The Client
A leading company in the cardiac medical device sector, specializing in the production of heart valves and solutions for mitral valve repair. With a global presence and a strong commitment to innovation, the company stands out for its dedication to improving the lives of patients affected by valvular heart disease.
The Challenge
The company faced the challenge of effectively managing a vast corpus of documents related to regulations, certifications, and compliance in the medical device industry. With constantly evolving regulations and the need to ensure compliance across multiple jurisdictions, the company required a system capable of:
1. Quickly accessing specific information within a large document base;
2. Correctly interpreting regulations and their implications for the company's products;
3. Keeping staff updated on regulatory changes and compliance requirements;
4. Supporting decision-making processes related to product development and regulatory compliance.
The Solution
Omnys proposed the implementation of a Retrieval-Augmented Generation (RAG) system based on Omnyscient, the GenAI platform designed to accelerate the adoption of Generative AI technologies.
What is RAG?
RAG, or Retrieval-Augmented Generation, is an innovative AI framework that combines the capabilities of large language models (LLMs) with information retrieval systems. This approach enables the system to:
- retrieve relevant information from an external knowledge base;
- use that information to "augment" or "enrich" the responses generated by the LLM;
- produce more accurate, up-to-date, and contextually relevant outputs.
The solution was developed using a combination of AWS services:
The AI Agent, optimized through advanced prompt engineering, was designed to:
Results and Impact
The implementation of the RAG system based on Omnyscient led to significant measurable improvements:
1. Fast information access: 75% reduction in time required to retrieve specific information on regulations and compliance requirements;
2. Improved compliance: 40% increase in accuracy and completeness of responses to regulatory compliance queries, supporting better adherence to regulations;
3. Decision-making efficiency: 60% acceleration in decision-making processes related to product development and compliance, thanks to immediate access to relevant regulatory information;
4. Continuous updates: 90% increase in the ability to identify and promptly communicate relevant regulatory changes to the appropriate personnel;
5. Resource optimization: 50% reduction in the workload of staff dedicated to regulatory research and interpretation, allowing them to focus on higher-value activities;
6. Reduced non-compliance risk: 30% decrease in non-compliance incidents due to better understanding and application of current regulations.
The Omnys solution, based on Omnyscient and powered by AWS technologies, enabled the company to transform compliance and regulatory management from a potentially burdensome process into a competitive advantage. The AI Agent demonstrated how Generative AI technologies, when properly integrated and customized, can significantly improve operational efficiency and regulatory compliance in the highly regulated medical device sector.
This success story highlights the potential of RAG and Generative AI in supporting companies as they navigate the challenges of managing large volumes of regulatory and compliance information, opening up new possibilities for innovation and operational excellence in the medical field.
