Projects
Device Scope is a specialist product development company and technology provider. We provide support across the full lifecycle of microfluidic design, development, and manufacture tailored to your team, technology and stage of development.
Our expertise includes:
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Design, development and manufacture of point-of-care diagnostic and laboratory instruments including Lab-on-a-chip, Microfluidic and complex IVD cartridges
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Biosensor development & mass manufacture
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Assay integration into microfluidic devices, including impacts due to reagent processing, material interactions and surfaces modifications.
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Microfluidic integration of wet & dry reagents, including blisters and lyophilised strategies for improved shelf life.
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Microfluidic cartridge rapid Prototyping, through to pilot & full-scale microfluidic manufacturing
Our mission is simple: lower technical risk, reduce development cost, and accelerate time to market. We achieve this by combining hands-on engineering expertise, established supplier chains and structured, proven development processes — from early feasibility through to manufacturing scale-up. We can help you whether you intend to build internal capability, or outsource, your development or manufacturing.
We structure our engagements as bespoke projects to address each client’s unique challenges. The following examples highlight key work packages where we provide specialist expertise:
Product Feasibility & Readiness Work Packages
Development Gap & Readiness Assessments
Our readiness assessments identify technical and program risks before entering critical development phases. This is particularly important for complex IVD systems where assays, microfluidic cartridges, and instruments are developed in parallel.
We ensure that:
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Critical assay inputs are available to support cartridge and instrument development
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Technical gaps are identified early
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Development plans align with performance, manufacturing, regulatory, and commercial goals
A Development Gap Analysis highlights missing or underestimated activities and helps prioritise actions required to achieve successful outcomes.
Development Planning
A structured development plan defines the pathway from concept to commercial manufacture. It aligns:
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Technical development
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Quality and regulatory requirements
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Risk management
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Cost and delivery expectations
Clear milestones, verification activities, and resourcing ensure predictable and quantifiable progress.
Concept Design
Concept design translates clinical needs and user requirements into robust system architectures. This phase explores:
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Assay principles
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Microfluidic chip and cartridge architectures
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Instrument configuration
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User workflows and technology options
The result is a feasible, lab-on-a-chip or IVD product concept aligned with technical and commercial goals.
Design for Manufacture (DFM)
Design for manufacture reviews assess suitability for scalable, cost-effective production. We evaluate:
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Manufacturing processes (e.g. injection moulding, bonding, surface treatments)
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Materials and tolerances
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Assembly, automation, and supply chain options
Early DFM reduces downstream risk and avoids costly redesigns.
Development Risk Assessments & Design Reviews
We conduct formal and informal development risk assessments in line with ISO 13485 and ISO 14971, identifying and mitigating technical and project risks.
Structured design reviews provide clear go/no-go decision points, ensuring designs are mature, compliant, and ready to progress.
Strategy, Planning & Technical Workshops
Strategy, Planning and technical workshops are customised to meet the team’s needs. These collaborative sessions can accelerate problem-solving, support robust technical decision-making and de-risk the project management. Multidisciplinary and experienced personal help review work to date, identify key risks, or provide insights into technical solutions, project tasks or management related activities.
Product Build & Prototyping Work Packages
Proof-of-Principle Microfluidic Designs
Early proof-of-principle microfluidic devices are fabricated to de-risk critical elements such as:
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Fluid handling
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Materials compatibility
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Assay integration
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Detection principles
These experimental devices are important to de-risk core assay functions in isolation of other variables, support early assay development within a microfluidic format, and establish performance criteria prior to integration.
Integrated Microfluidic Prototypes
Integrated prototypes combine multiple functionalities, often isolated and evaluated in the Proof-of-principle phase, into integrated devices to provide end-to-end functionality using a test-bench environment. These microfluidic prototypes enable early system-level testing and early performance verification in a representative format.
Alpha & Beta Prototypes
Alpha prototypes are in a format close to the final product and represents the first integrated system that meets key functional requirements. It is used for internal testing, feasibility studies, and early verification to confirm that the design can meet intended use objectives.
Beta prototypes are advanced, near final versions of the product built using intended manufacturing processes to support verification, validation, and regulatory engagement.
Packaging & Blister Development for Microfluidics
We support blister and packaging development for microfluidic cartridges, addressing:
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Reagent protection
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Usability
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Labelling and regulatory compliance
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Shelf-life and transport robustness
Manufacturing & Scale-Up Support
Design for Manufacture Updates
Following a Design For Manufacture review the DFM update incorporate design changes relating to feedback on the intended manufacturing processes, such as injection moulding, surface modification, bonding, component handling, reagent integration and automation. This step ensures the design is optimised for yield, quality, and cost prior to production.
Cost-of-Goods (COGS) Analysis
Cost-of-goods (COGS) assessments quantify material, labour, overhead, and supply chain costs. These analyses support commercial viability, pricing strategy, and design trade-offs early in the development process.
Production scale-up strategy
The production scale-up strategy defines how manufacturing will transition from pilot volumes to full commercial output. It addresses capacity planning based on market forecasts alongside investments, manufacturing setup and line qualification.
Production line implementation
Production line implementation establishes the physical manufacturing environment, equipment, tooling, process controls and qualification. This phase ensures repeatable, compliant production aligned with quality system requirements.
Production line transfer
Whether in-house or 3rd party production is required then Production line transfer provides the controlled handover from development to pilot or full-scale production. It provides knowledge transfer to enable manufacturing setup, process consistency, and regulatory compliance across manufacturing sites or partners.
Quality Management & Regulatory Support
We provide practical QMS support aligned with regulated IVD development, including:
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Development and manufacturing plans
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Requirements documentation
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Risk management files
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Design History Files (DHF)
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Device Master Records (DMR)
These deliverables support regulatory submissions and ensure compliant, repeatable manufacture.