Bloomer Tech: Tailoring healthcare for women

With the U.S. facing a physicians shortage by 2030, remote-patient monitoring is key to deliver efficient care within highly-populated cities. Since health is not one-size fits all, shortages lead to increased disparities in patient outcomes due to failure serving: patient variability, lifestyle, physiological differences between men and women, etiology of diseases between populations and patients who metabolize medicine differently. 44 million women in the U.S affected by cardiovascular disease are already facing worse outcomes, such as higher readmission rates than their male counterparts and 1in3 women die worldwide. By democratizing hidden devices to collect the missing patient data remotely, we provide access to more efficient health services and emergency management. Affordable, easy to use, patented, medical-grade sensors in an everyday bra with female-specific AI enables data-driven life-saving quality of care and access to the right care coordination. Scaling worldwide increases positive health outcomes through personalized medicine.

Diverse populations within a city are facing challenges with health systems from preventive to emergency care. With worse experiences and catastrophic care expenditures, rates of recovery and death are higher in minorities. 20 years ago, research showed sex-related differences in the cardiovascular system. Cardiovascular disease and stroke (CVD) is the leading cause of death and disability worldwide, with deaths projected to be over 20million in 2020. There is a national economic burden for the rising female cardiac epidemic. In just one of the hospitals we work with in the Boston Area, there is an average of 18,200 incoming female CVD patients per month visiting aprox. 100 cardiologists.  Women are 1.5 times more likely to die. 50% will suffer a recurring episode in the first year. An average lifetime cost to the healthcare system of $1million per survivor. 75% are preventable.  Experiencing CVD episodes at any age is often traumatic both physically and mentally. Encouraging these patients to lead healthier lifestyles without their own data is challenging. Women and care providers need better ways to understand the triggers of females own unique bodies and targeted/tailored treatments so they can confidently say women's health is not left to chance.

We are working with women of all ages diagnosed and at risk of cardiovascular disease and stroke. Young women feel more threatened by cancer than by CVD despite the alarming increase of CVD deaths in women between 35-65 years old in the last 15 years. Once diagnosed, young women will face self-guilt, frustration and other challenges like fear to lead healthier lifestyles. We also serve elderly women, whom live longer and face poorer quality of life that needs better interventions. We work with hospitals Women's Heart Programs and with patient advocate groups such as the American Heart Association Go Red for Women. We co-designed workshops, studies and interviews to understand the needs of women who have survived cardiac episodes. We also held feasibility studies for them to test the bra device. Understanding both: the doctor's interest for activity logs/patient diary and the patients lack of adherence to certain devices and medication, we automated this by providing the information they both need in summarized reports. With our technology and data service, women can be diagnosed efficiently and target their disease with treatment specific to them, their data and their lifestyles.

With our technology and data service we are personalizing cardiovascular and stroke healthcare with long-term data to understand each patients and their unique lifestyle. With this vast female dataset, we can help cities drive inclusive health management strategies. Using AI for knowledge gaps supporting clinicians understanding of patients symptoms' within the context of symptom onset and the patients life. Providing the best treatment for women within their communities without time-consuming, wasteful hospital visits and tests. 

Our solution has  3 core features: 

1) Non-invasive, textile-based sensors seamlessly in a bra women already use everyday near their heart. The hidden machine doesn't interfere with the user's daily activities and has medical-grade acquisition quality and no plastic. Designed for long-term health monitoring to detect heart rhythm abnormalities that can be intermittent, symptomatic or asymptomatic. Collecting female-specific biometric and lifestyle data that traditionally is challenging and enabling having the right health data at the right time 

2) A mobile-app that receives information from the bra performs checkups and automatically keeps a diary of symptoms correlated with activities in her lifestyle to further understand her uniqueness and triggers. The app also builds community providing access to a network of similar nearby patients so that they can support each other in leading heart-healthy lifestyles 

3) Automated reports with information that help doctors risk-stratify and make a definite diagnosis, and develop a treatment plan. Doctors will use monthly reports to guide the treatment with drugs and prevent recurring episodes.

