Nutrivide

For centuries, advancements in nutrition and medicine have dominated the scientific response to illness. However, over 150,000,000 children under 5 across the world remain undernourished or suffer from a life-threatening illness. Accordingly, not only does the need for these resources become a global issue, but the method by which they are delivered must be simple, convenient, and affordable for a solution to be implemented and scaled. This need is amplified for babies. 

Our solution is the Nutrifier, a pacifier that stores and dispenses nutrients and medicine. By providing premeasured, unit-dosed supplements in a device with functional exit holes, the Nutrifier simplifies the delivery pathway and maximizes the chance of dose acceptance. 

The solution could drastically save lives when scaled, as most chronic diseases and malnutrition cases are in developing countries. By leveraging existing supply chains of government-funded childcare centers/mobile clinics, we can distribute our solution to address a worldwide concern.

Nutrivide’s current focus is malnutrition, a chronic, destructive, and fundamentally preventable disease affecting over 150,000,000 children across the globe. From distant villages to dense urban settings, many parents are unaware that one nutritional deficiency during key years of development can have disastrous long-term consequences. Later manifestations extend to obesity, depression, and immune failure. 

Many mothers in the team’s college town of New Brunswick and around the world alike suffer from HIV (among other STIs), a low breast milk supply, the consequences of smoking/drinking, and the side effects of medication, all of which prevent healthy breastfeeding. Their infants grow up without access to essential nutrients, and remain chronically malnourished without an appropriate delivery system. Current vitamin delivery solutions carry specific problems: they necessitate daily precision and measurement, result in frequent loss of time and product, and can pose choking and reflux issues when improperly used. 

With the combined stigma and difficulty posed by these barriers, it is common for these critical supplements to not be used at all. We aim to disrupt this trend with a convenient, affordable, and accessible device.

Our solution is the Nutrifier, a pacifier that stores and dispenses liquid nutraceuticals for infants during use via an infant’s natural sucking reflex. The device makes use of pre-measured supplements that increase ease of administration, comfort of the child, and convenience of the mother. It fits effortlessly within a mother’s existing routine, and is cost-effective while being accessible on account of the team’s community-first business approach, enabling the device to serve infants from both high- and low-income regions. Having a more reliable method of delivery will counter the stigma many non-breastfeeding mothers and single fathers face every day. Furthermore, it will naturally bridge any micronutrient gaps from which these infants suffer and provide means for targeted development.

The solution directly serves the needs of new mothers for their newborns, especially those who are premature/of low birthweight, are not regularly breastfed, or suffer from a micronutrient deficiency. This beachhead market has been identified in communities across the globe, but to ensure the launch is focused on a group of mothers with generally shared needs and similar backgrounds, the team has chosen to begin in its home state of NJ, starting locally in New Brunswick, NJ. 

To better understand the customers, the team has been setting up interviews with mothers in New Brunswick, particularly at SuperFresh, a common supermarket among residents in Nutrivide’s target market. With feedback about the experienced problems and evaluation of the team’s proposed solution, Nutrivide can iterate to ensure mothers are making the design decisions for the product. 

Nutrivide seeks to integrate infant nutrition seamlessly into a parent's daily routine. Based on the customers the team has chosen to target, devices that only deliver medicine in small doses and require a parent’s judgment to determine the amount of nutrients an infant has actually consumed does not really solve their problem. A pre-measured, consistent source of nutrients seems more important for this demographic.

The problem of infant malnourishment is partly due to a lack of accessible nutrition, but largely due to a dearth of delivery devices for existing nutrient solutions (e.g. powders rely on clean water). Accordingly, the Nutrifier hits on many of Solve’s impact statements. Largely, use of the Nutrifier will decrease the risk of chronic diseases/malnutrition among newborns by including essential nutrients found in breastmilk in a dose-controlled cartridge system, which will increase compliance over the status quo. Importantly, Nutrivide’s model also allows for critical access expansion by distributing the products to community centers and government-funded hospitals with existing supply chains.

