SENSEI® was conceived by Lightpoint Medical (or Lightpoint) by identifying new technologies that allowed affordable miniaturisation of a gamma probe, a keen desire to improve cancer surgical outcomes and a clear view of the changing radiopharmaceutical products in the pipeline. At the start of the project SENSEI® only existed as a computer model and then as a large bench top prototype, making usability testing a challenge.

The vision:

The reality:

Commitment to a Human Factors process

Lightpoint were fully committed to getting early and consistent feedback from end users, in this case, surgeons. We needed high fidelity simulation models to identify user needs throughout all stages of technology readiness and efficiently propel the development of SENSEI®. This would ensure radiation exposure was minimised and animal models were used only when necessary so the device would perform optimally for the surgeon in order to best benefit the patient.

Existing phantom or surgical training models available were either high cost, simplistic or required significant modification to replicate radiation uptake. To address this, Lightpoint designed a transitional phantom using a combination of ethnographic observation, interviews, CAD modelling and 3D printing, leveraging the benefits of a multidisciplinary team and participatory design with a urological surgeon.

For early device development and formative studies run by Inspired Usability the team created an optical phantom to replicate complex and challenging anatomical structures. The phantom was designed to simulate radiation uptake using infra-red LED’s concealed within silicone.

We upgraded the phantom for the final human factors validation to increase tissue fidelity and incorporated radiation sources so that production ready devices could be tested.

We worked with European surgeons in formative and validation studies, conducting various search and find tasks to evaluate the usability and performance of the device. These usability evaluations were essential in: informing device design, obtaining CE mark and FDA registration, and supporting the journey to clinical trials. But the most notable future impact will be improved outcomes for cancer patients.

A proud moment

Given the challenges we have overcome and what we have achieved together over the last 4 years, I am enormously proud of this award. Lightpoint was one of Inspired Usability’s first clients. We started working together at the beginning of 2017 on their miniature surgical gamma probe called SENSEI® and we continued to be their human factors partner for the lifetime of the project. This culminated in a successful human factors summative study, CE approval and authorised sale in the US. I have worked in medical device development for a long time, and I know how rare it is for a consultant to see a project from conception through to approval within this sector, so for this to happen while at the company I founded, rather than during working as an employee, is especially significant.

Another reason this was such a great project was due to working closely with Lightpoint. It was a truly collaborative project that combined skills from human factors consultants, designers, engineers, physicists, surgeons and many more. I believe it is the reason we showed real innovation and received the CIEHF and Human Factors Innovation Award 2021.

Watch the video

• Medical Device Regulatory Support
• Anatomy & anthropometry in human activities
• Product design and consumer ergonomics
• Risk assessments – various work situations
• Task analysis
• Usability assessment

and agree to abide by the CIEHF’s code of conduct. You can learn more about the CIEHF and the practice of ergonomics and human factors on the CIEHF website.

Journey towards becoming a registered Human Factors Consultancy

2017 has been a busy year for both Inspired Usability and Human Factors. The MHRA launched their Human Factors guidance (read my article here) given more guidance for the Human Factors activities required for CE marking.

At Inspired Usability we have been involved with a surprising breadth of projects. Some of the highlights include:

• Seeing the inside of a patient’s abdomen during in 3D during a contextual inquiry for a device to be used during robotic surgery
• The breadth and insight from talking to healthcare professionals about a specific surgical procedure
• Actionable insights gained from formative usability studies
• Positive feedback from the FDA on summative study protocols
• Having my brain scanned as part of an Innovate UK funded project (you can see the film created by Radar Film here
• Carrying out the review of legacy devices

2018 looks to be another exciting year. We look forward to learning about your Human Factors needs for medical device and combination product developments in the coming year.