Case Study 02 · Point of Care Diagnostics

High-Speed Lateral Flow Assay Cartridge Assembly System

A rapid diagnostics manufacturer sought a fully automated assembly platform for influenza and COVID-19 lateral flow cartridges — 400 units per minute, Class 7 cleanroom, global regulatory compliance.

$3.1M
Program Value
11 mo
Sales Cycle
6
Buying Influences
Won
Outcome
Point of care diagnostic device
Background

The Opportunity

Following demand surge from pandemic-era contracts, a mid-tier in-vitro diagnostics company was expanding its lateral flow test manufacturing capacity at a new facility. The project required a multi-station automated platform handling membrane cutting, nitrocellulose lamination, conjugate pad placement, absorbent pad staging, and cartridge final assembly — all within ISO Class 7 cleanroom boundaries.

The integrator was engaged as a strategic advisor and program manager to lead vendor qualification, technical specification development, and commercial negotiation across a compressed 11-month cycle.

  • Confirmed $3.5M capital budget held by VP Operations with board pre-approval
  • Verified regulatory requirement: 21 CFR Part 820 + EU MDR Article 10 compliance
  • Champion identified: Director of Process Engineering — already drafted spec
  • Established no internal automation engineering staff; full outsource required
  • Confirmed 3 competing integrators at pre-qualification stage
  • Verified throughput target: ≥400 UPM validated in production environment
Stakeholder Map

Buying Influences

RoleName / TitleInfluenceModeKey Concern
Economic Buyer
VP OperationsBudget owner, final approvalGrowthOn-time facility readiness, throughput SLA
Technical Buyer
Dir. Process EngineeringSpecification author, technical leadSupportMembrane handling without delamination
Technical Buyer
Quality Assurance ManagerRegulatory compliance gatekeeperOverconfidentEU MDR documentation package
User Buyer
Manufacturing SupervisorOperational impact, changeoverEven KeelSetup time, OEE targets
Coach
Dir. Process EngineeringInternal advocate and championSupportWants to be seen as driving successful project
Coach
External Regulatory ConsultantMDR/FDA guidance credibilityGrowthValidation protocol pre-approval
Sales Process

Engagement Flow

Qualification Budget · Need Authority · Fit Spec Review Line Walk · Gaps Reg Mapping Concept Design UPM Modeling Membrane Trials Commercial Proposal · ROI Validation Plan Close T&Cs · FAT Schedule · PO Months 1–2 Months 2–4 Months 4–7 Months 7–9 Months 9–11
Win Strategy

Win Checklist

#TypeAction ItemOwnerDue DateDone
1 Internal Alignment Assign lateral flow process SME to support concept phase membrane handling trials Jake Malone Month 3 YES
2 Customer Engagement Executive walkthrough of existing manual line with VP Operations and Dir. Process Engineering Collin Phelps Month 2 YES
3 Technical Alignment Conduct nitrocellulose membrane delamination trials at our facility with customer-supplied material Chris Columbus Month 5 YES
4 Commercial Alignment Engage regulatory consultant to co-author IQ/OQ/PQ protocol aligned to EU MDR Article 10 Anna Watts Month 6 YES
5 Customer Engagement Present UPM throughput simulation model and FAT plan to VP Operations and QA Manager Collin Phelps Month 8 YES
6 Technical Alignment Provide reference data from comparable lateral flow line: OEE, uptime, changeover statistics Chris Columbus Month 7 YES
7 Commercial Alignment Structure payment milestone schedule tied to IQ/OQ/PQ completion gates Anna Watts Month 9 YES
8 Internal Alignment Pre-screen cleanroom subcontractors; confirm Class 7 compliance and installation timeline Jake Malone Month 8 YES
Why We Won

Key Win Factors

🧬

Membrane Trial Results

Running customer-supplied nitrocellulose membrane through our handling trial — and sharing the data with the Dir. of Process Engineering — removed the single biggest technical risk the team feared.

📋

Pre-Written Validation Protocol

Delivering an EU MDR-aligned IQ/OQ/PQ protocol in the proposal phase transformed a compliance threat into a commercial advantage — no competitor offered this.

📊

Throughput Simulation Model

A parametric UPM model built from the customer's own line data gave the VP Operations quantifiable confidence in the 400 UPM target before contract signature.

🔗

Payment Milestone Alignment

Tying payment milestones to IQ/OQ/PQ completion gates directly addressed the CFO's risk concern about capital commitment before equipment performance was proven.