After recognizing and studying modern competitors over three years, Nutrivide is confident that the Nutrifier actively meets pain points that other infant oral delivery devices are not built to address. Nutrivide’s main competitors are FridaBaby, Munchkin, and Safety 1st. 

These products, respectively, may induce suffocation in an infant’s nasal passage/throat if not administered at the correct flow rate, are top heavy and awkward for simple parental operation, and are only useful for dispensing medicine in very small quantities, which can be troublesome in the presence of a squeamish infant. All of these solutions further require parents to measure and administer medicinal dosages to infants for every dose, creating potential for measuring error. 

The Nutrifier stands alone on three accounts: pre-measured cartridges, passive administration, and functional nipple design. First, pre-measured supplements are unprecedented in the infant supplement market. Nutrivide’s patent-pending cartridge design takes this concept and presents it in appropriate dose-controlled encapsulations for convenient device insertion and use. The Nutifier’s passive administration prioritizes the infant’s comfort and allows for safe, near-independent use, unlike other nutrient supplement delivery systems that require continual parental presence and accuracy for the duration of the administration. Finally, functional channel designs within the proprietary nipple construction take advantage of a baby’s natural sucking instinct to bypass taste receptors. 

By valuing tenets of social impact design in development, Nutrivide has paid considerable attention to detail to manufacture practical technologies in two industries: infant vitamin supplements and delivery devices.

The core technology of the Nutrifier is a conglomerate of concepts that collectively remove the pain points leading to lack of use for current infant vitamin supplements. Over a singular, standout technology, the device is innovative because it is a combination of proven technologies and design features. 

At a high level, these components are the pre-measured cartridge, offset exit holes, and the functional channel design that together enable the device to deliver small volumes of liquid passively. This last feature is among the core benefits of the device, and is accomplished simply by embedding small fluid channels in the device body and nipple, whereas a conventional bottle pacifier or syringe pacifier (as seen in our competitors) would simply use the void space in its entirety, far too large a volume for the recommended dosages of most supplements (which also widen the margin of error in delivery).

The team has developed 6 major iterations of the device to date, and have created dozens of sub-iterations within the latest version alone for vetting in virtual focus groups. Currently, the device passes fluid successfully from an inserted cartridge, and though flow rates and exit velocity must be fine-tuned based on suction tests, the current prototype accomplishes the device’s purpose passively. 

It is a large benefit to do away with hard-to-read dose markings in populations of high health illiteracy, as described by Parents' Medication Administration Errors: Role of Dosing Instruments and Health Literacy (https://jamanetwork.com/journals/jamapediatrics/fullarticle/382784). Nutrivide also intends for the device to make certain claims, such as having offset exit holes to increase the acceptance rate, which is currently being tested and takes heavily from research that children are less receptive to taste placed near the edge of the tongue than they are to the center. However, quantitative data must be collected to show that the device indeed does increase acceptance rate of the internal medium.

Link to high-level product breakdown to show hardware feasibility: https://www.youtube.com/watch?v=IxU0OVtLBnU&feature=youtu.be

From the ground up, the Nutrifier has been designed around the prioritization of our target market’s largest pain points in the existing landscape: accessibility and acceptance. The existing methods of nutrient delivery are insufficient or dated, and so naturally placed a larger emphasis on the solution than ease of use. Quite simply, injections are unappealing, often unsanitary in developing nations, and require a costly professional to administer; pills are difficult for babies to swallow and in many cases cannot be crushed/mixed in with food; and liquid vitamin supplements are unpalatable, need to be measured for each use (which may not all be consumed by a squeamish infant), and can cause aversion to the foods in which they are mixed. 

To better target these priorities, we have consulted a diverse range of stakeholders, including physicians, material scientists, mechanical engineers, medical distributors, sustainable development organization leads, and above all, new mothers. 

