Rohan's_Favors_2722SpecEval-RHERrev01_(002).docx

Specifications and Evaluation Criteria Reusable Healthcare Elastomeric Respirator (RHER) – Conceptual Prototypes Specifications and Evaluation Criteria – Rev 01 – 7/19/2019

Reusable Healthcare Elastomeric Respirator (RHER) – Conceptual Prototypes Objective The objective of this project is to design and produce conceptual prototypes of Reusable Healthcare Elastomeric Respirators (RHER) that meet the specific requirements of the healthcare worker. These conceptual prototypes will be evaluated by respiratory protection and healthcare experts at NIOSH – NPPTL and used for further research and development. Designing a respirator is part engineering science and part art. Forming an effective seal onto the human face with a small deadspace and to fit a wide demographic population is a challenge to the designer due to the complex contours of a face that also change due to movement during the respirator use. A further challenge is to steer the design to meet the 42CFR-Part84 standard in a future production model. Specialist expertise and a lot of experience is needed for this type of design, development and prototype production. The successful contractor will need to leverage experience gained from past similar projects and proprietary knowledge from their own respirator designs that will benefit the government in this project. All information related to designing and producing the RHER conceptual prototype will be considered intellectual property that the government will use at its discretion for research and release to manufacturers for further development and production.

Configuration and Design The RHER will consist of an ori-nasal mask body incorporating an exhalation valve, filter attachment ports and possibly a speech diaphragm. A head harness assembly to be donned quickly and worn comfortably. The RHER would be low profile and ergonomically designed to allow the user a wide field of vision. The ori-nasal mask, attachments and harness would be cleanable and reusable. It would incorporate N95 Particulate filter element(s) that would be disposable after use. Other important features would be:

· Non-threatening appearance and color for the benefit of the patient

· Silicone face contact surfaces

· Exhaled breath directed away from patient

· Splash guards to protect against fluid ingress through service ports

· Packable for storing in small spaces

· Easy to dismantle (and assemble) without tools for cleaning and disinfecting More details of the required features, suggested material, design criteria and related comments are given in the Statement of Work (SoW).

The deliverables from this project will be a design package, report and prototype items, namely the conceptual RHER prototype and associated documentation as follows:

· One (1) package (on readable CD) Solid model/ drawings of conceptual RHER prototypes

· Ten (10) Conceptual prototypes. Note: Preliminary prototypes need to be constructed for analysis purposes. This would be an iterative process where multiple prototypes will need to be made and checked to improve the design incrementally

· One (1) Report of the RHER conceptual design in .pdf and MSWord format Evaluation Criteria The Evaluation Criteria details the factors and rationale by which the proposals received from this solicitation would be evaluated. It is based on best value to the program office, which is a trade-off evaluation that could lead to an award to other than low price if the technical advantages of a given proposal support that decision. Criteria 1 is more important than Criteria 2 and 3. Criteria 2 and 3 are of equal but less importance than Criteria 1.

1. Understanding the statement of work and its objectives The proposer demonstrates a clear understanding of the Purpose, Scope and Statement of Work (SoW) of this project. Understanding means an acute awareness of the objectives and a true interpretation of the SoW; not just a repeat of the language in the SoW in the solicitation.

The Statement of Work gives the broad configuration and design parameters. The proposer must expand upon the SoW and describe the detailed technical approaches demonstrating a thorough understanding of the design requirement for Reusable Healthcare Elastomeric Respirators, identifying potential barriers in all aspects of the design, and propose possible solutions.

2. Comparable developments

Examples of respirators designed and produced by the proposer should be given. Design features evident in comparable developments such as the proposer’s own R&D projects, current and previous products that demonstrate the proposer’s ability to be successful in designing and producing these type of respirators. Features related to comparable developments that may be used and/ or adopted in the subject respirators are identified and mentioned. Information on previous similar projects with NIOSH would be an advantage.

3. Corporate and Personnel Experience

The proposer demonstrates familiarity with respirators and their use; have extensive experience in designing respirators similar to that described in the SoW. The proposer is capable of, and committed to providing the necessary resources to complete all tasks in the project. The proposer had designed and produced respirators used commercially or by the military.

The proposer shall demonstrate the ability to produce conceptual prototypes and have the means to produce the necessary tooling for this purpose. The proposer has specialized test equipment such as a breathing machine to conduct breathing test simulations at their facility.

The proposer’s principal investigator (PI) must be an employee of the company and have extensive experience on respirators and related components such as filters. Further, the PI must have time allocated to be intimately involved in the design and have the availability to direct the project efficiently according to schedule to meet the respective milestones as the project progresses.