I have been passionate about medicine since I was 7 years old, when my Uncle Don died from full-blown AIDs. From my childhood experience, I pursued biomedical engineering where I studied abroad in Thailand and developed appropriate technology grey water recovery systems. I loved my focus on user-centered design principles and pursued a PhD to develop diagnostics for global health. In my PhD I learned about the disease cholera, and how it took up to a week to detect the bacteria in water, leaving communities vulnerable. Learning about cholera tied together my life experiences and I used my PhD to invent the OmniVis technology to detect for the cholera pathogen in water in under 30 minutes. I co-founded OmniVis in 2017 and am currently the company CEO, developing handheld devices for rapid cholera detection and other infectious pathogens.
One-line project summary:
We design handheld devices to rapidly detect dangerous pathogens, map them, and report them to relevant stakeholders.
Present your project.
At OmniVis, we envision a world where proactive disease detection advances the health of communities and cultivates a safer world for future generations. The 10/90 gap says that 10% of healthcare research resources are put toward healthcare in low resource nations, where over 90% of all preventable deaths worldwide occurred. We want to dismantle healthcare disparities by creating rapid detection technology that equips communities around the globe with the power and knowledge to protect their health. Our device is designed to detect dangerous pathogens, such as cholera in water sources, a disease that unequally effects vulnerable communities in 41 countries, and SARS-CoV-2 (causing COVID-19). We believe early detection of dangerous pathogens can alleviate healthcare disparities and, in turn, economic disparities that occur from being sick.
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What specific problem are you solving?
In 2019, Yemen is undergoing the largest cholera outbreak in history while Cyclone Idai initiated an outbreak in Mozambique. There are 41 countries and 5M people affected by cholera annually. This leads to $2B in costs spent in cholera treatments and lost productivity that could be avoidable through early detection. Current water-based cholera detection approaches take up to a week, and are intensive, costly, and imprecise. Lengthy or inaccurate approaches exacerbate wide-scale outbreaks.
Prevention strategies are a lower priority in low-resource communities due to the effort needed with current detection methods. Aid organizations work momentous hours to suppress disease spread. Early detection of the cholera pathogen in water with a rapid, portable device would enable proactive remediation strategies.
The time it currently takes for laboratories to detect cholera leaves communities vulnerable to illness or death. Proactive cholera detection can change humanitarian aid response, by knowing where and when to send resources. OmniVis works with NGOs, as they provide distribution networks and expertise. At OmniVis, success looks like providing 1.8M people with access to safe water over the next 18-months. Our key indicator will be the number of water sources where our technology proactively detects cholera before someone falls ill.
What is your project?
OmniVis wanted to change the way that cholera detection was performed in order to make progress toward disease eradication.
Our product is a mobile-based cholera detection platform that combines (1) a hardware platform that serves as a mobile laboratory, (2) a disposable test kit used to collect samples, and (3) software in the form of a mobile phone application. Our detection approach is novel, enabling us to detect for cholera in 30 minutes in water, rather than 1 week.
Where most point-of-use detection devices are handheld and easy-to-use, they lack automated data collection or analysis. Our technology uses a smartphone to perform advanced calculations, map and time-stamp the detection events, utilize a cloud-based platform for outbreak monitoring, and send automated data notifications to NGOs, governments, and community leaders. The data provides an advantage to our customers and partners, because they can use it to be proactive in disease outbreak control, rather than reactive and responding when the situation is out of hand.
Who does your project serve, and in what ways is the project impacting their lives?
OmniVis initially focused on tailoring our device to be used by community health workers, NGO field workers, and water testing laboratories. Their work in detecting dangerous pathogens, like cholera in water, would benefit the local community affected by disease, whether rural or urban. We focused on Kenya, Haiti, and Bangladesh as our initial target countries.
Diseases like cholera currently take a week to detect in water, using laboratory techniques that require infrastructure and years of training. We made a portable device for a user to take to the water source to detect cholera in water in under 30 minutes.
To understand the needs of our users, we have performed 285 customer discovery interviews and traveled to Kenya, Bangladesh, and Haiti to perform in-person human-centered design studies on our device. We have worked with men, women, different education levels, job titles, English and non-English speakers, and a variety of ages so that we could best serve our end user. We have tailored the language, color, symbolism, portability, rapidity, and physical interface of our device to best incorporate our users and their needs.
