The Case for Remote Ischemic Conditioning

Heart failure is a leading cause of mortality and morbidity affecting nearly a quarter of adults over the age of 70. Clinical trials have proven that Remote Ischemic Conditioning – repetitive cycles of limited blood flow followed by resumed blood flow – can protect against potentially lethal ischemia/reperfusion injury.

In developing the autoRIC Device, Kangaroo used all aspects of its Product Development Process, from preliminary feasibility research through to commercial regulatory approvals and manufacturing. And in the spring of 2012, CellAegis Devices Inc. received regulatory approval to sell the device in the European Union, their first target market.

Navigating the regulatory maze

A feasibility and early prototyping phase was conducted as part of the product’s Research and Development. This was followed by the design of the hardware and software through Kangaroo’s ISO 13485 Design Controls process. This project integrated Kangaroo’s Design, Regulatory and Manufacturing disciplines as the design was successfully transferred to Kangaroo Contract Manufacturing department. This project also included full regulatory support for the client including assisting CellAegis Devices with setting up their own ISO 13485 Quality Management System and preparing and submitting the technical documentation required for CE Mark for regulatory approval in Europe. The CellAegis autoRIC Device is approved for use in the EU and Canada.

Building on the exciting concepts and prototypes developed in the research phases, Kangaroo launched into the controlled development phase of the project following the ISO 13485 and FDA methodologies for medical device development. The device was designed with the requirements for medical device electrical safety.

Finding Balance in Design

As part of the early research and development phase, Kangaroo Design guided the aesthetic direction of the product with CellAegis. The design had to incorporate unique features within the Applicator cuff to provide good visual balance between sophistication and disposability. The aesthetic “look and feel” that was developed provided users and patients the sense that they are handling and being treated with a high-end medical device that is safe, functional and comfortable to use. The CellAegis device was designed with patient safety and usability in mind from the research stage through all phases involving a multi-discipline hazard analysis assessment, ongoing design and process failure analysis assessments and a usability validation. The result is a product that is designed to be safe, effective, commercial-ready life-saving device that will change cardiovascular treatment throughout the world.