Cold Chain Indicators - From Concept to Commercialisation

The Cold Chain Indicator (CCI) project started in 2014 and is now close to becoming a commercially available product. Marpe Tanaka — Innovation Lead — and Louis Potter — one of the Case Managers of the project —reflect on this journey and explain the processes and decisions that were made to get to this point. 

The CCI project has come a long way - in all honesty, it has not all been smooth running since its inception over five years ago. This project started as a scoping exercise led by the MSF Sweden Innovation Unit (SIU) for the logistics department of the MSF Operational Centre in Amsterdam (OCA). The initial aim was to investigate where there might be gaps in the current monitoring system of the cold-chain — the process of transporting and storing vaccines, medicines, diagnostics and other thermosensitive items between 2-8C from the manufacturer to the final use at field level. 

Initiation

During the first phase of the project, two key areas for improvement were identified: 

1. The level of packaging on which the current indicators were tracking temperatures - currently done at a tertiary level i.e. larger transport boxes, rather than secondary level (the smaller box containing the vials/tests, etc.); 

2. The monitoring of the last-miles of the cold chain (CC), especially in terms of the level of information provided to end-users; lab technician, vaccine campaign worker, or any other field staff that has to know if the CC item can be used or not. 

With these gaps identified, along with an unarguably complicated current cold chain monitoring system, it was felt there remained a gap where affordable, digital end-to-end solutions could play a significant role. 

Included in the scoping was a landscape analysis of existing technologies, which coincided with the early stages of printed electronics as an industry. This led us to Linköping’s University, Sweden — a leading hub regarding printed electronics and the Research Institute ACREO that is running the Printed Electronics Arena (PEA). ACREO is today part of Research Institutes of Sweden (RISE) Through their internal open innovation fund, an early proof of concept was made together with the SIU. This early-stage prototype essentially “translated” existing thermochromic label-based categories to the digital format demonstrating not just the concept of printed electronics but also a hint of its potential.  

Early Demo of CC indicator Photo: Marpe Tanaka

Development

With this as a focus, the SIU started a collaboration with TU Delft — a renowned design university in the Netherlands. A group of students, supervised by the SIU, initially produced a range of possible designs based on end-user research with MSF staff and those working in printed electronics. Based on this, the SIU applied for funding from Vinnova — the Swedish Innovation Agency along with two partners who had been identified during the students’ research (ACREO and Benelli). This funding was successful and then taken forward further by a master’s project, whilst the project was being managed by the SIU Case Manager. During this stage of the project, the indicator went through a range of iterations, building in new feedback and technological developments brought the technology to a stage where it could be tested with MSF staff in the field. Two field trials were conducted with the prototype labels to gain feedback from staff in Bangladesh. Testing with end-users is essential, especially for a product planned for international use. This was highlighted when the snowflake symbol used to indicate below 0 temperatures was identified as an unknown for Bangladeshi staff. 

During the project and the development of the different iterations, it became evident that besides the potential to address the initially identified requirements for humanitarian cold chain monitoring, there might be other potential benefits for using printed electronic monitors. 

• Individualized CC item profiles. Currently, cold chain items (several hundred of them only within MSF) are divided into rough categories of thermo-sensitiveness (levels of high and low temperatures). Printed electronics provide the possibility to tailor the temperature intervals for the individual items providing much more accurate indications on exposure to harmful temperatures.

• User-friendliness. Besides the very clear and instant information based on use/do not use a notice on the display, anyone with an Android device can download an app and get access to temperature exposure data. This data can easily be read out by the same person or forwarded to a specialist for consultation and advice.

• Overview of weaknesses in the cc system. If used more widely and systematically, the CCIs would provide a much more holistic overview of the CC system than any current tool. They would provide information on when and where breaches commonly happen, making it easier to investigate why and, more importantly, how to avoid that they happen in the first place. Considering also the fast acceleration of AI/machine learning technologies and applications, the vast amount of easily available and accessible data that a cloud-based system would provide could further spur system improvement.

After a 2-year period of funding from Vinnova, the prototype was functioning but needed to improve in terms of reliability and process for production. To make the push for this, it was decided to bring TSS — a specialist manufacturer in cold chain monitoring — onboard and apply for a second Vinnova grant. 

