Development of the Production of Swedish New Total Artificial Heart

Purpose and goal:

The Vinnova Grant supported a consulting project focusing on improving specific aspects of the design and manufacturing of the SRH total artificial heart as well as training the engineering team on medical device startup company best practices. This project had a specific, time bounded objective to develop and implement these improvements for devices for upcoming pre-clinical studies. All objectives were reached in the time allotted.

Expected results and effects:

The Vinnova grant provided funding to hire the consultant which enabled completion of device manufacturing for a crucial pre-clinical study. This additional help enabled solving of some manufacturing challenges which allowed the team to meet the planned timeline and reduced the stress on the company’s internal engineering team. Information transferred as part of this project will also help SRH’s ongoing development towards a human use device.

Approach and implementation:

The project focus was on practical improvements of components and manufacturing processes for pressure sensor assembly and training of the engineering team. The project plan included clear identification of process, component and assembly design development items and was guided by the preclinical study schedule. These development items were prioritized and addressed based on how critical they were to the schedule for manufacturing the devices for the study. The improvements were developed, tested and implemented in time to enable the study.