Croma-Pharma Case Study

The Medical Device Coordination Group (MDCG) recommends readability testing of Summaries of Safety and Clinical Performance (SSCPs) containing a part for patients or laypersons. This readability assessment can be done via a user consultation or another manufacturer-determined method. Read our case study about how Lionbridge helped Croma-Pharma improve the readability of its SSCP laypersons’ part.

AI-Powered Readability Testing and Readability Improvements

Lionbridge leveraged AI-powered readability assessment tools to test and re-author the SSCP laypersons’ part. This readability testing was done to ensure the SSCP was suitable for a sixth to eighth grade level reader, which is recommended by industry guidance on plain language content within clinical research. Medical writers may find writing for a lay audience unnatural and time-consuming, as they’ve spent years being trained and steeped in scientific and technical language conventions. AI can be an extremely valuable tool and co-author for readability tests and generating content intended for patients, consumers, or the public at large. 

Early Delivery of Readability Testing 

Using advanced prompt engineering with built-in health literacy principles and language instructions, Lionbridge delivered the readability testing project ahead of schedule. Our Large Language Model (LLM) is trained to generate an automated readability report instantly. The report initially analyzes the source text segment by segment. Next, it proposes a revised text with improved readability. The report is immediately actionable and a strong aid to medical writers responsible for authoring SSCPs. To remove the risk of LLM hallucinations, a medical device and language expert did a full review of the SSCP. The result was an SSCP comprehensively validated for readability against health literacy principles and Good Lay Summary Practices. Medical device manufacturers can use the readability certificate (signed by Lionbridge) for Conformity Assessment. This is because Lionbridge’s tool complies with recommended readability standards, and a subject matter expert reviewed the SSCP.

Get in touch.

Discover our other plain language summary services and life sciences translation services. We offer customized AI and life sciences solutions, as well as decades of industry experience. Let’s get in touch.