Helping parents keep their drug-exposed baby (and themselves) healthy
We can provide caregivers an award winning product to improve the health and reduce the burden of caring for drug-exposed infants.
Updates: How has your idea changed or evolved throughout the Prize? What updates have you made to this submission? (1500 characters)
While I've learned many things throughout the Prize process, two new learnings stand out above the rest. New learning #1 - there is a growing understanding, urgency and concern in every State with drug-exposed infants. Previous to the Prize, my belief was that some States were indifferent to the issue of drug-exposed newborns. New learning #2 - before the Prize we looked at helping infants diagnosed with neonatal abstinence syndrome during withdrawal and after withdrawal. We now realize that our product may be able to minimize the symptoms in drug-exposed newborns so much that infants could avoid be diagnosed with NAS. Why is this important? Most infants born with a drug-exposure are born in rural hospitals. NAS symptoms don't present themselves till a few days after birth. Once symptoms are observed and their observational scores go above a threshold - they are diagnosed with NAS. Once diagnosed they are typically sent to a hospital in an urban area with a level III or IV NICU - seperating mother and child. If our product can be used early enough after birth and reduce the scores it means mother and baby have a greater chance of staying together and the thousands of dollars spent caring for the baby in a NICU is saved. So, we are now looking at how we can help drug-exposed infants (and their caregivers) before, during and after withdrawal.
Name or Organization
Our company is in Concord , MA. Our product can help any drug-exposed baby born anywhere.
What is your stage of development?
Early Stage Innovator, with at least one-year experience in ECD
What is the stage of your proposal?
Piloting: I have started to implement my solution as a whole with a first set of real users.
Prapela - stimulating infant health
On October 4, 2017 the US Government Accountability Office issued this report on neonatal abstinence syndrome to Congress and the US Department of Health and Human Services. Among other items, the GAO report reinforced the recommendation of non-pharmacological approaches to treat NAS. The Prapela SVS baby box is the only non-pharmacological product that has been clinically proven to help NAS infants breathe and relax.
This chart, from an independent study by Elizabeth Bloc-Salisbury, et. al. published by PLOS One on April 20, 2017 indicates the improved cardio-respiratory stability and reduced movement (an indication of relaxation) in opioid exposed newborns with the SVS stimulation turned on versus off. This reported result provides the clinical evidence behind SVS with drug-exposed infants which Prapela is commercializing to help drug-exposed infants everywhere.
This illustrates the many different measures of improved cardiorespiratory performance and excess movement in opioid-exposed newborns as reported in the study publised on April 20, 2017 in PLOS One. With SVS "on" or active, NAS infants are more relaxed and experience improved rhythmic breathing and hear-rate compared to when SVS is "off".
On 2/7/2018, Prapela was selected as an award winner in our National Institutes of Health (NIH) “Start a SUD Startup” Challenge. As an award winner, we will benefit from the support provided by the National Institute on Drug Abuse (NIDA) with their initiative to further an understanding of neurobiology as it relates to substance use disorders. Our submission focused on how we can help improve outcomes and lower the cost to treat newborns with neonatal abstinence syndrome.
On 11/30/17, Prapela was awarded the top prize of $75,000 in the Next-Gen Baby Box Quickfire Challenge sponsored by Johnson & Johnson, Janssen and Finland's innovation agencies - Sitra and Tekes. We are proud to have the opportunity to extend the legacy of the baby box from a safe sleep environment to a product that improves the health of infants everywhere.
On 9/24/17 Prapela was awarded $25,000 during the FDA-sponsored pediatric medical device competition at the Fifth Annual Pediatric Device Innovation Symposium in San Jose, Calif. organized by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System. This is the #1 Neonatology hospital/health system in the US!
Boston Children's Hospital awarded Prapela as a finalist in its Innovation Challenge. As a finalist Boston Children's made arrangements for Prapela to connect with one of the Top 3 Medical Device companies in the World.
