Ensuring Readable Codes at Speed: Fisher Smith Helps Hologic Meet ISO Barcode Standards
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Introducing Hologic
Hologic is a global medical technology company focused on improving women’s health through diagnostics, imaging and surgical solutions. With a broad portfolio spanning high-throughput diagnostics, mammography and AI-driven imaging tools, Hologic supplies healthcare providers and laboratories around the world and operates at the higher end of regulated medtech manufacturing.
The challenge
A Hologic production site in Manchester needed to meet a new, mandatory level of barcode quality on products leaving the factory. Codes were being returned by customers because they could not be reliably read downstream. Crucially, the client had to verify codes to ISO grading standards (ISO 15416) while keeping the existing production machinery and footprint unchanged. The site also required capability to run other label and print inspections alongside the barcode verification.
Key constraints:
- The verification requirement was new and mandatory, not optional.
- Limited mechanical space on the existing lines meant adding a second inspection device was impractical.
- Existing vision systems on the lines could not achieve the required ISO grade.
Objectives
Hologic’s brief was straightforward and business critical:
- Achieve ISO-compliant barcode grading for 1D and 2D codes (ISO 15416 and associated standards).
- Avoid major mechanical changes to existing machines.
- Keep the inspection capability and barcode verification consolidated so operators maintain one reliable system rather than two separate devices.
Our approach
We began with a focussed assessment of the lines, their legacy vision systems and the physical constraints on-machine. Because Fisher Smith already had an established relationship with the customer, we could rapidly audit previous implementations and identify why they failed to meet the ISO requirements. That audit informed a retrofit strategy: design and deliver a single vision platform that combined both barcode verification and the label/print inspections the client needed.
Key items in our approach:
- Review and replacement of legacy vision hardware where necessary.
- Specification of a single device and optical setup that could perform verification and inspection from one position.
- Integration with Hologic’s PLC and control logic so no on-site PLC reprogramming was required.
- A common HMI and software platform applied across lines so operators and maintenance teams had a consistent interface and process.
The solution
Fisher Smith delivered an integrated, ISO-compliant barcode verification and inspection solution that:
- Performed 1D and 2D verification to ISO grading standards and produced audit-ready reports.
- Combined barcode verification with OCR, placement checks and label quality inspection within the same vision platform - removing the need for a separate verifier unit.
- Interfaced cleanly with the machine PLC and HMI so job setup, pass/fail signalling and data logging matched the factory’s existing workflows.
- Deployed our standard software stack across all installed units so training, remote support and maintenance were consistent and repeatable.
We tested the solution using sample product runs, then validated communications and HMI flows on the live lines before full production sign-off. Remote support capability was configured so needed changes or troubleshooting could be carried out quickly without waiting for on-site visits.
Results: measurable improvements
After installation and commissioning, the site saw clear, measurable benefits:
- Reliable ISO grading and readable codes: products leaving the site were verified to the required ISO grade, dramatically reducing returns due to unreadable codes.
- Higher effective throughput: with a single integrated solution we reduced inspection complexity and improved line availability.
- Lower waste and fewer returns: confidence in shipped product quality reduced customer returns and associated waste.
- Faster recovery from faults: a consistent software platform and remote support meant Hologic’s engineers could get lines running again quickly.
Informal feedback from the client and onsite teams has been positive: operators appreciate the clearer HMI and easier job setup, and maintenance value the reduced variation between machines. A formal testimonial is pending.
Why Hologic chose Fisher Smith
Hologic needed a partner who understood ISO barcode verification, legacy production systems and the constraints of retrofitting to existing machines. Fisher Smith delivered a single, supported solution that met regulatory requirements while keeping implementation impact low. Our experience in large, complex installations and our ability to combine verification with inspection in one system were decisive factors.
Further reading
For more on how Fisher Smith delivers barcode verification and integrated inspection platforms, read our overview:
And to understand the regulatory landscape that led to this project, see our guide:
About Fisher Smith
Fisher Smith Ltd designs, builds and supports machine vision systems for manufacturers who need reliable inspection, traceability and automation. We combine practical engineering, integration expertise and software development so clients can meet quality and regulatory goals without unnecessary complexity.
Ready to discuss your barcode and inspection challenges?
If unreadable codes, regulatory grading or legacy vision systems are causing risk in your supply chain, talk to us. We design ISO-compliant verification systems that can be retrofitted into existing lines and combined with broader inspection tasks so you get compliance, traceability and fewer returns.
Contact Fisher Smith to arrange a site assessment and sample trial.
