Abstract:

The Filtrexa paPURE is an affordable, 3D printed powered air-purifying respirator (PAPR) that provides our healthcare providers with better protection than even N95s, especially in high-risk and confined environments (E.g. ICUs, ERs). It incorporates readily available components and can be easily manufactured locally. We can thus increase accessibility of PAPR technology by enabling hospitals to produce and purchase it as per their need, optimizing the 3D-print to produce it at a cost that is over ten times cheaper than PAPRs currently offered on the market, and using exchanging highly specific components for readily available and affordable components. The Filtrexa paPURE also has made design changes to improve comfort, ease of use, and longevity of PAPR technology.

Introduction

One of the most immediate and impactful effects of the COVID-19 pandemic are global shortages of proper personal protective equipment (PPE), forcing healthcare providers (HCPs) to consistently work in high-risk environments and unnecessarily place their own lives at risk. Our product is a powered air-purifying respirator (PAPR) that creates a positive pressure field with filtered air to protect frontline healthcare workers from airborne threats such as SARS, TB, measles, influenza, meningitis, and most immediately COVID-19. This technology improves upon current PAPR devices in terms of cost-efficacy, ease of access, and ease of implementability. Our solution not only serves to combat general PAPR shortages across the country, but also eases PPE shortages that arise from COVID-19 and future patient surges through an on-demand 3D printing process.

Value Proposition

Powered, air-purifying respirators (PAPRs) are currently the gold standard in medicine when treating patients diagnosed with COVID-19 and other highly infectious respiratory diseases[1] due to their positive pressure system. This system filters air extremely effectively before it reaches the airway. However, this technology package is costly, often totaling over $1800[2] and requires highly specific components which are currently in short supply. Both well-established hospitals such as the Mayo Clinic (with a ratio of 4500 physicians to 200 PAPRs)[2] and smaller county hospitals such as the Hunterdon Medical Center (where not a single PAPR is available to physicians) are facing critical shortages of personal protective equipment (PPE). Evidently, the aforementioned barriers render PAPR technology inaccessible to most frontline HCPs, leaving them far more vulnerable to infection.

Alternatives to PAPR technology include N95s, surgical masks, and currently, homemade masks due to a worldwide shortage of PPE. Although they provide a barrier against aerosols, standard and surgical N95s are easily compromised with an improper fit and have an assigned protection factor (APF) of ten[4], while PAPRs have an APF of 25 to 1000, rendering PAPRs far more effective at protecting HCPs. Additionally, physicians tend to prefer PAPRs over N95s because PAPRs are reusable, easier to breathe through, do not require fit testing, and make them feel safer[1][5].

Our Solution

In order to provide purified air to those in the most high-risk environments, we have developed a novel, inexpensive, and accessible PAPR device that is both lightweight and 3D-printable within 24 hours. Printed using readily-available filaments (e.g. PLA, ABS), paPURE is mounted to the user’s hip and assembled via on-hand motors and batteries. (See Appendix 2.5).

Through PAPR technology, HCPs are given access to filtered positive pressure air systems (in which airflow serves to seal any gaps in masks, as well as reduce respiratory fatigue in HCPs), drastically decreasing infection risk in areas such as ICUs and ERs.

Our device’s customizability allows for interoperability with existing masks, filters, and hosing (See Appendix 3.1), enabling hospitals, or possibly surrounding hobbyists/machinists (regulatory dependent), to produce PAPRs for their physicians and nurses. For images and procedures: See Appendix 1 and 2.

The system features a dual battery set-up that allows HCPs to utilize one or both batteries independently, as well as swap out batteries while the device is in use (such as during an extended patient procedure that a physician cannot leave from). Additionally the belt system, with the fan/chassis on you lumbar and 2 battery on ports on both hips gives a better weight distribution for improved comfort in extended usages (such as a surgeon leaning in an awkward position during the operation). The use of an inline filter means that air is pushed into a filter at the end of the device, as opposed to regular PAPRs that pull air through filters. This setup means that the risk of an imperfect seal compromising air quality is virtually nullified as no negative pressure system exists after air filtration in our device. Additionally, the aforementioned inline filters are better at filtering biological particles without disturbing airflow than standard P100s and are already used extensively in anesthesiology and respiratory care departments of hospitals across the country.

After printing the device’s chassis and shroud, integration with an inline bacterial/viral filter, housing, and masks will be followed by on-site fit and efficacy testing to ensure proper device assembly.[6] Then, an HCP would don their mask, clipping the paPURE chassis and two smart power tool batteries to a provided utility belt, and connecting to the mask via a hose. At most, we expect equipping paPURE to add 1-3 minutes to a medical professional’s routine and greatly improve safety and comfort.

