Diagnostics Product Development
Getting from a promising assay to a product that is manufactured, validated and approved takes more than good science. Dolmen Diagnostics provides the development strategy, technical leadership and programme governance
Our Approach
What We Do
Development strategy and governance
Defining the product, the target performance, the regulatory route and the development plan, and setting up the governance — stage gates, design reviews, budget and portfolio oversight — that keeps a programme honest.
Assay development and verification
Technical leadership of assay design, optimisation and verification across molecular, immunoassay, sequencing and rapid-test formats, with experience spanning infectious disease, oncology and cardiac biomarkers.
Verification and validation programmes
Planning and running analytical performance studies, and designing clinical performance studies that generate the evidence IVDR, FDA and WHO Prequalification require.
Contract manufacturing and design transfer
Selecting and onboarding contract manufacturers, managing kit configuration, packaging, labelling and instructions for use, and transferring the design so that commercial product matches what was validated.
Companion software and platform integration
Oversight of the software, instruments and platform integration that a modern diagnostic depends on, and coordination between assay, software and hardware teams.
Interim development leadership
Our team have experience acting as Head of Product Development, Head of Assay Development or Head of Diagnostics for a defined period, with experience leading multidisciplinary teams of more than thirty scientists.
Who this is for
Research organisations and start-ups translating an assay into a regulated product for the first time.
Diagnostics companies scaling a development team or platform and require senior technical leadership.
Programmes that have stalled — over budget, behind schedule or without a clear route to a defined product.
Pharmaceutical and biotech companies developing companion diagnostics alongside a therapy.
Organisations needing an interim Head of Product Development or Head of Assay Development.
Pharmaceutical and biotech companies that require the establishment and delivery of diagnostic strategy for precision medicine assets
How an engagement runs
Product development engagements usually begin with a short review of the programme — the science, the plan, the team, the budget and the regulatory route — producing a candid assessment and a recommended course. From there the work may be advisory, hands-on or an interim role.
Design control and the quality system are built into the programme from the start rather than added at the end; see Design Control and Quality Services.
Related Services
Quality systems for diagnostics
Dolmen Diagnostics builds and repairs quality management systems for IVD and medical device companies, prepares them for certification, audits and inspections, and provides Quality leadership when the role is empty.
Quality systems for diagnostics
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Design Control
Design control is the discipline that turns an assay into a product a regulator can trust. Dolmen Diagnostics sets up design control that fits the organisation, brings existing programmes under control, and provides the independent oversight that design history files need.
Design Control
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Regulatory Strategy & Compliance
Regulation (EU) 2017/746 changed the rules for in vitro diagnostics in Europe. Most products now need a notified body, a performance evaluation that stands up to scrutiny, and a quality system that supports both. Dolmen Diagnostics helps companies understand exactly where they stand.
Regulatory Strategy & Compliance
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