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Promote vaccination by preventing pain

Needle-fearing adults (63% of Gen Z!) vaccinate less. We'll use proven pain + fear reducing tech to treat & prevent needle fear worldwide.

Photo of Amy Baxter

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Describe what you intend to do and how you'll do it in one sentence (required 250 Characters)

Lifelong needle fear starts at age 4-6 from trauma with boosters; 8% then don't vaccinate their own kids. Pain Care Labs will adapt proven Buzzy needle pain & fear relief for any environment and create cross-cultural Pain-Fear-Focus education kits.

Explain the idea (less than 2,000 characters)

1. The challenge is to support vaccinators to reduce pain and fear in preschoolers, preventing vaccination from becoming a traumatizing adverse childhood event. Our current vaccine skepticism largely results from needle fear. Children born before 1983 got 6 injections before they were two, no more than 2 on one day. No one developed needle fear from shots because children can't make verbal memories until later. Since 1983, we've added 30 separate injections to the schedule. 4-year olds DO remember, and increasingly fear healthcare. During NIH research developing a needle pain reliever, we discovered that the incidence of needle fear in 10 - 12 year olds had skyrocketed to 63%, 252% higher than previously reported. The increase in fear correlated with the number of same-day booster injections at age 4-6. In 2012, Anna Taddio PhD published the same incidence of kid fear, and found adult needle fear rose from 10% to 24%. Worse, 8% of needle-fearing adults said they wouldn't vaccinate their own kids. We proved and published (Vaccine 2017) this correlation data. Treating fear is harder than preventing it; when the children protected with this vaccine schedule have their own kids, many won't vaccinate unless we intervene. As more countries adopt the booster-heavy vaccine schedule, this issue can be prevented. 2. Children, parents AND vaccinators will benefit. Our ice and vibration device "Buzzy" is proven to reduce pain and fear, and increased compliance in nonadherent teens. Learning to treat pain, fear, and focus during preschool vaccinations will make vaccinators' jobs easier, and improve parents' satisfaction with vaccination. 3. Our idea is to educate about Buzzy and pain relief, creating culturally relevant materials to teach vaccinators of preschoolers how and WHY to address pain and fear worldwide. As the world adopts Western injection schedules, it's critical to assemble knowledge and prevention materials to prevent skepticism from spreading and empower kids.

Which part(s) of the world does this idea target?

  • Eastern Africa
  • Southern Africa
  • Caribbean
  • Central America
  • South America
  • Northern America
  • Central Asia
  • Eastern Asia
  • South-eastern Asia
  • Southern Asia
  • Western Asia
  • Eastern Europe
  • Northern Europe
  • Southern Europe
  • Western Europe
  • Oceania

Geographic Focus (less than 250 Characters)

This idea is most appropriate where common practice is already 4-6 injections on the same day during the preschool period. Only one or two injections at a time builds resilience in 4-6 year olds, so pain and fear interventions aren't critical.

Who are your end users and how well do you know them? (750 characters)

Our users are nurses and patients. I was a practicing pediatrician 20 years, publishing on needle pain and changing caregiver behavior & lecturing worldwide. I've heard 10 years of feedback: Buzzy has blocked pain from over 32 million needle procedures. We hear from adults too fearful to go to the doctor, who had loved ones die due to delayed diagnosis from needle fear, a child taken off a heart transplant list due to fear, and too many anxious teens to count. We've helped families of children started on biologics or insulin who have hours of stress from needle fear. We've worked with nursing leadership and child life, both those who want to decrease pain and those who belittle the weakness of anyone fearing needles. We know this area.

How is the idea unique? (750 Characters)

Our idea PREVENTS the development of needle fear that leads to vaccine reluctance. We have over 30 RCTs proving reduced pain and fear. We were the first researchers to identify and quantify the genesis of needle fear, and connect it with Taddio's connection between fear and anti-vax intentions. In addition, our group discovered the key nuance in Dan Salmon's 2005 vaccine reluctance work: partial vaccinators SAID they feared immunogenicity and vaccine harm, but were most likely to accept the [immunogenic, potentially harmful] ORAL polio vaccine. It was the NEEDLE. Our construct of Pain-Fear-Focus is adopted in published pediatric pain guidelines; Buzzy has its own PubMed identifier. We've changed behavior and know how to expand.