Specifically in our theory of change model, the Nutrifier serves as a novel distributed health product in community organizations local to high densities of chronic disease populations (e.g. in food deserts). Food banks and WIC clinics are two examples of federally grant-funded institutions that not only have a mission-driven alignment with providing affordable and complete sources of nutrition to their population, but they also exemplify the direct distributional advantage present in these tighter-knit communities. The short-term benefits are that (1) families will now directly be able to go to a familiar local organization to obtain a customized array of premeasured nutrients for their child, seamlessly adding convenience into the customer journey, and (2) families will be able to comfortably administer nutrients/medication in what could normally have been an exhausting process, especially with squeamish infants. The clear longer-term benefit is fewer children would experience stunting and physical defects associated with undernutrition and vitamin deficiencies; however, a more subtle longer-term benefit that derives from the short-term benefit is that, as we expand to devices that make use of unit-dosed cartridges as the infant grows (e.g. sippy cups, straws), families will show a greater adoption rate due to a developed familiarity of use case.

The solution has not yet launched, as Nutrivide will complete initial testing by Q4 2020 and be ready for short-run production by the end of the year. 

In year 1, 3,500 Nutrifiers will be distributed to local organizations and sold through online retail (nutrivide.org and amazon.com, and for both Nutrivide has ties to discounted shipping). The team expects 80% of the revenue to come from B2B sales on account of existing relationships to community organizations. 

In years 2 to 4, over 200,000 Nutrifiers are expected to be distributed. The explosive growth is expected to occur when regulatory approval enables specialty pharmacies to dispense unit doses of oral medication as already prescribed by physicians, as the team is in nascent conversations with a small scale NJ-based pharmaceutical company. Additionally, Nutrivide is looking to build a pipeline of functional Nutrifiers that deal with gaps in infant care (e.g. for infants who are born prematurely, suffer from Down syndrome, and live with recurrent seizures). 

With scale, technologically-capable variations of the Nutrifier exploiting Bluetooth Low Energy (“smart” pacifiers) will also be developed in wealthier communities, with the ability to notify parents that contents need to be replaced/cleaned, to take the infant’s temperature, and to collect other information about the infant’s feeding habits. This will make it easier to employ a one-for-one model for the standard Nutrifier. By year 5, nearly 300,000 Nutrifiers will be sold, and the team seeks to innovate in other infant consumer products to promote a more health-conscious design focus.

Within the next year, Nutrivide aims to complete the final prototype, begin short-run production, and complete pilot testing, with a goal to get the product to market by Q1 2021. The final prototyping phase involves running focus groups within the specified beachhead market and incorporating 3rd party technical design reviews to finalize device engineering. Both of these will be completed prior to a design freeze that is projected to occur in Q4 2020, whereby short-run production will start to develop the initial batch of product for use in pilot testing.

Over the next five years, outside of expanding to the aforementioned Nutrifiers that close current gaps in infant care and expanding to medicinal cartridges, Nutrivide hopes to further scale with technologically-capable variations of the Nutrifier exploiting Bluetooth Low Energy (“smart” pacifiers) for wealthier communities. Particularly, potential investors have agreed with the additional value of such a device if it is able to notify parents that contents need to be replaced, device needs to be cleaned, infant’s temperature should be checked, device can be tracked if lost, and other information about the infant’s feeding habits should be monitored. This will make it easier to employ a one-for-one model for the standard Nutrifier, incorporating social impact into the business model and allowing wealthier segments to cross-subsidize the product for more remote regions.

Currently, the internal team lacks the specific technical expertise to complete DFM, as Nutrivide is currently consulting with 3rd party engineering firms for insight into best industry practices. While fine for the time being, these talent capabilities will be necessary for rapid iterations moving forward. Additionally, COVID-19 provides newer roadblocks, with many overseas manufacturing centers operating at reduced capacity and not taking on new clients. Though short-run production was planned to be conducted statewide, full-scale production may end up being cost-prohibitive. The current pandemic also limits the ability to run in-person focus groups, meaning that many parents who would be part of these conversations will not be able to get hands-on with the final device, limiting the types of insight we can get from these engagements. 

