EZ-X
EZ-X is the first low-cost, compact mechanical ventilator attachment for continuous & remote respiratory management
The specific problem we are addressing is improving the ease of long-term in-hospital respiratory care management for physicians and respiratory therapists to improve clinical productivity and patient outcomes.
The global mechanical ventilator market, valued at US$6787 million in 2020, is projected to grow at a CAGR of 5.8% during the forecast period 2021-2031 (1). Several factors can impact the growth of the ventilator market. Some of the main factors that may influence the market's growth include the prevalence of respiratory diseases and disorders, the rise in the geriatric population, the availability of funding and resources for developing and distributing ventilators by government initiatives, and the regulatory environment for medical devices. Covid-19 has reshaped the global mechanical ventilator market, substantially increasing the need for ventilators due to respiratory illness induced by Covid-19.
Other market drivers include rising number of geriatric patients on mechanical ventilators and government and organizational initiatives to boost ventilator production. With more patients requiring mechanical ventilation, it has never been more critical to have access to the information you need to make necessary interventions to support adequate respiratory function.
EZ-X obtains real time pressure readings of the ventilator and displays them on an easy-to-use app on the phone via MQTT. With the app, a user can manually adjust the pressure as desired remotely, which directs a command on an Arduino board to then open/close the sliding door of the system as necessary. The opening of the door will increase the airflow from the ventilator to the patient, while the closing of the door will redirect the airflow towards the atmosphere instead of the patient. At one extreme (with the door completely opened), the ventilator assistance provided to the patient is maximized, while in the other extreme (door completely closed), ventilator assistance is completely terminated, resulting in atmospheric pressure being directed towards the patient. The app will also display additional metrics to the healthcare provider that can be useful in the decision of whether or not to make adjustments to the ventilator. Some of these metrics include pulse ox, breathing rate, chest rise and fall, and heart rate.
The target population for our solution is all patients with respiratory problems in the hospital setting that require ventilator assistance. However, our solution is meant to be targeted towards long-term ventilator patients in particular, as these patients tend to be the ones that require most supervision and adjustments to ventilator assistance. Our solution will maximize the efficiency of this process by reducing the cost and also maximizing the availability of healthcare providers in the hospital setting. Remote access to the patient vitals and remote adjustments to the ventilator settings will make it easier for healthcare providers in the hospital setting to multitask and take care of multiple patients at once in a more efficient manner. Given that this solution is an attachment to be compatible with all existing ventilators available on the market, it is also meant to minimize cost by not requiring the purchase of a new, advanced, and costly ventilator.
Our team is a diverse set of individuals who collectively bring together a wide range of academic backgrounds including majors in biomedical engineering, computer & electrical engineering, and finance. We teamed up together with the vision of combining our experiences in order to create a life-critical medical device that interfaces with an app. Having all been heavily impacted by the onset of COVID-19 and seeing first-hand the damage it produced, we saw the need to bring greater efficiency to the current ventilation system as these systems were heavily utilized. Being engineers, it was a natural course of action to create a product to address the current shortcomings.
We have been actively speaking with clinicians and researchers in fields directly related to mechanical ventilation. This includes Anesthesiologists, Pulmonologists, and Critical Care doctors. Through the lens of these experts, we were able to understand the current shortcomings of existing solutions and how patients can be better served. We regularly discuss solutions and ideas with the doctors to continue to validate our product and vision.
- Improving healthcare access and health outcomes; and reducing and ultimately eliminating health disparities (Health)
- Prototype: A venture or organization building and testing its product, service, or business model
Our solution is innovative as there are no current products on the market that specifically serve as external ventilator attachments that can modify ventilator settings remotely. Currently, there is a Johns Hopkins research product that is trying to address this need. Their solution involves expensive robotic technology that is not ultimately scalable. Our solution is far more economical and serves the same purpose. Additionally, by improving efficiency in mechanical ventilation, this will serve to improve overall hospital efficiency as doctors will not have to spend as much time serving patients under mechanical ventilation and will also reduce negative impacts such as premature patient extubation.
We wish to partner with mechanical ventilation giants such as Medtronic to combine our product with existing mechanical ventilators in the most streamlined way. In this way, when the next COVID-19 pandemic hits, hospitals can feel that much more comfortable knowing that their ventilators are better equipped to handle a widespread global pandemic.
Our tech stack covers a wide range of technologies both in the hardware space and the software space. From a hardware standpoint, our flagship innovation is a valving mechanism that uniquely splits air flow coming from a ventilator. It splits this air flow in two directions, one towards the patient and one to open air. In this way we are able to accurately modulate air pressure going towards the patient without ever having to touch the actual ventilator itself. From a software standpoint, we have an app that allows us to externally control our device settings in order to perform this pressure modulation. The hardware and software is tied together using a communication middleware known as MQTT.
