Allurion’s Swallowable Gastric Balloon

Pioneering a Non-Invasive Weight Loss Solution

Problem

Allurion sought to launch a first-of-its-kind swallowable gastric balloon, eliminating the need for anesthesia or endoscopy. However, prior to HaA PD’s involvement, early-stage development faced challenges in thin film material performance, valve precision, and scalable manufacturing putting commercialization at risk.

Solution

HaA PD was hired to collaborate with Allurion’s internal team and its manufacturing partners to refine the device’s design and production. Our team developed precision CAD models, custom tooling, and a reliable filling system. We improved throughput and yield, helping bring a safe, non-invasive solution to market.

Outcome

The device created was effective and safe and was successfully commercialized. Allurion’s success led to a 2023 IPO, now trading under ALUR on the NYSE.

Services Provided to Develop Allurion’s Swallowable Gastric Balloon

Workflow Optimization

  • Mapped the full surgical procedure to pinpoint failure points.

  • Streamlined workflow to reduce complexity and enhance efficiency.

Project Management

  • Managed the project timeline from start to finish, assigning roles and responsibilities of both internal and external resources.

Regulatory Compliance

  • Operated within the company’s Quality Management System (QMS).

  • Supported and provided regulatory documentation and work instruction development as part of our regulatory compliance services.

Engineering

  • The HaA engineering team helped design a safe and effective device and worked closely with high capability contract manufacturers to make sure the device could be made repeatedly and within specifications.

CAD Development

  • Developed detailed 3D CAD models of the product and associated tooling based on final product specifications.

Prototyping

  • HaA worked on-site at the contract manufacturer to assist in tooling and prototype creation.

Testing 

  • The HaA team performed medical device testing to confirm safety and effectiveness and identify any workflow or user challenges. 

Manufacturing Support

  • HaA worked closely with the contract manufacturer and was trained on their procedures and forms to be able to provide a seamless experience for the client.