COVID-19: Made-in-Canada Compostable Elastomeric Materials for Medical Glove Manufacturing

From: Innovation, Science and Economic Development Canada

The National Research Council of Canada (NRC), in collaboration with Environment & Climate Change Canada (ECCC), Health Canada (HC) and Natural Resources Canada (NRCan), are seeking solutions for Made-in-Canada sustainable elastomeric materials, that are compostable, to be used in the manufacturing of an equivalent alternative to disposable medical gloves.

Challenge sponsor:
National Research Council of Canada (NRC)

Funding mechanism:
Grant

Opening date:
November 25, 2021

Closing date:
December 23, 2021 14:00 Eastern Standard Time

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Prospective applicants should refer to the Innovative Solutions Canada Grant Instructions and Procedures document.

Challenge

Problem statement

The COVID-19 pandemic has generated an increased consumption of disposable personal protective equipment (PPE) by healthcare workers and by the general public. As of June 29, 2020, based on federal government projections for PPE demand over the next year, it is estimated that approximately 63,000 tonnes of COVID-19 related PPE will end up as waste, being ultimately landfilled.  This includes an estimated 4 billion pairs of medical gloves with an estimated weight of 16 tonnes.

To reduce the environmental footprint of PPE in Canada, the Government of Canada is supporting the development of solutions to manufacture more sustainable PPE and to better manage their end of life.  Strategies include re-usability, alternative materials and novel recycling technologies, as well as compostability.

This challenge is in support of the alternative materials and compostability elements of that strategy. For this reason, the Government of Canada is seeking solutions for Made-in-Canada sustainable elastomeric materials that are compostable to be used in the manufacture of an equivalent alternative to disposable medical gloves, as an eco-friendly and safe replacement.

Desired outcomes and considerations

Essential (mandatory) outcomes

  1. Clearly identify whether the solution will propose an elastomeric material that is compostable, specify if Canadian sourced or imported raw materials will be used.
  2. Production capacity should be sufficient enough to manufacture 1 million pairs of gloves / month. (All medical gloves are class II medical devices.)
    1. In Phase 1 applicants must present a strategy with clear plans to demonstrate capacity for industrial scale manufacturing of compostable elastomeric material.
    2. In Phase 2 applicants must clearly demonstrate that they can scale up production of raw material for industrial scale manufacturing of 1 million pairs of gloves.
  3. Produce sufficient raw material samples for testing and assessment, as specified in the test requirements listed below (see essential outcome #8).
  4. Provide 15 samples to NRC (each sample size: minimum 8 x 8 inch) by the end of Phase 1.
  5. Describe the properties of the raw material. Applicant must show that material prototype has the potential to be authorized by Health Canada.
    1. Material must meet current design, testing and manufacturing standards for nitrile gloves set by Health Canada (see essential outcome #8).
    2. Material must also meet compostability standards in line with international standards (see essential outcome #8.9).
    3. Material must be hypoallergenic.
  6. Demonstrate, via a cost analysis, that reasonable cost targets can be met to support a competitive commercial/market adoption (compared to current medical glove material costs).
  7. Bring environmental benefits compared to conventional, non-compostable equivalents, as demonstrated by Life Cycle Analysis (LCA). Applicants must present an LCA that will estimate the impacts or costs of resources associated with their proposed solution from 'cradle to grave' (raw materials to disposal) – including extraction, processing, manufacturing and consumption of resources (including energy), as well as releases to air, water, and soil, quantified throughout all stages. The LCA should show how their solution is less environmentally damaging than current medical gloves on the market.
  8. In Phase 2 applicant must demonstrate that the new compostable elastomeric material will meet requirements of the following Standards test methods. Note that results need to meet or exceed requirements for nitrile gloves (ASTM D6319). These tests must be done by an Accredited laboratory, preferably Canadian.
Standards test methods recognized by Health Canada
Medical glove test methods

