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BD-GenCell

Development of an operator manual for BD-GenCell to ship with its BD CLiC instrument, a fully integrated and automated workflow for rapid library preparation for Next Generation Sequencing (NGS).

 

BD-GenCell specialises in instrumentation for biological testing. The company has successfully partnered with leading biotech companies to develop instrumentation for multiple applications – from DNA library preparation to genotyping for agricultural applications. Founded as GenCell Biosystems in Limerick, Ireland in 2011, the company was acquired by BD Biosciences, a leading global medical technology company, in October 2014.

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THE CHALLENGE

BD-GenCell needed an operator manual to ship with its BD CLiC instrument, a fully integrated and automated workflow for rapid library preparation for Next Generation Sequencing (NGS). The BD CLiC instrument is designed for use in genetic research. It is an innovative and cutting-edge product that incorporates both hardware and software. BD-GenCell required technical writers with good documentation skills who could come up to speed fast on this highly specialised instrument, and who would not be daunted by the level of scientific knowledge assumed by the source content.

BD-GenCell needed writers who could talk comfortably with subject matter experts coming from both scientific research and software development backgrounds. The writers had to be capable of gathering complex technical information and turning it into a clear, accurate, and readable manual aimed at a diverse audience ranging from general operators to lead research scientists.

After their recent acquisition by BD Biosciences, BD-GenCell also needed to align with the parent company’s documentation guidelines. They didn’t have any Adobe FrameMaker experience in-house, so they needed writers who could quickly familiarise themselves with the required templates and standards, and produce documentation of a similar quality and style to the technical manuals published by the parent company.

It was also essential that the operator manual met the requirements for certification to international product safety standards. This included the translation of parts of the manual into French for distribution in North America and Canada.

OUR SOLUTION

We developed an operator manual to guide lab technicians through every aspect of daily operation and maintenance of the BD CLiC instrument, and experienced scientists through the process of customising library preparation protocols for the instrument. To develop the operator manual, we:

  • Made contact with the internal technical publications team at BD Biosciences in the US at the start of the process, and familiarised ourselves with existing content and style requirements.
  • Arranged for several onsite visits to BD-GenCell so that we could get hands-on with the BD CLiC instrument and fully understand its operation.
  • Examined the software functional specs and thoroughly tested the instrument software to cover all use cases.
  • Used Adobe FrameMaker to develop the manual in line with BD Biosciences requirements and published it as a screen-optimised PDF.
  • Worked closely with the product engineers and testers to get feedback on our drafts and ensure technical accuracy.
  • Provided weekly status reports to BD-GenCell throughout the process so that the client was always up to date on our progress.

To ensure that the manual met the requirements for product safety certification, we:

  • Analysed the initial findings report returned to BD-GenCell by the certification body, identified gaps in existing content, and updated the manual accordingly.
  • Organised the translation of safety information from English into French using a trusted partner as required for distribution in other jurisdictions.

THE RESULT

BD-GenCell reported that they valued TWi’s clear communication structure, accessibility, and regular updates on progress. Our team and the product experts at BD-GenCell developed good working relationships, which were strengthened by visits to the client site for face-to-face meetings and information gathering.

The clients were impressed by the depth of product knowledge displayed by our team after the initial introduction, and were pleased with the high quality of the new content. They appreciated our flexibility in allocating resources on the project to work around their schedule and support them in accommodating on-going change requests to meet certification requirements.


KEY BENEFITS

  • Required operator manual in place in time for product release
  • Professional, high-quality content in line with client and parent company standards and templates
  • Compliance with legal requirements for product safety documentation
  • Adherence to foreign-language requirements without having to independently source, assess, or manage translation vendors

 


We are developing the world’s first fully integrated, automated bench-top library prep workflow, BD-CLiC. To accompany such a ground-breaking product, we needed a top-quality, comprehensive Operator Manual, suitable for an audience ranging from lead research scientists to basic operators.

TWi’s team worked closely with our experts to learn about the highly specialised subject matter and how to use the product. They plotted out a logical structure for the manual, ensuring that the new content met vital certification requirements. We needed TWi’s assistance in understanding and adhering to the detailed style and content guidelines stipulated by the larger Becton Dickinson (BD) group’s Technical Publications’ division. TWi simplified things for us further by sourcing and managing a translation partner, meaning we didn’t have to worry about that ourselves or engage with a second vendor. We’re very happy with TWI’s performance to-date. I’ve already recommended their team to assist with other documentation requests within BD.

John Malone, Quality Manager, BD-GenCell


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