We enhance patient-centered care through experiences that are tailored to individuals. Elderly women just need to wear the bra, a habit they've had their whole life and now medical reports will be automatically sent to their doctors to improve their care. To engage and empower young women at risk or diagnosed, integrating into their already hectic lives is key. Also, the community in the mobile app shares resources and experiences of others quitting smoking, improving physical activity, and other behaviors. The detection tools enable lifestyle interventions, risk factor screenings to help reduce their risk for heart disease, stroke, and other chronic diseases. 

We provide a data-driven approach which is important to understand how to better serve these patients. Our technology is key for better outcomes and reducing readmission rates. It motivates adherence to a comfortable, cost-effective medical device and machine learning that can change the speed to accurate diagnosis and better inform care providers for targeted disease prevention.

With our solution, human-machine interactions are augmented through the real-world evidence data we collect, enabling access to healthcare services to those who otherwise would take longer time to diagnose or would need to undergo an emergency instead of a more preventative approach. In the future, within connected-cities, more features will be enabled through machine-machine communication such as medication delivery due to automated medication-adherence tracking through our sensor data, first responders due to emergency detection such as a heart attack or stroke. 

A human-centered design approach was used to design the system. We are the first to combine apparel and medical-grade technology into a seamless, intimate heart monitor specific for a woman and that is powered by proprietary algorithms specific to female physiologies. Evidence suggests that some medical devices currently in the market do not identify female thresholds and differences. Incorporating female-centered design to tackle this huge problem is our core. Current devices in the market are really uncomfortable, especially for women and have constraints with their data usage. Doctors have applauded our efforts by sharing with us that they often have to bargain with female patients to use a  traditional cardiac monitor and lack of adherence is a huge problem. Our design increases adherence to 100% as women already wear a bra, everyday.And it also collects female-specific data that none of the other cardiac devices take into account.

Our patented Advanced Fabrics Technology and AI

We improve the individual's quality of care, and change the time-consuming visits to the hospital to virtual, home care that is more efficient, all while reducing costs burdening the system and reducing physician burnout. We expect: 

• 100% adherence using bra monitor, increased knowledge on the health of the patient 

• Increased early detection of abnormalities, reducing emergencies for female patients.

• Decreasing time finding appropriate treatment/medication by collecting data on its effects to the patient over time. 

• Community building and support systems for healthier lifestyles

Evidence includes:

Agency for Healthcare Research and Quality’s 2016 meta-analysis of remote patient monitoring used 17 systematic reviews comprised of 202 individual studies and 48,321patients, finding  “sufficient evidence to support the effectiveness of remote patient monitoring for patients with chronic conditions such as cardiovascular and respiratory disease.”

Agency for Healthcare Quality. Telehealth: Mapping the Evidence for Patient Outcomes 2016; https://effectivehealthcare.ahrq.gov/topics/telehealth/technical-brief technical-brief

Veterans Administration (VA): Since 2000, the VA’s Care Coordination/Home Telehealth (CCHT) program has provided remote management of veteran patients using home telehealth and disease management technologies. In 2016, the VA has provided 2.17 million episodes of care via telehealth, serving more than 702,000 veterans. Multiple published studies have shown that the VA remote management program has improved access to care, improved health outcomes, reduced hospitalizations, reduced VA costs.

Care Coordination/Home Telehealth: the systematic implementation of home telehealth, and disease management to support the care of veteran patients. Telemed J E Health. 2008;14(10):1118-1126. 

>150 women served in development studies

We expect to serve at least 500 patients through our pilot studies. Once we get FDA approved, our first year we aim 6,500 per month (1/3 of avg incoming female patients in 1 hospital), in 3 years 48,000 monthly patients  and in 5 years 250,000 monthly patients

Goals relate to scaling manufacturing, launching pilots in hospitals, going through the regulatory process  and improving early detection (outcomes) in women.

