Customer Success Stories
GANSHORN: Strengthening Clinical Evaluation and PMS Workflows with MedBoard
Company: GANSHORN Medizin Electronic GmbH
Industry: MedTech
Location: Germany
MedBoard Solutions Used: PMS, Literature Reviews and Clinical Research
For more than 40 years, GANSHORN Medizin Electronic GmbH has been manufacturing high-quality, easy-to-use measurement devices covering the full spectrum of respiratory diagnostics. Founded in 1982, the company has become a global leader in pulmonary function testing, with many of its innovations and patents now recognized as gold standards in the field.
Since 2014, GANSHORN has been part of the SCHILLER Group, continuing to develop advanced medical systems and software while maintaining its own production facilities. Hospitals, clinics, and respiratory specialists worldwide rely on GANSHORN’s technologies to deliver effective diagnostic solutions that improve patient care and quality of life.
GANSHORN places a strong emphasis on regulatory compliance, requiring a robust system to manage within that, literature reviews and vigilance proceses. To streamline these activities, and enhance efficiency and collaboration, the GANSHORN team adopted MedBoard for their regulatory and clinical processes.
Dr. Michael Ok, Manager for Clinical Evaluation and Post-Market Surveillance at GANSHORN, shared with us their experience with MedBoard.
The Challenge: Complex and Time-Consuming Literature and PMS Searches
Dr. Michael Ok, Manager for Clinical Evaluation and Post-Market Surveillance, shared that conducting systematic literature searches and proactive vigilance monitoring used to involve complex and time-consuming workflows.
Developing robust search strategies based on PICO methodology often required multiple iterations to refine search strings and identify relevant publications. Differences between database structures, duplicate records, and limited export capabilities made the process even more complicated.
“Developing well designed search strings based on PICO search strategies was initially challenging, primarily because the classic approach often resulted in a low yield of relevant publications.“
Dr. Michael Ok, Manager for Clinical Evaluation and Post-Market Surveillance at GANSHORN
Maintaining good documentation practices also required significant manual effort.
“This process was also heavily influenced by the structure and limitations of the databases themselves and frequently led to revisions of planning documents – such as the Clinical Evaluation Plan – a back and forth cycle that no one wants to experience, yet one that used to define routine literature searches“
Dr. Michael Ok, Manager for Clinical Evaluation and Post-Market Surveillance at GANSHORN
Limitations were often coming directly from the external sources needed for searches, representing an obstacle in managing evidence for critical processes such as Clinical Evaluation Reports and State of the Art assessments.
“Finally, the export functionality of some databases lacked essential options, which limited – or in some cases – prevented the effective use of retrieved results in reference management tools. This represented a major obstacle when preparing Clinical Evaluation Reports or State of the Art assessments, both of which require proper referencing of publications in a consistent and standardized format.“
Dr. Michael Ok, Manager for Clinical Evaluation and Post-Market Surveillance at GANSHORN
For PMS vigilance activities, searches were conducted across several safety databases with different interfaces, and every step had to be documented through screenshots to maintain traceability.
Dr. Michael Ok, Manager for Clinical Evaluation and Post-Market Surveillance at GANSHORN
The Solution: A Faster and More Structured Approach with MedBoard
By implementing MedBoard, GANSHORN introduced a structured and standardized approach to literature and vigilance searches.
“MedBoard enables fast, multi level searches across multiple databases, with search strings that can be easily adjusted to increase the number of relevant publications offering strong clinical evidence for the medical device under evaluation.”
Dr. Michael Ok, Manager for Clinical Evaluation and Post-Market Surveillance at GANSHORN
The platform allows GANSHORN to conduct preliminary searches that quickly indicate how effective a search strategy will be across different databases. Search strings can then be refined and tailored to database-specific requirements, significantly improving efficiency.
Automating the processes results in time savings as well as outputs more in line with expectations and socpe of the research process, in which targeted AI functionalities are integrated.
