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Early Childhood Sleep Literacy Project: to Study Sleep Quality Using AI and Sensors, Develop a Pillow, and Educate to Promote Good Sleep

We will promote early childhood sleep for better cognitive and social development that will improve the quality of life for young children.

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Updates: How has your idea changed or evolved throughout the Prize? What updates have you made to this submission? (1500 characters)

In my Early Submission I proposed two initiatives: 1. Develop a therapeutic sleeping or napping pillow for children ages 1 to 3 years old, based on our experience at Sammi Pillows with cervical pillows for grown-ups; and 2. Develop a sensorized pillow to monitor and measure sleep quality of young children by using AI and biometrics, such as motion, noise, and breathing rate. However, after reviewing the literature on adequate and good sleep for newborns, infants and toddlers and assessing the pillow market for them as well as discussing the topic with sleep professionals, I learned that there is a critical need for awareness regarding the effects of good and poor sleep on a young child's cognitive and social development, not only among parents with young children, but also health care providers and child health advocacy groups. So, for our Project involving children ages 0-3, we will: 1. Conduct R&D and gather early childhood sleep data, in part by using AI and pillow sensors; 2. Based on this data, commercialize a safe and effective Early Childhood Pillow to promote better sleep for children either age 6 months or older or 1 year or older; and 3. Improve sleep health literacy for parents of children 0-3 years old by creating a good sleep education platform, building a Community for action, and including low income families with young children. Another major evolution to our idea is a decision to revisit whether Sammi can develop a safe sleeping pillow for infants 6 months or older. The American Academy of Pediatrics ("AAP") has pronounced that sleeping or napping pillows should not be used for children younger than 1 year old due to the risk of suffocation. Yet some literature states that children younger than 18 months should not use a sleeping or napping pillow. However, we believe these warnings are based on the types of pillows that are currently sold. NIH reports that 90% of deaths due to Sudden Infant Death Syndrome ("SIDS") occur before 6 months of age but the cause is unknown. So, what if we were to develop sleeping pillows that have no risk of suffocation, i.e., ones that have a firm surface for support and are breathable? And provide therapeutic benefits? This is something that we would like to explore. At the outset, we know there many factors other than the design and construction of a pillow that can affect the quality of sleep and napping by young children. In fact, noise, light, room temperature, odor, stress, diet, physical activity, illness, the bed, sharing a bed with parents or siblings, and even genetics, all can affect the quality of sleeping or napping. However, by using AI and sensors with a pillow, we would be able to compare the quality of sleep and napping in a controlled environment. Finally, I conferred with Dima Boulad, my EC Mentor assigned by OpenIDEO, my colleagues at Sammi, and other professionals for advice. During my mentoring session with Dima, she helped me focus on the human centered design, i.e., speaking to the emotional side of the parent of a young child and what they know and don't know. We discussed how design research that targets the audience or the persona could help us to know who would benefit the most from this Project. Thus, individualizing the target customer and making them human could help me identify their needs and tailor Sammi's approach in this regard. Dima also had me identify a disruptive thought such as 7 of 10 young children suffer from poor sleep and its consequences. That was very powerful. Another powerful thought is that our Project can truly have a profound effect on young children's cognitive and social development and lessen the onset of chronic disease, thus helping to reduce the medical and societal costs as our kids grow up. Dima also provided invaluable comments on my original slide presentation. She graphically showed me how a number can be a power image to begin a conversation. She gave me the link to her Ted Talks on the Greening of Gray Beirut to illustrate how an average green space per person in Beirut is only 0.8 square meters and physically showed 0.8 square meters of grass turf. Hence, I revised my presentation to say that up to 71% of a young child's life should be sleeping well. Sammi co-founder Vivian Jiang suggested ways we could make an impact on helping young children of poor families have better sleep. We can make a low cost version of the Early Childhood Pillow and donate a portion of the proceeds from sale of these pillows to charities that actively promote good sleep hygiene for young children of poor families. Dima added that we might want to discuss the price of the pillow, what goes into the price, and how NGOs in each country can purchase them in bulk to give to local charities for distribution to parents with young children. To conclude, I conferred with other professionals who gave me invaluable ideas about pitching my Project, which are reflected here.

Name or Organization

Sammi Sleeping Systems LLC ("Sammi") is the applicant for this EC Challenge innovation project. We are collaborating with an affiliate, Shenzhen Shan Mi Technology Co., Ltd ("Shan Mi"), based in Shenzhen, Guangdong Province, PR China.

Geography

S*Park Innovation Hub & Labs, 5 Science Park at Yale, New Haven, CT. Also, PR China, and Hong Kong.

What is your stage of development?