Describe how your solution could be a game-changer for your selected Opportunity Area (600 characters)
Our award winning, "Next-Gen Baby Box" with its gentle, stochastic vibrating sleeping pad improves the withdrawal and post-withdrawal experience for drug-exposed newborns and their mothers. Used in the hospital to treat infant drug withdrawal symptoms, our baby box helps relax newborns as it improves the rhythmicity of heart and lungs. Used after discharge from the hospital, the Prapela SVS baby box makes it easier for caregivers to console infants, helping baby and everyone else at home get the sleep they need to stay healthy.
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)
The gentle, stochastic vibration from the Prapela SVS baby box stimulates nerves and as the brain processes the signals, pacemaker neurons enhance the rhythmicity of the lungs and heart increasing relaxation and improving cardiorespiratory function crucial for healthy infant development. This is no ordinary vibration. It’s precise displacement is controlled by 2 micro processors and proprietary firmware developed over 7 years at the Wyss Institute.
There have been 4 studies on SVS, the most recent independent study on infants diagnosed with neonatal abstinence syndrome (NAS) published in April reported a 35% improvement in relaxation along with statistically significant improvement in respiratory rate and cardiac intervals. And there is an on-going study funded by the NIH examining the cognitive and behavioral benefits of SVS with drug-exposed infants. The technology is covered by an issued patent with another 4 submitted and under review. Most recently, on February 7th 2018, the NIH awarded Prapela a grant supporting its efforts to improve the care and reduce the cost to treat infants with NAS.
What problem are you aiming to solve? (3 sentences)
Our substance abuse epidemic is tragically impacting our newborns and mostly poor families. Called neonatal abstinence syndrome - newborns suffer from irritability, tremors, respiratory distress and struggle to sleep. This year 50,000 NAS infants will be treated at a cost of more than $3 billion – straining caregivers in hospitals and at home. This situation indicates the need for a clinically proven, drug-free product to treat and support of drug-exposed infants & caregivers.
Explain your idea (5000 characters)
Our plan is to provide affordable, clinically proven, medical and consumer products that improve infant health based on our core competency in stochastic vibro-tactile stimulation (SVS). Thus far, in clinical evaluations, our technology has proven to help infants relax, enhance their cardio-respiratory function and improve oxygenation - all vital to healthy human development. We have the potential to alleviate many infant health issues including; recovery from drug-exposure, apnea of prematurity, colic and even cognitive and behavioral development. And when we say affordable, we mean affordable to every health system and community wellness program in the World. At Prapela, we think big and believe we have the opportunity to impact the health and wellness of every child.
The Prapela SVS Prototype Baby Box
Our first product is a baby box including a sleeping surface inserted inside the bottom of the box with controls integrated into a power cord that extends outside the box. The box ships flat and pops up to be about 27" long, 17" wide and 10" high. The box is constructed of corrugated cardboard. The sealed platform inserted inside the bottom of the box contains a vibrating actuator and uses extremely low power. A foam mattress covered with both a waterproof liner and a natural cotton fitted sheet sits on top of the platform. A small hole in the box below the platform accommodates the pass through for the power cord. The vibration is turned on for a cycle of treatment by depressing a button - much like a heating pad switch. Set up takes about a minute and with one setting the product is easy to learn and use.
While treating NAS infants during withdrawal our baby box would be used as a complementary relaxation/sleeping site in the hospital nursery as well as in-room with mother. Whenever caregivers are unable to hold or cuddle a NAS infant, the patient would be placed in the baby box and the switch turned on to activate the SVS platform. After discharge from the hospital, the baby box would be used at home either as the primary sleeping environment or supplemental site for both daytime naps and evening sleep. The SVS baby box easily fits inside a bassinet or playpen. Again, whenever a caregiver at home is unable to console an infant by touch, swaddling, skin to skin contact or rocking, the baby would be placed in the box and the switch turned on to help console the infant. A second touch of the button will shut off the vibration cycle. To start the cycle again, the caregiver touches the same button. A dim LED on the control switch will confirm the vibration is active. When the LED light is off, so is the vibration.
