Home testing is not new.

Pregnancy tests are a great example of a mass-based home testing kit that has adapted for ease of use and is so ubiquitous it probably isn’t seen as a home diagnostic. My guess is that most women in the Western world have used a home pregnancy test with the hope of a positive or negative result at least once in their adult life. Pregnancy tests have, of course, come a long way since when they were first available in the 1970s, both in terms of speed of results, reduction of steps and clear information to the user. You can read an interesting history of pregnancy tests here and there is a great recreation of using a home pregnancy test in the 1980s in the Netflix series Glow:

Ruth’s test in the Glow series probably took about 20 to 30 minutes compared with 2 minutes for a modern test and there are now no complex steps or mixing. “Just” pee (of course accuracy is needed) on a stick and wait. The potential for error is now in the interpretation of the results. In the film Juno, the main character re-did her pregnancy test over and over claiming that they must be “defective” or the “plus sign looked more like a division sign”. I know from personal experience that I had to double check what the different symbols meant. Is plus good or bad? It depends what you want the outcome to be of course.

I was obviously not the only one who was getting confused or lacking in confidence of the results. Marketers latched on and now many pregnancy tests have the code printed on the outside and of course you can a get a digital pregnancy test that will tell you whether you are pregnant by displaying the words “pregnant” or “not pregnant” on digital display to avoid any confusion.

Working in a technology consultancy I learnt that the internal workings of the digital pregnancy tests were the same. The digital ones just used the electronics to interpret the results of a normal test kit rather than doing the actual test. The BBC also a wrote about this in 2020 here. So when I was potentially pregnant with my second child I bought the cheapest pregnancy test strips you can get, which just comprise of a paper strip with no plastic housing. There was no single use battery and electronics and extra plastic and an overall smaller package. Of course it did require me to have the confidence that something so simple would give me the same results as the fancy test that cost over 10 times as much, which I had because I knew people who had worked in that industry. And it did require a bit more reading of the instructions, which I did because I was invested in getting the right results based on my decision to choose that type of test. But given the overall “cheapness” of the packaging and rarity in supermarkets or pharmacies I’m probably one of the few people who go down that route.

I was reminded of this experience in considering the waste for the lateral flow tests. The pregnancy test falls into a consumer-based choice where customers are enticed by “quicker”, “easier” etc. But at what cost? Both to the consumer and the environment. As more tests are sent to home users these are questions, we need to consider carefully whether they are in response to a global pandemic or for mass screening. Meaning there is even greater need to consider how design both of a home test kit and the instructions can make the end user feel confident about the results but also minimise waste and avoid unnecessary packaging.

If you want to learn more about developing and testing good instructions for use see our services here.

References

https://history.nih.gov/display/history/Pregnancy+Test+Timeline
https://inspiredusability.com/2021/08/10/lateral-flow-testing-for-covid-19-a-positive-human-factors-experience/
https://www.bbc.co.uk/news/technology-54025997
https://www.futurelearn.com/info/courses/creating-the-amazing-engineering-the-future/0/steps/65276[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

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.

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