I’ve never been to an awards ceremony before, and I’ve definitely never been to an online awards ceremony, so I wasn’t really sure what to expect. I knew that the application Francesca Oldfield (Creative Product Designer at Lightpoint Medical) and I submitted had been accepted as an entry but nothing else. So, as I sat on the sofa in my less than glamorous sports kit and saw the first two entries for the Innovation Award (you can see Vitrue Health and Neil Clark’s great entries here, along with 3 others), I was totally bowled over to find out that we were the WINNERS of the Innovation Award for our unique work on an anatomic pelvic phantom to test novel imaging and sensing devices for minimally invasive and robotic prostate cancer surgery.
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.
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.