  • Early Stage Innovator, with at least one-year experience in ECD

Type

  • For-profit

What is the stage of your proposal?

  • Prototyping: I have done some small tests or experiments with prospective users to continue developing my idea.

Describe how your solution could be a game-changer for your selected Opportunity Area (600 characters)

Up to 71% of a young child’s life should be sleeping well but many don’t. The consequences could be severe with behavioral, cognitive development and health problems. And they are worse for low-income preschool children. The problem is that early educators who teach children 0-3 during their waking hours haven’t done much, if anything, to help them get good sleep. Now, we want to do something about it. Our work will have a profound effect on young children's cognitive and social development and lessen the onset of chronic disease, thus reducing medical and societal costs as our kids grow up.

Select an Innovation Target

  • Product: A new or enhanced physical product that creates value for end beneficiaries.

Tell us more about your innovation (1500 characters)

We will do research and development and gather data with AI and sensors to monitor a young child's quality of sleep. From this data, we will do product development to create a Sammi® Early Childhood Pillow for young children ages 6 months to 3 years old to sleep and nap with. We will then create a good sleep education platform, build a community for action, and engage low income families to better understand why young children need good sleep and what to do about it. Finally, we will provide our Sammi Early Childhood Pillows at low cost. For young children, we want to make pillows that are 100% natural without animal parts. The pillowcase would be 100% linen or cotton. The primary and secondary pillow covers would be 100% cotton. The buckwheat hulls that fill the primary pillows are naturally grown without fertilizers or pesticides, and are rendered hypoallergenic with no nutritional value to attract bugs. The secondary pillows would contain 100% cotton batting. Our affiliate Shan Mi has developed several round shaped pillows for young children and we are looking to improve the design and function of these pillows. One possible beginning point to develop a cervical pillow for young children would be to adapt our adult pillows into one that is tailored for young children. However, we are open-minded as to what the final product would look like and how it functions. We are truly excited to embark upon this journey together with OpenIDEO and Gary Community Investments.

What problem are you aiming to solve? (3 sentences)

We have a vision to educate everyone across the generations and globally, regardless of culture or tradition, about the therapeutic benefits of good sleep. With the Sammi Early Childhood Pillow for young children, we want to encourage parents and families to be conscientious about good sleeping habits even for those children at the earliest age. We also want to encourage parents and families to use our pillow as a tool for helping their young children sleep or nap well to avoid sleep problems.

Explain your idea (5000 characters)

Adequate and good sleep is one of the most fundamental requirements for a child's healthy growth and development. Thus, we need to improve good sleep literacy among parents with young children and their families, health care practitioners, including pediatricians, and NGOs and health care agencies that specialize in early childhood care. Second, we will develop a version of this pillow using artificial intelligence ("AI") with built-in sensors to measure biometrics, such as motion, noise, and breathing rate, to correlate them to the quality of a young child's sleep. Third, we would design and develop a Sammi Early Childhood Pillow that serves the same functions as our Sammi Therapeutic Pillows for adults, using the data we collect from our study and survey. Our idea is to develop a Sammi Early Childhood Pillow for children ages 1 to 3 years of age, and possibly one for children 6 months to 1 year of age if it can be safely designed to avoid the risk of suffocation, as warned by the American Academy of Pediatrics. As for the features of our Sammi Cervical Pillows, their internal structure is what differentiates ours from all the others on the market, including those that claim their pillows are adjustable with interlocking fill. In addition, our pillows have several openings that are closed with zippers. These openings are used to fill or remove the buckwheat hulls to adjust the level of the pillow in each critical place where the cervical neck, head and shoulders make contact. Our pillows are not "one-size-fits-all" just as the human anatomy of each person is not the same. Another critical feature of our pillows is the use of high quality buckwheat hulls. Just like not all pillows are the same; not all buckwheat hulls are the same either. The hulls we use as filling for our pillows are grown in North Dakota, Maine, or New York. These hulls are heated to a high temperature and cleaned so that they are dust free and hypoallergenic. The good hulls are like a mussel with both shells intact but without the mussel meat. This is the valued 3-D structure of the hulls that helps them interlock in place to maintain their supporting shape. The 3-D structure also allows natural ventilation to dissipate heat generated by the head. Unlike other pillows filled with down feathers, polyurethane foam, or polyester fiberfill, our pillows filled with buckwheat hulls dissipate rather than capture and retain body heat. The result is a cooler head while sleeping, which induces a better, deeper sleep. No wonder the Chinese, Japanese and other Asian people have used buckwheat hulls as filling for sleeping pillows for over 1,000 years. To properly develop the Sammi Early Childhood Pillow as a prototype, we will need to conduct one or more studies and research the literature, including peer-reviewed articles in medical journals, regarding young children and sleep and the associated benefits of good sleep as well as the maladies associated with poor sleep. We also would like to take into account the user experiences of adults using our pillows. Finally, we would like to survey the pillows that already are available and marketed for use by young children. Our survey analysis would include gaining a better understanding of their attributes and shortcomings as well as using this information to help improve our prototype with the aim to develop a minimum viable product ("MVP"). As a first step to select sensors to build into a pillow, we will first need to agree to the sensor features and benefits. Then we will need to research sensor technologies that are available. We believe that the key sensor will include accelerometers to characterize sleep motion patterns and digital acoustic sensors to characterize the breathing patterns. Another sensor to be investigated will be measuring the breathing rate. Further investigation will involve working with an electronics design firm to identify an onboard micro-controller system, including memory and power management, integration, and a Bluetooth or Wi-Fi data communication option. Hardware could be off-the-shelf but a smart phone app will need to be developed. Software, including developing algorithms, will need to be written. We will then need to conduct experimental sleep trials. Our idea for a specialized sleeping and napping pillow, both with and without sensors, for young children is novel but will have a profound effect on young children. And picture this: our Sammi Early Childhood Pillow as an MVP will be used by young children for UP TO 71% OF A 24-HOUR DAY! That's because, according to the National Sleep Foundation, toddlers up to 2 years of age need 11 to 14 hours of sleep, including naps throughout the day. It also recommends that children from 3 to 5 years of age need 11 to 13 hours of sleep each night and should still take naps, even though their naps during this age range should be shorter and happen less often.