Ongoing > Partnership with a recognized bra brand for our age population and production efforts of first commercial batch in different sizes.

Oct19: enroll  patients in pilot launches

March20: Phase II data analysis proves >100% device adherence and > 25%control.

March20: File for FDA clearance, expected by end of the year

After first year post-FDA, Scale through prescriptions-based model: sustainability and impact by  growing at a rate of one hospital every quarter, serving ~12000 new people,  we will be serving >48k people per month by 2022. At this rate we will have served >250k  women per month by 2024. 

Partnerships: we aim to work with women's heart centers across the country and patient groups to enable tech-enabled care. Once we have a CPT code As health financing options we can more easily scale.

The women's health market widely recognized as reproductive health and breast cancer is a major barrier for market potential recognition of the impact and financial projections of the large unmet needs for cardiovascular disease patients. It is also not obvious how they correlate, the U.S has the worst rate of maternal deaths in developed nations and the major contribution, common cause is due to cardiovascular disease, the field of cardio-pregnancy has emerged and can benefit from our solution and another non-obvious correlation is that women that survive breast cancer or any cancer face increased risk of heart disease, cardio-oncology is another field. Under-recognition of these challenges is a problem. 

Going through the regulatory process, even though we do have our quality management system and team in place to succeed, its a barrier to constantly improve and bring to market the best tools for patients, therefore getting as much diverse data with our first pilot studies pre-FDA is key to have the best possible for our patients..

We have a lot of data on heart survivor needs, patterns and cost and would like to work with partners (health payers,NGOs, governments) to raise awareness of the market potential and co-create models where female patients get access to female-specific remote patient monitor through more paid pilots, this way we can prove the market is huge and reduces significant economic burden and we can continue improving our technology pre-FDA.

N/A

Full Time: 2

Part Time: 2

Contractors: 8

We are personally triggered to solve this unacceptable problem that has affected our families. Jointly we have 20+ years of experience. Our core expertise is designing semiconductors, intelligent sensors, medical devices and product design. We have been leading teams across the US, Asia and LATAM. 2 of our founders have previously founded for profit and non profit organizations still growing today. Our other founder has implemented services and experiences used by hundreds of thousands of users globally. Jointly, we have raised $1M for R&D and innovation projects. We met at MIT and completed theses on Sex-specific biomarkers at the MIT Computational Biophysics Group and on forecasting behavioral science at the MIT Collective Intelligence Center. We have surrounded ourselves with the nation's best cardiologists at leading women's heart programs, highest growing volunteer patient organizations as well as C-level executives from the largest medical device companies.

• MIT Legatum provides office space and growth and entrepreneurship support.
• Bra Brand from one of the Top 5 retailers in the world, this multi-billion industry partner is providing manufacturing and bra design expertise by enabling integration to top selling designs free of cost.
• Two Major Hospitals in the Boston Area, we are piloting the solution and using their capital and resources. Legal documents are in process and awaiting their permission for public announcements. 

Pre-FDA through paid pilots enabling access to investigational data from women (current stage).

Post-FDA we have a prescription, subscription based model with a CPT code so patients can get reimbursed and use this chronic remote patient monitor monthly. Doctors will also obtain revenue for evaluating the data. With an initial $100 per device and additional subscription of $50/month, we expect a 72% profit margin per quarter.

Mixed Model: Organizational Support Model & 

Via a combination of grants, paid pilots and a seed round that enables us to reach fulfill a regulatory process which is when our scalability occurs and  our revenue streams increase significantly enabling our path to financial sustainability. 

Solve can provide visibility and a global impact network to facilitate breaking barriers for advancing women's health with technology and preventing AI bias in healthcare. Also bringing heart disease, the #1 cause of death in women to the forefront. 

