Case Study:
Collaborating to pioneer award winning Human Factors methods to get a novel medical device to market

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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.

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 relied on Miranda’s engineering knowledge and experience of working in a robotics lab at MiT and was able to work seamlessly with the engineering, medical and technical teams. Miranda also mentored the designer at Lightpoint throughout the collaboration.

The team at Inspired Usability are light on their feet and highly responsive to clients, and so were able to not only integrate with the team at Lightpoint and carry out training but also prepare all Human Factors documentation, including the use specification, task analysis and risk analysis.

The findings of the summative study were published in the Journal of Urology in 2019 and was awarded the CIEHF Innovation award 2021.

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Below is a summary of the Human Factors process used in the design and development of the SENSEI® probe.

The device

Lightpoint Medical designed the SENSEI® System in response to the approval of the use of radiopharmaceuticals (which bind to cancer cells) in hospitals, to help detect the location of cancers.

The SENSEI® Tethered Probe is intended for use in the intra-operative detection of radiopharmaceuticals in adult male patients diagnosed with prostate cancer. So, it is needed to be suitable for a range of surgery styles including robotic assisted laparoscopic surgery.

Inspired Usability’s Human Factors Process

Inspired Usability’s testing process is uniquely designed for each client’s needs. The main challenges for this project were replicating radiopharmaceutical uptake and that early working prototypes under evaluation were not initially the correct form factor to obtain meaningful results from usability testing. The problems were overcame and testing in a realistic environment was possible by creating a phantom model (see ‘Rigorous usability testing’ below) and procuring the use of a lab to deal with radiation.

Interviews

The first port of call was to identify and interview stakeholders around the world. Surgeons specialised in robotic and non-robotic radical prostatectomies were interviewed to find out more about the internal anatomy of the pelvis, the overall workflow, surgeon’s preference for radiopharmaceuticals and the situations they would use the medical device in. This directly informed and influenced the design and use of the SENSEI® System.

Surgical observations

Robotic, manual laparoscopic and open surgical procedures for the treatment of prostate cancer were observed being carried out.

Rigorous usability testing

The SENSEI® System underwent rigorous usability testing with end users, in this case surgeons. The first test was to assess manual handling and possible early limitations of the Tethered Probe design using a standard pelvic phantom and da Vinci robot. Next, a bespoke 3D printed model of the pelvis with lymph nodes was produced. Infrared LEDs were hidden inside these nodes to mimic radiation. Surgeons were then asked to detect the LEDs using the Tethered Probe.

The next step was for surgeons to test the Tethered Probe in a wet and realistic environment inside a female porcine model. Vials of radiation were placed inside the model to be detected with the Tethered Probe, primarily assessing usability. Then a male porcine model was injected with radiopharmaceuticals, focussing on the performance characteristics of the system.

Summative study

Nearing the end of the project, a summative study was conducted to validate the SENSEI® System. Surgeons were given a training video to watch at least 48 hours before the study and then asked to set up and carry out the procedure to detect the radiopharmaceutical using the intra-operative Tethered Probe.

Outcomes

Through extensive collaboration and high-quality research with Lightpoint Medical, Inspired Usability helped bring a revolutionary Tethered Probe that detects the presence of radiopharmaceuticals to the forefront of cancer surgery. The SENSEI® System is successfully CE marked, registered with the FDA and is currently in clinical trials.

The final cherry on top was Inspired Usability and Lightpoint Medical winning the Chartered Institute of Ergonomics and Human Factors Innovation Award in 2021 for their unique and collaborative work.