8.1 ASTM D5151 (2019) – OR EQUIVALENT

  • Standard Test Method for Detection of Holes in Medical Gloves

8.2 ASTM D412 Elastomer Tensile Strength Testing

8.3 ASTM D573-04(2019)

  • Standard Test Method For Rubber—Deterioration In An Air Oven

8.4 ASTM D3767 – 03(2020)

  • Standard Practice for Rubber—Measurement of Dimensions

8.5 ASTM D6124 (2006 R2017)

  • Standard Test Method for Residual Powder on Medical Gloves

8.6 ASTM D3772 (2015)

  • Standard Specification For Industrial Rubber Finger Cots

8.7 ASTM D5712 (2015)

  • Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method

8.8 ASTM D6499 (2018)

  • Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products

8.9 Compostability requirements:

  • ASTM D6400 standard, OR
  • European Committee for Standardization - EN 13432. standard, OR
  • Provide assurance that these products would compost in Canadian facilities (i.e. a field testing component confirming the material/product biodegrades within comparable timelines of food and yard waste) and that Canadian composting facilities would accept the products.

Additional outcomes

  1. Use Canadian sourced, extracted and blended raw materials.
  2. Predominantly bio-based (as close to 100% but not less than 60% by weight or volume).
  3. Be designed to be distinguishable from non-compostable material to ensure it is sent to the correct facility at end-of-life.
  4. Include information on shelf life characteristics and packaging requirement of your compostable material.

Background and context

The COVID-19 pandemic has generated an increased consumption of personal protective equipment (PPE) by healthcare workers and by the general public. The consumption of disposable gloves, non-medical masks, surgical masks, respirators, and surgical gowns has increased significantly.  As of June 29, 2020, based on federal government projections for PPE demand over the next year, Health Canada (HC) estimates that approximately 63,000 tons of COVID-19 related PPE will end up as waste.

Because of their multi-material structure and potential contamination by bio-hazards, waste PPE cannot be recycled using conventional mechanical recycling technologies.  At the end of their service, waste PPE is treated according to federal, provincial and territories guidelines:

  • The vast majority of PPE disposed by the Canadian healthcare system is treated as non-dangerous general solid waste, and ultimately landfilled. The remaining fraction is treated as biomedical solid waste, and is either i) disinfected and landfilled, or ii) incinerated. Source: Guide de gestion des déchets du réseau de la santé et des services sociaux, Gouvernement du Québec, 2017. https://publications.msss.gouv.qc.ca/msss/document-001817/ 
  • The vast majority of PPE disposed by the general public is treated as non-dangerous general solid waste, and ultimately landfilled. An unknown fraction is improperly disposed of (e.g., littered or flushed) and lost to the environment where it may be harmful to habitat and wildlife (e.g., ingestion, entanglement) and may pose risks to the efficient functioning of wastewater treatment infrastructure. Finally, an unknown fraction is mismanaged (i.e., put in recycling or composting bins), which may increase the costs of processing recyclable and compostable waste.

In November 2018, the Canadian Councils of the Ministers of the Environment (CCME) has adopted Canada's Zero Plastic Waste Strategy to reduce the environmental impact of plastics and promote a circular economy. To support this strategy and to reduce the environmental footprint of PPE in Canada, the Government of Canada is supporting the development of solutions to manufacture more sustainable PPE and to better manage their end of life. Strategies include re-usability, alternative materials, improved recyclability and compostability.

Nitrile Gloves:

Nitrile gloves (made with nitrile butadiene rubber or NBR) are intended for jobs requiring dexterity, and they stand up even after prolonged exposure to substances that cause other gloves to deteriorate. They offer protection when working with oils, greases, acids, caustics, and alcohols but are not recommended for use with strong oxidizing agents, aromatic solvents, ketones, and acetates. They are one of the most puncture-resistant disposable gloves available, which is why they're often used in food processing and medical  facilities. There are other alternatives to such gloves, but the known alternatives such as Butyl gloves, Latex gloves, and Neoprene gloves have their own weaknesses such as limited dexterity, allergenic, high-energy production, or poor performance against certain chemicals.

The sustainability of nitrile glove production process is essential both in the financial and energy perspective. Nitrile glove has the lowest material cost with positive mechanical and chemical performance quality for the disposable glove market. Nitrile glove also holds a major market in disposable gloves sector, and nitrile rubber compounds may contribute to the huge reduction of the capital cost for a pair of surgical gloves due to the inexpensive raw material compares with other synthetic polyisoprene or neoprene. Disposable gloves by principle are not environmentally friendly as they are designed to be single-use products that are discarded into the waste stream destined for the landfill.

