reagent lots, repeats and decisions must be collected from several systems, relationships reconstructed and documentation chains traced manually. Often only a few very experienced people know where which information sits and how it connects — audit readiness becomes person-bound rather than system-supported. The risk is rarely missing documentation, but its lack of fast availability. Mobiolink lets documentation emerge within the process and links it to the respective run, so evidence is structurally available instead of having to be assembled laboriously before every audit.

In detail

Concretely, Mobiolink sits between sample intake and result return to the LIS and organises the batch and multi-step workflows in between: intake and routing, plate layout, run and QC states, traceable interpretation, technical validation and documentation. It does not see itself as a device extension but as organisational infrastructure above instruments and systems — a vendor-neutral layer where processes, data and decisions converge. It runs on-premise in your infrastructure and complements LIS and automation rather than replacing them. PCR is the most mature; the same batch and organisation logic also carries analytical chemistry.

In detail

The LIS remains the leading system for order and result and keeps its role fully. Mobiolink steps in where the LIS reaches its sample-oriented limits — in the batch-oriented space between intake and result return — and hands the validated result back to the LIS in a structured way at the end. It therefore replaces neither a LIS nor a LIMS and does not compete with them; it closes the organisational gap in between that both system designs conceptually leave open.

In detail

Maturity is highest in PCR: clinical molecular biology, infectious disease screening, toxicology/forensics, and human and cancer genetics. Analytical chemistry (LC-MS/MS, HPLC, ELISA) is also in production use because the same underlying structure applies: batch logic, QC review, raw data, interpretation and instrument integration. Structurally the common bracket is not “PCR” or “chemistry” but the batch-driven specialty-lab process. Multi-analytics is therefore not a promise but already reality — yet the focus of our statements deliberately stays on PCR, where maturity is highest.

In detail

What is replaced is not a single system, but the patchwork that many labs have built out of necessity over time: Excel plate lists, paper protocols, isolated device software, manual notes and parallel documentation. These structures work in daily practice but are fragile and strongly person-bound. In their place comes one continuous, visible and documented workflow. The instruments, their software and the LIS all remain — they are brought together organisationally, not replaced.

In detail

Device software is optimised for its own step — instrument control, measurement, instrument-level evaluation — and ends at the instrument boundary. That is sensible, but it does not cover the lab level: workflow control, routing and priorities, status overview, cross-system traceability, central raw-data storage, reagent and lot management, and shift communication. Most systems optimise the analytical side; the biggest organisational problems arise on the organisational side. Mobiolink lays a vendor-neutral organisation and data layer on top: a central process overview across instruments and systems, visible run and QC states, traceable decisions — and therefore less dependence on individual key people.

In detail

The application is designed for focused work at the lab workstation and built for an HD desktop screen. The core views — plate layout, run and QC status, validation of amplification curves — are very information-dense and aimed at precise work at the workstation. Mobile operation would not do justice to this density and is therefore deliberately not intended; it is an architectural decision, not an open point.

In detail

Mobiolink applies the interpretation rule pre-parameterised by the lab consistently and traceably and makes every step visible and documented — from raw signal through rule application to the proposal. This makes interpretation reproducible and less dependent on daily form and individuals. The expert assessment and final release, however, stay under human responsibility in the lab; Mobiolink makes no medical or diagnostic statement itself. It is therefore decision support with full traceability, not a standalone diagnostic automatism.

In detail

Confirmed in production are MOLIS, MCS, MELOS and OSM. Native HL7 compatibility and custom connectors allow further systems to be connected. What matters is the type of connection: Mobiolink integrates “like a lab device” and uses the device interfaces already established on the LIS. As a result no heavy reconfiguration or migration project is needed on the LIS itself, and the existing LIS processes stay unchanged.

In detail

Mobiolink registers with the LIS “like a lab device” and uses the interfaces the LIS provides for instruments anyway. This avoids a deep change to the LIS configuration, and the connection does not touch the existing LIS workflows. The concrete effort depends on the interface situation and assays and is made transparent per lab in advance, so it stays plannable.

In detail

Real PCR labs often run several instruments, vendors and software platforms in parallel — full automation for standard tests, open systems for special analyses. Instead of treating each system separately, Mobiolink forms a vendor-neutral organisational layer above the instruments. Traceability, data access, reagent and lot management and control are unified across systems, vendors, assays and lots. This keeps the lab as a whole traceable and controllable — even when the instrument fleet is mixed, designed redundantly, or grows step by step.

