Miranda Newbery, who founded Inspired Usability, worked with Lightpoint Medical (Lightpoint), a medical device start-up, to provide end-to-end Human Factors support.
The collaboration lasted 3 years and in that time, Inspired Usability provided Human Factors support for the design and development of novel non-imaging probe, called SENSEI®. SENSEI® is designed to help revolutionise operations on patients with prostate cancer and was awarded the CE mark in January 2021.
Given that the Lightpoint and Inspired Usability teams were working at the forefront of cancer surgery, the new technology required a clever strategy for Human Factors testing and included the use of phantom and porcine (pig) models.
Lightpoint utilised Miranda’s engineering knowledge and experience of working in a robotics lab at MiT and she worked seamlessly with the engineering, medical and technical teams. Miranda also supported the designer at Lightpoint throughout the collaboration.
The team at Inspired Usability are light on their feet and highly responsive to clients and were able to not only integrate with the team at Lightpoint but also prepare Human Factors documentation, including the use specification, task analysis and risk analysis.
The human factors approach was awarded the Chartered Institute of Ergonomics 2021 Innovation Award and the outcome of the clinical study showed 100% detection rates in sentinel lymph nodes Lightpoint Medical Announces Positive Clinical Trial Results The findings of some of the studies were also published in the Journal of Urology in 2019.
‘Inspired Usability provided Lightpoint with comprehensive Human Factors support for the design and development of our miniature surgical probe, SENSEI®. The Inspired Usability team is highly experienced, knowledgeable and thorough in their approach to usability and Human Factors in medical device development. They quickly became an integral part of our design and engineering team and were a critical component in taking the device successfully from concept to regulatory approval’.
Graeme Smith CEO, Lightpoint Medical
Below is a summary of the Human Factors process used in the design and development of the SENSEI® probe.