Idea Proposal Stage (Select 1)

  • Majority Adoption: We have expanded the pilot significantly and the program product or service has been adopted by the majority of our intended user base (i.e. 50% to 83% of the target population or 50,000 to 1,000,000 users).

How many months are required for the project idea? (140 characters)

6 months to design cross-cultural DistrACTION cards for Fear & Focus; 4 months for a Buzzy Pain relief education template

Organization Name (less than 140 characters)

Pain Care Labs (a dba of MMJ Labs)

Type of Submitter

  • We are a For-Profit Startup or Startup Social Enterprise

Organizational Characteristics

  • Female-led organization
  • Women’s health/rights focused
  • International/global organization (implementing in multiple countries)

Organization Location (less than 140 Characters)

Atlanta GA USA

What is the current scale of your organization’s work?

  • Global (within 2 or more global regions)

Website URL

www.buzzyhelps.com

Tell us more about your organization/company (1-2 sentences)

Our mission is to eliminate unnecessary pain: as the industry leader in noninvasive pain relief, we use the body’s own physiology to inhibit pain and uncouple pain and fear. To change the way people treat and even think about pain, we combine advocacy, honest science, cool design and REUSABLE technology, so changing how the world vaccinates and preserving herd immunity are passions we've championed for years.

Who will work alongside your organization in the project idea? (750 characters)

I am on the board of the Standish Foundation and support the Child Life Community, groups who address needle pain worldwide. I've been a Shot@Life champion, and our Facebook communities are broad and enthusiastic. We have multiple design and manufacturing connections, and have worked with the University of Iowa, Cook's Children's, Children's Healthcare of Philadelphia and others on integrating our devices and teaching into vaccination clinics. The energy from a Gates grant will give added enthusiasm. Ideally the DistrACTION cards and education materials would a collaboration with one of the other grant applicants with expertise in culturally relevant collateral creation, and fund a Buzzy, Cards, and education materials.

How many people are on your team?

6

Tell us more about you and your team

Dr. Baxter directs innovation, invention, operations and strategy for Pain Care Labs and lectures internationally about procedural pain relief. Accomplishments include the 2009 1.1M NIH SBIR, writing and overseeing patent strategy, and successfully pursuing 510K FDA clearances. After graduating from Yale University and Emory Medical School, as a double boarded pediatric emergency physician, Dr. Baxter founded PEMA Emergency Research, Scottish Rite, Children’s Healthcare of Atlanta while founding Pain Care Labs. Recognition includes Forbes Ten Healthcare Disruptors, Inc. Top Women in Tech to Watch, Top 10 Innovative and Disruptive Women in Healthcare, a Wall Street Journal “Idea Person”, and the Most Innovative CEO of 2014 from Georgia Bio. National and international lecturing highlights include MakerFaire, AARP, and TEDMED. https://buzzyhelps.com/pages/our-staff

Overview of How Your Concept Has Evolved (5-6 sentences):

Initially we anticipated that the vaccine givers would want to reduce pain; instead, the vaccination process was so overwhelming that we realized they weren't the stakeholders. Instead, parents wanted to reduce the pain, and are the primary consumers of Buzzy. To sustainably improve the vaccination experience, those giving the injections need to understand how pain relief enhances their mission. We initially focused on a solar powered option. After listening to Unicef and others, the barriers seemed not to be batteries or ice, but speed and making vaccination appealing. We decided creating country-specific DistrACTION cards to be used WITH the existing Buzzy & appealing "comfort vaccines!" collateral would pull more toward vaccinating.

Viability (3-4 sentences and activity upload):

https://canvanizer.com/canvas/rrnf2LPOi0dC9

Feasibility (3-4 sentences):

The device has been used in over 50 countries; while pain is universal, the Distraction component to reduce pain and fear requires more specific cultural cues and written instructions in different languages. Reconfiguring for solar power would be satisfying. However, after teaching Child Life workers in the Republic of Georgia we realized that the easy, low tech addition of DistrACTION cards taught healthcare workers that child friendly pain relief mattered. Since Buzzy is reusable and 0.9 cents/injection already, creating a medium that IS the message is a better use of funds.

Desirability (3-4 sentences and activity upload):

Community Focus (2-3 sentences):

Community Impact (2-3 sentences):

We've been invited back to Tbilisi to educate more of the doctors.

