Sarah Leida | STC Member
When technical communicators think of writing for medical device manufacturers, writing Instructions for Use (IFUs) is the first thing that comes to mind. In my role as a Technical Writer for the Data Export Compliance team at Smiths Medical, I have yet to write a single IFU. We have a whole pool of technical writers housed in the regulatory department who tackle the challenge of creating clear and compliant IFUs. Consequently, I often find myself clarifying what I do—even for fellow technical writers.
One difficulty in explaining my team and job is finding a way to do it that doesn’t sound boring. Most people don’t want anything to do with the words “data,” “export,” or “compliance.” However, my role captures the heart of what technical communication is all about—diving deep into a technical, complex subject and conveying it to different user groups in a wide range of outputs tailored to each audience.
What is data export compliance?
The Data Export Compliance team is responsible for designing the systems and processes to collect and publish product data on a global scale. Our team implements a unique device identification system that allows products to be barcoded, scanned, and tracked from our manufacturing floor to their use on a patient. Why do we do this? Medical device manufacturers like Smiths Medical can’t sell products into entire countries without first sending mandatory electronic product data. Device manufacturers and healthcare providers need us and our boring data to be able to do business! This product data is the key to full traceability and patient safety. We all like to know where our food has been in its journey from farm to table; now patients and healthcare providers are rightly expecting the same transparency from medical device manufacturers.
What does data export look like?
At first glance, collecting product data seems like a straightforward process. It involves: 1) putting barcodes on our products and packaging; 2) adding product data like brand name, latex information, MRI compatibility, and sterility to our data and document management systems; and 3) sending this data to requestors.
Back in 2013, when only the FDA required manufacturers to submit product data to their Global Unique Device Identifier Database (GUDID), this process was a lot easier. Now the demand for data has grown, and device manufacturers must evolve their systems and processes to keep up with the changing landscape.
To give you some perspective, a mid-sized device manufacturer like Smiths Medical submitted around 24,000 device identifier records by 2016 to the GUDID, and each record contains around 30 attributes describing that product or packaging level. Multiply that by all the countries that require data, take into consideration that many countries require more attributes or different attributes, and you can see how the amount of data and complexity quickly adds up. Product data maintenance and submissions require continual system updates, staying up-to-date on complex, country-specific regulations, and juggling many global data deadlines to keep products available for sale in our markets.
How does technical writing fit in?
My job is to design and create comprehensive technical communication for everything associated with product data. This means writing a wide range of materials, co-presenting trainings for employees, and developing web content for our customers. Initially, I was hired to help with an application implementation and the significant process changes needed to meet upcoming product data deadlines. Throughout the ten-month project, I built a technical communication strategy for the team and designed and authored a documentation set for our various audiences.
By including technical communications in the planning and implementation process, our team was able to identify gaps in documentation and make the resulting communication set one that is comprehensive and useful for our audiences. Many of our employees don’t work in product data all the time and need materials that are easy to access and at varying levels of depth. For example, we provide the same information in a 90-page unique device identification training manual aimed at new employees, a one-page new fields quick reference guide for seasoned users, and in a standard operating procedure (SOP) that contains process information important for everyone.
Storing and updating materials on a product data intranet page is also a key piece of our internal communication strategy—it allows users to access the level of depth they need and makes them aware of materials that might be appropriate for new employees or those from other departments.
Being a technical writer on the Data Export Compliance team is all about variety and opportunity. Whether I’m evaluating user groups, delivering systems training, or writing a new SOP, no two days are the same. Because of this, I find my work in product data far from boring. gi
SARAH LEIDA (firstname.lastname@example.org) has almost 15 years of experience in the education and technical writing fields. She enjoys the challenge of taking complex technical materials and making them approachable for everyone. She is responsible for product data technical communication and training for Smiths Medical in Plymouth, Minnesota. Sarah can be found on LinkedIn at: https://www.linkedin.com/in/sarah-leida-ma-cptc-918b705b.