Who benefits? (1500 characters)

Quality sleep, adequate nutrition, and love, support and protection are the three pillars for healthy growth and development of young children. The Sammi Early Childhood Pillow will help young children get enough quality sleep. And getting good sleep is like getting an immunization against disease. "It's almost like another vaccine we can give our kids to help them fight off illness and promote physical well-being," according to Cora Breuer, MD, of the American Academy of Pediatrics. Parents and families also will benefit by becoming aware that everyone needs a pillow with an internal structure to properly support the cervical neck, align the natural curvature of the spine, and maintain a cool head while sleeping. Right now, most adults complain about the inability to get good sleep with their pillows but they don't know why. Making the Sammi Early Childhood Pillow available will empower parents and families to do something now to improve the sleeping habits of their young children. Our Sammi Early Childhood Pillows will provide a sleep solution for young children to prevent or address sleeping problems. Customizable, adjustable, and contoured to the individual sleeper or napper, young children who use our cervical pillows will sleep or nap longer, more comfortably, and with sleep problems such as snoring, mild sleep apnea or neck pain reduced if not eliminated. When they awake, they will be refreshed, more alert and ready to learn.

What kind of impact will your idea have? (1500 characters)

We tend to work on cognitive and social skills of young children during their waking hours. However, we as society don't do a good enough job at promoting good sleep hygiene for young children during their sleeping or napping hours totaling up to 17 hours per day. Our work will improve good sleep literacy. The impact of our Sammi Early Childhood Pillows on young children will be long-lasting and profound. Those who sleep or nap on them will be more rested, and during their waking hours will be more alert and ready to learn. Our pillows will support their cervical neck and maintain the natural curvature of the spine, resulting in better posture and avoiding problems with pinched nerves, tingling fingers, or blockage of the air passage while sleeping. Their parents and families will feel empowered to help their young children sleep and nap better by our making this pillow, possibly with built-in sensors, available to them as a tool. There also is an educational component to this in that the parents and families will learn about how important good sleep is, even for those sleepers or nappers at the earliest age. They also will be able to monitor the biometrics to determine whether the young child is sleeping properly. On a broader scale, any child is more ready to learn when alert and well rested. Therefore, a good sleeping or napping pillow could have a positive effect on a young child's cognitive skills and performance in school.

How does or how could your idea impact low-income children? (1500 characters)

Our Sammi Early Childhood Pillows do not need to be high priced or fancy. We can offer a lower priced, more affordable edition of this cervical pillow that functionally will be equally as effective as the higher cost edition. If they only provide the much needed support of the cervical neck, we believe the pillow will do its job. Having said this, we do recognize that low-income children often face chronic stress caused by living in impoverished and chaotic surroundings. Living in a stressful environment can cause emotional and behavioral problems, often accompanied by attention deficit, memory loss, and poor sleeping habits. This greatly affects a child's cognitive and emotional development that in turn often adversely affects the child's scholastic performance in school. At Sammi, we believe we have a corporate social responsibility to be concerned with more than just making a profit. One aspect of our social responsibility is to protect the environment. And, in fact, our plan to make the Sammi Early Childhood Pillow out of 100% natural and renewable material is our commitment to the environment. The other social responsibility that we have is toward addressing poverty and hunger. To this end, we pledge to donate a portion of our annual sales of Sammi Early Childhood Pillows to one or more NGOs or 501(c)(3) groups that assist low-income children in education and cognitive development.