22 comments

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Spam
Photo of Ashley Tillman
Team

Hi Amy Baxter I am curious if you have formed any additional partnerships or connected with anyone further on solar components of your project? More generally did you connect with any end users / potential partners in low resource settings like East Africa?

Spam
Photo of Amy Baxter
Team

Hello, Ashley- After speaking to stakeholders in countries like Azerbaijan and Georgia and with people who are currently using Buzzy in Kenya, it seems that the issue was less whether it was battery or solar powered and more why pain care mattered. From the unicef webinar I took away that novel ways to encourage caregivers to feel a sense of urgency about getting vaccinated What is far more important than whether the device is solar powered. The device can use rechargeable batteries that are attached to a solar powered adapter, which is currently available. I also realized that $50,000 is not enough to re-design and retool, but it is enough to create meaningful education materials and provide Buzzy units in a way that will provide proof of concept in 10 countries. I changed my application to reflect this new goal a week or so ago after returning from a state Department trip to the Republic of Georgia.

Spam
Photo of Ashley Tillman
Team

Thanks so much for the additional information!

Spam
Photo of Amy Baxter
Team

It’s in the “feasibility” section above. Mind you, This isn’t to say we wouldn’t do this in the future, just that it does not seem to be a good match of need, time, objectives and resources.

Spam
Photo of Paul Collins
Team

Hi Amy, I would be very pleased to share some ideas and explore the possibilities. I can totally understand your proposition and the reasons for it.
Warmest regards. Paul

Spam
Photo of Ashley Tillman
Team

Amy Baxter and Paul Collins looking forward to hearing if there are any intersections between your work!

Spam
Photo of Paul Collins
Team

Thanks Ashley, what I would like to put on the table for discussion is how we may collaborate especially if we use discharged waste heat from the equipment and by using that heat to drive a small thermal generator which may be good enough to charge a 'Buzzy' say. We know it can charge a phone or other small tech kit like a couple of LED lights for instance.
Also, to explore how our cooling could be used to chill the gels. Especially in situations with unreliable or no electricity. We could pick up the thread here Amy and then open it up.
Warm Regards. Paul

Spam
Photo of Amy Baxter
Team

Hello, Paul - so sorry I've been delayed in responding. Do you think your solar power could be sufficient for a peltier device? I wonder if there would be sufficient energy to power, say, a metal ingot to retain cold while it's in place rather than using the ice packs?

Spam
Photo of Paul Collins
Team

Hello Amy, that is no problem, good to see your questions and I will answer part for now but we will also have questions. Our Technical Director and Co-Founder Michael has experience of Thermoelectric Generators, the waste heat from the Solar Polar unit can drive an attachable thermo generator, our question here is how much power would be needed for the size of a peltier device suitable for your requirement? As far as directly cooling an ingot this is most possible, what we will need to know is the mass of the ingot, the metal and the usage requirements. By all means, email me directly so we can share pictures and documents.

Spam
Photo of Amy Baxter
Team

What's you're email? Tried to find you on linked in - shockingly, you Paul Collins sorts are legion!

Spam
Photo of Paul Collins
Team

Ha, Here I am. p.collins@solar-polar.co.uk

Spam
Photo of Geenie Choy
Team

Hi Amy, I love that your device is noninvasive and uses a simple combination of vibration and cold to physiologically block pain. Growing up I have never been fond of getting shots and I am sure the idea of Buzzy alone is effective to a certain degree to psychologically lower patients' anxiety and consequent pain as the muscle relaxes. I also really like that your idea is scalable and viable to be implemented across the globe, as many other proposals seem to target only less developed areas. I was wondering what distribution channels have you considered for Buzzy. Will you be selling directly to patients' families or just hospitals and local healthcare providers? What about the distribution in areas that have fewer healthcare providers, have you considered partnering with NGOs or schools with nurses that administer vaccinations?

