From streamlining operations to addressing emerging challenges like PFAS (Per- and Polyfluoroalkyl substances) compliance, witness the evolution of RegTech. Explore how Gen AI is reshaping RegTech with precision, adapting to complex regulations, and leading the way into the future.
The Regulatory Terrain: Challenges for MedTech
In the rapidly changing MedTech sector, regulations are being significantly transformed. This change centers on increased attention to patient safety and the effectiveness of products, which is altering industry priorities. Every phase, from the early stages of idea creation till the last steps of product launch and ongoing market presence, is being closely examined. Quality standards and regulatory requirements are being strictly enforced and are being customised according to the unique needs of each market.
This isn’t confined to new inventions alone. Legacy device manufacturers are also compelled to present robust evidence affirming their products’ safety and performance efficacy. This paradigm shift in the industry is pivotal: non-compliance not only delays approvals, but they also increase the likelihood of product recalls. Consequently, regulatory bodies are enforcing stricter measures to uphold product specific compliance to elevate quality standards.
Moreover, the landscape is further complicated by the emergence of country-specific regulations. Europe’s EU MDR and IVDR, alongside the USA’s FDA, are continually introducing new mandates. These range from product quality specifics to environmental considerations like PFAS and sterilisation protocols. As a result, manufacturers find themselves in a constant race, striving to comply with these evolving standards and maintain their competitive edge in a marketplace.
Gen AI: Revolutionising RegTech
Navigating through the intricate web of country-specific regulatory demands and documentation in healthcare is becoming increasingly complex. To tackle this challenge, the industry is turning towards the innovative capabilities of Generative AI. This technology promises to streamline operations and automate the monotonous, time-intensive tasks that clutter the workflow.
Key areas like Design History Files (DHF), Clinical Evaluation, Testing, Collection of Post Market Data, crucial for Technical Documentation, and Global submissions stand to benefit immensely.
Generative AI’s true prowess lies in its ability to adeptly identify and decipher the subtle changes unique to each country’s standards. It can help facilitate harmonisation by crafting customised templates, creating frameworks and harmonise regulations that regulators can use to make consistent guidelines.
This agility accelerates the process of extending product portfolios. It also empowers manufacturers to seamlessly introduce their products into multiple markets much faster, breaking geographical barriers with ease.
Gen AI Use Cases
- Gathering RegTech Intelligence
- Clinical Literature and Evaluation Reports
- Risk Benefit Analysis
- Automate PFAS Identification
- Streamlining PFAS Reduction Process
- Enhancing Quality Monitoring
- Post Market Surveillance
- Pharmacovigilance
- Update Submission Dossiers
Navigating the PFAS Puzzle: Unleash Gen AI's Ingenuity with Tata Elxsi
In response to the ECHA’s new policy, prohibition on medical devices and products containing PFAS elements in the environment has become a significant concern due to the harmful effects it has on human health. It’s a daunting task for healthcare manufacturers and suppliers to identify PFAS components in medical devices, which are now under the restricted substance list.
Dive Deeper
PFAS, or Per- and polyfluoroalkyl substances, are ubiquitous in various products. They are integral in the manufacturing of numerous items, including dental floss, inhalers, ventilators, artificial heart pumps, pacemakers, contact lenses, surgical attire, and much more, making their presence in production processes indispensable.
Tata Elxsi’s Gen AI breakthrough for PFAS Analysis and Material Substitution
- Sift through scientific literature to analyse PFAS estimation models at corporate and product level
- Assist medical device and product manufacturers in uncovering alternate material substitution options
- Pioneering the development of an authentic supplier scoring model
- Streamlining data gathering processes for accelerated insights
- Delivering comprehensive impact analysis reports for informed decision-making
TEDREG - A Tata Elxsi Global Regulatory Intelligence Platform
Key Features
- Collecting Regulatory Intelligence
- Actionable insights extraction
- Reports on recent changes
- Data Assimilation
- Impact Analysis
- Real-time information availability
Gen AI: Precision and Adaptability in the Face of Evolving Healthcare Regulations
Gen AI stands at the forefront of healthcare innovation, boasting unmatched precision and adaptability amidst the ever-changing regulatory landscape.
Foundation models like GPT, Bloom, and MedPalm are continually trained with the newest information and are publicly accessible. Gen AI ensures access to this latest global data which is crucial for staying ahead in a rapidly evolving field.
By consistently fine-tuning, maintaining, and training our bespoke models in line with regulatory shifts, Gen AI delivers precise and adaptive outputs.
As regulations vary by country, so does the compliance framework, necessitating the development of country-specific technical documentation. Gen AI offers a solution, enabling quicker interpretation of these diverse regulations and effectively reducing the time-to-market for the product. Gen AI is being experimented for automated creation of contents for regulation compliance dossiers, creation of summaries for post market surveillance reports based on field reports is one example. Analysis of complaints, their correct categorisation and severity detection using Gen AI is also delivering accurate results and is improving execution efficiencies.
30% of the warning letters from USFDA, EMA, MHRA inspections are due to inadequate process and SOPs, which many a time is the result of missing a regulatory compliance update. Gen AI enables automated interpretation and actionable insights extraction, allowing instant communication of important, relevant alerts to regulatory intelligence teams.
Conducting a literature survey is an essential and strategic component in the preparation of clinical and post-market surveillance reports. This process involves sifting through hundreds of articles that align with specific search criteria. However, the challenge lies in identifying the few that are truly pertinent.
Currently, this task demands considerable time and expertise, as subject matter experts dedicate several days to meticulously filter these articles to determine which one’s merit inclusion. The integration of technological solutions into this process offers a significant strategic advantage. By leveraging technology, not only can we reduce the time required for a task by more than 50%, but we can also greatly diminish the risk of manual errors. By using Gen AI, we can handle large volumes of medical literature more efficiently, accurately, and in a reliable way, thereby enhancing the quality and effectiveness of our reports.
Quest for desirable accuracy |
Navigating content bias (limited to specific information) |
Availability of skilled talent pool |
Know-how of the latest tools that are being introduced in the market |
Safeguarding Data Privacy and Security – Adhering to HIPPA and GDPR guidelines |
TESafe - Intelligent Global Regulatory Process Automation Platform
Key Features
- Gen AI-enabled documents analysis and summarisation
- Automated literature search and analysis using RPA
- Automated scanning for duplicates
- Auto application of inclusion/exclusion criteria
- Automated workflows with notifications
- Intelligent Data Extraction from structured and unstructured documents
- Dashboard with analytics
Envisioning the Future of RegTech and Gen AI: A Tata Elxsi Perspective
We anticipate a significant uptick in the adoption of Gen AI, much more than routine automation. We advocate for its strategic deployment in areas such as historical data analysis, swift insight gathering, risk prediction, and pre-emptive measures to avoid industry recalls.
Regulatory bodies themselves are expected to integrate Gen AI into their processes for more efficient review and management of submitted files.
In essence, we foresee Gen AI technology stepping into a more pivotal role. It will help to reshape not just the medical device sector but extend its transformative impact into Pharmaceuticals and Life sciences as well.