In detail

The technical interface is usually the smaller, well-solvable part. The real lever is workflow integration: how processes are structured, how interpretation is organised and documented, how scattered information is linked and how states are made visible. If integration is treated only as an interface topic, the underlying structural problem remains — the data flows, but the organisation does not become clearer. This is exactly where Mobiolink focuses: the interface is a means, not the goal.

In detail

Raw data is almost always stored technically but sits distributed across device systems, local machines and exports, in different formats and without a link to the process information. In a problem or follow-up case a run then has to be reconstructed laboriously, which costs a lot of time and mental energy. The real risk is therefore rarely data loss, but the lack of fast availability. Mobiolink links the raw data centrally to the corresponding run, QC and lots and makes it quickly and traceably findable again on follow-up questions.

In detail

Mobiolink is deliberately operated on-premise in your infrastructure. Patient and process data never leave your premises; there is no external data transfer and no processing outside your environment. Responsibility for GDPR and hosting therefore stays clearly and fully with the lab and under your control — without additional external dependency. This is a deliberate architectural decision, not a temporary state.

In detail

Mobiolink has no standalone diagnostic intended purpose: it makes no medical statement about a sample but organises, documents and makes processes traceable. The parameterised interpretation rules are defined by the lab; expert assessment and final release stay under human responsibility in the lab. Mobiolink therefore lies outside the IVDR scope and is not an in-vitro diagnostic device but an organisation and traceability tool. The concrete regulatory classification for your use case is discussed transparently in the project.

In detail

Requirements from ISO 15189, DAkkS or RiliBÄK demand gap-free traceability, consistent documentation and reproducible processes. In practice this rarely fails because of missing documentation, but because it emerges distributed, after the fact and person-bound. Mobiolink supports the organisational fulfilment of these requirements by letting documentation emerge within the process, logging decisions with rationale and keeping evidence structurally available. It remains explicitly an aid for process organisation — not a diagnostic device and not a substitute for the lab's expert responsibility.

In detail

Formally, traceability is often present — everything is documented “somewhere”. In practice, however, it is frequently person-bound: only a few very experienced people know where which information sits, which systems to consult and how a run is reconstructed. If that knowledge is absent — holiday, turnover, bottleneck — traceability becomes fragile even though it is formally met. That is a hidden organisational risk. Mobiolink makes traceability system-supported: the links between sample, run, QC, lots and decisions are retrievable without special knowledge and therefore operationally usable independently of individuals.

In detail

Many software validations focus on the question “Does the result arrive correctly in the LIS?”. But most organisational risks arise earlier: QC decisions, interpretation, run review, exception handling, process deviations and manual corrections. Exactly these steps are often poorly structured, hard to trace and person-bound. Mobiolink makes that decision logic structured, consistent and traceable — where the real uncertainty lies — and thereby complements pure interface validation rather than replacing it.

In detail

Manual interventions are unavoidable in lab routine — what matters is not preventing them but making them traceable. Mobiolink logs them centrally (journaling), including the rationale: why a QC was accepted, a repeat ordered or a release granted, by whom and when. These decisions are thus consistently traceable for the whole team instead of staying in individual heads. This reduces queries, supports consistent decisions and is immediately demonstrable in an audit.

In detail

All data stays exclusively in your infrastructure, since Mobiolink runs on-premise and performs no external data transfer. There is no cloud component, no external processing and no additional external access. Responsibility for GDPR, hosting and access control stays fully with the lab; Mobiolink adds no new sharing to the existing data holding, it only structures it internally. Data sovereignty therefore stays unchanged with you.

In detail

Reversibility is foreseen from the start and is not an afterthought: your data is returned in open, reusable formats so that no technical lock-in arises and a switch or rollback stays possible. The concrete modalities — scope, formats, deadlines — are fixed bindingly in the contract so there is clarity from the outset.

In detail

Onboarding follows a clear phased method: kick-off and goal definition, parameterisation of methods and rules, team training, go-live and a supported hypercare phase after launch. The concrete duration depends on scope, number of assays, interface situation and complexity and is agreed per lab. The cut is deliberately chosen so that ongoing operations are not blocked — onboarding happens guided and step by step, not as a big bang.

