Request for Expression of Interest for Oxygen Concentrators

Background:

UNICEF is driving innovation of oxygen concentrators that are better suited for low-resource settings (LRS). As a first step towards this, UNICEF and NEST360 published a Target Product Profile (TPP) that outlined the ideal concentrator requirements for LRS. The TPP is available at: https://www.unicef.org/supply/documents/target-product-profile-oxygen-concentrator

TPP-based innovations may take 12-48 months to come to market. In the meantime, it is important that UNICEF secures continuing supply of concentrators to meet the needs of countries and programmes. To meet this ongoing need, UNICEF will launch a “Supply Continuity Tender” in the first half of 2023 to ensure the most fit-for-purpose concentrators are available in the Supply Catalogue. To better identify commercially available concentrators that can perform well in low-resource settings, UNICEF is inviting manufacturers via this REoI to participate in third party lab testing of their products to inform this future tender.

Following the Supply Continuity Tender, UNICEF will launch a multi-year open “Innovation Tender” in the second half of 2023 to accept proposals for TPP-based oxygen concentrators as they become commercially available.

In summary, this REoI has two streams for expressing interest, which correspond to the two sequential tenders launching in 2023.

UNICEF has a mandate to meet the procurement needs of countries and programmes and will strive to ensure continuity of supply today and into the future. By publishing the TPP, UNICEF has also indicated an aspiration to transition towards supplying TPP-based oxygen concentrators as they become available, while ensuring our supply needs continue to be met effectively. This REoI and the two tender streams are steps in that direction.

Purpose of this REoI:

The purpose of this REoI is to solicit expressions of interest from manufacturers and innovators for participation in one or both of the Supply Continuity and Innovation streams.

Supply Continuity stream:

• Who is this stream for?

This Supply Continuity stream is intended for manufacturers of existing commercially available oxygen concentrators.

Wholesalers are not eligible for this REoI, however they will be eligible for the Supply Continuity Tender once launched in 2023. Response to this REoI is not required for wholesalers to qualify for the Supply Continuity Tender.

Wholesalers may encourage manufacturers whose products they supply to express interest in the REoI and to volunteer those products for lab testing under the Supply Continuity stream.

An exception is made for wholesalers who have an exclusive agreement with a manufacturer to represent their products and thus are responding to this REoI on behalf of a manufacturer. In such cases, we request that the wholesaler submit a statement from the manufacturer stating that they authorize the wholesaler to represent their products and participate in the lab testing.

• What is the objective?

The Supply Continuity stream of this REoI has two objectives:

1. The REoI gives an opportunity for manufacturers of existing commercially available oxygen concentrators to indicate their interest in the upcoming Supply Continuity Tender.
2. The REoI gives an opportunity for manufacturers to volunteer their products for environmental lab testing through the Oxygen CoLab.

Please note that the results of the lab testing will be reviewed during the technical evaluation for the Supply Continuity Tender. Preference will be given to oxygen concentrators with better lab testing results. Thus, participation in the lab testing is strongly encouraged.

At this stage, only 10 LPM concentrators will be included in lab testing as this is the priority product for UNICEF based on historical demand. Manufacturers are however welcome to submit as part of their response to this REOI any 5 LPM, 8 LPM, or other concentrators, as these may be considered for future testing. The future Supply Continuity Tender will also be open to 5 LPM, 8 LPM and 10 LPM concentrators.

• What will be involved in lab testing?

Most commercially available concentrators were not designed for the challenging environments and use cases seen in LRS. To better understand which products are likely to succeed in LRS, the Oxygen CoLab will coordinate lab testing of existing concentrators. This testing will be conducted by an independent certified testing lab. The result of this lab testing will inform UNICEF’s Supply Continuity Tender.

The lab testing protocol will be shared with manufacturers for feedback before testing. This protocol is focused on the environmental requirements from the TPP. Results of the lab testing will be shared with manufacturers to give an opportunity for learning and making modifications to the devices. The final results will inform procurement by UNICEF and may inform other parties as well.

• What are the qualification requirements for participation in lab testing?

Only manufacturers with a Quality Management System in conformity with the following standard are invited to express interest in the Supply Continuity stream:        

(a) ISO 13485:2016

Only products with at least one of the following pre-market approvals / market clearances are invited to express interest in the Supply Continuity stream:

(a) Australia: TGA Device Licence

(b) Canada: Device Licence

(c) European Union: CE Mark; Regulation (EU) 2017/745 (EU MDR)*

(d) Japan: Device Licence

(e) USA: 510(k) market clearance

* For products that still comply with MDD 93/42/EEC, manufacturers should indicate their transition plan to MDR by 2024. See https://www.unicef.org/supply/documents/technical-requirements-medical-devices for more details.

