Case Study: IntraPace achieves streamlined requirements traceability and change control for its abiliti implantable obesity device with Jama Software

Intrapace is Solving a Heavyweight Challenge Using Jama

IntraPace, a Mountain View medical device company backed by investors including Johnson & Johnson and Boston Scientific, is developing abiliti — an implantable, sensor-driven device that detects eating and delivers low-energy gastric stimulation to help patients reduce food intake. Facing the urgent global obesity challenge and strict medical-device documentation requirements, the product team needed a reliable way to manage complex hardware and software requirements, traceability, and the ripple effects of change across many interrelated documents.

IntraPace adopted the Jama platform to capture marketing specs through system, hardware and software requirements, risk analyses and validation plans, keeping all documents cross-referenced and in sync. Jama streamlined change management and regulatory traceability, enabled rapid staff adoption, and gave the team clear oversight of requirements and test validation throughout development, improving control and collaboration as abiliti progresses through clinical trials.

IntraPace

Mace Volzing

Software Development Manager