Bagging with the precision of a ventilator

What it does

Irrespective of qualification, experience, or confidence, providers deliver unsafe breaths with the manual resuscitator. Our design provides intuitive haptic, visual, and auditory feedback enabling users to manually ventilate patients safely and optimally.

Your inspiration

The manual resuscitator or the Bag Valve Mask (BVM) is an essential first line of care device for breathless patients. 13.1 million BVMs are used in the USA annually. Unlike a ventilator, it is very difficult to deliver precise breaths to patients with the BVM. Due to a lack of financial incentives proportional to the high R&D risk, there is minimal innovation by established companies in this space. This has generated a quality gap in the care a patient receives from a BVM vs a ventilator. Through our customer discovery process, we realized that a solution that fits in the current workflow would have a high clinical and business impact.

How it works

As a high volume consumable, we focused on the ratio of value/cost at scale. Each feature provides value to our customers and end-users. The success criteria were biocompatibility, durability, cost-efficiency, portability, and integration into workflow and supply chain. A BVM can be used to deliver air with variable pressure, flow, rate, and volume combinations. We narrowed this variability with our pressure-flow control valve. When an unsafe breath is delivered, our device’s valve closes, limiting flow, and generating visual, auditory, and haptic feedback. When the orange valve closes it generates a snapping noise and creates backpressure and rigidity in the bag, which is immediately felt by the user. Upon realization of the unsafe breath delivered, the user will intuitively adjust their technique and deliver the next breath safely. Our device will ensure safe and optimal air delivery with a BVM regardless of the patient’s lung disease state.

Design process

As an FDA regulated Class II medical device, early in the design process, we ensured compliance with ISO standards and FDA testing requirements. A risk document and a design history file was developed to track all changes. We utilized rapid prototyping, 3D printing, and hand injection molding to develop a proof of concept. We tried and tested several versions in a benchtop setting. The initial iteration consisted of a spring-piston mechanism. BVM dimensions, fluid dynamics principles, and clinical parameters were taken into account when calculating the optimal spring constant of our piston and other device specifications. We quickly learned that the design was inefficient, difficult to optimize, and unscalable given our strict design criteria. We then pivoted to a more elegant and cost-efficient design consisting of a custom valve mechanism. Our custom valve has several features that could be modified to obtain the optimum pressure and flow control. We utilized gold standard ventilator testing equipment to fine-tune our prototype. Later, we conducted a fresh cadaver pilot study under a state EMS director to gauge the effectiveness of the device. Based on user-feedback from large customers, we made further changes primarily from a usability and cost standpoint.

How it is different

Currently, there are no solutions in the market that bridge the gap between the BVM and the ventilator while fitting into existing clinical workflow, hospital operations, and supply chain. The combined visual, auditory, and haptic feedback mechanisms provide an objective real-time assessment on ventilation techniques. As a result, healthcare workers and their supervisors have increased confidence and patients receive better. The WIPO/ PCT has already accepted our critical independent and dependent claims for novelty and inventive step. We will be in the national phase of patent filing this fall. Our invention has been extensively studied for safety and efficacy. Recently, a prominent health system in the USA completed two investigator-initiated randomized controlled crossover trials comparing our device, the BVM, and two ventilators. The results showed that our device brings key airflow paraments closer to a ventilator’s performance.

Future plans

Over the coming quarters, we will conduct rigorous tests on the prototype as mandated in the FDA and ISO standards. There is an opportunity to optimize the design for manufacturing and functionality. We will also develop pediatric, infant and neonate versions of the device. Depending on our claims and intended use, the FDA has suggested in our presubmission to potentially expand our fresh cadaver pilot study. Following regulatory clearance, we plan to go into production with multi-cavity tools. For this, we will identify an ISO 13485: 2016 certified manufacturer that can produce units at scale.

Awards

NSF, SBIR Phase I Award of $256,000; FDA for EUA COVID-19 application (Under review); Idea to Prototype Grant; 1st place University of Minnesota DMD Conference; Gold prize 2019 European Product Design Award; 2019 EMS WORLD Innovation Award; NASDAQ Milestones Maker Program Spring '19; MassChallenge Boston Accelerator 2020