Which dimension of The Elevate Prize does your project most closely address?Elevating opportunities for all people, especially those who are traditionally left behind
Explain how your project relates to The Elevate Prize and your selected dimension.
"Cholera is a disease of inequity" [GTFCC, 2017].
Women + Children: Women are often burdened with the tasks of cleaning water and taking care of sick family members, especially when cholera is one of the leading causes of death in children under 5. This is why we believe rapid cholera detection would empower women in these communities. Lowering disease burden enables women more time to enter the workforce and reduce gender inequality.
War: To date, Yemen is undergoing the world's largest cholera outbreak (2.1M cases). Rapid detection in war zones would eliminate surging numbers in vulnerable regions.
How did you come up with your project?
I pursued my PhD because I watched my own uncle die from full-blown AIDs in the early 1990's and from witnessing healthcare disparities in rural, low resource villages in Thailand. In my PhD I was acquiring a wide breadth of technical skills and wanted to apply them in global health. A woman, Taylor Moehling, from my laboratory spent 7-weeks in Haiti in a pathogens laboratory and upon arrival back to the United States, shared her knowledge of cholera. I learned that cholera was not in Haiti for 100 years, but after the 2010 earthquake, the disease spread through the country causing outbreaks until this day.
I was working on the fundamental physics of my PhD dissertation and translated my work toward cholera detection in water. During my dissertation, I worked with incredible students throughout three different laboratories to develop the initial stages of OmniVis. After years of working on the device and proving its efficacy, my cofounders, three Purdue professors, and myself incorporated OmniVis as a company. Since, we have tested our device and performed numerous user-centered design studies to iterate on our ideas and product.
Why are you passionate about your project?
I pursued biomedical engineering because of my experience with my Uncle Don dying of AIDs. 14 years after his passing, I studied abroad in Thailand, 10 hours away from the closest hospital. It was in Thailand that I began to realize that I believed healthcare should be a basic human right rather than a privilege. After coming back to the United States, I devoted my engineering studies toward global health. I believe that by making healthcare more accessible through easy-to-use technology, we can serve more people globally. Through better healthcare, communities have to spend less time caring for the ill, and instead focus on educational and economic opportunities.
Cholera, in particular, has remained a complex disease, as it has underlying political, economic, infrastructure, and healthcare issues in many nations. With our partners in Haiti, Bangladesh, and Kenya, I have developed a connection with each of these communities that uniquely are faced with cholera outbreaks every year. However, I believe that complex problems need complex, diverse, multisectoral solutions for so many people. At OmniVis, we can incorporate a diverse group of people, with their thoughts and opinions, to co-create technologies that are part of the ecosystem needed to eliminate cholera worldwide.
Why are you well-positioned to deliver this project?
The underlying algorithms of all OmniVis technology originated from my PhD work. My passion of translating academic global health research to commercial devices that lead me to form OmniVis with the help of fellow co-owners. I have led OmniVis to win 10 pitch competitions and winning $2.5M in grants and awards for the company. I have filed two patents for OmniVis technology and authored multiple peer-reviewed scientific manuscripts on our work.
In addition to my scientific and technical expertise, I am dedicated to building and mentoring a community of globally-minded individuals through serving on thesis committees, speaking on college panels, and mentoring 27 undergraduate through PhD students. This experience has strengthened my ability to effectively communicate with many partners and develop strategies to work together on device creation.
I jumpstarted my efforts in learning and applying business strategy through enrolling in two business accelerators, seeking mentorship with dedicated mentors and entrepreneurs-in-residence. Mentorship has been essential in hiring, manufacturing, logistics, warehousing, sales, and marketing to move from ideation toward implementation.
I believe my co-founders have incredible expertise needed to deliver our project. Drs. Tamara Kinzer-Ursem, Jacqueline Linnes, and Steve Wereley are experiences in start-up, biotechnology, optics, microfluidics, and molecular diagnostics for global health with active collaborations in Haiti, Ecuador, and Kenya. My OmniVis team also brings their passion and drive in finance, operations, engineering, global health, and science in growing OmniVis and delivering rapid cholera, and other disease, detection devices globally.
Provide an example of your ability to overcome adversity.