For commercialization, we have already identified and started the product development process with our US based contract manufacturing partners and we will bill and ship from a central site in New England. Our unique, foldable box will be made by an established box manufacturer. Our electronics package will be assembled and tested by an electronic manufacturing services company in operation for almost 40 years. We will be proud to say our product will be made in America.
Priced at approximately $150 each, we will position the product to help reduce stay, reduce morphine use and improve care after discharge. For hospitals that prefer not to provide the product at discharge, the same product will be available online at our eCommerce website at $150 with two-day delivery.
NAS is a concentrated market which makes it easy and affordable to reach. Neonatologists and Neonatal Nurse Practitioners are the most active health care practitioners and regularly attend a few national organization meetings/conferences. Special meetings on NAS held by State agencies and professional medical organizations are well promoted and attended. Our plan is to cover the market with a small number of neonatal specialists and an informative and efficient e-commerce website. Further, through social media we plan to educate the community on the benefits and affordability of our product, encouraging them to evaluate and purchase the product.
Our goal is that within 2 years after launch, we expect more than 50% of the drug-exposed newborns and their caregivers will use the product - improving their overall health and giving them a better chance at a lifetime of wellness
Who benefits? (1500 characters)
50,000+ drug exposed newborns each year - by improving their health & wellness
The parents/caregivers of drug-exposed newborns - reducing their stress and workload of care.
Social workers who help support new parents recovering from addiction while caring for their NAS baby.
The community where our drug-exposed babies are raised - with better health these kids will be free to help their communities be stronger/better as they grow into adulthood.
Medicaid - with a non-pharmacological tool that improves care and lowers the cost to take care of the 80% or more of drug-exposed babies covered under Medicare.
US Citizens - by reducing the amount we spend to care for NAS infants (>$60,000 each) while improving outcomes
When parents and caregivers experience how our technology consoles their baby they sometimes begin to cry. Often its the first time they have seen their baby relaxed, making eye contact or not screaming. The impact of our product is often deeply emotional.
What kind of impact will your idea have? (1500 characters)
Over 10 ago, the CHIME studies found that 62% of even healthy infants experience intermittent breathing and low oxygenation levels. Some researchers suspect that, depending on the frequency and severity, these episodes may negativey impact a child's health & development. Our product reduces the frequency and severity of these episodes. So, we could possibly have a systemic positive impact on the development of every child. While it will take years to prove/disprove some long-term benefits of SVS technology, we can help kids with drug-exposure right now!
The Protecting our Infants Act law, tasks the HHS to develop the strategy and treatment for NAS. On 10/4/17, the GAO cited the HHS for falling behind and recommended to “prioritize non-pharmacological approaches to treat NAS and to provide resources for an infant after discharge." Working with HHS and Medicaid (which reports to HHS) we can provide a drug-free solution for pre & post withdrawal care of NAS infants.
In their April 2017 report on "Heroin in Colorado", the Colorado Department of Public Health and Environment reported an 83% increase in NAS cases among Colorado infants from 2010 to 2015. Many believe the incidence of NAS is still under reported as many hospitals do not correctly identify NAS with the new reporting ICD-10 codes. Working with the State, Prapela can help reduce the incidence, improve treatment and reduce the cost to treat NAS.
How does or how could your idea impact low-income children? (1500 characters)
According to the October, 2017 US Government Accountability Office (GAO) report on NAS to Congress, 80% or more of drug-exposed infants are on Medicaid due to their families low-income level.
Our product helps relieve withdrawal and post-withdrawal symptoms drug-exposed newborns experience after birth and helps caregivers get the rest they need. Additionally, the Prapela SVS baby box may become useful in reducing the number of infants diagnosed with NAS. As a 'first response" non-pharmacological treatment for suspected drug-exposed infants, it could prove to console infants so effectively that a NAS diagnosis is prevented. This would result in fewer drug-exposed newborns treated with costly and riskier morphine or buprenorphine for withdrawal.
