Taking the SentiMag® system from concept to volume manufacture
The Endomag System
The Endomag (previously Endomagnetics) sentinel lymph node detection encompasses the SentiMag®, a solid state probe and Sienna+®, an injectable magnetic tracer.
In operation, the Sienna+® is injected near the tumour to provide a trackable signal and the SentiMag® is then used by surgeons to locate the sentinel lymph node(s) where the Sienna+® is located.
This system is a revolution in breast cancer treatment as it uses no radioactive material, thus improving the standard of care whilst also improving workflow and costs.
At the start of the project Endomag was a small, UK-based, start-up company which was spun out from University College London (UCL) and the University of Houston, Texas. They had developed an initial concept for their system which, whilst highly sensitive, required the use of liquid nitrogen and a superconducting quantum interface device (SQUID).
In 2008 ITL was tasked with taking this proof of principle instrument to a commercially viable, bench-top medical device which could be manufactured in volume.
As their design partner, ITL worked with the R&D team from Endomag to define and specify detailed system requirements before developing the SentiMag® instrument.
These specifications coupled with ITL’s established credibility and consultancy services helped Endomag to secure a £400k R&D grant from the UK Technology Strategy Board (TSB).
Now that funding has been secured, ITL began work on developing and testing the instrument.
ITL took the SentiMag® system from concept to volume manufacture by:
- Producing engineering prototypes to prove the concepts for non-SQUID-dependent electronics solutions.
- Proof of principle work on the design and manufacturability of the probe.
- Industrial design of the aesthetic and ergonomic elements of the SentiMag® and the solid state probe.
- Regulatory assistance for safety testing, EMC testing and guidance throughout the CE marking process.
- Design and integration of all required software and firmware including the graphical user interface
- Tooling for manufacture.
- Pilot manufacturing supported by the R&D and production engineering department.
- Full volume manufacture.
- Providing training and servicing manuals for Endomag’s major distributor.
ITL and Endomag forged a strong relationship throughout the development and early stages of production.
Over the years, ITL has supported Endomag through a range of further developments of the SentiMag® and remain their manufacturing partner as production volumes increase.
Endomag has won a number of awards for the SentiMag®, the 2014 Business Weekly Best New Product Award as well as the 2013 ETPN Nanomedicine Award and was a finalist in the 2015 MacRobert Awards.
“ITL helped develop Endomag’s first medical device in a collaborative R&D project. That product is now in the market and sales are growing, and we have found ITL to be capable in supporting our growth every step of the way. We are not (yet) their largest customer, but ITL’s dedication to Endomag is as if they are part of our team.”
Eric Mayes- CEO