Spam
Photo of Amy Baxter
Team

Hello, Geenie - Thank you for your feedback! Interestingly, while we DO think that the empowerment of bringing a Buzzy should reduce fear, Buzzy had the greatest effect in a study with severely cognitively impaired adolescents and adults - so, they weren't able to benefit from the fear part of the pain/fear/focus triumvirate. We initially thought pediatricians would be the ones who cared the most about the device, but since injections are more commonly given by overwhelmed nurses we've learned that patients are the ones who tend to buy Buzzy. We sell about 1/3 of the devices direct to consumer online and through hospital gift shops. About 1/3 are bought by hospitals and drug companies or clinical research organizations trying to improve the patient experience, and 1/3 internationally. We have contacted Shot@Life and the Gates Foundation in the past to partner, but admittedly it was a few years ago before our meta-analysis and 30+ papers were in press. In New Zealand, Buzzy is part of the national guidelines for Bicillin injection; we were hoping that the company that makes Bicillin and distributes it in most of the countries in Africa for rheumatic heart disease would purchase Buzzy to improve adherence with treatment, and thus clinics would have units they could use for vaccination. (We've found it's easier to focus on Buzzy's impact on adult adherence than on reducing children's pain. I think it's easier for adults to identify with other adults). One of the barriers is how to structure "partnering". Most NGOs and nonprofits want us to donate the devices, but since they're reusable there's not a sustainable business model there. Do you have any ideas about structures that would keep us in business while doing good?

Spam
Photo of Estela Kennen
Team

Amy, I just finished watching your TedX talk. Powerful stuff, and I'm now fully convinced of the importance of addressing needle pain, not only for the sake of vaccination but also for the future of preventative medicine in general. It looks as though you are doing wonderful things with Buzzy. As I was looking over your proposal, one idea kept floating around: since you have already launched your business but this challenge is geared more towards the ideation/prototype stage, what would it look like to start over and answer a question along the lines "How do we alleviate pain (eg, confuse the senses) at a manufacturing cost of, say, $5 or less, so that we can still sell at a profit, but in a way that is widely affordable/scalable in East Africa?" Good luck with everything!

Spam
Photo of Amy Baxter
Team

Hi, Estela! Thank you so much for your kind words, and for taking the time to watch the TEDx. As for starting over and making it less expensive, the problem is that the motor itself has to be very powerful and small - even at quantities of 100K we can't get the price down enough for the motor alone to make $5 for the unit. The thing is, the device is completely reusable - with Paul Collins' tech, we could perhaps obviate the need for batteries, but even so - at present, it's 20 cents a use even if you throw away the device instead of replacing batteries. Because I think being reusable is more important, I've somewhat given up on profit with Buzzy in those settings. It's difficult to get distributors interested without a disposable component, and I'd rather have a $100 reusable device than many, many $5 ones that break or don't work. I'm hoping this challenge a) raises awareness of the problem and b) gets across the idea that while Buzzy reduces IM pain 74%, distraction reduces pain 50%. The latter is free once someone is trained. Nonsequitur, but TBH while there are 3M deaths from vaccine-preventable illnesses every year, there are 27M people addicted to opioids, with 450K deaths. I'm focused right now on leveraging the intense pain relief of ice and vibration to reduce or eliminate post-operative opioids to prevent exposure and addiction. (in a trial our cryovibration actually reduced opioid use 35%... ) so that's where my bandwidth on new devices is oriented. I'm hoping if we are chosen for this challenge, we could partner with a group making easy to understand instructions. If they can make instructions for pain relief, and each mobile vaccination area got one or two Buzzy units, that would be sufficient for thousands of kids.

Spam
Photo of Ashley Tillman
Team

Hi Amy Baxter great to have you in the Challenge. You mentioned being interested in connecting with teams working on solar in the space. Might be worth checking out Solar powered recharge stations and Ensuring access to safe supply of temperature sensitive vaccine even in regions with unstable or non existing electrical provision. I'm also curious to learn more about how for this Challenge how you would think about contextualizing your idea for low resource settings, where would you start?

Spam
Photo of Amy Baxter
Team

Hi, Ashley - I'd get IDEO to design a lithium-ion board with an inductive charger that could hook to a solar charger and do a bit of NRE to the Buzzy casing to accommodate this power source. The device is already reusable, less than $100, and can do thousands of injections for about 20 cents each if you DON'T replace the batteries, so a solar charger adaptation would reduce that further by eliminating the need to replace batteries.

Spam
Photo of Paul Collins
Team

Hi Ashley, thank you for this message. I would be very interested in communicating with Amy.
There are some interesting twists to consider and develop.