- Biotechnology / Bioengineering
- Internet of Things
- Materials Science
- Software and Mobile Applications
Our solution is currently not serving any patients, but we plan on implementing our device in a clinic as a matter of testing. Simulators and clinical ventilators will be used as final validation of our device. Within a year, we plan on having our solution serve about 10 patients. After the first year, we expect (and hope for) our solution to exponentially grow in the number of patients it will serve. We are primarily focused on the long term ventilation patients with tracheostomies, which make up less than 10% of the ventilation population. Provided that mechanical ventilation affects 800,000 hospitalized patients in the United States each year, we are focused on about 80,000 of those individuals that are long term ventilation patients. Moreover, given that there are other competitors in the market already, we can assume we won’t immediately take over the entire market segment. As such, we aim to gain 50% market share and serve 40,000 patients a year.
One of the biggest barriers that currently exists is the fact that our device would connect to a life critical application making FDA approval extremely challenging. Testing our device in actual clinical settings has many hurdles that we have to carefully navigate.
We are currently partnered with the Bioengineering Lab at the University of Pennsylvania Labs. We are all enrolled in a senior thesis class that structures our semester to create a proof of concept prototype as well as a minimim viable product protoype last semester. This semester we are continuing this progress finalizing the aesthetics and valving mechanism as well as creating pitch materials and validating the device with clinical testing.
Business Model
Problem
Mechanical ventilation is a life-saving intervention that breathes for individuals unable to breathe for themselves. Many individuals require ventilation, such as those with neurological injuries, diseases, or disorders of the muscles or lungs. We primarily focus on long-term ventilation patients, who comprise less than 10% of the ventilation population (1). We have identified three main pain points in the current standard of care for ventilator management of long-term patients. First, putting on and taking off PPE adds 6 minutes to the process of adjusting a ventilator, time which could have been spent delivering high-quality patient care (2). Second, these patients require meticulous monitoring to avoid complications such as sepsis or - pneumonia, yet despite best efforts, extubation failure rates are still relatively high. Third, extubation failure is associated not just with an increased risk of death but also with more prolonged ICU stays and the use of hospital resources. The current process burns through limited supplies.
Value Proposition
No technology on the market is compatible with every ventilator that could allow for remote control monitoring of patients. Remote control access to ventilators can benefit hospitals in several ways. First, remote control access would reduce the need to enter the room, saving doctor time. It would also mitigate doctors' exposure to infectious materials. Remote control access can reduce the risk of cross-contamination, as healthcare providers do not have to physically enter the room to adjust the settings on the ventilator. This can help prevent the spread of infectious diseases and protect both patients and healthcare workers. Second, with the ability to rapidly monitor and respond to clinical changes, the quality of patient care will be improved. Third, hospital costs would be reduced by wasting less PPE and improving workflow efficiency.
Stakeholders
There are several stakeholders involved in medical devices for hospital ventilators. These stakeholders include patients and their families, healthcare providers, regulators, insurance companies, and manufacturers. Patients and their families are a key stakeholder group, as they are the primary users of ventilator devices and are directly impacted by their performance and reliability. They may have concerns about the devices' safety, effectiveness, and affordability and may be involved in decision-making about their use.
Healthcare providers, such as doctors and nurses, are also important stakeholders, as they administer ventilator devices and provide patient care. They may have concerns about the availability and accessibility of the devices, as well as their ease of use and compatibility with other medical equipment.
Regulators, such as the Food and Drug Administration (FDA) in the United States, play a critical role in ensuring the safety and effectiveness of medical devices, including ventilators. They may have concerns about the quality and performance of the devices and may be involved in setting standards and approving new devices for use in hospitals.
Insurance companies are another key stakeholder group, as they are responsible for covering medical care costs, including ventilator devices. They may have concerns about the cost and value of the devices and may be involved in deciding which devices are covered under insurance plans.
Finally, manufacturers of medical devices, including ventilators, are also important stakeholders. They are responsible for designing, producing, and distributing the devices and may have concerns about the market demand for the devices and their profitability and competitiveness.
Market Research
Many companies are investing in research and development to develop new and innovative ventilator technologies that can improve performance and functionality. For example, some companies are developing ventilators with advanced wireless connectivity, advanced monitoring, and control capabilities, and improved user interfaces.
Another factor driving competition in the market is the availability of cost-effective and user-friendly solutions. Many companies are looking for ways to provide remote control capabilities for ventilators that are affordable and easy to use for healthcare providers and patients. This can involve developing ventilators compatible with existing smartphone and mobile device platforms or developing dedicated apps that can monitor and control the ventilators remotely.
The competitive landscape for remote control monitoring of ventilators is dynamic and evolving, with many companies competing to provide the best products and services. The market is likely to continue to grow and evolve in the coming years as new technologies and innovations are developed and introduced.
Customer Segments
A customer segment for an external ventilator attachment for remote control monitoring could be hospitals or other medical facilities that use ventilators to help patients breathe. The attachment would allow medical staff to monitor and control the ventilator remotely, improving patient care and reducing the need for staff to be physically present in the room with the patient. Other potential customer segments for this product include home health care providers, who may use the attachment to monitor patients receiving ventilator support at home remotely, and individuals who use ventilators themselves and want more control over their breathing support.