As Nutrivide completes the design and manufacturing process, the team continues to seek U.S. Consumer Product Safety Commission certification. As medication cartridges are introduced into the market, the team hopes to file as a Class 1 medical device with the FDA, using a 510(k) submission process with a noted substantially equivalent predicate device. Throughout the manufacturing process, the team needs to ensure all manufacturers and distributors in the chain follow CPSC and FDA GMP guidelines. COVID-19 also causes a delay in obtaining vendors, and the current response rate of the FDA has slowed down, albeit marginally from the team’s recent experience. These may cause delays in the overall timeline from submission to market.

Through a mix of engagement with existing mentors and consulting with design engineering teams (already underway), Nutrivide should be able to complete the final design process by Q4 2020, outsourcing later parts of the design process (such as mold making) as needed. Team members have already identified mentors from the Rutgers University Honors College and School of Engineering who have experience in powering technologies with IoT capabilities for its future goals. The team has received some social impact grants and awards in the recent past, which should provide a base level of capital for endeavors up to the final design review. The rest of the capital should be achievable through further grants, pre-seed investment, and larger scale competitions such as MIT Solve.

As Nutrivide continues the process of filing with the FDA, the team hopes to leverage its network and seek input from various Rutgers Law School experts with knowledge of FDA pathways as well as FDA consulting agencies (e.g. Registrar Corp) to ensure manufacturers and device distributors are following the correct protocol or proactively preparing the necessary documentation needed in preparation for FDA inspections. 

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Currently, there are 7 committed members of the Nutrivide team: Akshay Kamath (Co-Founder & Team Lead), Joseph Bajor (Co-Founder & CTO), Yash Dave (Chief Scientific Officer), Juliet Petillo (Head of R&D), Claire Whang (Head of Medical Affairs), Harrison Zhang (Head of Finance), and Alyssa Krisinski (Head of Community Outreach). The team also possesses an experienced board of advisors for consultation at key points of development.

Nutrivide’s highest competitive advantage is its team, which is well-equipped to enter this space with backgrounds ranging from public health to biomedical engineering. Moreover, the team has a variety of experiences in the social entrepreneurship landscape, an encouraging feat as engaging with established partners becomes crucial in rapid development. Collectively, the team has experience in filing patents (utility and design), protecting IP, modeling and 3D-printing prototypes, communicating with relevant regulatory bodies, instigating customer discovery, laboratory work, financial modeling, and market sizing.

However, the team understands that there are wide gaps in capabilities for a project of global scale in healthcare. Accordingly, its advisory board is composed of a comprehensive array of professions, including a pediatrician, food science professor, mechanical engineer, reliability engineer, material scientist, medical device designer, lawyer, and serial entrepreneur.

Currently, Nutrivide is partnering with many institutions within Rutgers University, including the Honors College, Rutgers Business School, and Rutgers Law School. To date, they have been bastions of financial support, as Nutrivide’s many initial milestones were made possible on account of receiving access to 3D-printing laboratories, funding for development-related travel, and access to a wide array of specialized mentors and alumni.

With these partners, Nutrivide is working to seek external partnerships with other universities (e.g. Colorado School of Mines) in mutually beneficial agreements to expedite device design from the advice of experts across the country as well as to provide an opportunity for faculty and students alike to collaborate on a social impact project that affects their own communities.

Nutrivide will be employing both B2B and B2C arms in a two-stage business model. Initially, Nutrivide will be reaching out to community organizations and local health centers by providing Nutrifiers and pre-measured cartridges in bulk, as discussed prior, customized based on prevalence of vitamin deficiencies in the region. As the sales funnel garners initial revenues, Nutrivide plans to expand to its B2C component via online retail. Within this component, the team plans to employ a razor-and-blade business model that involves selling the Nutrifier for a one-time fee, and nutrient cartridges as recurring purchases. The company plans to sell each standard package for $19.99, containing one Nutrifier and a month’s worth of nutrient cartridges. Initially, the team will be targeting middle-class regions in order to generate enough profit to cross-subsidize the product for lower-income communities.