Innovation: What makes your concept innovative? (5000 characters)

Healthy sleep by young children is key but often neglected or misunderstood, even by public health agencies. Critical is building a foundation of healthy sleep habits during early childhood to minimize insufficient sleep, behavioral sleep problems and sleep-disordered breathing. These problems can adversely affect cognitive and social development, and lead to poor academic skills, behavior problems, hyperactivity, obesity and more. If we can intervene by improving good sleep literacy and developing a safe and effective pillow for young children, we can improve their quality of life. Our Project's concept addresses the worldwide critical problem of poor sleep among young children that is getting worse. We are providing a solution that is not only sustainable but also relatively inexpensive to deploy. Our concept is also unique. A survey of the posted EC Open Submissions reveal that virtually ALL of their concepts involve helping a newborn, infant or toddler during their WAKING hours. Our concept is different; we concentrate on their SLEEPING hours, i.e., the 58% to 71% of the time that the young child age 0 to 3 is supposed to be sleeping or napping. Neuroscientists know that the child's neurons and synapses in the brain govern functions like the heart rate and breathing, eating and sleeping. During the first three years of a child’s life, the neurons and synapses develop incredibly fast. According to the Child Welfare Information Gateway, at its peak rate, “the cerebral cortex of a healthy toddler may create 2 million synapses per second.” And by age 3, the child’s brain has reached nearly 90 percent of its adult size. As noted by Gateway, the growth in each part of the brain depends on receiving stimulation, which is the foundation for learning. Our solution is to begin by using AI and sensors to monitor and measure the two primary cycles of sleep: active (rapid eye movement, or REM) and quiet (non-REM). In active sleep, the brain undergoes cognitive development. Non-active sleep helps clear waste, toxins, and stress, together with restoring and growing the muscles and tissues, and strengthening the immune system. So, with better sleep, young children can be healthier and better perform during their waking hours with increased abilities in language, attention, and impulse. The other part of our innovation involves changing the status quo. Short shrift seems to be given to the quality of sleep of newborns, infants and toddlers. While there is a substantial body of peer reviewed literature relating to the effects of sleep on young children, there appears to be a disconnect with products available in the market to promote healthy sleeping for young children, with the exception of prescription sleeping aids. Sammi would like to educate parents with young children and their families, do performance testing, and develop an inexpensive, safe and effective cervical pillow for young children ages 6 months to 3 years of age. We also would like to collaborate with organizations that already train community partners, such as public health nurses, the clergy, social workers and daycare providers, on the safe sleep guidelines for infants. We are acutely aware of the risk of sudden infant death syndrome ("SIDS") and sudden unexpected infant death ("SUID"), including accidental suffocation, that are prevalent mostly among infants during the first 12 months of life. We also recognize that, while SIDS occurs in all socio-economic, racial and ethnic groups, those babies among the lower socio-economic families, particularly African American, Native American, and Hispanic babies, are 2-3 times more likely to die of SIDS than Caucasian babies. Experts attribute this disparity to the lack of resources and education that are available to these communities. Sammi wants to make a difference in this regard by supporting not-for-profit organizations to do outreach. For example, FirstCandle is an agency that has been working to eliminate SIDS and SUID through education and research. They have launched the Straight Talk for Infant Safe Sleep Campaign that is a two-part initiative. The first part is to train daycare workers. Since the majority of deaths occur during the first week a baby attends daycare, training on AAP safe sleep guidelines is essential. They also are trained to create a safe sleep contract with the baby's parents and to familiarize the parents with the AAP safe sleep guidelines. The second part of this initiative is to conduct parent workshops where trainers host new and expecting parents for an interactive session on safe sleep, including back sleeping. During these sessions parents are provided with portable cribs, wearable blankets, pacifiers and other products to help promote sleep. Once our Sammi Early Childhood Pillow is proven safe and effective, Sammi would like these pillows to be distributed at sessions like these.

