We sat down with Technical Writer Kirstie Wilson, to discuss navigating medical device compliance, building confidence in technologies through documentation, and translating technical information for different audiences.
“As a writer it’s important to understand a concept before writing about it – in this way what lies behind the obvious helps a writer to see significance in what otherwise might seem ordinary. This in turn creates good documentation tailored to the intended audience.”
Kirstie Wilson, Technical Writer
Can you tell us a bit more about your background before joining Feedback Medical?
I trained as a technical writer at a cheminformatics and bioinformatics firm in Oxford. From there, I became a freelance writer and documentation consultant for many years, taking on projects across the UK and some time working in France.
Freelancing means going where the work is. Initially this led me into the financial sector in the City of London for around five years, before later moving on to GlaxoSmithKline. At GSK I got involved in the manufacturing supply chain and gained exposure to the consumer health, pharma and vaccines business units. The pharmaceutical industry is also highly regulated, and this gave good grounding for moving into health tech.
Health science had always been my preference, and Feedback Medical felt like a natural choice after freelancing.
What does the role of a technical writer involve at Feedback Medical?
Technical writers translate complex concepts into easier to understand clear and concise content. That can include user guides, reference guides, installation notes, policy documents, processes and procedures, white papers and other types of documentation for both internal and external audiences.
Maintaining our technical file for Bleepa® is a large component of what I do – with generally two releases a year, along with patches for minor updates and security flaws. There can be ad hoc tasks such as supporting work on marketing materials and tender submissions, and ongoing process writing and maintaining our company knowledge base. Other recent documentation deliverables include working with our security engineer on a cybersecurity report.
There is a lot of documentation to maintain, and we need to keep abreast of the tools available to help with that. In the past couple of years, we have migrated a lot of information, including product requirements and test cases, into an application lifecycle management system. That has supported the process of producing our technical file – these tools are constantly evolving.
That starts at the foundational level, which could be something as simple as a computer usage policy, and scale all the way up to server infrastructure.
With the upcoming Bleepa 1.7 release, there has been a lot of work going into the technical file. What is the technical file, and why is it necessary for products like ours?
The technical file is a regulatory ‘document’ that demonstrates a medical device’s safety, performance and compliance with regulatory standards.
We are audited periodically, and auditors scrutinise the documentation, including the technical file. It is a living body of evidence that has to be maintained throughout the life of a product, and is made up of approximately 50 controlled documents.
That is a significant amount of work in the background that people may not always think about when they think of an app or medical device.
There is. Security standards are also becoming increasingly important. While the ISO 27000 series is not explicitly required for medical devices, it is increasingly relevant because security is paramount. We are dealing with patient data, and by following cyber security best practice we mitigate the possibility of data breaches.
Are there particular challenges in preparing technical documentation in a regulated healthcare environment?
Yes. There are a number of regulations and standards we need to work within. We operate under medical device requirements and follow ISO 13485. There are several other industry standards that apply as best practice too, including those around risk management, software development and usability engineering.
We have to make sure the technical file aligns with those regulatory requirements and frameworks, and the documentation itself has to be accurate while respecting release deadlines and timelines. That can be challenging because documentation is often expected and required at the same time as a release.
How do you balance precise, compliant language with making content clear and accessible for end users?
Always keep the audience in mind. That means understanding individual pressures and trying not to overload people with documentation.
Documentation best practice leads to content being accurate and complete, err on the side of brevity and explanation to the point. Everything is spell checked, definitions provided for terms and abbreviations, capitalisation, terminology (such as user interface items), and formatting and style used consistently throughout. All this reduces cognitive load and aids the learning process.
As a writer it’s important to understand a concept before writing about it – in this way what lies behind the obvious helps a writer to see significance in what otherwise might seem ordinary. This in turn creates good documentation tailored to the intended audience.
When we spoke previously to other members of the team, regulation was described as a “blueprint for excellence”, more than a burden. From your perspective, how does regulation support high standards in medical devices?
I agree. I think it raises standards and gives us a bar to work towards. It encapsulates what is expected of us as a medical device company and gives us a framework to work within.
The technical file is that body of evidence, and the final stage is the UKCA Declaration of Conformity. Once that is signed, it proves that we are compliant and have a product that can be marketed in the UK region.
Good documentation promotes confidence in a product, for our clients and potential customers; that’s especially important for a medical device, where clinicians need to trust that the product meets exacting standards.
The UKCA mark and the documentation behind it help provide that assurance. It shows that the product has gone through the necessary processes and that we have the evidence to support it.
Read the previous entries in our staff expertise blog series:
- A chat with Ben Edrich, Head of Engineering
- A conversation with Chief Financial Officer Emma Oswick
- A conversation with Kell Webber, Information Security Manager