BIG IdeaBounce 2024 | 14 Finalists Dazzle In SharkTank Contest

Team Airalux | The First Smart Incentive Spirometer

School Affiliation: University of Pennsylvania

Description: Airalux is a digital incentive spirometer and companion mobile app designed to significantly improve postoperative recovery outcomes by enhancing patient compliance to therapeutic breathing exercises, addressing challenges faced by clinicians, and providing valuable data insights for informed treatment decisions.

Problem:

The prevalence of postoperative pulmonary complications (PPCs) represents a significant healthcare challenge, impacting 3-8% of all inpatient surgeries and incurring an annual cost exceeding $9 billion in the United States alone. Notably, the incidence of PPCs escalates substantially after cardiothoracic surgeries and pulmonary resections, leading to prolonged hospitalization, elevated mortality rates, and a substantial financial burden on healthcare systems. With each readmission stemming from PPCs costing hospitals an average of $25,000 per patient, the cumulative cost surpasses $9 billion annually. This underscores the urgent need for effective intervention to mitigate PPCs to improve outcomes for patients and alleviate the associated economic strain on the healthcare system.

The current standard of care (SOC) for preventing PPCs relies on deep breathing exercises executed with plastic incentive spirometers postoperatively. Despite their demonstrated efficacy in reducing PPC risk, healthcare providers face a significant challenge due to poor patient compliance. In our interviews with dozens of healthcare providers (surgeons, pulmonologists, nurses, respiratory therapists, etc.), they have almost all identified poor compliance as an issue. This compliance gap translates into missed opportunities to fully realize the benefits of incentive spirometry, thereby necessitating an innovative solution to enhance compliance and improve postoperative recovery outcomes.

Solution:

Airalux’s smart incentive spirometer aims to revolutionize postoperative recovery outcomes by introducing a digital incentive spirometer along with a companion mobile app. This multifaceted approach is designed to enhance patient compliance and provide clinicians with data for informed decision-making. The Airalux device employs a digital pressure sensor to collect inhalation volume and flow measurements during incentive spirometry exercises, addressing the limited data collection in traditional incentive spirometers. This real-time data is transmitted via WiFi to a mobile app and electronic medical records, enabling clinicians to remotely monitor patient compliance and performance trends.

To tackle the root causes of low compliance, Airalux incorporates features within the app to remind, instruct, and incentivize patients to complete exercises correctly. The patient-centric interface includes elements such as exercise gamification and progress tracking, fostering engagement and motivation. Simultaneously, the clinician view of the app empowers healthcare providers with the ability to monitor individual patient data efficiently rather than individual bedside monitoring. The device’s physical design, including a lightweight form factor, detachable disposable components for hygiene, and a full day’s battery life, ensures practicality and ease of use for patients across age groups. It also includes a screen and speaker to guide the patients through their exercises. Furthermore, Airalux is designed to seamlessly integrate with existing hospital networks through dedicated internet of medical things (IoMT) infrastructure, facilitating broad implementation in diverse healthcare settings.

Market:

Airalux will initially target postoperative indications at hospitals ranging from small community practices to large academic research hospitals. The initial focus on both large and small hospitals is intentional; larger hospitals offer a conducive environment for research and trials, influencing broader medical communities and streamlining the path to market, and smaller hospitals are more likely to suffer staffing difficulties that make incentive spirometry even more difficult to monitor.

The market potential for Airalux is substantial and poised for growth, with 19 million post-surgery patients receiving SOC incentive spirometers annually in the United States. The device’s strategic entry into specific post-operative indications, such as thoracic, abdominal, and trauma surgeries, targets segments with a cumulative patient population exceeding 4.5 million individuals annually. Clinicians perceive these surgeries as high-risk scenarios, where midline incisions compromise breathing and elevate the risk of pulmonary complications. Successful implementation and validation in these segments are expected to drive broader post-operative adoption and open avenues for expansion into additional pulmonary indications, including cystic fibrosis, COPD, asthma, and long COVID, presenting a potential patient population exceeding 50 million individuals.

Conversations with representatives from the University of Pennsylvania Health System (UPHS) affirm the anticipated sales pathway, where a physician serves as a clinical champion, leading to value analysis and potential pilot programs before final purchasing decisions. This detailed market understanding positions Airalux as a solution tailored to address specific clinical needs, ensuring a focused and effective market entry strategy.

Competition:

Airalux stands out in the market due to its comprehensive approach to addressing the challenges inherent in traditional incentive spirometers and their digital attachments. Existing incentive spirometers typically employ one-time-use, piston-based designs with limited capabilities for data collection and patient engagement. Despite their efficacy, these devices suffer from low compliance, inefficient clinician workflows, and a lack of real-time data.These are the key issues that Airalux actively seeks to address.

Digital attachments to incentive spirometers, such as the InSee attachment, attempt to collect volume and flow data using distance sensors. However, these solutions are prone to measurement errors and fail to solve compliance issues effectively. In contrast, Airalux’s digital pressure sensor ensures accurate measurements and is complemented by features within the companion app that actively encourage patient compliance through reminders, instructions, and gamification. The device’s design considers hygiene and practicality, with detachable and disposable components adhering to hospital cleaning standards. Airalux’s compact, lightweight form factor makes it a practical and user-friendly alternative to both traditional spirometers and complex, expensive athletic breathing trainers.

Airalux also provides features that are absent in other digital spirometers. Digital spirometers (ie. micro-spirometers) are mainly used to measure patients exhales (eg. FEV1) in pulmonary function testing. Airalux’s guided breathing exercises provide therapeutic benefits rather than only diagnostic benefits to patients. These breathing exercises are absent in other digital spirometry devices.

Value Creation:

Airalux’s value creation extends across economic, healthcare, and technological dimensions, promising long-term sustainability and impact. Besides immediate clinical impact, the device’s potential to prevent hundreds of thousands of PPCs translates into substantial cost savings for the healthcare system up to $9B annually. The economic benefit is derived not only from mitigating readmissions, which cost hospitals an average of $25,000 per readmission, but also from the potential for a 50% reduction in healthcare provider time spent managing incentive spirometry, saving 25 million nurse hours annually.

Beyond immediate economic gains, Airalux’s innovative features open avenues for future services and applications. The device’s unique data collection capabilities on novel lung recovery data could serve as a foundation for developing algorithms that predict early onset of pulmonary complications or optimize patient recovery. This data holds promise for applications in biopharmaceutical and insurance spaces, offering an alternative method for measuring drug efficacy or assessing health risk. Furthermore, the collected data supports the potential for remote monitoring of patients through telehealth applications, positioning Airalux at the forefront of digital health approaches in postoperative care.

The multifaceted value creation aligns with both economic sustainability and measurable clinical impact, positioning Airalux as a transformative force in postoperative care and beyond.

The Team:

Jackson Dooley, Penn BSE’23 Joshua Freedman, Penn BSE’23, MSE’24 Yi-An Hsieh, Penn BSE’23, MSE’24 Isabella Mirro, Penn BAS’23 Parth Mody, Penn BSE/MSE’23