Scale: Describe how your idea could reach a significant number of end-users. (1500 characters)

On a broad basis, millions of young children suffer from cognitive and social development due to poor nutrition, lack of stimulation, and exposure to stress. According to the World Bank Group ("WBG"), in low and middle income countries, 250 million children under 5 years of age are at risk of not reaching their developmental potential due to poverty and stunted growth, including one third of children in Africa. As mentioned, good sleep, good nutrition, and nurturing are the three pillars for a young child's healthy growth and development. Thus, while good sleep alone cannot reverse developmental issues suffered by young children, it can have a significant impact on them during their waking hours. Therefore, we would like to make our Sammi Early Childhood Pillows available to the WBG and its various partners, such as UNICEF’s The Early Childhood Development Action Network, UNESCO, WHO, Children’s Investment Fund Foundation’s Early Learning Partnership, Novak Djokovic Foundation, Global Partnership for Education, and the broader early childhood development community, to work on better sleep for young children. Locally, our plan is to use e-commerce channels, including Amazon, to tap into the B2C market. We also will use brand awareness through social media, such as Facebook, Twitter, and LinkedIn. Once sales volume increase, we will use distributors to sell to retailers. We also plan to tap into the B2B market by selling our Pillows to sleep disorder professionals.

Feasibility: Where are you with understanding the feasibility of your idea? Describe what you’ve done so far and your plans. (3000 characters)

Shan Mi has been selling the Shan Mi pillows in China since October 2016 and the volume of sales are now over 400 pillows per month sold mostly online, with 40% generated from repeat sales (compared to that pillow seller with ubiquitous advertising and reportedly sells 40,000 branded pillows per month). This year, Shan Mi is poised to sell over 10,000 pillows to adults, teenagers and children, including babies. Sammi recently began selling Sammi Cervical Pillows in the USA, some of which are identical to the Shan Mi pillows. The Sammi Cervical Pillows come in a medium size for $119 and a large size for $129. For those who would like to try our more luxurious version with aromatherapy pockets, the medium size sells for $159 and the large size sells for $169. The manufacturing of our pillows are presently being outsourced in China. The buckwheat hulls are sourced in the country where the pillows are sold. In the case of those sold in the USA, the buckwheat hulls are grown in the USA. Prior to sale of the pillows, light assembly is required, namely that our Pillows are filled with buckwheat hulls, its parts combined, and the total product slipped into a zip lock bag and carrying case, and packaged prior to shipping. The same would be done with the pillows to be sold for use by young children. We also are actively cultivating relationships with medical doctors, acupuncturists, naturopathic physicians, chiropractors and other health professionals who deal with sleeping disorders to create patient awareness of our pillows as a solution to sleep dysfunction. In addition, we recognize that we need someone in this health field to champion our pillows and hope to find in the near future someone who is influential in this space. It cannot be understated that every young child (AAP does not recommend pillows for children younger than 1 year of age due to the risk of suffocation) needs a good sleeping pillow. Moreover, as previously discussed, we are exploring making a prototype for infants age 6 months and older. However, few realize that the reason to use a sleeping pillow is not just to elevate the head but to address the cervical neck and shoulders. So, besides providing the product, we recognize that a large part of our work to sell the idea of the Sammi Early Childhood Pillow for young children is by educating the parents and families. And, while becoming aware of their young children's need for the Sammi Early Childhood Pillow for sleeping or napping, they also can focus on their own adult needs with the hope that they will realize that our pillows will fill that need, too. Since Sammi and Shan Mi are already selling our pillows, we feel confident that we can advance the idea of a Sammi Early Childhood Pillow for young children into fruition and demonstrate that it really works to promote REM sleeping.

Business Viability: How viable is your business model? (5000 characters)