With nitrile and latex gloves holding over 87% of the global disposable gloves market, technological innovations must be pursued in order to minimize the environmental impact this industry has on the global ecosystem.

Note: Typical compostable materials will weaken over time and the average shelf life is usually 18 months before the material starts to deteriorate. Packaging of compostable material is often influenced by heat and humidity, which may reduce its shelf life capacity. Some recommendation, such as storing compostable materials in dry climate controlled, may help prolonged shelf-life.

Maximum grant value and travel

Multiple grants could result from this Challenge.

Phase 1:

  • The maximum funding available for any Phase 1 Grant resulting from this Challenge is : $300,000.00 CAD
  • The maximum duration for any Phase 1 project funded by a grant resulting from this Challenge is up to 6 months
  • Estimated number of Phase 1 grants: 2

Phase 2:

  • The maximum funding available for any Phase 2 Grant resulting from this Challenge is : $1,000,000 CAD
  • The maximum duration for any Phase 2 project funded by a grant resulting from this Challenge is up to 10 months
    • Note: Only eligible businesses that have completed Phase 1 could be considered for Phase 2.
  • Estimated number of Phase 2 grants: 1
    • Note: Selected companies are eligible to receive one grant per phase per challenge.

This disclosure is made in good faith and does not commit Canada to award any grant for the total approximate funding. Final decisions on the number of Phase 1 and Phase 2 awards will be made by Canada on the basis of factors such as evaluation results, departmental priorities and availability of funds. Canada reserves the right to make partial awards and to negotiate project scope changes.

Travel

Kick-off meeting

A project kick-off meeting will be conducted by video conference or teleconference.

Progress review meeting(s)

Progress review meetings will be conducted by videoconference or teleconference.

During the project, NRC may request a site visit to the applicant's facilities, at NRC's expense, to better understand the technology/manufacturing processes and validate production facilities. Any site will respect pandemic-related health and safety protocols, procedures, and approvals.

Final review meeting

Virtual meeting- A final review meeting will be conducted virtually, via videoconference or teleconference.

Eligibility

Solution proposals can only be submitted by a small business that meets all of the following criteria:

  • for profit
  • incorporated in Canada (federally or provincially)
  • 499 or fewer full-time equivalent (FTE) employeesFootnote *
  • research and development activities that take place in Canada
  • 50% or more of its annual wages, salaries and fees are currently paid to employees and contractors who spend the majority of their time working in CanadaFootnote *
  • 50% or more of its FTE employees have Canada as their ordinary place of workFootnote *
  • 50% or more of its senior executives (Vice President and above) have Canada as their principal residenceFootnote *

Evaluation criteria

The applicant must complete the Challenge Stream Electronic Submission Form with a degree of information sufficient to enable Canada's assessment of the proposal against the criteria and the Evaluation Schema. The information must demonstrate how the proposal meets the criterion.

Part 1: Mandatory Criteria

Proposals must meet all mandatory criteria identified by achieving a "Pass" in order to proceed to Part 2. Proposals that do not meet all mandatory criteria will be deemed non-responsive and given no further consideration.

Mandatory Criteria

(Applicant's proposal must address)

Question 1 a: Scope

Describe the proposed solution and demonstrate how it responds to the challenge. Include in your description the scientific and technological basis upon which the solution is proposed and clearly demonstrate how the solution meets all of the Essential (Mandatory) Outcomes (if identified) in the Desired Outcomes section in the Challenge Notice.

Evaluation Schema (Mandatory - Pass/Fail)

Pass

The Applicant's proposed solution is clearly articulated, within the scope for the challenge and addresses all Essential (Mandatory) Outcomes (if identified) in the Challenge Notice.

Fail

The proposed solution is articulated as out of scope for the challenge.
OR
The proposal does not clearly demonstrate how the proposed solution addresses all Essential Outcomes listed in the challenge.
OR
The proposed solution is poorly described and does not permit concrete analysis.
OR
There is little to no scientific and/or technological evidence that the proposed solution is likely to meet the challenge.