With no business background, I started OmniVis feeling rather timid. However, this was nothing new. In high school, I never took trigonometry or physics but pursued biomedical engineering. I pursued a mechanical engineering PhD, where I took none of the prerequisite courses and I struggled to pass my qualifiers. I was used to often being told why I will not succeed.
Being new to business, I wanted to reach more individuals and seek further guidance. I enrolled in numerous business pitch competitions to learn how to answer new questions, rework my business model, and gain confidence as a business owner. In my third pitch competition I was told by a judge, "you must be an idiot". Stunned, I went home and redesigned my pitch, practiced, and entered another competition a week later. Since then, I've competed in well over 15 competitions.
I've moved past feeling timid and realize that I will continue to run into baseless comments, such as, “who actually invented your technology?". Now it’s my job to remain coachable but to also have the conviction to move forward and succeed.
I've failed in front of many, my confidence has been shaken, but I relentlessly chase my dreams.
Describe a past experience that demonstrates your leadership ability.
My love of leadership started after teaching 1,600 college students subjects like fluid mechanics and biotransport, mentoring 27+ students in research, and speaking on panels about women in STEM and social entrepreneurship.
My marketing interns were interested in creating a social media ad around water testing in Bangladesh. The ad backfired, where we received racist and uninformed comments about the individuals who were in the photographs.
At the time it was very easy to feel frustrated and angry, but I kept my composure as I knew my interns were feeling defeated by reactions that were out of their control. It was their first time developing and launching an ad, and witnessing so many ill-willed comments, when they were wanting to instead present the idea of hope and community. We discussed head on the aggressions and micro-aggressions we witnessed and lead the team in our stance to be actively anti-racist.
My diverse team of employees are what makes OmniVis an exciting and compassionate place to work at. Since the ad, we #ShutDownSTEM to rewrite our employee manual incorporating anti-microaggression policies, openly discussing Black Lives Matter, and working everyday for a more inclusive, inspiring workspace.
Leadership involves teamwork to create lasting change.
How long have you been working on your project?
Where are you headquartered?San Francisco, CA, USA
What type of organization is your project?For-profit, including B-Corp or similar models
Describe what makes your project innovative.
OmniVis wanted to change the way that cholera detection was performed in order to make progress toward disease eradication. OmniVis demonstrated innovation with their technology in two ways. The first is through the method in which they detect for cholera. We have room temperature stable chemistries that, when in contact with water, rehydrate and react with the toxin DNA gene of cholera (if it is present). After the DNA reaction occurs, OmniVis uses proprietary algorithms to detect for cholera presence. This method enables us to detect for cholera in 30 minutes in water, rather than 1 week.
The second innovation is in the data. Where most point-of-use disease detection devices are handheld and easy-to-use, they lack automated data collection or analysis. Our technology uses a smartphone to perform advanced calculations, map and time-stamp the detection events, analyze the data and store it on a cloud-based platform with a personal log-in portal, and send automated data notifications to NGOs, governments, community leaders, or other participants. This data component provides a newfound advantage to our customers and partners, because they can use it to be proactive in disease outbreak control, rather than reactive and responding when the situation is out of hand.
What is your theory of change?
We will provide an example of the theory of change for cholera and developing a cholera detection device in water.
Problem Statement Definition:
The problem appears to be that populations in cholera endemic countries are at risk for cholera due to contaminated water sources and lack of water infrastructure. This occurs in urban and rural areas with poorer/more vulnerable populations. Examples include the slums of Dhaka, throughout rural Haiti or in the tent cities, and in the Kibera area of Nairobi. It is a problem for populations residing in cholera-endemic areas and the NGOs who are working with communities to develop access points to clean water in times of (1) outbreaks, (2) war, (3) crowded slums or refugee camps.
Current cholera testing either involves (1) rapid diagnostic tests intended for clinical settings that have 65% accuracy, or (2) laboratory tests requiring years of user training time and 1-week turnarounds for test results.
The theory of change is provided in the table layout below. This includes the inputs, outputs, outcomes and assumptions that need to be made for our long term goal to be true.
Select the key characteristics of the community you are impacting.
Which of the UN Sustainable Development Goals does your project address?
In which countries do you currently operate?
In which countries will you be operating within the next year?
How many people does your project currently serve? How many will it serve in one year? In five years?