There will be a constant revenue stream over time from the customer on account of the recurrent need for nutrient/medicinal cartridges, and potentially replacement Nutrifiers due to wear and tear. 

As Nutrivide will start with a B2B model focusing on mom groups and small clinics, selling the Nutrifier to organizations that have a vested interest in the company mission will provide an early stage marketing advantage, as mothers in these demographics will naturally disseminate baby-specific solutions within their tight-knit social circles.  As Nutrivide gains traction, the team hopes to reach larger clinics and other health product distributors before expanding to its B2C models, which would require being able to sell with significantly lower margins (especially for big-box retailers). Upon going through the relevant FDA clearance process, the team eventually hopes to reach hospitals, where professionals are able to recommend the Nutrifier for convenient delivery in orally-indicated medication. 

Nutrivide’s mission at its core is to combat global infant malnutrition while also reaching the greatest number of customers. After expanding the array of products, Nutrivide hopes to expand to a one-for-one model, as explained earlier, which can maintain the prior financial sustainability on account of the larger partners that have historically invested in low-cost health products for the developing world (e.g. Gates Foundation).

With Solve’s support, Nutrivide can push forward the Nutrifier’s technical design and bring it to vulnerable communities. As the team has historically relied on internal capabilities, and now third-party engineering firms, to engineer the Nutrifier’s final design, targeted funding and high-touch mentorship from Solve would be valuable to refine product development. 

Furthermore, with the intended focus group timeline disrupted due to COVID-19, Nutrivide must rely on new approaches to connect with mothers and speak to potential customers. The team would greatly benefit by joining a class of peers at Solve who are also figuring out adjustments to their endeavors and approaches to customer communication in the midst of the pandemic. Additionally, the exposure the team would gain through Solve would help offer larger population pools from which to test product-market fit and attract investors. In a world on edge, Solve would help Nutrivide gain consumer and investor confidence. 

Finally, Nutrivide seeks the mentorship of Solve’s cross-sector leaders and organizations because the market is multifaceted. The Nutrifier’s potential for impact is extensive: the device addresses an issue present in communities both across the globe and in our backyards. This not only exemplifies the need for accessible delivery, but it also highlights the need for larger networks to address the massive and diverse serviceable market, for the common problem of infant malnutrition is prevalent in demographically distinct regions. To translate the team’s mission to reality, conversations with other cross-sector organizations that work with Solve, such as the Medtronic Foundation, are pivotal.

These partnership goals have been chosen to deliberately address Nutrivide's current pain points and plan for future gaps in the team skill set. While the solution technology has been tested to work with mentors, the team finds it highly important to vet the design from experts in other industries to develop a highly effective, scalable product. The team also finds it important to identify early sources of funding to ensure maximum advantage of marketing prowess is taken prior to a soft launch and that no corners are cut in the approval processes. Nutrivide additionally aims to establish local partnerships with maternal health organizations to grow relationships with the mothers the company predominantly serves. Lastly, as a team focused on helping cause a long-term shift in the health of vitamin-deficient children globally, it is important Nutrivide can monitor and evaluate the impact of the device in the specific communities of implementation.

Nutrivide would like to partner with additional pediatricians and nutritionists for validation. These professionals will help the team perfect design elements of the Nutrifier so that it is positioned to maximize impact on infant health in its soft launch. Nutrivide finds it essential to have the support of various doctors and healthcare professionals behind the product to gain the appropriate community acceptance necessary for the Nutrifier to address infant nutrition on an unforeseen scale. 

Furthermore, the team would like to partner with medical distributors and supply chain experts who can advise and assist on the path to wide-scale production. It would be helpful to gain access to health distribution networks to push production and distribution of the Nutrifier, leveraging existing infrastructure to create a largely centralized supply chain.

