Background
Founded in 2015, Ablatus is the first spin-out from the Norfolk and Norwich University Hospital NHS Foundation Trust (NNUH), where Bimodal Electric Tissue Ablation, which underpins the Luna device, was invented. The company’s vision is to offer improved patient outcomes across a range of clinical conditions through the application of its next-generation soft tissue radio frequency ablation (RFA) technology. Luna improves on standard RFA techniques and the Luna device offers a novel, cost-effective and efficient approach to in-situ destruction of abnormal tissue – such as tumours and fibroids – whilst protecting healthy adjacent tissue, without the need for open surgery.
eg acted as a trusted advisor & partnered with Ablatus on multiple Innovate UK grant funding applications
The Challenge
eg has a long-standing relationship with Ablatus, which began when the team initially approached us with the challenge of developing the company’s IP into a medical device, based on early clinical data. Ablatus wished to leverage our credibility and experience as an ISO 13485 accredited medical device development consultancy and asked us to partner on its Innovate UK (IUK) grant funding application. Over the years, eg has been a trusted development partner and advisor for Ablatus, supporting the team’s long-term development goals. To date, we have partnered successfully on two IUK grants with a total value of over £3m.
Developed In accordance with IEC 60601, IEC 62304, ISO 14971 & ISO 13485
With our support, the Ablatus team was successful in its application for funding and asked us to develop the proof-of-principle prototype used in the original research by NNUH into a medical device. As the device consists of both an electro-surgical generator and an invasive surgical instrument (probe), safety and efficacy were paramount. Ablatus naturally required the device to be fully compliant with all of the applicable standards – including IEC 60601, IEC 62304 and IEC 62366. The whole project was undertaken within our ISO 13485 quality system and developed in accordance with ISO 14971.
Engineering the Solution
The eg engineering team provided a turnkey solution across the whole programme and drove the technical development of the system through its various phases. eg acted as an autonomous, yet fully integrated engineering resource for Ablatus, with our Software, Electronics and Industrial Design (Human Factors) teams working concurrently across a phased development programme, covering concept generation, risk management, proof-of-principle designs/models, alpha and beta prototypes, early-stage lab testing and formative usability testing.
The first phase of the project (covered by the company’s first IUK grant) was dedicated to the design of the core hardware, which includes the generator, probe and a custom grounding pad. The prototypes underwent rigorous testing within our labs prior to pre-clinical evaluation at external lab facilities in both the UK and the US. The core Ablatus technology was developed for invasive surgical use, with strict regulatory requirements, particularly with respect to electrical safety and sterilisation. Our team took the core technology developed in phase one and incorporated a comprehensive safety strategy, which directly addressed the control system on the device and sterilisation requirements with regards to the single-use disposable.
As Covid-19 hit, our team was able to continue working remotely on the development, adapting to shifting project requirements and pandemic-related complications, whilst still abiding by the terms and conditions of the IUK grant. Despite the disruption caused by the pandemic we still managed to make good progress on the project for the next phase.
This was a fully-managed, end-to-end project with emphasis on Software & Electronics engineering
End Result
As a start-up, Ablatus was able to leverage our extensive and detailed engineering expertise and experience within the MedTech sector, not only for the development of its prototype device but also in support of its IUK Grant applications. Our team acted as an integrated resource for Ablatus, providing visibility and transparency into the development and engineering of the project with regular reporting and update meetings.
Our expertise and thorough understanding of the product development process and applicable standards, ensured the product meets safety standards, having been developed in accordance with ISO 14971, IEC 60601, IEC 62304 and IEC 62366. The software and electronics architecture were also designed with the high reliability, integrity and safety expected of a surgical system.
Using formative usability testing, we were able to develop a novel and intuitive user interface, which has been evaluated and refined through regular engagement with clinicians. We created custom designs for both the generator and probe, with the first units now ready to go through initial regulatory assessment ahead of first-in-human clinical studies.
Are you ready to develop your product or idea?
For further information on how eg technology can support in getting your technology or ideas to market or to chat with one of the eg team about your product design and development requirements, please get in touch.