Innovation: What makes your concept innovative? (5000 characters)
The Prapela SVS baby box is innovative by providing a solution to a large, growing, expressed and unfulfilled need - a cost effective treatment for drug-exposed infants.
Specifically, Prapela's SVS baby box has the potential to become a key part of a new standard of treatment of drug-exposed infants. Today, there is no accepeted standard of care for NAS infants and the US Department of Health & Human Services, State and Local healthcare agencies are looking for a solution.
As the only non-pharmacological product proven to console and improves cardiorespiratory function in NAS infants, with additional evaluations we believe health care practitioners will adopt its use for; 1) treating infants before a NAS diagnosis, 2) support during withdrawal and 3) to assist caregivers at home after withdrawal.
Scale: Describe how your idea could reach a significant number of end-users. (1500 characters)
We have several tactics planned to reach a siginficant number of end-users. 1) We plan to reach out to each of the State programs funded by the programs supported by the Maternal and Child Health Bureau of the US Health Resources & Services Administration/HHS. 2) We are in discussions with the largest on-line nursing community (650,000 members) in the U.S. to provide on-line education on NAS and our product. 3) Additionally, the community of professional caregivers focused on NAS infants is relatively small, making it affordable and easy to reach. In the US there are less than 1,000 sites with neonatal intensive care units and approximately 5,000 neonatologists. A majority of sites treating NAS infants are Level III and Level IV NICUS which number less than 300. Thanks to improved tracking and reporting, we know which States have the highest incidence of NAS patients. Targeting our efforts will provide us faster uptake and provide the references we need to help other locations. 4) We will attend major medical meetings on NAS - presenting our technology and 4) through, our eCommerce platform, with free 2 day delivery we will distribute our easy to ship, easy to set up and easy to learn product nationwide at an affordable price.
Feasibility: Where are you with understanding the feasibility of your idea? Describe what you’ve done so far and your plans. (3000 characters)
Two (2) peer-review studies have documented the benefits of SVS with NAS infants
One (1) current study is examining its long-term benefits on the cognitive and behavioral development of NAS infants
We have been recognized by the #1 & #2 ranked "Best Hospitals for Pediatric Neonatology", Children's National Medical Center (Washington DC) and Boston Children's Hospital for Innovation in Pediatric Devices.
On 2/8/18, Prapela was honored to be selected as an award winner in our National Institutes of Health (NIH) “Start a SUD Startup” Challenge. As an award winner, we will benefit from the support provided by the National Institute on Drug Abuse (NIDA) with their initiative to better to further an understanding of neurobiology as it relates to substance use disorders. The award provides a $10,000 grant and connectivity with the National Institute on Drug Abuse.
On 11/30/17, Prapela took top honors in the "Next-Gen Baby Box QuickFire Challenge".
The Prapela(tm) SVS Baby Box was selected over 135 entries from 17 different countries as a leading innovation to promote child health and facilitate healthy parenting. Prapela receives some funding as well as support from Johnson & Johnson, Janssen, the Finnish Innovation Fund - Sitra, Tekes - the Finnish Funding Agency for Innovation and VTT Technical Research Centre of Finland. We are humbled to be selected as a winner in the country that made the Baby Box famous for helping infants sleep safe.
We are preparing our pre-submission for the FDA to review in Q1, 2018
We have identified our key suppliers and with funding begin product safety testing and then our pilot build in Q1 of 2018. We will be evaluating 2nd gen working prototypes in February. Plus over the next 2 months we will be getting user feedback on our set up instructions as well as our switch to turn the product on and off.
With a successful pilot build and clear regulatory path we plan to be on the market by Q2, 2018.
Business Viability: How viable is your business model? (5000 characters)
In terms of product acceptance, during 2017 we completed a survey with approximately 100 parents to test our product's value proposition ( value proposition = primary benefit, to what target customer and price). The survey results indicated broad a large number of parents would likely purchase the product at our target price. However, until the product is made available we will not understand exactly the types of parents and how many will become customers.