The team also recognizes value in partnering and collaborating with community organizations. For example, Nutrivide would like to partner with local organizations focused on maternal health, breastfeeding support services, and food banks--all of which directly correlate to the issues Nutrivide aims to solve, while already serving as influential hubs of community involvement. From these partnerships, Nutrivide would aim to gain access to pre-established networks of mothers, and in return, the company can offer the value of shared goals of nutrition, maternal, and newborn health in live/online sessions at community centers prior to showcasing the Nutrifier. The team views these partnerships as a strategic starting point for achieving high impact in communities and garnering momentum from a successful launch.

The Nutrifier is qualified for this prize on account of its use of an innovative conglomerate of technologies to directly focus on new mothers in communities that are underserved in health/medical benefit, have become food deserts, or have a large chronic disease population. Oftentimes, mothers who suffer from HIV, a low breastmilk supply, the side effects of medication, or substance abuse are simply unable to healthily breastfeed their kids. This causes the infant to suffer from a lack of essential micronutrients due to two reasons: (1) lack of accessible, measured nutrients, and (2) lack of an affordable delivery system. The Nutrifier, designed to dispense pre-measured doses of vitamins (initially those present in breastmilk), can serve this population of mothers directly. Mothers of premature/low birthweight infants will also gain particular benefit from a targeted delivery system distributed by local partner clinics. 

The team can use the Innovation for Women Prize to advance the solution by immediately conducting a final design review and beginning the molding process for at-scale production. As the team has filed patents and maintained conversations with certification labs, the funds can be used nearly exclusively for completing the design based on stakeholder feedback.

While the Nutrifier is currently not IoT-enabled, investors have brought up to the team the high value this would have in the infant consumer product industry. Accordingly, the team intends for a version of the device to make use of Bluetooth Low Energy to add reminders for contents to be replaced, the device to be cleaned, infant’s temperature to be checked, and device to be tracked (if misplaced). Other information about the infant’s feeding habits can be monitored and deemed highly relevant for a 21st century parent.

The team will use the AI for Humanity prize to advance this solution by making use of existing mentors from Rutgers University, particularly developed connections in the Honors College (such as Dr. Aaron Mazzeo [Mechanical & Aerospace Engineering Professor, MIT alumnus]) to ensure funding is tied to the mentorship and to explore relevant biomarkers that can be used (e.g. from saliva, taste receptors). The capital will be directly invested in "smart" pacifier device design and connective capabilities to pilot a version of the device for wealthier communities in the northeast and quickly determine the metrics considered important to monitor device impact.

The Nutrifier was originally designed for use in the developing world in an attempt to combat infant malnutrition by empowering communities with low-cost delivery devices. With minor modifications and an increased dose after obtaining revenues from the developed world to cross-subsidize (and eventually a one-for-one model), the device will still be able to fulfill this purpose. Though Nutrivide its a for-profit social enterprise, the team aims to distribute the device with partnerships at WIC clinics, government-funded child care centers (such as Anganwadi centers in rural south India), and food banks, further exploring distributing the device to more remote areas through entities like USAID and the ICRC. 

Distributing the device to developing nations immediately would be extremely resource intensive, and the team has determined that it would make more sense to start stateside to build up the capabilities required for international rollout, working with larger humanitarian organizations to supply the device to the developing world. The support of the Bill & Melinda Gates Foundation Funded Award would enable the team to have the financial backing and network needed to prioritize rollout into the developing world, as was originally intended.

As a for-profit social enterprise, Nutrivide aims initially to address a total available market of over 150,000,000 children: malnutrition. This number drastically soars as chronic diseases are added into the mix. For the device to be a financially sustainable product to manufacture, it will require a softer launch in the U.S. to generate the funds to cross-subsidize the product in areas of high need that currently possess distribution channels.  

Nutrivide will use the Future Planet Capital Prize to directly fulfill its initial phases of development in this plan, including running a short-run production/pilot, iterating on injection molds based on feedback, and offering a wider selection/combination of packaged nutrients for remote regions. As the team has enough initial resources from social impact awards and university-level support to obtain the necessary marketing support, these funds will be devoted exclusively to making sure the product becomes more accessible, functional, and affordable.