Any business that does not make money will be out of business, no matter how noble and valuable the product or service, That being said, our business model is exceptionally viable to succeed given our unique pillow products, resources and margins. Here's why: Our Sammi® Pillow is not like any ordinary pillow. All of our competitors' pillow sheaths have no structure. Ours has walls and compartments and zippered openings to fill with all natural, hypoallergenic buckwheat hulls, which are pillow filling materials that have been used by the Chinese and Japanese people for over 1,000 years. We have married advanced technology with a tried-and-true Asian tradition to develop pillows that are far more effective to promote sound and cool sleep. Our Sammi Pillows are innovative and not like anything on the market. We have an IP portfolio that includes a China issued utility patent, three USPTO pending patents, and know-how to protect our pillow's function and design. SAMMI also is a US and China registered trademark. We have pending a FDA 510(k) application for a Sammi Therapeutic Pillow and are seeking FDA clearance for this pillow as a medical device to effectively and safely treat obstructive sleep apnea ("OSA"). We are located at the S*Park Innovation Hub and Labs, Science Park at Yale, in a biotech corridor that spurs innovation. At Yale as well as UConn Health Center, we have the opportunity to collaborate with a number of groups involved with medicine and health care for children and families. For example, we plan to access the expertise of data scientists at the Yale Institute for Network Science and avail ourselves of the resources provided by the Connecticut Children's Center for Innovation. We already have a good working relationship with Yale's Office of Cooperative Research and Yale School of Medicine. My co-founder Vivian Jiang's and my involvement through our business development consulting firm SinApac Group positions us at the epicenter of this biotech corridor in the shadow of Yale University. In fact, Connecticut is well situated within driving distance to Boston, New York, and even Washington, DC. Making up the Northeastern US corridor, this geographic area is the most heavily urbanized region of the United States. And Vivian and I are very active in the medtech and life sciences fields and well connected with leaders in this field in Connecticut and beyond. We believe we have the know how and expertise to assure the vitality of the Sammi Pillow business model. At Sammi, we have the core experience to succeed. For instance, I am a practicing business lawyer, with a BA in Economics from Columbia and a JD from NYU Law, with 28 years of business management and legal experience at major food and beverage, chemicals, and defense companies, namely Sara Lee, Olin and Colt, respectively, involving technology transfer and strategic transactions. Vivian has a background in bioengineering, with MS degrees in molecular and cellular biology, and a BS in nursing from SUNY Buffalo, and previously worked at Harvard and Pfizer Pharmaceuticals. Our associate is Haotian Jiang, who began working for Sammi last May, returned to work for us after earning a BA in Economics from Illinois Wesleyan and a MA in Economics from University of Texas at Austin. As additional team members, we have Melien Lavoie and Corlia Van Tonder who are digital marketing gurus who are positioning us in the social media space. In addition, we are building our research and development capabilities by bringing on in-house talent as well as relying on outside partners. From a needs point of view, virtually everyone needs a supportive pillow to sleep with. But even adults don't know which pillow provides the comfort and support they need. Symptomatic of this is that they have multiple pillows on their bed. The question is how they can select a sleeping pillow that actually works, i.e., one that supports the cervical neck, head and shoulders. On the market today not only in the USA but in China, virtually all sleeping pillows are nothing but unstructured sacks filled with loose material. Even the memory foam pillows made of one-piece, solid, perforated foam rubber fail to provide any active resistance to support the neck and shoulders more than the head (view the above video, entitled "Buckwheat Hulls Therapeutic Pillow Structure to Align Neck Curvature"). People we are trying to reach tell us that they or their loved ones have sleeping problems and are interested in knowing more about our pillow. We are building interest in sleeping better and are engaging sleep professionals. We also are in discussions with prospective investors. Finally, we are actively involved in digital marketing, including social media, that drives interest to our Website at www.sammipillows.com. There, we have our e-commerce platform to close sales and are expanding to other e-commerce outlets, such as Amazon.

HCD: How have you used human centered design to build or refine your concept? (5000 characters)

Our affiliate Shan Mi maintains a sleep research laboratory called Shanmi Institute of Sleep Science (“SISS”) to work on human centered design for pillows. SISS has been conducting sleep research for the last three years involving design verification and validation testing. SISS has observed that the normal cervical physiological curvature of a human is a protrusion from the side, seen from the front and in line with the thoracic spine. To maintain this normal neck structure, the muscles and ligaments are needed to support this curvature. However, weakening muscles and ligaments can cause a deformation of the cervical spine, resulting in cervical spondylosis. Cervical spondylosis or neck arthritis is a disorder affecting the joints and discs of the cervical spine in the neck. It is becoming common with the popular use of electronic devices. It develops from wear and tear of cartilage and bones. For some, it can cause chronic, severe pain and stiffness. According to the Mayo Clinic, the condition is present in more than 85 percent of people over the age of 60, although some people who have it never experience symptoms and many people who have it are able to conduct normal daily activities. While the condition is largely due to age, it can be caused by other factors as well. Some factors include poor posture, poor working conditions, and a poor sleeping environment. In fact, a growing number of cervical spine experts and doctors are recognizing that a cervical pillow not only can improve sleep quality but also provide an effective conditioning and improvement of cervical spondylosis. SISS has discovered that a lot of people like soft or elastic pillows. These pillows provide little or no support of the cervical spine and that use for a long time can cause neck muscle strain and injury. It found that the three critical attributes of a healthy pillow to maintain the naturally curved structure of the cervical spine by maintaining or increasing the neck muscle strength are height, curve, and support. SISS observed that, while sleeping at night, people tend to roll over to the side or on the back an average of 30-40 times. While a pillow might provide support while on the back, when turning to the side the required height for the cervical spine, curvature and tolerance will not be the same. Therefore, the task at hand is to develop a pillow that provides the correct height and curvature for sleeping both ways. This is what the Sammi Cervical Pillow addresses. When sleeping, SISS recommends that lordosis of cervical neck be present to gently support the physiological curve of the shoulder and head and keeping the cervical spine and thoracic spine on the same plane to prevent twisting of the neck. This is what the Sammi Cervical Pillow addresses. Lordosis is an increased inward curving of the lumbar spine (just above the buttocks). The spine has three types of curves: lordotic, kyphotic (the outward curve of the thoracic spine at rib-level), and scoliotic (sideways curving). Then, recognizing that every sleeper is not the same height and size (just as everyone's shoe size is not the same), the pillow height requirements also are not the same. Therefore, the Sammi Cervical Pillow is designed with multiple zippered openings on the back of the primary pillow, secondary pillow and neckliner for enabling the height of the buckwheat hulls or filling material to be adjusted in the middle, sides, and neck elevations for the specific sleeper’s individual needs. In fact, the Sammi Cervical Pillow is constructed of almost 40 separate pieces of cloth and six zippers that are sewn together to work as a system to meet the structure and shape requirements. In addition, SISS studied over 40 different varieties of pillow filling materials from around the world and finally after testing decided to use high quality, premium buckwheat hulls as the Sammi Cervical Pillow’s filling material for its primary pillow and neckliner. The benefit to use buckwheat hulls are their ability to be stuffed into the pillow, their 3-D structure, their support with moderate hardness, their ability not to absorb heat but to enable fast heat dissipation and air flow, their inability to break down over time, and their hypoallergenic quality. To conclude, the Sammi Cervical Pillow’s mechanical and natural material attributes support a critical role: first, to effectively alleviate the fatigue of the muscles and ligaments of the neck, balancing the increased neck muscle power to prevent and correct structural deformations problems of the cervical spine, second, to improve the cervical distortion caused by a stiff neck, breathing disorders, neck aches, dizziness and other symptoms of distress; and finally, to allow for comfortable, deep sleep. Based on SISS' work in human centered design on pillows and the work it has performed, we look forward to collaborating with SISS to help us develop a Sammi Early Childhood Pillow.

