Get your diagnostics operation ready for launch, scale-up, or a deal.
Independent operations advisory for IVD and medical device companies: readiness assessments, Sales & Operations Planning (S&OP), master data, and M&A diligence, delivered hands-on by a practitioner with 21+ years inside the industry.
Data details matter at every handoff. I connect the functions so things get done right the first time.
Four specialties, often combined
Operational Readiness and Health Checks
Before a launch, scale-up, or investor review: a structured look at where operations will break, and what to fix first.
More on readiness checksS&OP Design and Standup
A working monthly S&OP cycle that sales, finance, and operations actually use, sized for a growing diagnostics company.
More on S&OPMaster Data and SAP Quality
Data quality assessments, product phase-in and phase-out, and SAP enhancements grounded in IVD and pharma know-how.
More on master dataOperational Diligence for M&A
Carve-outs, legal entity changes, and MAH transfers: operational risk spotted early, and a separation plan that holds.
More on M&A diligenceResults clients can measure
artwork changes implemented on time, without discards
Global pharma post-approval change program: spinoffs, legal entity mergers, and MAH transfers.
SKUs transferred to a spinoff, 4 months ahead of schedule
Pharma serialization GTIN transfer, coordinated across 3 European packaging sites.
people freed from part-time manual work
IVDR batch-update automation in SAP, rolled out across 7 sites, freed their time for higher-value work.
recommendations from a hands-on review of 387 finished goods
IVD master data deep dive that sparked a broader data governance initiative.
functional areas
from the gap analysis
Operational readiness assessment and S&OP standup
For a diagnostics company preparing to scale: a KPI framework, maturity scorecard, and gap analysis, turned into an 18-month phased implementation roadmap, plus support standing up its S&OP process.
Truth on Time
20 Essential Principles for Operational Excellence
By Alex Bourdon and David Finlay. The operating principles behind this practice, from “If You Lie to MRP, MRP Will Lie to You” to “Rely on Systems, Not Heroes.” Paperback and Kindle now; audiobook in Q4 2026.
David Finlay
Founder and Principal Advisor
21+ years in IVD operations: 16 at Bayer Diagnostics and Siemens Healthineers, working in Ireland, Germany, and the US, and independent since 2020. When you hire Data Driven Associates, you work with me directly, and sometimes a handpicked team of other associates depending on agreed scope and skill sets.
Facing a launch, a carve-out, or an operation that won't settle?
A 30-minute call is usually enough to tell whether I can help.
Book a 30-minute call