In detail

Effort for the lab is deliberately limited by the “integration like a device” principle: no heavy LIS project, no deep reconfiguration of existing systems. The lab team's involvement is clearly scoped per phase — above all for parameterisation and training, that is, where your expertise is genuinely needed. The concrete effort is made transparent and planned together up front, so it stays calculable and fits into ongoing operations.

In detail

Long onboarding rarely arises from lack of competence, but because much knowledge sits in heads rather than in structures — where information is found, how relationships are reconstructed, how special cases are decided. When information is instantly available, states are visible and processes are guided, new staff have to laboriously build up less implicit knowledge and become independently productive faster. This at the same time reduces dependence on individual key people and makes the lab more robust against turnover and part-time models.

In detail

Especially in high-load phases — such as the winter season — test volumes, sick leave and organisational effort often rise at the same time. If administrative tasks are then postponed, documentation backlogs, stress and increased error-proneness build up, often exactly when experienced people are missing. Structured, visible processes in which documentation emerges continuously within the process and states are readable at any time make the lab more robust against these load peaks. The goal is not more staff per sample, but less organisational fragility as volume grows.

In detail

On the contrary: often it is not the technology that blocks introducing new assays, but the tie-up of scarce management capacity through audit and accreditation preparation and operational daily pressure. Improvement projects are postponed because no time windows remain — a classic organisational paradox. When the information needed for audits and evidence is structurally available, exactly this bottleneck is relieved. This tends to create additional room for new assays and process improvements, rather than an extra hurdle.

In detail

A scoped pilot on a defined process section — for instance one method or one instrument environment — with success criteria agreed up front is possible and often a good entry point. This lets you assess impact and effort in your own lab concretely and with low risk before rolling out more broadly. We discuss the right scope, the criteria and the duration together in the demo call.

In detail

Scope differs considerably per lab — number of assays, connected systems and interfaces, processes covered — so there is deliberately no flat list price. We agree on a suitable model in a personal conversation, transparently and based on your actual needs rather than on an artificial standard configuration. We discuss the commercial frame early and openly, so it is robust enough for your internal decision.

In detail

Instruments improve analytics but do not solve the overarching organisation — and that is exactly where many hidden costs arise: coordination, search and waiting times, postponed decisions, experienced staff tied up by routine and administrative tasks. These costs do not appear as a line on an invoice but add up considerably. On top of that: instruments are visible and prestigious, organisational software is “invisible” and often only valued in a problem case. The point is therefore not “software instead of instruments”: the value of existing — even expensive — automation is only fully realised when the organisation and data structure grow with it. Mobiolink acts as an amplifier of those investments, not as an alternative to them.

In detail

No — and that is a deliberate stance. Automation and full automation often centralise the physical process very effectively and are frequently necessary in larger labs. They simply show a structural limit: they centralise the physical process but tend to decentralise data, control and organisational responsibility across several systems. Mobiolink occupies this overarching organisational level and thereby reinforces the value of existing instruments and automation, rather than competing with the vendors. The question is not “automation or software”, but: how does an increasingly automated lab stay controllable, traceable and flexible as a whole?

In detail

For management, what counts is less a single feature than the effect on operations. Concretely: more stable, less failure-prone workflows; less dependence on individual key people; better scalability as sample volumes grow, without proportionally more coordination; lower operational risk; and higher regulatory confidence through documentation that emerges within the process. On top of that an often underestimated effect: less daily organisational friction relieves experienced staff and frees up room for expert rather than administrative work again. For many managers the real value is not just efficiency, but calm and predictability.

In detail

You leave a few details about your lab and your role via the form — deliberately only a few, qualifying fields. We get back to you personally, briefly clarify your context and question and then schedule a slot for a demo tailored to your situation. There is deliberately no anonymous online calendar: this ensures the conversation fits your actual needs and that you speak with the right person — not a mass appointment.

In detail

Mobiolink is in production use in European labs. Out of consideration for our customers we do not name references publicly on the website, but on qualified request and on the basis of a mutual confidentiality agreement. This lets us name a reference that matches your specific use case — analytics, instrument environment, lab size — rather than an arbitrary logo. We discuss the right frame for this in the conversation.