Project Implementation

What a build-out covers

Standing up a sequencing laboratory is five parallel workstreams, not one. We run all of them, and hand over a lab that is ready to take samples rather than a room full of instruments.

• Lab build-out: workflow engineering, air handling for positive and negative pressure rooms, equipment acquisition, and hiring the lab and clinical staff to run it.
• Quality system: CAP readiness, ISO 15189 and NABL accreditation, designed in from day one rather than retrofitted after the first audit.
• Lab informatics: LIMS, a CRM system, and EHR-connected APIs so results reach the people who ordered them.
• Diagnostic test menu: market and reimbursement assessment, assay design and validation, and clinical reports with decision support.
• Sales enablement: sales-team curricula, training programmes, and the sales and marketing collateral to launch with.

Operate, scale, transfer

Build is the first of four stages. The other three happen after the laboratory opens.

• Operate: we run the laboratory with your staff for 12 to 24 months, and prepare the laboratory and the team for accreditation.
• Scale: from the first runs to the monthly volume the laboratory was planned for.
• Transfer: informatics handover, training for the operational team and a review of everything handed over, after which the laboratory is yours to run.

Who provides what

• You provide: the space, the power and the local approvals, the capital for the build and the instruments, and the employment of the staff who will run the laboratory.
• We provide: the laboratory design, procurement, recruiting the team you employ, assay and pipeline validation, accreditation preparation, the informatics, and training.

What the build is planned around

Most of what decides whether an in-house laboratory works is not the instrument. The plan is built around the rest.

• Cash: for six to twelve months the capital is committed and salaries are running before the first billable in-house result, while the send-out arrangement is still being paid for. The plan shows how deep that trough goes and when it ends, not only the breakeven volume.
• Accreditation: scoped for the whole service, including the analysis pipeline, reporting standards and external quality assessment, not only the wet lab.
• People: the dry lab staffed and trained before go-live, including someone qualified to sign out a variant.
• Utilisation: real samples on a weekly cadence, because cost per sample holds only when the flow cell is full.

Implementation or consulting?

Both end in a working laboratory. The difference is who runs it while it is being built. With Bespoke Consulting, your team builds and runs the laboratory, and we advise at each step and stay for three years after launch. With Project Implementation, we build it, operate it with your staff for 12 to 24 months, scale it to the volume it was planned for, then hand it to your team. The order the decisions come in, the volumes at which each step pays, and the shape of a build-out are on the consulting page.