Market Size and Growth
The global mechanical ventilator market, valued at US$6787 million in 2020, is projected to grow at a CAGR of 5.8% during the forecast period 2021-2031 (3). Several factors can impact the growth of the ventilator market. Some of the main factors that may influence the market's growth include the prevalence of respiratory diseases and disorders, the rise in the geriatric population, the availability of funding and resources for developing and distributing ventilators by government initiatives, and the regulatory environment for medical devices. Covid-19 has reshaped the global mechanical ventilator market, substantially increasing the need for ventilators due to respiratory illness induced by Covid-19.
Other market drivers include rising number of geriatric patients on mechanical ventilators and government and organizational initiatives to boost ventilator production. With more patients requiring mechanical ventilation, it has never been more critical to have access to the information you need to make necessary interventions to support adequate respiratory function.
Competition
Several key players in the ventilator management market include General Electric (GE), Philips, Medtronic, and ResMed. Some of these companies have achieved remote control access to ventilators. Several companies have gained remote control access to ventilators. For example, ResMed is a global medical technology company offering various products and services, including ventilators with remote control capabilities. The company's ventilators are equipped with wireless technology that allows healthcare providers to monitor and adjust the settings remotely using a smartphone or other mobile device (4).
In addition, Philips is another company that offers ventilators with remote control capabilities. The company's ventilators are equipped with advanced wireless technology that allows healthcare providers to monitor and adjust the settings remotely using a dedicated app on a smartphone or other mobile device (5).
Furthermore, researchers at Johns Hopkins University have developed a new robotic arm system that allows for remote control for COVID-19 patients on ventilators. While the system is still being tested, initial trials demonstrated how it could be deployed to aid hospitals in preserving PPE, limiting staff exposure to infectious materials, and providing increased workflow efficiency (6).
Many companies offer ventilators with remote control capabilities, and the market for these devices is growing. Remote control access to ventilators can provide many benefits, including improved patient outcomes and increased efficiency and care availability. Nevertheless, there still needs to be technology compatible with every ventilator for remote control monitoring of ventilators for long-term ventilation patients.
Sources
Path to Financial Sustainability
Brief Project Overview (and Cost)
Our solution, EZ-X, involved the development of an intricate valve mechanism to control the pressure in the system through an app remotely (see Figure 1 and Figure 2 in Appendix). One of the primary goals of our design was to minimize the cost of maintaining ventilator assistance, with the intent of reducing the cost of hospital stays and healthcare overall. Since this device will be an affordable attachment to existing ventilators, avoiding purchasing a brand new ventilator at a higher price, our design will successfully keep the total expenditure on the low end below $300 (see Table 1 in Appendix).
Secondly, we wanted our device to occupy as little space as possible since ICU and operating rooms tend to be cluttered with a lot of advanced technology, tubing, and hospital staff. Our device is expected to be less than one cubic foot, with the intent of being placed on a tabletop setting.
Third, our device is also expected to control the pressure in the system between 5 - 30 cmH2O, which is the standard range of pressure support for ventilators. This provides a manner of weaning patients off ventilator assistance over time as their condition improves.
Lastly, we also want this device to be compatible with ALL standard ventilators available in the hospital setting. Our device will have various attachments to ensure proper fit with all available ventilators.
Cost
The cost of creating an external ventilator attachment that allows for remote control access through an app will vary depending on a number of factors, including the complexity of the attachment, the materials and components used, and the development and testing processes involved. We currently value the cost of our device to be $300 based on the raw materials necessary for its production, as well as the integration processes of these materials.
In general, creating a new medical device like an external ventilator attachment can be a complex and expensive process. It may require significant research and development, as well as testing and clinical trials, in order to ensure that the attachment is safe and effective. Our clinical mentor has given us access to a breathing mannequin and ventilator simulation lab, so EZ-X can be tested real-time. This system will allow us to hook up EZ-X to a real ventilator and see if it can produce reproducible and reliable results in a hospital setting.
Revenue Model
The revenue model for our external ventilator attachment for remote control monitoring would be a one-time sale or perpetual license or access to the remote monitoring and control features. The attachment could be sold as part of a package that includes the ventilator, remote monitoring, and control features. In this case, the customer would pay a single upfront fee for the complete package. This would provide quick, accessible communication and a low-maintenance relationship with a consumer. However, this transaction's singular nature may limit this device's monetization model. Upon purchasing the device, we would also provide the necessary tubing attachments to ensure compatibility with any ventilator on the market.
IP
Medical device development and introduction in any market require substantial, strict regulator compliance and intellectual property (IP) clearance and protection. Depending on the specific features of the attachment, it may be possible to obtain patents, trademarks, or copyrights to protect the technology and prevent others from using it without permission. IP can be an essential part of building a successful business, as it can help prevent competitors from copying your product and give you a competitive advantage in the marketplace. In addition, having IP protection can also make your product more attractive to potential investors and partners, as it can provide them with added confidence in the value and potential of your product.
Sources
Bioengineer & Data Scientist