We collaborate with icddr,b, working with 28 staff members. Together, we have tested 120 water sites that affect over 5000 people. The following table indicates the number of people who will be served in 1 and 5 years.
Further, we work with universities to provide project opportunities and have shown job creation at our own company. This is demonstrated in the following table.
What are your goals within the next year and within the next five years?
OmniVis wanted to change the way that cholera detection was performed in order to make progress toward disease eradication. OmniVis demonstrated innovation with their technology in two ways. The first is through the method in which they detect for cholera. We have room temperature stable chemistries that, when in contact with water, rehydrate and react with the toxin DNA gene of cholera (if it is present). After the DNA reaction occurs, OmniVis uses proprietary algorithms to detect for cholera presence. This method enables us to detect for cholera in 30 minutes in water, rather than 1 week. The second innovation is in the data. Where most point-of-use disease detection devices are handheld and easy-to-use, they lack automated data collection or analysis. Our technology uses a smartphone to perform advanced calculations, map and time-stamp the detection events, analyze the data and store it on a cloud-based platform with a personal log-in portal, and send automated data notifications to NGOs, governments, community leaders, or other participants. This data component provides a newfound advantage to our customers and partners, because they can use it to be proactive in disease outbreak control, rather than reactive and responding when the situation is out of hand.
What barriers currently exist for you to accomplish your goals in the next year and in the next five years?
A challenge in being a global health company is having enough access to upfront capital to create, manufacture, warehouse, and distribute medical devices worldwide. We believe that we will distribute our devices for revenue in 2021, but want to achieve scale in order to eliminate cholera cases in 41 countries, and then develop detection assays for other diseases (we are underway with malaria, SARS-CoV-2, and HIV viral load). We are small and nimble while maintaining over 1 year of runway, however further capital would allow us to hire more talent, manufacture more devices, and distribute our technology in more countries, then tackle other important diseases.
Another challenge for OmniVis is distribution. Emerging markets have vastly different and intricate ways of distributing medical and testing supplies, which can be challenging from a financial perspective.
The final challenge relies on sale cycle and inventory. Cholera is a seasonal disease (i.e. more prevalent during the rainy season) and unpredictable (outbreaks change from year-to-year). This seasonality is confounded by the fact that OmniVis needs to produce enough inventory to fulfill RFPs when these outbreak events and the rainy season does occur. Not maintaining this balance can lead to financial burden or partnerships severed.
How do you plan to overcome these barriers?
Capital: We are continually applying to grants in order to grow our team and produce more product that reflects the needs of our end user. OmniVis has been grant and award funded in order to sustain our R&D phase. We are switching to a C-corp to allow us to find other alternatives of capital, such as working with angel investors and venture capital.
Distribution: One immediate path OmniVis wants to explore is working with distributors in-country to sell the technologies. Their expertise and the trust they provide to their communities would far extend beyond what our start-up could initially provide. Secondly, we are gaining relevant mentors to better understand how to navigate this path. We are also building important partnerships to provide us with access to their resources, established local networks, and are potential customers.
Sales cycle and inventory: To overcome this challenge, we worked with vendors to understand the shelf life of our products (2 years) which would allow us to maintain inventory for several rainy seasons. Further, our customers operate in multiple countries and regions, and could find use for our device throughout numerous regions. To fulfill RFPs, we need to maintain enough capital to manufacture enough units for inventory. This will involve seeking funding, having at least 12 months of financial runway, and negotiating advance payments from customers to fulfill orders.
What organizations do you currently partner with, if any? How are you working with them?
- icddr,b: We work with the largest cholera hospital in the world for performing field trials and user feedback of water testing throughout Bangladesh.
- Médecins sans Frontières: MSF is providing user feedback, in the field, for our cholera detection device.
- Code for Africa: We have a partnership to perform field studies in urban and rural Kenya.
- Haiti Outreach: We will work with Haiti Outreach to test water sites throughout the country.
- FIND: We are working with FIND to test blood samples for malaria in Rwanda with Purdue University.
- Purdue University: We work closely with Purdue University (biomedical and mechanical engineering) to help with R&D on our device, publish work in peer-reviewed scientific publications, and perform field testing.
- University of Notre Dame: I mentored two MS of Global Health students to perform field trials in Bangladesh with icddr,b for two months.
What is your business model?