Question 2: Current Technology Readiness Level (TRL)
  • Indicate the current TRL of the proposed solution. (Drop Down Menu of the Challenge Stream Electronic Submission Form)
  • Describe the research and development activities that have taken place to bring the proposed solution to the stated TRL.
Evaluation Schema (Mandatory - Pass/Fail)

Pass: The Applicant has demonstrated that the proposed solution is currently between TRLs 1 and 6 (inclusive), and provided justification by explaining the research and development (R&D) that has taken place to bring the solution to the stated TRL.

Fail: The Applicant has not provided sufficient evidence to demonstrate that the current TRL is between 1 to 6 (inclusive) including:

  • There is insufficient/no evidence provided for TRL judgment.
  • The solution involves the development of basic or fundamental research.
  • The solution is demonstrated at TRL 7 or higher.
  • Insufficient/unclear/no justification explaining the R&D that took place to bring the solution to the stated TRL.
  • The explanation simply paraphrases the description of a given TRL level.
Question 3a: Innovation

Demonstrate how the proposed solution meets one or more of the ISC definitions of innovation below:

  • An inventionFootnote *, new technology or new process that is not currently available in the marketplace.
  • Significant modifications to the application of existing technologies/components/processes that are applied in a setting or condition for which current applications are not possible or feasible.
  • An improvement in functionality, cost or performance over an existing technology/process that is considered state-of-the-art or the current industry best practice.
Evaluation Schema (Mandatory – Pass/Fail)

Pass:

The Applicant has demonstrated that the proposed solution meets one or more of the ISC definitions of innovation.

Fail:

  • Applicant has not provided sufficient evidence to demonstrate that the proposed solution meets any of the ISC definitions of innovation; OR
  • Applicant has demonstrated that the proposed solution is an incremental improvement, "good engineering", or a technology that would go ahead in the normal course of product development (i.e. the next version or release).
Question 3b: Advance on State of the Art

Describe in detail the competitive advantages and level of advancement over existing technologies. Where appropriate, name existing technologies as well as potential substitutes or competitors.

To demonstrate this, proposals should include the following information:

  • Improvements (minor or major) over existing technologies or substitutes. Use direct comparison.
  • How the proposed innovation will create competitive advantages in existing market niches or market spaces.
Evaluation Schema (Mandatory Criteria – Pass/Fail + Points)

0 points/Fail:

  • The Applicant has not demonstrated that the proposed solution advances the state-of-the-art over existing technologies, including available competing solutions; OR
  • The proposed solution improves minimally upon the current state of the art, though not sufficiently enough to create competitive advantages in existing market niches; OR
  • The stated advancements are described in general terms but are not substantiated with specific, measurable evidence.

5 points/Pass:

  • The Applicant has demonstrated that the proposed solution offers one or two minor improvements to existing technologies, including available competing solutions, that have potential to create competitive advantages in existing market niches.

12 points/Pass:

  • The Applicant has demonstrated that the proposed solution offers three or more minor improvements to existing technologies, including available competing solutions, that together are likely to create competitive advantages in existing market niches; OR
  • The Applicant has demonstrated that the proposed solution offers one significant improvement to existing technologies that is likely to create competitive advantages in existing market niches

20 points/Pass:

  • The Applicant has demonstrated that the proposed solution offers two or more significant improvements to existing technologies, including available competing solutions that are likely to create competitive advantages in existing market niches and could define new market spaces; OR
  • The Applicant has demonstrated that the proposed solution can be considered a new benchmark of state of the art that is clearly ahead of competitors and that is likely to define new market spaces

Part 2: Point-Rated Criteria

Proposals must meet the overall minimum pass mark of 50% to be deemed responsive. Proposals that do not achieve the minimum pass mark will be declared non-responsive and given no further consideration.

Point-Rated Criteria

(Applicant's proposal to address)

Question 1b: Scope

Demonstrate the scientific and technological basis of how the proposed solution addresses the Additional Outcomes (if identified) in the Desired Outcomes section in the Challenge Notice. If no Additional Outcomes are identified in the Challenge Notice, text entered in this section will not be considered.

