Airway Shield

The COVID-19 pandemic has highlighted inequalities in access to care and resources such as personal protective equipment. Airway Shield fights inequality focusing on a life-saving procedure, endotracheal intubation. Intubation permits artificial ventilation and is required by 20% of patients with severe COVID-19, but presents a 10% risk of healthcare worker infection. It is a complex procedure, requiring high levels of expertise, and is usually carried out in the hospital environment. Patients in rural, low-resource and understaffed environments have lower access to this life-saving technique.

Airway Shield is a low-cost, lightweight barrier mouthpiece which significantly lowers healthcare worker exposure to airborne pathogens (COVID-19, SARS, MERS, H1N1, etc.) during intubation while enabling faster, accurate intubation, reducing the need for specialist training. 

If globally scaled, Airway Shield reduce inequality by providing low-cost protection to healthcare workers and increasing patient access to intubation, especially in under-resourced populations and low-to-middle income and developing countries. 

Airway Shield aims to reduce inequality by protecting at-risk healthcare workers from infection during intubation of patients with COVID-19 and other airborne diseases, and increasing access to this life-saving procedure in understaffed, prehospital and rural settings. 

The COVID-19 pandemic has highlighted inequalities regarding access to fundamental resources. For example, the vast majority of US healthcare workers dying from COVID-19 are people of color, many of whom voiced concerns regarding the shortage of personal protective equipment (PPE). Developing countries are also at disadvantage regarding access to PPE and other necessary resources for combatting pandemics. Reasons include the inordinately high, demand-driven price of PPE due, as well as logistical difficulties hampering delivery. Other problems faced by disadvantaged minority and underserved communities include shortage of specialist care, reducing access to crucial procedures such as ETI.

Airway Shield is a low-cost, compact and easily transportable medical device which protects healthcare workers from exposure to airborne diseases such as COVID-19 during ETI, either as a stand-alone solution or in combination with PPE. It facilitates ETI, reducing the need for specialist training and making the procedure feasible in prehospital, primary care settings. 

Airway Shield is a medical device which is inserted into the patient's mouth just before endotracheal intubation (ETI). Its design combines mechanical principles with in-depth anatomical knowledge of the human airway and the mechanisms of disease transmission. It comprises of a barrier mouthpiece which reduces the dispersion of aerosols and droplets during ETI, thus leading to reduced risk of healthcare worker infection, attached to a tubular channel through which the laryngoscope and endotracheal tube pass, guiding them quickly and accurately towards the target - the larynx - where the tube is inserted to permit artificial ventilation. 

Airway Shield is a low-cost, compact and easily transportable medical device which protects healthcare workers from exposure to airborne diseases such as COVID-19 during ETI, in combination with PPE or as a stand-alone solution in under-resourced settings. It facilitates ETI, reducing the need for specialist training and making the procedure feasible in prehospital, primary care settings. 

*Preclinical trials under review for publication at the International Symposium of Intensive Care and Emergency Medicine and European Society of Intensive Care Medicine Congress

During the current COVID-19 pandemic, millions of healthcare workers have been infected and thousands of healthcare workers have given their lives while caring for victims of the pandemic, leading to increasing staff shortages worldwide. The loss of lives has been greatest amongst people of color and in low-to-middle income countries, due in part to unequal access to resources such as personal protective equipment.

Airway Shield serves healthcare workers who care for the critically ill, in intensive care, anaesthesia, emergency medicine and primary care, especially in under-resourced clinical settings and developing countries. To date, the Airway Shield prototype has been evaluated by specialists and trainees in anaethesiology and intensive care in a preclinical setting in Spain (one of the European countries hit hardest by the COVID-19 pandemic) and Australia. After the regulatory process which is due to end in July 2021, we will perform clinical trials with Airway Shield both in specialist and prehospital settings, after which we intend to partner with non-profit organizations in order to donate Airway Shield to primary and urgent care providers in developing low-to-middle income countries such as India and Bangladesh. Airway Shield will also be launched commercially in Europe and posteriorly in the United States and other countries. 

Airway Shield has received outstanding feedback from healthcare workers involved in endotracheal intubation.

Airway Shield protects last-mile healthcare providers from exposure and infection by airborne pathogens (such as SARS-CoV-2, H1N1, SARS and MERS) during the endotracheal intubation procedure, as well as increasing access to ETI in primary and prehospital settings by lowering the complexity of the procedure, thus reducing need for specialist training. This is of vital importance especially in under-resourced settings, countries with a shortage of trained medical staff, and developing countries where prehospital intubations are frequent due to increased transfer times between primary emergency care to specialist centers. 

Airway Shield has been prototyped in 3-D printing, with proven safety and efficacy in preclinical studies. The first batches of Airway Shield will soon be produced by injection molding in medical-grade material. We are awaiting CE mark approval, due at the end of July, to carry out our first clinical (in humans) studies. 

Facilitating rapid and accurate endotracheal intubation while completely covering the patient's mouth and thus shielding healthcare workers from exposure to airborne pathogens is the revolutionary concept behind Airway Shield.

Once regulatory approval has been granted, Airway Shield is expected to become the new standard of care for healthcare provider safety during endotracheal intubation. Airway Shield will protect healthcare workers worldwide, especially those in under-resourced clinical settings,  from COVID-19 and other emergent threats, while increasing patient access to endotracheal intubation in rural, prehospital, primary care and other contexts, especially in countries where availability of specialized medical care is limited. 

