DESIGN NAME: YO Home Sperm Test
PRIMARY FUNCTION: multi-functional Smartphone Microscope
INSPIRATION: Globally, roughly 15% of couples face infertility. 30% of the 'problem' is attributed to men. In many cultures, the male is NEVER tested or only after no female cause is established. The embarassment/fear a man faces when openly confronting his infertility hits his core masculinity and biological 'purpose' in life - procreation. We wanted to provide a personal, accurate, affordable, interactive, easy to use product for men to encourage and support their need to test themselves in order to have kids.
UNIQUE PROPERTIES / PROJECT DESCRIPTION: YO is a Smartphone based home sperm test. A YO Clip mini-microscope (attaining X400 magnification) slides over the phone utilizing the phone light and camera to capture and analyze a video of sperm. The sample, delivered via a proprietary YO slide is analyzed by the YO app algorithms and provides step by step instructions for sample prep/testing. The consumer receives test results and a video of their moving sperm. YO has a patent on the YO Clip and pending patents on the YO slide.
OPERATION / FLOW / INTERACTION: Testing your sperm is stressful. To reduce stress & provide accurate results, the YO kit/app makes it nearly impossible to make an error testing your sperm at home on a smartphone. Interactive, step by step instructions, animations & kit contents are all designed to be fool proof. Examples: Place a drop of sperm on a red dot and the YO slide sucks it in; the YO Clip (mini-microscope) slides on the phone & focuses automatically to capture a clear sperm video; a funny/informative Sperm Trivia Challenge reduces stress during sample prep time; in 1 min. YO automatically shows 97% accurate results.
PROJECT DURATION AND LOCATION: The YO Home Sperm Test project began 4 years ago in early 2013 and the product was launched to the consumer in March, 2017. The location of the product R&D & production is in Caesarea, Israel. The product launch was in the United States, based in Los Angeles, California. The product has been reviewed, reported and featured in more than 130 media publications.
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PRODUCTION / REALIZATION TECHNOLOGY: Designed to be: Cool and cheap for the Millennial consumer market, easy to use, cost effective at low volumes/scalable to mass production. What we designed:
o Fixed coverslip plastic slide w/hydrophilic properties to fill automatically (easy to use)
o Autofocus based on fixed slide depth, thickness of coverslip and interaction w/ball lens (easy to use)
o Known ball lens technology (cost effective)
o Snap together YO Clip designed for easy assembly (scalability)
o YO Clip designed to provide phone stability/perfect viewing angle (cool look)
SPECIFICATIONS / TECHNICAL PROPERTIES: Physical product dimenssions: 90mm x 48mm x 57mm
Width x Height x Depth
TAGS: YO Home sperm test, male fertility test, smartphone sperm test, multifunctional microscope test
RESEARCH ABSTRACT: The OTC YO medical device required multidisciplinary coordination between clinical, engineering & software R&D teams.
• Safety/accuracy: FDA/ISO driven criteria/trials >500 participants
• Lens: Research publications for simple, cost effective solution to magnify X450
• Focal depth: Fixed focus trial & error to reach optimal focal depth to provide clear video w/narrow +/- tolerance)
• Plastics properties for YO Slide: Research, plastics consultants, trial & error for easy, accurate slide filling solution
• Algorithm development: Internal knowhow to develop new tech/algorithm
CHALLENGE: The most daunting obstacle for this OTC medical device was regulatory clearance by the FDA & CE. This three year process began in parallel to our product development cycle. We had to test YO in every possible way: Algorithms for the software, confidentiality because it was on a Smartphone platform, performance clinically for accuracy, precision at multiple sites worldwide, function of the YO Clip, endurance of the YO Clip, contamination, quality control when using the YO Clip and app. YO is a breakthrough product (home testing on a Smartphone platform – using your phone as a microscope).
ADDED DATE: 2017-05-03 15:22:59
TEAM MEMBERS (1) :
IMAGE CREDITS: Medical Electronic Systems and Rimoni IND, 2017.
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