OmniVis’ customers are the procurement officials within humanitarian aid organizations, medical facilities, and community leaders in regions where particular pathogens are present. Though these individuals may not be the end-user of the physical device, the data the device generates is targeted towards them. There currently lacks a reliable method for collecting results and generating reports. Therefore, our data generation not only enables aid organizations to respond more quickly to the presence of an outbreak, but also provides quantitative information for performance and budget justification.
The users of our device are the field workers within each of these customer segments or laboratory technicians. Instructional material and training on the usage of the device will be provided by OmniVis representatives. The end beneficiaries of the OmniVis technology are the community members that may be affected by or vulnerable to certain infectious diseases.
Our business model is a razor-razorblade model with the hardware testing platform as the razor and disposable test chip as the razorblade. This strategy allows us to generate reliable and recurring income while locking customers onto our platform, building long-term relationships. As a one-time purchase, our hardware platform will be sold at $1,000 with recurring income in the form of our disposable test kits at $10 a piece. While we are focusing on the creation of our products, we have started customer discovery conversations to understand the tools our customers need to accomplish their reporting goals with the minimal amount of friction.
What is your path to financial sustainability?
OmniVis is currently pre-revenue, to date we have raised $2.5M in non-dilutive grants and awards. We want to grow our company with additional grant funding through 2021 to enable us to include a Marketing/Design associate, and laboratory technician, have our product go to market, and have a Biosafety Level 2 lab space. In the coming year, we plan to expand our product for disease multiplexing.
We will initiate sales early 2021 and intend to breakeven between 2022 and 2023. At this point, predicted expenses will be sustained by revenue streams from grant funding along with consistent sales to long-term customers. Our sales strategy involves initial hardware and concentrator investments and recurring revenue of disposable test kits and filters. This strategy allows us to generate reliable and recurring income while locking customers onto our platform, building long-term relationships. Additionally, we can continue to develop new products without significant outside investment or funding.
In 2021 OmniVis will need to raise a series A round for $500,000 (VC funding) to carry us through 2022. This will allow us to grow our market and focus beyond waterborne testing to bloodborne testing. With the series A round, we should be able to grow our company headcount and get the initial data on HIV bench testing to achieve a series B funding. The series B funding round will be used to manufacture devices tailored specifically for bloodborne testing (starting with HIV), progress toward FDA clinical trials, and further grow our company.
If you have raised funds for your project or are generating revenue, please provide details.
OmniVis is currently pre-revenue and has generated $2.5M in funding from SBIR grants, other non-dilutive grants, awards, and donations.
In the last 12 months, OmniVis has been funded by a number of completed and ongoing grants, including a grant from the National Institute of Standards and Technology (8/1/19 - 2/29/20) for $99,999.48. OmniVis was also awarded $49,999.74 from Elevate Ventures in October, 2019 as supplemental funding for SBIR Phase I activities. OmniVis received funding from Humanitarian Grand Challenge (4/15/19 -9/30/20) in the amount $189,000 for the project A Water Monitoring Device for Vibrio cholerae Detection. OmniVis has also been funded by a subaward for $91,000 from Purdue University through the National Institute of Health (8/01/19 - 07/31/21). Recently, OmniVis received an SBIR Phase II grant for $743,559 from the National Science Foundation (04/15/20 - 03/31/22).
Aside from grant funding, we have also received awards from MIT Solve ($40,000), Cisco ($12,500), and bioLOGIC ($50,000) in the past year, which have helped to propel our work on designing a field-ready device. We are currently running two crowdfunding campaigns for 3D-printed mask donations for distribution to at-risk individuals in need of PPE, and a campaign run through the Islamic Development Bank for cholera detection in Bangladesh.
OmniVis also has pending contracts with GSMA for a grant of $390,000, and IsDB for a grant of $100,000.
If you seek to raise funds for your project, please provide details.