If no Additional Outcomes are identified in the Challenge Notice, Applicants will receive 10 points.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the solution will address any of the Additional Outcomes. 0 points
  2. Information provided clearly demonstrates that the solution will address some (<50%) of the Additional Outcomes. 3 points
  3. Information provided clearly demonstrates that the solution will address most (50% or more) of the Additional Outcomes. 6 points
  4. Information provided clearly demonstrates that the solution will address all (100%) of the Additional Outcomes. 10 points
Question 4: Phase 1 Science and Technology (S&T) Risks

Describe potential scientific and/or technological risks to the successful development of the proof of feasibility and how they will be mitigated in Phase 1.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the Applicant has considered potential risks and mitigation strategies and/or information provided contains significant gaps. 0 points
  2. Information provided demonstrates that the Applicant has considered some potential risks and associated mitigation strategies but there are minor gaps in risks and/or associated mitigation strategies. 5 points
  3. Information provided clearly demonstrates that the Applicant has sufficiently considered the risks and defined associated mitigation strategies. 10 points
Question 5: Phase 1 Project Plan

Demonstrate a feasible Phase 1 project plan by completing the table.

  • Indicate if any milestones and activities will be completed concurrently
  • Indicate the estimated exit TRL at the completion of Phase 1. (Drop Down Menu of the Challenge Stream Electronic Submission Form)
Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate a feasible project plan for Phase 1 and/or the project plan exceeds the maximum duration indicated in the Challenge Notice. 0 points
  2. Project plan for Phase 1 is conceivably feasible but not clearly demonstrated and/or includes gaps. 10 points
  3. Information provided clearly demonstrates a feasible project plan for Phase 1. 20 points
Question 6: Phase 1 Project Risks

Describe potential project risks to the successful development of the proof of feasibility and how they will be mitigated in Phase 1.

Applicants should address the following risks, as applicable:

  • Human Resources
  • Financial
  • Project Management
  • Intellectual Property
  • Other project-related risks

Note to Applicants: S&T risks should not be included in this section. Question 4 addresses S&T risks.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the Applicant has considered potential risks and mitigation strategies and/or information provided contains significant gaps. 0 points
  2. Information provided demonstrates that the Applicant has considered some potential risks and associated mitigation strategies but there are minor gaps in risks and/or associated mitigation strategies. 5 points
  3. Information provided clearly demonstrates that the Applicant has sufficiently considered the risks and defined associated mitigation strategies. 10 points
Question 7: Phase 1 Implementation Team

Demonstrate how the project implementation team has the required management and technological skill sets and experience to deliver the project plan for Phase 1 by completing the table. A member of the implementation team can have more than one role.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the project team has the required management and technological skill sets and experience to deliver the Phase 1 project plan. 0 points
  2. Information is provided but there are minor gaps in required management and/or technological skill sets and/or experience to deliver the Phase 1 project plan. 10 points
  3. Information provided clearly demonstrates that the project team has the required management and technological skill sets and experience to deliver the Phase 1 project plan. 20 points
Question 8: Inclusivity

If your business were to receive funding from Innovative Solutions Canada, describe what actions (e.g., recruitment strategy, internships, co-op placements, etc.) might be taken in Phase 1 to support the participation of under-represented groups (e.g., women, youth, persons with disabilities, Indigenous people, visible minorities) in the research and development of the proposed solution. Each Applicant in their response to this question must focus only on describing relevant programs, policies, or initiatives that it currently has in place or would put in place to support the R&D effort in Phase 1.

Note: Do not provide any personal information of individuals employed by your company or that of your subcontractors in the response.

Evaluation Schema (Point-Rated)
  1. No description and/or concrete examples of actions provided that would be taken to encourage greater participation of under-represented groups. 0 points
  2. A description and concrete examples of actions to encourage greater participation of under-represented groups provided.5 points
Question 9: Phase 1 Financial Proposal

Demonstrate a realistic financial proposal for the Phase 1 project plan by completing the table.