Only products in conformity with the following standard are invited to express interest in the Supply Continuity stream:              

(a) ISO 80601-2-69:2020*

* For products that are in conformity with a previous version may also be considered. Please indicate this in the survey.

Only products that meet this minimum threshold for environmental performance are invited to express interest in the Supply Continuity stream:       

(a) Maximum operating temperature >= 35 C

(b) Maximum relative humidity >= 80%

Interested suppliers should put forward only one version of each unique product within their portfolio for testing. For example, if a particular product has both single flow and dual flow versions, only one should be submitted for testing. At this time only 220-240V products will be considered for testing as this makes up the majority of UNICEF’s historical procurement and demand.

Innovation stream:

• Who is this stream for?

The Innovation stream is intended for manufacturers and innovators that are, or will be, involved in innovation based on the TPP.

Wholesalers are not eligible for this stream, however an exception is made for wholesalers who have an exclusive agreement with a manufacturer to represent their product and thus are responding to this REoI on behalf of a manufacturer. In such cases, we request that the wholesaler submit a statement from the manufacturer stating that they authorize the wholesaler to represent their product and participate in this process.

• What is the objective?

The Innovation stream of this REoI serves as a means of identifying which manufacturers and innovators are, or will be, involved in innovation based on the TPP. Furthermore, this stream of the REoI is intended as an entry point for collaboration with UNICEF on innovation, referred to as “co-creation”.

• What will be involved in co-creation?

Success of any innovative medical device in LRS markets requires: understanding the demand landscape (buyers, payers, users, policy, guidelines, procurement, etc.); ensuring the right product-market fit, product requirements and features, willingness-to-pay for these, and price point; generating the right evidence through lab and field trials; driving advocacy and awareness; influencing alignment and uptake among buyers at the global and national level for the new product and its specifications, and much more.

This co-creation process with UNICEF offers manufacturers, innovators, and product developers the opportunity to have an ongoing 1-on-1 open dialogue and collaboration with UNICEF as a stakeholder and partner in the activities listed above. UNICEF has a shared interest in seeing the right product developed and then succeed in the market to achieve its potential impact in saving lives, and therefore applicants are encouraged to engage and work with UNICEF throughout the development and commercialization process. 

Throughout this process, applicants can choose the level of information sharing with UNICEF that they feel comfortable with. All information shared with UNICEF will be kept strictly confidential.

As with the Supply Continuity stream, lab testing will be used to inform the Innovation Tender. Depending on time to market, lab testing may be available through the Oxygen CoLab (before Mar 2024) for commercially available products or advanced prototypes that have not yet achieved regulatory market clearance. Products coming to market after this timeline may be required to independently complete the lab testing and provide results during the tender.

Innovators are encouraged to engage with the Oxygen CoLab who are supporting innovators engaged in R&D, evidence generation, advocacy, market introduction, and scaling efforts.

UNICEF is currently exploring the possibility of a pull incentive (e.g. advanced market commitment) to de-risk investment in TPP-based products. The scale and structure of a pull incentive is in development and will be shared with Innovation stream applicants when appropriate.

• What are the qualification requirements?

Applicants to this Innovation stream of the REoI should be currently working on, or planning to initiate within the next year, a product development project based on UNICEF's oxygen concentrator TPP.

Your organization or your existing partners should have the capacity to bring these to market (regulatory and quality management; transfer to manufacturing and manufacturing at scale; marketing, distribution, and sales channels).

Applicants should demonstrate investment of resources (people, time, or funds) and commitment towards this project.

Procedure for submission of EoI:

Interested parties are encouraged to complete the linked survey below on or before October 31, 2022 at 11:59pm CET.

Q&A session:

A virtual Q&A session will be held on October 19, 2022 at 9:00am EST / 3:00pm CET. Interested suppliers are requested to contact by email Florin Gheorghe (fgheorghe@unicef.org) and Ayako Okamura (aokamura@unicef.org) to confirm attendance and submit any questions in respect of this REoI before October 18, 2022 at 11am EST / 5pm CET.

EoI is not to be sent to the individuals stated above. Any submissions sent to the individuals will not be reviewed.

Please note:

(a) Prices are not required at this stage;

(b) This REoI does not constitute a solicitation. Submitting an EoI does not automatically guarantee receipt of the solicitation document when issued;

(c) UNICEF reserves the right to require compliance with additional conditions as and when issuing the final solicitation document.

(d) UNICEF reserves the right to change or cancel the requirement at any time during the REoI and/or solicitation process.