Tell us more about you (3000 characters)

Our co-founder Allen Weng was suffering from many sleep-related medical issues. Refusing to give into a bad night of sleep, Allen was determined to find a solution to improve his sleep and in the process better his health. Giving in and giving up on his snoring, insomnia and neck pain was not an option so he started the long path of research, development and testing towards a pillow that would solve his problems. Allen had the vision to market and sell the pillows in the USA and sought us out to launch a new company, that being Sammi. Our co-founder Vivian Jiang and I are owners of SinApac Group LLC, a business development advisory firm that concentrates in the medtech and life sciences fields with USA-China cross border transactions. We both are entrepreneurial-minded and assist pharmaceutical and medical device companies outside of China, predominantly located in the USA, to do business in China. What excites us about working in this early childhood space with the Sammi Early Childhood Pillow for young children is three-fold... the entrepreneurial challenge, viewing the pillow as potentially a medical device, particularly with the sensors, and a genuine desire to improve the quality of life, particularly of the Chinese people as Vivian and I are both of Chinese descent. First, Vivian and I are both very entrepreneurial. Vivian has developed businesses involved with child education, healthy living, and life sciences. As for me, I have always thought like an entrepreneur, even while working at Fortune 500 companies. Today, I serve as a SCORE business advisor and have helped a lot of small businesses succeed. As a business lawyer at my law firm, I have counseled and represented many businesses, including startup companies. Second, we view our pillow to have the potentiality of being regarded as a medical device. My background is as a business lawyer with most of my experience serving as in-house counsel for large multi-national companies in the defense, chemicals and food & beverage business. Vivian has a medical, nursing and bio-science background and has done stem cell research at Harvard and was a research scientist at Pfizer. SinApac has been immersed in the medtech and life sciences fields since 2013. And third, one of the satisfying things about working in medtech and life sciences involving USA-China cross border transactions is that we are able to introduce medicine and medical advances in the West to China that are not available to the Chinese people for treatment and therapies. We feel very good about improving the health and quality of life of the Chinese people through what we are able to do. We feel the same way about introducing a pillow in the early childhood space to help young children thrive.

Do you have the people and partners you need to do what you’ve described? (600 characters)

We have the people and partners to provide the Project deliverables. We have Allen's staff in China, our associate Haotian Jiang in New Haven, together with our marketing guru Melien Lavoie and her sister Corlia Van Tonder in South Africa, Dima's wisdom in Lebanon, and Rebecca Tuttle's ideas and inspiration. We also have others to rely upon for collaboration that will help us develop our in-house capacity regarding AI, sensor technology, design, and engineering. Finally, I will assume the role of protecting Sammi intellectual property rights, something that I have done for others for years.