Evaluation Schema (Point-Rated)
  1. Insufficient information provided and/or information provided significantly lack credibility. Does not demonstrate a realistic financial proposal for the Phase 1 project plan. 0 points
  2. Information is provided but some costs lack credibility and/or are unclear for the Phase 1 project plan. 7.5 points
  3. Information provided contains credible elements to clearly demonstrate a realistic financial proposal for the Phase 1 project plan. 15 points
Question 10: Phase 1 Financial Controls, Tracking and Oversight

Describe the financial controls, tracking and oversight that will be used to manage the public funds throughout Phase 1. Applicants should indicate if an individual or firm will be managing the public funds and provide their credentials and/or relevant experience.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate the Applicant's ability to manage public funds in Phase 1. 0 points
  2. Information provided is vague and/or contains gaps. The Applicant has some controls, tracking and/or oversight in place to manage the public funds in Phase 1. 5 points
  3. Information provided clearly demonstrates that the Applicant has strong financial controls, tracking and oversight to manage public funds in Phase 1. 10 points
Question 11: Phase 2 Overview

Demonstrate a realistic overview for the prototype development plan if selected to participate in Phase 2.

Responses should include:

  • key tasks
  • estimated cost for materials
  • human resources
  • project risks and mitigation strategies

Note: A more detailed proposal will be requested if selected to participate in Phase 2.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the Applicant has contemplated a realistic overview for the Phase 2 prototype development. 0 points
  2. Information provided demonstrates a conceivably realistic overview for Phase 2 prototype development, however there are gaps and/or the strategy is vague. 6 points
  3. Information provided demonstrates that the Applicant has a clear and realistic overview. 12 points
Question 12: Commercialization Approach

Demonstrate a realistic overall commercialization approach/business model that can successfully take the technology/service to market, and how the technology/service will help you develop and sell other products.

Responses should include:

  • Target markets (excluding Government of Canada)
  • Non-ISC funding sources
  • Transition to a commercially-ready product or service
  • Any other indicators of commercial potential and commercial feasibility

Note: A more detailed proposal will be requested if selected to participate in Phase 2.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the proposed solution has commercial potential. 0 points
  2. Some information provided to demonstrate that the proposed solution has commercial potential, however there are gaps in the commercialization approach. 6 points
  3. A realistic commercialization approach is provided that demonstrates that the proposed solution has commercial potential. 12 points
Question 13: Resulting Benefits to Canada

Describe the benefits that could result from the commercialization of the proposed solution. Applicants should consider the potential benefits using the following three categories and provide justification for each claim:

  • Innovation Benefits: Expected contribution towards the enhancement or development of new industrial or technological innovations within your firm. Responses could include: potential spillover benefits, creation of intellectual property, impact on productivity of the new technology, etc.
  • Economic Benefits: Forecasted impact on the growth of Canadian firms, clusters and supply chains, as well as its expected benefits for Canada's workforce. Responses could include: number of jobs created, number of high-paying jobs, investment in Canada's economy, etc.
  • Public Benefits: Expected contribution to the broader public to the degree that the solution is expected to generate social, environmental, health, security or other benefits to Canada. Responses could include: solution-related environmental benefits, solution-related accessibility benefits, and solution-related impact on Indigenous communities.
Evaluation Schema (Point-Rated)

  1. Innovation Benefits

    Benefit not identified or insufficient claim of benefit. 0 points

    Benefit has marginal increment or limited justification. 1 point

    Benefit is significant and well justified. 2 points

  2. Economic Benefits

    Benefit not identified or insufficient claim of benefit. 0 points

    Benefit has marginal increment or limited justification. 1 point

    Benefit is significant and well justified. 2 points

  3. Public Benefits.

    Benefit not identified or insufficient claim of benefit. 0 points

    Benefit has marginal increment or limited justification. 1 point

    Benefit is significant and well justified. 2 points

Questions and answers

All incoming questions regarding this specific challenge should be addressed to solutions@ised-isde.gc.ca.

All enquiries must be submitted in writing no later than ten calendar days before the Challenge Notice closing date. Enquiries received after that time may not be answered.

You can also consult the Frequently asked questions about the Innovative Solutions Canada Program.

A glossary is also available.

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