Spam
Photo of Manisha Laroia
Team

Hey Amy Baxter 
Thank you for sharing this very interesting idea.
While the evaluation phase is on...we would encourage you to also look at our other OpenIDEOvaccine challenge and share your innovation there also. It would make a good fit.
Please have a look:
https://www.openideo.com/challenge-briefs/infuse-urban-immunization

Spam
Photo of Amy Baxter
Team

Thank you! My concern is that the goals for urban immunization are for all vaccines by the time children are two. Our Buzzy solution is physiologically most appropriate for age 2 and up; psychologically the need for pain mitigation to reduce fear is most appropriate for age 28+ months. While we have well-established data for older children, because younger children don't have DNIC feedback loops (and speed and breastfeeding have the best data for reducing infant vaccination distress) I wouldn't want to advocate our solution in this younger population. It is certainly possible that parents will be more likely to bring all their children for infant and catch-up vaccinations if pain relief is provided. It is also true that parents rate their children's pain and fear as less when Buzzy is used. It is simply that I don't believe Buzzy is the best approach for the age that is the stated goal of this challenge. If it is worth applying just SPECULATING that more families will bring all kids if it's advertised that there are pain relief options for older kids, and anticipating letting parents hold a Buzzy without ice on an infant or toddlers' tummy if they're not breastfeeding during shots, let me know. I wouldn't want an extremely effective solution for older children to be felt to be ineffective because it was used for the wrong age group, particularly in place of better research-supported interventions for infants.

Spam
Photo of Isaac Jumba
Team

Hello Amy Baxter and team
Great to see your idea here. I really liked reading through your idea, especially on the video highlighting testimonials of caregivers who have used Buzzy, and your understanding of the problem you are solving through the research that you have shared.
Could you share more on:
1. How would you envision your product being low-cost and available for mass reach especially when implementing it in areas where the standards of living are quite low, but still faces the same challenge?
2. Could you share more on what areas in the world where you are currently operating? Are there regions in mind where you are thinking about scaling to?

Also, we would love for you to have a look at our other vaccine challenge and share your innovation there also. It would make a good fit. Please have a look:
https://www.openideo.com/challenge-briefs/infuse-urban-immunization

Any thoughts on this Anne-Laure Fayard  Manisha Laroia  Ashley Tillman ?

Spam
Photo of Amy Baxter
Team

Thank you, Isaac - First, the device is totally reusable and costs less than $100 - it can be used for 1000's of times. My IDEO change was to make it adaptable to a solar charger, and incorporate a small peltier so that both cold and vibration could be used where solar rather than AC was available. It's not just pain - pain/fear/focus is critical, so the educational component is as valuable as the pain relief part. Also, the challenge actually only becomes the same where communities are giving 3-5 injections on the same day when the kids are old enough to remember. Much more important to let communities know this and stagger. However, when parents travel miles and days to get their child immunized, it's important that the child not go home determined to never put HER child through that, so that is a case where I'd apply our research. 2) We're in 29 countries but really only have good penetration in US and Brazil and Australia/NZ. In New Zealand we are in the national guidelines for Bicillin injection adherence - this would actually be really important in countries where rheumatic heart disease is endemic (estimated childhood mortality due to rheumatic heart disease greater than 0.15 deaths per 100,000 population among children 5 to 9 years of age. ATG denotes Antigua and Barbuda, BRB Barbados, COM Comoros, DMA Dominica, E. Med. eastern Mediterranean region, FJI Fiji, FSM Federated States of Micronesia, GRD Grenada, KIR Kiribati, LCA Saint Lucia, MDV Maldives, MHL Marshall Islands, MLT Malta, MUS Mauritius, SGP Singapore, SLB Solomon Islands, SYC Seychelles, TLS Timor-Leste, TON Tonga, TTO Trinidad and Tobago, VCT Saint Vincent and the Grenadines, VUT Vanuatu, W. Africa West Africa, and WSM Samoa. - https://www.nejm.org/doi/full/10.1056/NEJMoa1603693) That's not your challenge, but needle pain and subsequent fear fits in here.

As to the urban challenge, apart from perhaps making the device dock in a hub so that taking a device would be pointless, I'm not sure what we would do differently. (The devices DO tend to fly away, we're told.) Many urban and public health centers have Buzzy, but neither they nor we have resources for the Pain/Fear/Focus training that is so important in often burned-out caregiver situations; often public health offices don't have funding for the devices, either, reusable or not. So innovating to make them MORE expensive seems... counterproductive?