As you consider your next steps, what kinds of help could you use? Is there a type of expertise that would be most helpful? (1800 characters)

We could use help in assisting to design a work plan to using sensors in a cervical pillow designed to measure sleep and napping quality of children 6 months to 3 years of age. We already have filed Sammi's FDA 510(k) application for a Sammi Therapeutic Pillow to treat mild obstructive sleep apnea, which application is pending. But additional help from someone with experience in medical devices and the FDA 510(k) process would be helpful. We would like assistance in the development of a research design and methodology for design, testing, research and evaluation. Part of the exercise will involve AI, particularly the use of sensors, whether self-contained or fabric inbedded, to measure biometrics associated with sleep, including to measure movement, snoring, body temperature and more. We could use the services of a sleep laboratory located in the United States to better understand non-rapid eye movement (NREM) or "quiet" sleep and rapid eye movement (REM) or "active sleep. NREM sleep is when a child's blood supply increases, energy is restored, tissue growth and repair occur, and hormones are released for growth and development. REM sleep is when a child's brain is active and dreaming occurs. During this time, cognitive capabilities are developed. We would like to understand the effect of suboptimal environmental conditions on the REM sleep and sleep cycles on newborns, toddlers and pre-schoolers. Finally, as discussed above, we are speaking with others but will need to secure technical support in research and selection of sensor applications for the sensorized pillow. We also need someone with electronic design expertise for the onboard micro-controller system and data communications. In addition, we need the services of a smart phone app developer.

Would you like mentoring support?

  • Yes

If so, what type of mentoring support do you think you need? (1200 characters)

For the mentoring session, the most useful mentor would be one who could let me know how responsive our Open Submission is based on the EC Challenge requirements, how to tell our story, and to improve upon what the reader needs to know for our story to resonate. In my situation, Dima Boulad was a great fit given her background as a professional storyteller and art director in graphic and motion direction.

Are you willing to share your email contact information submitted on OpenIDEO with Gary Community Investments?

  • Yes, share my contact information

[Optional] Biography: Upload your biography. Please include links to relevant information (portfolio, LinkedIn profile, organization website, etc).

www.linkedin/in/carltonchen for my LinkedIn profile www.sammipillows.com for Sammi Sleeping Systems LLC, the applicant www.sinapac.com for SinApac Group LLC, an affiliate of Sammi www.kurienouellette.com for Kurien Ouellette LLC, the law firm where I am a member of the firm and a practicing business lawyer

[Optional] Attachments: Please upload relevant attachments or graphics or show us how you prototyped.

We prototype first by drawing and then making the various parts of the Sammi Cervical Pillow. After testing prototypes, Shan Mi and we sell or give them to customers and solicit their customer reviews and impressions. These are collected online and some of these reviews and impressions appear in the "HCD" Section above. Where it says "Trail," we really mean we give a 30-day "Trial" and ask those who try out our pillows to provide their impressions. This is how we improve on our prototypes.

Mentorship: How was your idea supported? (5000 characters)

I worked with Dima Boulad as my EC Mentor and implemented her suggestions, including the following: 1. Focusing on the human centered design, i.e., speaking to the emotional side of the parent of a young child, what they know and don't know; 2. Identifying a disruptive thought such as 7 of 10 young children suffer from poor sleep and the consequences, unbeknownst to parents; 3. A design research that targets the audience or the persona and knowing who they are; 4. Individualizing the target customer and making them human; 5. Discuss the price of the pillow, what goes into the price, and how NGOs in each country can purchase them in bulk to give to local charities; 6. Regarding artificial intelligence (AI), how it will work, depicting a simulation of the system to show the readings off the pillow sensors to the cloud and read by the smart phone; 7. Using infographics to bring studies forward with the main target being parents and their understanding of the value of the Sammi Early Childhood Pillow; 8. Why this Early Childhood Sleep Literacy Project can have a profound effect on young children; and 9. How a number can be so important. Regarding this last point, Dima's Ted Talks presentation illustrated to me how well a number can be so powerful. I still remember 0.8 square meters of grass! In our situation, my PowerPoint presentation began with as much as 71%, which is the percentage of time in one's life a young child, i.e., a newborn, infant and toddler, respectively, should be soundly sleeping, including taking naps. We should have everyone remember this largest number of up to 71% in a 24-hour day, which is the amount of time a newborn should spend sleeping to help develop his or her cognitive abilities for use during the remaining time of the 24-hour day that the newborn is awake.

Attachments (1)

Sammi EC Pillow 2.pdf

Presentation that tells who we are and provides a summary of our Early Childhood Sleep Literacy Project for the OpenIDEO Early Childhood Challenge.

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