End-to-End Process Map for Virginia Manufacturers

Understand PPE Needs and Determine PPE to Produce

Understanding end-user PPE needs and assessing internal capabilities will inform the decision to produce PPE.

Step 1: Understand end-user PPE needs. Step 2: Determine what PPE we are best positioned to produce.

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"Understand" Flowchart Alternative Text

  1. Am I interested in helping produce PPE for the COVID-19 crisis?
  2. Are end-user PPE needs enough incentive to retool?
    1. If Yes, go to 3.
    2. Yes but I require financial assistance to cover start up expenses.
      1. Submit assistance request to VEDP to identify if financial resources are available to support my business.
      2. If potential assistance identified, go to 3.
    3. If No, go to 4.
  3. Assess current business model to determine if well-positioned to produce critical PPE—N95s/Masks (Textiles, Chemicals); Gloves (Commodity chemicals); Gowns (Textiles, Apparel); Eye protection (Plastics, apparel); Other.
    1. If Yes, go to 5.
    2. If No, go to 4.
  4. Find alternative ways to support COVID-19 PPE supply efforts (e.g., donate PPE on hand).
  5. Do I have enough in-house expertise to produce PPE?
    1. If Yes, go to 6.
    2. If No, go to 7.
  6. Do I have access to the necessary raw materials?—N95s/Masks/Gowns (Various; more restricted for medical use devices); Gloves (Nitrile, natural rubber, chemicals); Eye protection (Polycarbonate); Other.
    1. If Yes, go to 8.
    2. If No, go to 7.
  7. Leverage GENEDGE resources and manufacturing expertise.
    1. Assistance provided, go to 8.
  8. Determine best type of PPE to produce.
  9. Proceed to "Identify PPE requirements and technical specifications."

Identify PPE Requirements and Technical Specifications

Proper interpretation of specific manufacturing requirements will help
to identify supply chain constraints ahead of time.

Identify PPE requirements and technical specifications

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"Identify" Flowchart Alternative Text

  1. Do I understand the PPE requirements and specifications differences for long-term and short-term (e.g., for COVID
    duration) manufacturers? For the duration of the COVID-19 pandemic, the FDA has issued EUAs and Enforcement Policies that have temporarily reduced regulatory requirements.
    1. If Yes, go to 3.
    2. If No, go to 2.
  2. Review the PPE specific FDA, NIOSH, and OSHA requirements within the additional resources. Consult GENEDGE on technical requirements.
    1. Go to 3.
  3. Do I want to produce PPE for medical use?
    1. If Yes, go to 5.
    2. If No, go to 4.
  4. Proceed to “Produce prototype and test with regulators / end users.”
  5. Determine remaining material needs to produce PPE for medical use. Go to 5.
  6. Am I facing additional supply constraints?
    1. If Yes, go to 7.
    2. If No, go to 8.
  7. Contact VEDP and/or GENEDGE to leverage additional supply chain resources (e.g., connect with local raw material suppliers)
    1. Assistance provided, go to 8.
  8. Can I start producing medical-use PPE with my current machinery and equipment?
    1. If No, go to 9.
    2. If Yes, go to 10.
  9. Contact VEDP and/or GENDEGE to identify additional equipment requirements and conduct cost analysis.
    1. Assistance provided, go to 10.
  10. Is it a good business decision to produce medical-use PPE?
    1. If Yes, go to 12.
    2. If "I don't know," go to 13.
    3. If No, go to 11.
  11. Seek alternative ways to support the COVID-19 PPE response.
  12. Yes, my business is well positioned to source and produce medical-use PPE. Proceed to “Produce prototype and test with
    regulators / end users
    .”
  13. Submit assistance request to VEDP to identify if financial resources are available to support my business.

Produce Prototype and Test with Regulators / End-users

Retooling manufacturers should incorporate targeted end-user feedback and contact Virginia DOLI as early in the process as possible.

Produce prototype and test with regulators / end users

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"Produce" Flowchart Alternative Text

  1. Manufacturer producing PPE
    1. If for medical use, go to 2.
    2. If for non-medical use, go to 3.
  2. Produce PPE prototype for medical use.
    1. Leverage AAMI, ANSI, ASTM and NIOSH standards for product guidance (see additional resources).
    2. Test prototype with targeted end users to inform design.
    3. Go to 4.
  3. Produce PPE prototype for non-medical use.
    1. Test prototype with targeted end users to inform design.
    2. Go to 5.
  4. Coordinate with the Virginia Department of Health (VDH) to receive a product review and approval (POC in additional resources appendix).
    1. Receive feedback from end users that have reviewed the product.
    2. Go to 6.
  5. Coordinate with VDH to ensure PPE products are appropriately labeled for non-medical use. Go to 7.
  6. Did my PPE prototype receive approval from the VDH?
    1. If Yes, proceed to "Connect with Buyers and Scale Production."
    2. If No, go to 8.
  7. Did my PPE prototype receive approval from the VA DOLI?
    1. If Yes, proceed to "Connect with Buyers and Scale Production."
    2. If No, go to 8.
  8. Seek assistance from the Virginia Department of Health (VDH) and/or GENEDGE to ensure prototype meets the appropriate standards. Go to 9.
  9. Does my PPE now pass VDH review?
    1. If Yes, proceed to "Connect with Buyers and Scale Production."
    2. Keep working with VDH and/or
      GENEDGE, as needed.

 

Connect with Buyers and Scale Production

The Commonwealth and partnering organizations can assist manufacturers with connecting with PPE end users.

Connect with buyers and scale production

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"Connect" Flowchart Alternative Text

  1. Manufacturer producing PPE
    1. If for medical use, go to 2.
    2. If for non-medical use, go to 4.
  2. Do I meet FDA approval requirements to begin distribution of my PPE? Review FDA requirements and approval process (references provided in Additional resources section).
    1. If Yes, go to 4.
    2. If No, go to 3.
  3. Seek guidance from VDH and additional assistance from GENEDGE to work through the approval process.
  4. Identify potential buyers. Go to 5.
  5. Am I connected with a network of buyers?
    1. If No, go to 6.
    2. If Yes, go to 7.
  6. Submit request for assistance to VEDP to learn more about Commonwealth business opportunities. Go to 7.
  7. Schedule delivery of PPE, and be prepared to adjust design based on end user feedback. Go to 8.
  8. Could I benefit from scaling up production to meet demand?
    1. If No, go to 10.
    2. If "I don't know," go to 9.
    3. If Yes, go to 11.
  9. Reference eVA to get an updated view of the Commonwealth’s PPE demand signal.
  10. Continue producing PPE as appropriate.
  11. Contact VEDP to determine if there are financial resources available to support your production expansion.

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WORKING DOCUMENT, SUBJECT TO CHANGE. NOT EXHAUSTIVE.

DOCUMENT INTENDED TO PROVIDE INSIGHT BASED ON CURRENTLY AVAILABLE INFORMATION FOR CONSIDERATION AND NOT SPECIFIC ADVICE.