“Preliminary search capability saves significant time and provides an early indication of how successful the search will be in each individual database. It also allows search strings to be tailored to specific database requirements.
In addition, the integrated AI functionality helps by summarizing key information from each publication and offering practical, targeted suggestions. The AI quickly adapts to the context of the systematic review, resulting in increasingly accurate and useful responses as the review progresses.
This approach also reduces the effort required to prepare a robust Clinical Evaluation Plan, as the anticipated outcomes are more closely aligned with the planning phase.”
Dr. Michael Ok, Manager for Clinical Evaluation and Post-Market Surveillance at GANSHORN
With standardized search templates and configurable workflows, GANSHORN has been able to establish a consistent process for both literature reviews and vigilance monitoring.
“The platform provides an intuitive interface with standardized search templates. These searches can be refined through sub searches, making them easy to configure, update, and maintain. After completing the analysis and appraisal for both the literature review and PMS, the generated reports provide excellent traceability.”
Dr. Michael Ok, Manager for Clinical Evaluation and Post-Market Surveillance at GANSHORN
Consistency and Quality Across Clinical and Vigilance Reviews
One of the aspects GANSHORN values most about MedBoard is the integration and consistency between vigilance and clinical literature review processes.
“Systematic reviews for Vigilance and Clinical literature searches are comparable in their design, usability, and the quality of the reports they generate. This consistency makes it straightforward to integrate both processes into existing workflows and to reflect them clearly in work instructions for routine searches.”
Dr. Michael Ok, Manager for Clinical Evaluation and Post-Market Surveillance at GANSHORN
Dr. Ok also highlights the value of MedBoard’s appraisal templates, streamlining the setup of systematic reviews while ensuring consistent and high-quality data extraction across relevant publications.
“The availability of appraisal templates — whether customized or selected from predefined options such as IMDRF AER codes — is extremely valuable.”
Dr. Michael Ok, Manager for Clinical Evaluation and Post-Market Surveillance at GANSHORN
A Platform That Continues to Evolve
GANSHORN has also seen significant improvements in MedBoard since first adopting the platform, highlighting the continuous improvements efforts from the team, aligned with professionals’ needs and the users feedback which are always appreciated.
“Today, the AI assistant can quickly generate an overview of publication content and provide tailored suggestions for answering questions specific to the systematic review – whether these are custom questions or standardized ones such as IMDRF AER codes.
This evolution has been impressive, and each new feature has proven genuinely useful. It has shown us that MedBoard clearly understands the needs associated with continuous literature reviews and actively develops tools that deliver real value.”
Dr. Michael Ok, Manager for Clinical Evaluation and Post-Market Surveillance at GANSHORN
The responsiveness of the MedBoard team has also played an important role in the collaboration.
“We requested the AI-supported translation of PDF documents in languages other than English or German, and the request was addressed within the next quarter.”
Dr. Michael Ok, Manager for Clinical Evaluation and Post-Market Surveillance at GANSHORN
Why GANSHORN Chose MedBoard
GANSHORN evaluated MedBoard alongside several comparable platforms, considering usability, access to scientific and safety data, AI capabilities, and the overall impact on PMS and literature review workflows.
“We evaluated MedBoard alongside comparable platforms by considering multiple aspects, including platform usability, access to scientific and safety data, availability of AI support for analysis, appraisal and translation, and the effectiveness of our own PMS and literature review workflows after implementing MedBoard.
One of MedBoard’s major strengths is its well engineered approach that integrates key domains – Vigilance, Clinical Literature, and Regulatory Affairs.“
Dr. Michael Ok, Manager for Clinical Evaluation and Post-Market Surveillance at GANSHORN
The platform’s all-in-one ecosystem combined with powerful search capabilities and flexibility, including the option to use MedBoard’s integrated reference manager or third-party tools, ultimately made it the preferred solution.
MedBoard in one or few words?
“Brilliant and fast evolving data ecosystem“
Dr. Michael Ok, Manager for Clinical Evaluation and Post-Market Surveillance at GANSHORN
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