Currently, OmniVis is a grant-funded organization and we will continue to seek grant funding to propel us to make initial sales of the OmniVis hardware platform. We currently have pending support from the National Institutes of Health, Biomedical Advanced Research and Development Authority, National Science Foundation, United States Department of Agriculture, National Institute of Standards and Technology, Point-of-Care Technologies Research Network/ Rapid Acceleration of Diagnostics through NIH, ProtoLabs, Draper Richards Kaplan Foundation, Booz Allen Foundation, and Robert Wood Johnson Foundation. We will initiate sales early 2021 and expect to sell at a loss while we are still manufacturing at a small scale. During this period, we intend to raise at least $900,000 in non-dilutive grant funding in order to continue operations, develop relationships with our customers, and iterate on our product design before moving towards large-scale manufacturing. We expect to breakeven in 2022-2023, and although our projected revenue will sustain our predicted operating expenses, we intend to continue to apply for grant funding in order to continue expanding our team and scope of work. With additional grant funding, we want to translate our device for use towards detecting other waterborne pathogens, such as E. coli and typhoid, and blood borne diseases, such as malaria, HIV, and dengue.
What are your estimated expenses for 2020?
In 2020, we have already expanded our team and expect to continue expanding by adding additional full-time employees and moving into a lab and office space to accommodate our members. We are able to predict the following expected expenses based on trends in our typical monthly spending and financial projections for the remainder of the year, which total to $895,695 in estimated expenses.
Rent for lab and office space: $50,850
Legal/insurance/licensing fees: $11,060
Dues and Subscriptions: $6,525
Advertising & Marketing: $1,200
Fringe Benefits: $262,000
Lab & office supplies: $116,270
Why are you applying for The Elevate Prize?
The Elevate Prize focuses on a community of socially minded people, which is a group of individuals I want to work with. After participating in Halcyon, a social impact incubator, I have learned the importance of integrating within a community that wants to serve their community. OmniVis is applying for some of the following reasons:
- The USD $300,000 would allow my company to distribute our products to more people, and create stronger training and education programs behind cholera and disease detection. A current barrier is capital to manufacture and this would greatly propel us toward providing more devices.
- The Elevate Prize Foundation’s network would help us navigate the regulations, logistics, and market entry into numerous countries and help grow our business. The network would allow me to seek mentorship for navigating sales cycle and distribution in other countries.
- The annual convening would allow for me to create a strong network of individuals who mutually benefit from learning and acting in a social impact space.
- Support for the mission of the entity is essential for entrepreneurs, as we are growing our company, trying to get the word out to create new partnerships, and learn how to market ourselves.
- Tailored media campaigns would allow myself and OmniVis to participate with further community outreach and educational opportunities while having a distinct brand and message of our vision.
In which of the following areas do you most need partners or support?
Please explain in more detail here.
Funding + Revenue Model: We are seeking ways to better fund our manufacturing for scale-up.
Talent Recruitment: We are specifically looking to hire a mechanical engineer with both design and manufacturing experience and need guidance.
Mentorship: How to navigate a bigger team and where to put forth efforts.
Board Members/Advisors: We are building our Board of Advisors and looking at how to ask them to join our team and what incentives to provide.
Regulatory: How do we best set up traceability in our lab and what steps do we take to receive regulatory approval (WHO vs. FDA vs. CE mark).
Marketing, Media, Exposure: How to best design marketing plans and branding within the global health space that are most advantageous for partners and OmniVis.
What organizations would you like to partner with, and how would you like to partner with them?
OmniVis is interested in partnering with the following organizations:
- NIH NIAID: We would like to work with NIAID for help with relevant funding, connections within the human health space, and aid in the FDA approval process.
- Bill and Melinda Gates Foundation: We would like to partner to distribute our devices in more areas of the world and create ecosystems with their networks of cholera vaccination efforts (with Gavi) and water and sanitation groups.
- WaterAid: To test with and partner with for determining clean and contaminated water sources worldwide, and to create campaigns about hand washing and detection/prevention of cholera.
- Global Task Force on Cholera Control: The GTFCC's science and technology arm would provide us with connections to scientific experts working on cholera in over 21 countries worldwide. Their expertise would help us iterate on our product.
- WHO: To fulfill the needs for cholera test kits recommended by the WHO, also to get WHO emergency use approval and navigate their health priorities.
- CDC: To partner with their water and sanitation epidemiology group to see if there are opportunities to work together in emergency response and epidemiology modeling.
- IFRC: At the UN General Assembly they announced a large fund for cholera work, and we would love to work with a like-minded organization supporting cholera efforts.
- UNICEF: We would like to partner with UNICEF to pilot our device in many countries and access their complex and advanced distribution networks.
- Dr. Katherine Clayton Co-Founder and CEO, OmniVis LLC