An Improvement from Traditional PAPRs

Our technology eliminates the need for a middle-man manufacturer. Because the only required components are readily available to hospitals and clinics, hospitals can produce the device as per their need. We anticipate working with local 3D-printing facilities to produce and assemble the product, then to distribute the Filtrexa PAPR to hospitals. Physicians and NIOSH officials (most notably Richard Metzler, the first Director of the National Personal Protective Technology Laboratory at NIOSH), have already given us promising feedback regarding the need for this technology, and we are looking into potential partnerships with PPE developers and/or motor manufacturers. Some hospital purchasing experts have additionally communicated a need for affordable PAPRs. Our solution is over 10 times cheaper than current PAPR technologies ($155; see Appendix 2, Figure 2), increasing likelihood of adoption. To allow smaller hospitals to easily obtain our technology, we plan to raise awareness of our business through phone calls and emails to hospitals throughout the country.

Implementation Plan

paPURE’s solution is implementable almost immediately. The main barrier between our tested prototype and implementation is FDA/NIOSH approval (FDA EUA Sec II/IV Approve NIOSH Certified Respirators). We have also identified conditions that will allow us to expedite the regulation and roll-out of the production (such as the IDE and 501(k) pathways suggested to us by regulatory experts).[15] Because our device is based on existing PAPR technology, this predicate nature in combination with existing precedents for 3D-printed medical technology, can help expedite its deployment.[16]

Our technology minimizes the need for a middle-men. We are partnering with regional additive manufacturers to allow for quick, standardized, yet still decentralized production of the device. The only required components are readily available to hospitals and clinics, allowing HCPs to produce the device as per their need. Additionally, if regulatory approval permits, we may utilize local schools/universities/hospitals with on-site 3D printers in order to allow for fully decentralized manufacturing. After NIOSH Approval, our device (and depending on regulatory guidelines, possibly our CAD file) will be sent to those with 3D printers available, 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 easily assembled by anyone (the only limitation being that assembly be done under a fume hood to prevent contamination). Physicians we’ve already talked to have given us promising feedback regarding the need for this technology. We are currently looking into potential partnerships with PPE developers (See Appendix 3.2) and/or motor manufacturers. Our solution is over ten times cheaper than current PAPR technologies (See Appendix 3.3), increasing the likelihood of adoption.

Due especially to the length of this health crisis, hospitals are facing dire 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).
Since this product has yet to be implemented in hospitals, we are writing to you today to gauge your interest in paPURE. Additionally, any feedback you have relating to our product or interest in helping us with laboratory testing of paPURE would be greatly appreciated.

We anticipate our project to reach full fruition within 6-12 months. Our timeline is as follows. Our second iteration of prototyping for clinician testing will conclude in 2-3 weeks, followed by initial clinical testing, which will finish in around 1.5 months. As soon as clinical testing is finished and the product is validated, we will submit our product officially to NIOSH for regulatory approval. We anticipate receipt of regulatory approval within 1.5 months from submission. After approval is obtained, we will also apply for either a provisional patent or copyright, depending on legal advice. Within 1-2 months after regulatory approval, we plan to roll out our product to hospitals via centralized 3D-printing. During the next 1-2 months, we will continue to iterate and optimize the product. Official hospital rollout, with multiple 3D-printing partners and company partnerships, will occur around a month later. This will be around 6-7 months from now. As seen, our timeline is aggressive as we wish to equip healthcare providers with PPE as soon as possible. The prior goals mentioned in our timeline are our key goals and objectives for the project at this time.

Current Testing and Partnerships

Technical Testing is being carried out at Filrexa's primary residence and at Johns Hopkins University and includes analysis of airflow data, battery life, and filtration efficacy. For clinical testing, we already have established connections for clinical testing with both Johns Hopkins Medical Institute and Stanford University. In regards to business-focused assistance, we have also partnered with FastForwardU for advising regarding intellectual property protection, strategic marketing, and clinical networking.

Planned Partnerships

We plan to designate one 3D-printing company (current candidates include Xometry, Protolabs, Cowtown, and Health3D) as our manufacturer during our initial launch into the market, but will continue to partner with additional 3D-printing companies as our business grows. Due to our unique manufacturing approach, all hospitals, regardless of their size, will be able to order and quickly receive PAPRs, lowering the impact of the current shortage. In order to supply the auxiliary materials such as motors, batteries, and more, we plan to initiate company partnerships with large corporations such as 3M, Dyson, Black and Decker, GE, Cuisinart, Hitachi, Makita, Shop Vac, Hoover, Bissell, Shark, iRobot, and Bosch.

Additional Video

https://youtu.be/iFMtzt52BEQ

Appendix and Citations

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