To identify the risk in our business model, we developed a five-year plan with over 2,000 documented assumptions that generates our financials by month for 60 months. Additionally, we have competed a SWOT (Strengths, Weaknesses, Opportunities & Threats) analysis and identified potential solutions and programs to mitigate business risk. Further, our operational plan for the company includes quarterly operational reviews to identify and address issues and risks that may prevent the company from reaching its objectives. Based on an evaluation of the market opportunity and our solution combined with our mangement experience, we believe we have the knowledge, skills and abilities to succesfully manage the company through unforseen risks.
HCD: How have you used human centered design to build or refine your concept? (5000 characters)
We have completed surveys with parents, spoken to neonatologists, pediatricians and researchers about our product. As we complete our next working prototype we plan to meet and ask health care practitioners for input on product set-up and operation. What we are most excited about is how individuals react to our product's simplicity. Out of the shipping container, the product can be ready for use in one minute or less. Control of the unit is achieved by pressing the only button on the only control panel provided. With the button pushed, a light is activated on the panel and the stimulation begins. Another touch of the same button turns off the stimulation and the light on the panel. A new user (in testing) "learns" how to use the product in less than a minute. For busy healthcare practitioners, who have little time to stop and learn how to operate a product - ours is easy to learn and easy to use.
Tell us more about you (3000 characters)
Last year, while I was consulting for Harvard's Wyss Institute, a member of my family overdosed on Heroin. I've found life for a recovering addict and family was difficult. However, I couldn't imagine how much more difficult it would be for a recovering addict with a newborn exposed to drugs.
About a month after the overdose, the principals at Harvard's Wyss Institute asked me to evaluate and recommend how to commercialize the SVS technology they had spent 7 years to develop. At the time, faculty at the Wyss were mostly interested in its use for apnea in premature infants. I recommended instead to initially focus on helping drug exposed infants. Then late this past Summer, I came up with the idea to put SVS into an affordable baby box so it could be used in the hospital and then taken home. In September we presented our idea to Childrens National Medical Center and they awarded us $25,000 to help. I'm excited to leverage my University of Colorado MBA and 35 years in medical devices to help address our opioid epidemic.
That's just my side of the story.
The inventor of SVS for infant health, Dr. David Paydarfar, has his own story which begins with his discovery and the challenge of helping preemies with apnea of prematurity.
The SVS product developer, Jim Niemi, has his story which revolves around a desire to develop an affordable stochastic resonance technolgy to help babies breathe, senior citizens keep their balance and to help the disabled improve proprioception and recovery. He's been at it the past ten years of his life.
Then there is Liz Salisbury, PhD, who had the inspiration to explore the use of SVS to help drug-exposed infants more than five years ago and well before we understood the magnitude and the pain of neonatal abstinence syndrome. Her research is independent.
Finally, there is my wife, who agreed to sell off some of our assetts so that we could use the proceeds to finance this endeavor to help kids everywhere.
Do you have the people and partners you need to do what you’ve described? (600 characters)
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)
Support and feedback from more pediatricians and neonatologists
Community infant sleep education expertise.
Would you like mentoring support?
If so, what type of mentoring support do you think you need? (1200 characters)
I would benefit from having anyone with intelligence, desire and passion for what we are doing to jump in and give advice on any topic. One of the things I learned over the past years is that you can never have enough good people or good ideas. Diversity makes every team better.
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).
Mentorship: How was your idea supported? (5000 characters)
My mentor - Jessie - was fantastic. While we did not change anything about our product concept, she did provide great insight into other organizations that would have an interest in our solution. She also provided an explanation on how best to reach out and interact with these organizations. We're really grateful for her help and insights and can't wait to reach out to these "new to us" organizations.
What is your stage of development?
Early Stage Innovator, with at least one-year experience in ECD
What is the stage of your proposal?
Piloting: I have started to implement my solution as a whole with a first set of real users.