Table 3.
Timeline of the mask development process including date, occurrence, decision maker/participants, and design phase
| Date | Occurrence | Decision-makers and participants | Design phase | |
|---|---|---|---|---|
| Early March 2020 | Supply chain shortage declared by WHO; University and Medical Center leadership prioritize solution to N95 shortage. | L | Explicit need | |
| Mar. 18, 2020 | Institute for Engineering in Medicine (IEM) converges experts to address N95 mask shortage in response to a request from Vice Dean for Research at Med School. | L, C, I, D&E, R&T, MC | Research and problem statement development | |
| Mar. 18, 2020 | Problem statement developed in coordination with industry experts. | I, D&E | ||
| Mar. 19, 2020 | Filtration testing of alternative media begins at Center for Filtration Research (CFR) on university campus; Cummins Industries indicates they have media supply available to test and utilize. | L, C, I, R&T | ||
| Mar. 19, 2020 | N95 concept meetings: Two directions emerged—Reusable mask options utilizing three-dimensional printing and/or oxygen mask base and disposable mask options. | C, D&E, R&T, MC | ||
| Mar. 21, 2020 | The first disposable prototype (MNmask v1) was developed and presented to the team. | L, C, D&E | Filtration research and media testing | Prototyping and testing |
| Mar. 21–25, 2020 | MNmask v1 prototypes developed with nontraditional filtration recommended by CFR. | D&E | ||
| Mar. 26, 2020 | Filter Media from Cummins arrives on campus. | C, I | ||
| Filtration efficiency of Cummins media tested by CFR. | R&T | |||
| MNmask v1 prototyped in Cummins media and tested using TSI porta-count quantitative fit test (OSHA standard). | D&E, R&T | |||
| Filtration media and prototype fit tests pass NIOSH N95 standards. | R&T, D&E | |||
| Mar. 27, 2020 | Filtration research and MNmask v1 testing results presented to hospital CEO, leadership, and clinicians; Approval and seed funding to move forward with MNmask v1 development. | L, C, D&E, R&T, IH, MC | ||
| Mar. 29, 2020 | Leadership and medical clinicians organize evaluation of MNmask v1. FT-30 qualitative fit testing of mask occurs at the hospital for 20 clinicians. Four sizes of masks were tested. D&E team attends session remotely. Mediocre results across a range of face shapes. | L, C, D&E, R&T, IH, MC | ||
| Apr. 1, 2020 | Mask designs and manufacturing methods were discussed with the Office of General Council. A decision was agreed upon to license mask designs and production methods for free. | C, D&E, R&T | ||
| March to April 2020 | Media chemical composition and skin safety research are led by a chemist and filtration engineer to ensure the human safety of media. | R&T, IH | ||
| MNmask v1 design refinement continues through component and quantitative fit testing; Mask design refined to two sizes; Second round of hospital fit tests produces more promising results. | L, C, D&E, R&T, IH, MC | |||
| Apr. 2020 | MNmask Procedure design is presented to leadership as a procedural mask alternative and is a simplified modification of MNmask v1. MNmask Reusable design is presented as an alternative for those that do not fit into MNmask v1 | |||
| Mid-April 2020 | MNmask v1 design hardens. The manufacturing process developed with insights from industry contacts. Process tested with a small group of workers to ensure product quality and worker safety. | C, D&E, I, IH | Design hardening and manufacturing | |
| April to May 2020 | UVGI and heat decontamination protocols were developed and tested by CFR and hospital for N95 supply and MNmask v1. | R&T, IH | ||
| Mid-April to May 2020 | Full-scale manufacturing of MNmask v1 using a small workforce. Over 10 working days, 10–20 students worked 3–6 h shifts and produced 6000 masks. Phased-in manufacturing steps determined the most productive for small-scale production. | L, C, IH, D&E | ||
| May to June 2020 | Final quality control of 6000 MNmask v1 and 200 MNmask Re-usable supply ready for delivery to the hospital. 500 MNmask Procedural design kits assembled and distributed across campus. | L, C, D&E, IH | ||