Our Goal

Use Case

The intended users of this product are frontline HCPs caring for those affected with highly virulent pathogens such as COVID-19. In ICUs and ERs, hospitals see a high concentration of COVID-19 patients. When medical professionals treat patients in these areas, they are exposed to a high viral load. To properly protect these frontline workers—from nurses to the doctors—it is paramount that they be equipped with the gold standard of PPE. paPURE aims to modify the current PPE that medical professionals use, by adapting existing masks to PAPR technology. With our technology, an HCP would don their mask, clipping the paPURE device to their belt, and connecting to the mask via a hose. Following paPURE assembly, the medical professional will need to use sucrose (saccharine) spray to test proper device assembly.^[6] At most, we expect setting up the paPURE to add 5-10 minutes to a medical professional’s routine, but it would greatly improve safety and comfort.

We must more thoroughly test the filtration capability of paPURE, the porosity of the 3D-printed solution, and the battery life and longevity of the prototype. Filter integrity testing—in which a mineral oil spray can be cleanly distributed over the filter on the outside, followed by traditional aerosol photometry—is well validated and has been used for over 70 years in HEPA filter testing in cleanrooms. The same test should allow us to observe our filter’s capability of filtering out small particles.^[12] Air leakage (e.g. bubble test^[13]) tests can be easily performed. Regarding the porosity of PLA, our 3D printing filament, and the fine particles emitted while printing, evidence^[9][10] suggests that thorough washing or paraffin coating should resolve the issue. Further testing is required in regards to the ideal filament, not only for porosity, but also for accessibility in hospitals. Finally, due to location limitations throughout this pandemic, we are yet to run the prototype through its full lifecycle to measure battery life (run until ~80% airflow). It is important we also perform this test before distribution so HCP can plan for when to recharge the device. In terms of general testing, if we are able to validate these requirements, our device is projected to pass barriers to FDA approval.

Implementation Plan

paPURE’s solution is implementable almost immediately. After the preliminary testing summarized above, the only barrier between our tested prototype and implementation is FDA approval. We have, however, identified conditions that will allow us to expedite the regulatory pathway (such as the 501(k) pathway suggested to us by regulatory experts).^[15] paPURE uses the same technology as existing PAPRs (and non-3D printable components such as the motor are sold individually). Thus, taking advantage of our additive manufacturing model will allow us to accelerate FDA approval. Additionally, Prisma Health’s 3D-printed ventilator-splitter received emergency use authorization from the FDA,^[16] and we have drawn parallels between Prisma Health’s technology and paPURE’s. Therefore, from a regulatory perspective, we don’t anticipate major regulatory challenges. Concerns have been raised by the FDA regarding safety of 3D-printed technology for medical use,^[15] but because any particles emitted from our 3D print will be purified through a filter, these concerns aren’t relevant for our prototype.

Our technology eliminates the need for a middle-man manufacturer. The only required components are readily available to hospitals and clinics, allowing HCPs to produce the device as per their need. Local schools or universities with 3D printers can accommodate a lack of 3D printers at some hospitals. After FDA approval, our CAD model and assembly instructions will be sent to hospitals and clinics, who could print and assemble the device (See Appendix 3.1).

Players involved in the production of this technology would be hospital assembly workers, but the design is truly assemblable by anyone (the only limitation being that assembly be done under a fume hood to prevent contamination). Physicians we’ve already talked to will be taking our design to the board of directors and have given us promising feedback regarding the need for this technology. We are looking into potential partnerships with PPE developers (See Appendix 3.2) and/or motor manufacturers. From hospital purchasing experts have communicated a need for affordable PAPRs. Our solution is over 10 times cheaper than current PAPR technologies (See Appendix 3.3), increasing likelihood of adoption.

Experts we’ve talked to anticipate a surge of cases within the next two to three weeks and are already facing shortages of PPE. This has accelerated our timeline, but we are confident that it is feasible given the current state of emergency (See Appendix 3.4). With the support of Johns Hopkins Center of Bioengineering Innovation and Design, we anticipate the rollout of our CAD model and Assembly instructions to hospitals and clinics by Wednesday, April 13th (week of April 19th at the latest), which would hopefully enable healthcare providers around the country to prepare themselves for the surge in COVID-19 patients before it occurs.

Resources Needed for Completion

Due to the few resources that we require, our team has considerable potential for excelling in efficiently producing and distributing our product. We have access to materials needed to build, design, and initially test the prototype (i.e. 3D printer, Glovebox, Fusion360, etc.), maintaining accessibility. We may need assistance communicating this idea to hospitals (and schools or businesses with 3D printers if need be). We will need some assistance in developing instructions for assembly and use of our technology, as well as in optimizing our 3D model to reduce printing time. Financial and/or technical guidance to navigate the regulatory pathways to obtain FDA approval for our product will also be necessary. Some aforementioned aspects of the testing protocol require additional resources currently unavailable to us (e.g., helium testing, viral particles, photometer). We have accessed personal connections in the clinical and regulatory space, as well as at JHU through our BME Design Teams.