Case Study: Enable Injections Inc. achieves rapid scalability and streamlined FDA compliance with Navisite’s SAP S/4HANA

Medical Device Manufacturer Enables Rapid Scalability and Innovation with SAP S/4HANA Implementation

Enable Injections develops the enFuse on‑body delivery device to let patients self-administer high‑volume, high‑viscosity therapeutics outside clinical settings. Facing plans to scale to millions of units with multiple pharmaceutical partners, the company needed to navigate complex FDA approvals and rapidly ramp operations, but lacked an enterprise IT system that could scale precisely and affordably.

Navisite implemented a phased SAP S/4HANA solution that delivered full integration across finance, production planning, materials and quality management, product lifecycle and regulatory document control. The system automated FDA requirements (training, traceability, recalls, documentation), reduced paperwork, tightened controls, and enabled seamless integration with pharma partners—positioning Enable Injections for rapid, cost‑effective growth.

Enable Injections Inc.

Tim Flahety

CFO and Executive VP