Founded in late 2017 as a spinoff of the University of Granada and the Andalusian Health Service (SAS), Innitius is devoted to differentiating between false and true preterm labour threats at the point-of-care. Their technology is based on breakthroughs in the application of torsional waves for measuring tissue status.
Their inaugural product, FineBirth, is a portable diagnostic device that provides Obstetrics and Gynaecology doctors with a real-time assessment of the risk of spontaneous preterm delivery. This can dramatically reduce the negative clinical impact and the cost of over-treating false preterm labour (PTL) threats.
Having previously attended eg technology workshops, Innitius were selected as winners of the EIT Health Catapult ‘most Innovative Product’ award, sponsored by eg. They were awarded some complimentary engineering time, and leveraged our expertise in technical due diligence and Failure Modes and Effects Analysis (FMEA) to review their existing design. The aim was to reduce overall project risk, identifying potential issues at the earliest opportunity, and to suggest potential design improvements.
As a FemTech medical diagnostic device, the technical due diligence and FMEA were carried out within our ISO 13485 risk management framework, as well as being guided by ISO 14971.
It was important that the eg engineering team developed a detailed understanding of the device and its use cases. We worked closely with Innitius’ in-house design team to review their existing design and documentation. Innitius wished to develop the device across three key technical subsystems with a focus on the torsional wave system, camera integration and wireless functionality and the impact that developing these would have upon the entire design and development programme.
Starting with a thorough review of the electromechanical subsystems with Innitius, we proceeded to hold internal review design sessions during which a select group of eg engineers studied the user requirements and the way that FineBirth was designed to meet them. We prioritised our examination on four key development requirements, but were also careful to consider wider and additional functionality of the device as a whole, cross-referencing our findings with the client’s existing documentation and adding any comments, scoring, mitigations, additional risks and user-related recommendations. The final deliverable was a comprehensively updated and reviewed FMEA document, as well as a risk report highlighting the most critical risks found in our review.
Innitius have used our recommendations to further develop the device. FineBirth is in the clinical evaluation stage, with plans for it to enter the market by the end of 2024.