Document automation on the road to EU MDR compliance
European Union Medical Device Regulation rapidly approaching
Smith+Nephew is a public limited company incorporated and headquartered in the UK that supports healthcare professionals in more than 100 countries in their daily efforts to improve the lives of their patients.
As a leading portfolio medical technology company, Smith+Nephew provides a wide range of surgical devices and wound care products.
With the European Union Medical Device Regulation (EU MDR) deadline rapidly approaching, Smith+Nephew is using Fonto with goals to semi-automate the creation of more than 1000 compliance documents per year.
Achieve cost reduction whilst complying to EU MDR legislation
Instead of hiring dozens of additional medical writers to manually keep up with the increased EU MDR documentation demand, Smith+Nephew opted to build an IT solution to semi-automate significant portions of the document generation process. This aids in creation of items ranging from Post Market Surveillance Plans to Clinical Evaluation Reports and many essential compliance documents in between.
A significant number of data sources, ranging from internal PLM systems to public complaint registries, needed to be combined to fulfil the ongoing surveillance obligations in the post market phase, and save valuable time of highly qualified subject matter experts.
The solution enables users to create report templates, providing Smith+Nephew with business agility. A template contains predefined text, generated content and areas where medical writers create their unique content.
Create once, reuse anywhere
With the new solution, content is generated from existing master/authoritative data, preventing manual and error-prone copy and pasting. Suitable and approved content components are available for reuse within other reports. Data tables and graphs are imported from Microsoft PowerBI after analysis of all appropriate data within the solution.
This way subject matter experts can focus on content that is unique, since up to 80% of a document is fixed in place as part of an approved template.
Best of breed software combined in one structured content solution
The solution is built with the following components:
- DITA XML: defines the structure in which the content is stored.
- MarkLogic: database, storage and versioning of data and content assets.
- Apache NiFi: ingestion of the 30+ data sources.
- Microsoft PowerBI: analysis of incoming data.
- DocuSign: review and approval of documents.
- Fonto Editor: design document templates, author documents, peer review, citation management and author guidance.
- Fonto Document History: review changes made to documents, understanding of how generated content is changed.
- EndNote: catalog and organize research articles
- Apache FOP: generate PDFs.
The solution allows subject matter experts to create documents from smaller, potentially reusable pieces of content. Authors start from pre-structured and pre-filled documents which they can only edit where the template designer allows them to. They can reuse any content component from any other document. In addition, they get alerts when the data underlying their document changes so they can decide to use the latest version of the data.
Authors can import their bibliographic references from their EndNote research tool and can perform data analysis by accessing ingested data available in the system via PowerBI. The resulting table or graphic can be imported within the documents while provenance information is captured.
Every action and relationship is automatically tracked in order to make every document traceable and auditable to help achieve compliance.
“Before the implementation of this solution, authors would spend hours to create the parts list and complaints tables. Now the tables can be automatically populated from the PLM or complaints systems.”
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