Access to cross-sector partnerships is key to accelerate our work. Building inclusive healthcare datasets for the future of digital healthcare is important so that the models perform well in diverse populations. We'd like to perform pilots in communities outside the east coast to improve our technology so meeting community leaders, hospitals, insurance and other decision-maker stakeholders interested in partnering to improve women's health outcomes is key. Also, we'd like to address policies that currently widen the gap in health care disparities and think will be an important part of our growth process.

Healthcare Stakeholders

Medtronic Foundation, Johnson & Johnson, Novartis Foundation 

UN Women, Women Deliver, WHO

Health City Departments 

Heart Institutes and Organizations raising awareness and fighting heart disease.

Foundations, Institutes and Organizations with interest in accelerating progress for Women and for Women's Health.

Hospitals and other stakeholders of patients with heart disease.

If selected, this prize will enable either 1)Scaling our pilots impact 2)Depending on the amount, hiring another full-time data scientist 3)Use for the third-party testing and validation on our commercial device.

AI has been used widely to demonstrate its ability to detect heart abnormalities. Accessible datasets such as MIT-BIH Arrhythmia and non-accessible datasets such as Apple Heart Study have higher male than female data. In fact, besides the Women's Health Initiative in 1993, the datasets for women are limited. Bias in AI is a challenge when using traditional features for training. Our models currently perform 2x better with ¼ of training data

Generating female-specific computational biomarkers that enable breakthroughs for women's health is our bold vision. The female-specific data we are collecting are prognostic of long-term outcomes. 

Through physiological and lifestyle data acquisition via their everyday bra. Feature extraction that enriches the models are used in data from both pre-menopausal and post-menopausal women. Novel biomarkers like screening for elevated potassium levels without requiring any blood (hyperkalemia) have already been achieved with similar methods.  To improve disease diagnosis and identify onset of complex disease, we use computational methods for identifying potential biomarkers, and also shows its potential for the identification of warning signals.

The power of this approach is that these biomarkers are continuously collected in real time with no apparent change in the patients’ experience or any additional cost of care. This could lead to treatments that ultimately improve quality and extend the lives of female patients.

If selected for this prize, we would utilize it by 1)We will enrich the lives of more women by scaling our manufacturing batch in commercial production, and impact more women through our pilots 2) Execution and operational expenditures throughout the clinical trial of the first medical device for women using emerging technologies such as advanced fabrics and AI developed and led by multicultural female engineers from MIT with support by world-class renowned female cardiologists.

If selected, this prize will enable 1)Paying for any missing security and privacy costs and third-party testing of vulnerabilities 2)Legal support and documents related to privacy described below.

The architecture we are building is HIPAA-compliant, using servers level 4 for Very sensitive information storage from 5-levels. To store any data we require patient consent. We employ software and hardware security measures to protect the data acquired and stored. Using  encryption to transmit data from bra device to the app, and Secure Sockets Layer (SSL) so information sent between our app and our servers is protected and robust. Authentication methods to access our systems in 2 levels, one for aggregated data and the highest level for patient data. Personal information, physiological and lifestyle data are each stored in physically separate computing environments, in line with the industry standards for security. Aiming to reduce the likelihood that de-identified could be identified.  Patients decide how their information is stored, used and shared. We are responsible to protect their data. Aggregate information is stripped of personal details. We provide a female patients and their care providers a secure, private place to explore their data. 

We have legal documents such as privacy statement and terms of service, we need to prepare a research consent document, bra device storage consent document and frequently asked questions on security and privacy. We're also committed to complying with the EU's new data protection law, referred to as the GDPR and will need legal support to ensure we do.

If selected for this prize, we would utilize it by 1) Bringing to the forefront, by making public announcements of the importance of heart disease as a major women's health issue that has unmet needs that can be empowered through technology thanks to the acknowledgement that UN Women and Johnson & Johnson would give us by awarding us this amazing prize.  2) Scale our production so we can impact more women  in our pilots 3) Generate materials for recruitment of women to clinical trials of the first medical device using emerging technologies such as advanced fabrics and AI developed and led by multicultural female engineers from MIT with support by world-class renowned female cardiologists.