At present Airway Shield is in the prototype optimization and manufacturing tooling stage, and has been used in preclinical trials by a total of 15 independent healthcare providers, all of whom gave Airway Shield excellent feedback. 

In one year, Airway Shield will have passed the European regulatory process and will be serving a minimum of 165,000 patients of healthcare providers in Spain, Italy, Great Britain, France and Germany, based on our projection of a 3% market penetration per year and an estimated 5.5 million yearly endotracheal intubations for these 5 countries, with another 100,000 patients served in underdeveloped countries through partnerships with non-for-profit organizations. 

In five years, Airway Shield will have gained FDA and TGA approval and scaled up to reach 33 countries including the rest of Europe, Australia, New Zealand and the United States of America. We will be serving over 29,640,000 patients and over 140,000 healthcare providers worldwide.

In preclinical trials, we have measured progress by validating the safety and efficacy of Airway Shield in high-fidelity simulations of endotracheal intubation scenarios. The indicators used to validate our solution include:

- Time to endotracheal intubation in seconds.

- Number of aerosols detected by imaging software.

- Number of droplets detected by imaging software.

Our indicators for progress after Airway Shield's commercial launch include:

- Number of procedure-related cases of COVID-19 in healthcare workers performing endotracheal intubation/100,000 healthcare workers (by country and globally)

- Number of COVID-19 related deaths in healthcare workers performing endotracheal intubations/100,000 healthcare workers (by country and globally)

- Number of patient deaths due to COVID-19 associated with delayed access to endotracheal intubation/100 patient deaths due to COVID-19

2 full-time staff.

3 part-time staff.

1 contractor.

Airway Shield's CEO and founder is Dr. Julio Alonso, M.D., an intensive care specialist with over 15 years of experience in critical care and prehospital airway management. He has won grants from the Australian Government (Ignite Ideas Grant) and has also won pitch competitions at both the MIT-Harvard Medical School Healthcare Bootcamp in the USA and the 'Building Better Future for Health Challenge’ in Australia. His deep humanitarian motivation and passion for innovation sparked the creation of Airway Shield as a solution to the drama faced by him and his colleagues during the COVID-19 pandemic. Julio's exceptionally talented, experienced, and inclusive team features:

- Medical researcher and bioethics expert Dr. Bernadette Pfang, M.D., a specialist in internal medicine with more than 5 years' experience in emergency medicine

- Senior industrial designer Cambell Smyth, with more than 8 years of experience in the field of industrial design.

- Specialist in technological transfer and business development, with 6 six years of experience in medical devices, Joanne Zuo.

- Digital marketing expert Silvia Chan.

- Product manager Eduardo Guitierrez. 

We have a broad, well-balanced team in terms of gender equality and racial inclusion. Half of our team are women. Regarding ethnicity, two of our team members are Hispanic-Caucasian, one is Asian-American, two are Asian and one is Caucasian. Our nationalities are British, Spanish, Brazilian, and Chinese. 

Although access to funding is of obvious importance, Airway Shield values the opportunity to become a Solver because of the impact that mentorship from experts in inclusive healthcare strategy will have on achieving Airway Shield's full potential as a scaleable, low-cost solution to protect healthcare workers during the current and future pandemics, as well as increasing access to life-saving endotracheal intubation for critically ill patients in low-to-middle income countries and under-resourced clinical settings. 

Solve's valuable opportunities for partnership with distributors will help Airway Shield to reach the global healthcare community with the urgency the current situation requires. The network of legal assistance Solve offers will be of great help when we take the next step in regulatory matters - applying for FDA approval for Airway Shield.

Airway Shield believes that the opportunity for media exposure will help our solution to gain traction and attract the attention of potential investors to help our project get off the ground. 

Airway Shield plans to apply for FDA approval in order to lawfully conduct clinical trials, donate and commercialize Airway Shield in US territory. Advice and partners with expertise in quality management and regulatory affairs will be of great aid in order to achieve this goal.

Airway Shield is looking for partnerships with experienced, global distributors in the medical device sector in order to scale our solution for reducing healthcare worker infection rates and making safe endotracheal intubation available to all. In this regard, connecting with potential distributors and expanding our network of potential clients (healthcare providers, hospitals and health care systems) is a priority. 

Airway Shield seeks partnership opportunities with mentors from the MIT School of Humanities, Arts and Social Sciences to empower our solution based on inclusive healthcare strategy. 

In order to cause a direct impact on healthcare worker safety and equal access to care in underserved communities, Airway Shield seeks to partner with Solve members from low-to-middle income countries and non-for-profit organization such as Doctors Without Frontiers.

Airway Shield also seeks to partner with distributors and manufacturers in the medical device sector.

The pitfalls of the US healthcare system have been highlighted during the COVID-19 pandemic, with shortages of fundamental resources such as personal protective equipment, ventilators, and healthcare staff leading to increased infection and mortality, especially in minorities and lower-income communities. The vast majority of healthcare workers dying from COVID-19 in the USA are people of color, many of whom voiced their concerns about reduced access to personal protective equipment. Airway Shield offers affordable and effective protection to front-line healthcare workers during endotracheal intubation while making this life-saving procedure available to patients in low-resource, understaffed communities by reducing the complexity of the technique and thus lowering the need for specialist training.