Operational Diligence for M&A
Operational due diligence for medical device and diagnostics deals: operational risk identified before signing, and separation or integration plans that hold up after close.
Book a 30-minute callWho it is for
Investors, acquirers, and sellers in medical device and diagnostics deals, including:
- Carve-outs and spinoffs that must stand alone on day one
- Legal entity changes and mergers
- Marketing authorization holder (MAH) transfers
- Deals where packaging, artwork, and product identifiers must change
What device deals get wrong
General M&A diligence looks at finance, legal, and commercial risk. In medical device and diagnostics deals, much of the operational risk sits somewhere else: in packaging and artwork changes, product identifiers, MAH transfers, and the master data behind every SKU. These are slow to change, tightly regulated, and easy to underestimate until they delay close or day one.
What you receive
Operations diligence findings and red flags
What could go wrong operationally, and how serious it is.
Carve-out and TSA operational scope
What the separated business needs on day one, and what the transition service agreement must cover.
Legal entity and MAH transfer workplans
The sequence of changes, owners, and dependencies.
Packaging change coordination
Artwork and labeling changes planned and tracked across sites.
How it works
- 01
Scope
Agree the deal perimeter and the questions diligence must answer.
- 02
Assess
Review operations, dependencies, and change workload.
- 03
Report
Findings, red flags, and the operational scope for separation or integration.
- 04
Plan
Workplans that carry through to close and beyond.
Typical lengthIndividually tailored. Possible in 4 weeks with advance preparation.
Recent results
artwork changes implemented on time, without discards
Global Artwork Lead for a pharma post-approval change program covering spinoffs, legal entity mergers, site name changes, and MAH transfers, including program integration across 5 packaging sites.
SKUs transferred to a spinoff, 4 months ahead of schedule
A GTIN change process that avoided replacing SKUs, coordinated across 3 European packaging sites with end-to-end milestone tracking.
Need an IVD operations or master data specialist on your program?
I join larger programs as a subject-matter expert under your engagement, from diligence through integration.
Working on a device or diagnostics deal?
Tell me where the deal stands and I’ll tell you where the operational risk is likely to sit.