#USA #MedTech #Jersey City #AI Builder #Pure Global

Revolutionizing MedTech: Pure Global's AI Builder

In a groundbreaking development for the medical technology sector, Pure Global has launched the AI Builder, a pioneering platform that significantly speeds up the process of registering medical devices internationally. This innovative solution aims to reduce the lengthy and often complex documentation timeline from weeks to mere days, allowing MedTech firms to navigate the intricate world of regulatory submissions with unprecedented ease.

The Core Challenge

The inception of AI Builder arose from a common frustration shared by many MedTech manufacturers. After securing regulatory approvals such as FDA clearance or CE marking, companies often found themselves facing the daunting task of reconstructing extensive submission packages tailored for different countries. Ran Chen, the Chief Technology Officer (CTO) at Pure Global, described this process as feeling like launching two entirely distinct projects for submissions in Mexico and Brazil. Recognizing the inefficiencies and exorbitant costs inherent in this approach, Pure Global dedicated its resources to creating a solution that addresses these systematic hurdles.

AI Builder's Innovative Features

The AI Builder employs five essential capabilities designed to streamline the registration process:

1. Intelligent Data Extraction - This feature automatically extracts pivotal information from home-market submissions, drastically reducing manual data entry errors and improving accuracy.
2. Automated Gap Analysis - The AI compares existing content against the specific regulatory requirements of target countries, such as Brazil's ANVISA and Mexico's COFEPRIS, ensuring compliance.
3. Rapid Document Generation - It generates draft submission documents for new markets within minutes, transforming how companies prepare for international entry.
4. Missing Information Highlighting - Incomplete sections are flagged, guiding regulatory teams on what to address, thereby minimizing confusion and oversight.
5. Simultaneous Multi-Country Processing - AI Builder allows users to prepare submissions for multiple markets using a single source file, enhancing efficiency.

Tailored Solutions Through Customization

Every project managed through the AI Builder is tailored to meet the unique requirements of individual devices and target markets. The platform accepts a wide range of source documents, modifying the output based on the specific regulatory landscape of each destination country in its network, which currently includes nearly twenty locations globally.

The combination of AI automation and human regulatory expertise is a core strength of the AI Builder. Pure Global's network of local regulatory specialists ensures that templates and rule sets are continually updated, keeping draft submissions aligned with the latest legal requirements. This ongoing enhancement process prioritizes accuracy, security, and confidentiality.

Early Successes and Adoption

Initial results from pilot programs have been remarkable. For instance, Pure Global's team in Brazil successfully reduced document assembly time for 27 projects from 25-30 business days down to just 5-8 days, representing an impressive reduction in time spent. The streamlining of projects has allowed regulatory experts more freedom to focus on strategic tasks rather than getting bogged down in administrative work.

A Disruptive Pricing Model

In addition to automation, AI Builder introduces a new pricing structure that is set to disrupt traditional costs associated with regulatory submission. Clients can now access an all-inclusive annual fee covering the registration of each device. This fee includes not only the compilation of documents and necessary translations but also submission to local authorities, import authorizations, and post-approval modifications, all of which simplify budgeting and provide complete transparency to users.

Unlike conventional regulatory intelligence platforms, AI Builder is not an isolated software solution. Instead, it acts as an engine for Pure Global's extensive registration services, allowing them to deliver results faster and more affordably. As Chen remarked, “Others might provide the rules, but we deliver the end result — submission files that are ready to move forward.”

Future Expansion Plans

Currently operational in Brazil, Pure Global is poised for further expansion in markets such as Mexico and Southeast Asia. Looking ahead, the company aims to deepen the automation capabilities of AI Builder and broaden its reach, edging closer to their ambitious vision of creating an ‘Amazon-like’ experience for global medical device registration. This ideal platform will allow manufacturers to upload their existing documentation and instantly generate draft submissions for multiple regions.

Conclusion

With the introduction of AI Builder, Pure Global is setting a new standard in the MedTech industry by ensuring that global market access is not only feasible but also efficient, transparent, and on-demand. This innovative approach significantly reduces the friction traditionally associated with regulatory submissions, enabling clients to reach a broader audience and improve patient access across different countries far more swiftly than ever before. As the landscape of medical technology evolves, so does the potential for Pure Global's AI Builder to transform how the industry operates.

For those seeking more information on AI Builder, please contact Alma Miftari at [email protected]