Implementation 

For MSF and the SIU, how to deal with this move towards the commercialization of a product that started life within MSF, was a tricky decision to make. On the one hand, the scaling of the technology to something that could be bought on the market was exactly what was needed. But, on the other, how should MSF deal with the potential questions over ownership and time that had been invested from MSF staff into the project? There was also a need for MSF to ensure that the CCI remained a product for the humanitarian sector. 

To this end, it was decided that MSF would withdraw for the partnership. Whilst leaving a project that you have been instrumental in leading from the start is tricky, we decided this was the right decision for several reasons:

1. MSF/SIU’s main role had been fulfilled. Identifying the need/problem, providing the requirements and design features is our largest and most important contribution. The project had already been ongoing for more than 4 years. Not knowing how many more years for a final, commercially available product on the market would take – if it would happen at all – in combination with the relatively unknown area of commercialization we were entering made the choice easier.

2. Ownership. MSF could potentially have pursued a claim of partial ownership in terms of background IP. Still, the main bulk of IP and patents were linked to the printed electronic technology, so assessing how much MSF ownership was difficult. In addition, there was no clear guidance on ownership of IP within MSF. Even if there were patent claims, in Sweden, where the project Is based, a patent can only be owned by a physical or juridical person (person(s) or company)which makes things even more complicated for a non-profit organization such as MSF.

3. Negotiation is expensive. Entering a new sector can be expensive for any organization. The more the project progressed the more complex the partnership became with the other stakeholders who came in. This added complexity left MSF more reliant on support from expensive legal counsel. 

4. Commercialization is not MSF’s area of expertise. Whilst MSF’s expertise provided the need requirements for the label, and the SIU’s design approach helped build this into a working prototype, MSF is neither a manufacturer nor a distributor. It’s important to know when you don’t know, and it was felt that the additional effort required to attain a level of understanding that could provide useful input to following the production process of the CCI was not worth the investment. Especially considering the TSS brought this coordinating expertise to the new form of the partnership. 

5. MSF cannot receive direct funding from EU governments. Following the migrant crisis, MSF decided to refuse all EU funding. With this in mind, accepting money from Vinnova could possibly have contravened this edict. 

6. It frees the partnership to pursue the most efficient route to market. At this point, the biggest challenge was how to bring the CCIs to market so production could scale in order to decrease price as well as make the indicators more durable and validated in terms of accuracy, duration, etc. To do so, it is important to have an identified market and one of these was Big Pharma actors. This made MSF involvement more unfeasible for various reasons including but not limited to the fair pricing advocacy work driven by MSF through the MSF Access Campaign. 

7. MSF staff turnover. Since the project began, the staff at OCA who had initially been the clients in the project had changed and the buy-in had gone down. Thus, there was less operational support for testing and developing the labels for the final stage with MSF help. 

What’s next?

We recently received the latest version of the CCIs from TSS. They look pretty much the same as before, but it’s what we can’t see that has developed the most, the software and backend components. 

The CCIs are now looking for its first client to commission an order of the indicators. Some unknowns are still there hindering the first steps into wider adoption:

• Performance and validation. It is not fully clear to us if the CCIs are fully field ready when it comes to for example battery life. In addition, as we understand it, they have not been used on such a scale that accuracy, reliability, and endurance has been verified. This provides an inherent challenge as validation of such a product needs to be in place in order for it to be adopted.

• Cost. We still do not know what the unit price will be as it so much depends on the level of production. If it is 10,000 or 1,000,000 units that are produced will obviously make a big difference in the price per unit. In addition, as it is such a new concept and product, it is unclear how many potential clients are willing to pay, especially within the humanitarian field which remains a matchmaking issue. Our initial target was an indicator that costs $1 per label, however, if we’re able to undercut existing solutions significantly, that in itself will be a big win. 

It’s exciting to see the CCI reach the point where it’s ready to be tested and move towards mass-production. Of course, there remain some unanswered questions on performance, but we’re seeing the project reach a stage which, frankly, has been unusual for many humanitarian innovations in recent years. It may have taken longer than ideal, but we are hopeful this is the start of a fruitful harvest for the years of work that was put into the early stages of the project. 

General insights:

• Innovation takes time. We’ve now crossed the five-year mark and are finally close to reaching the market. 

• It takes a range of actors to make something successful. MSF is notoriously skeptical of the private sector. Sometimes we need to be better at understanding where our strengths and weaknesses lie. 

• Know what you don’t know. There was a clear trade-off in deciding to leave the project, but, ultimately, the decision to withdraw enabled us to save resources at a point where the project was getting harder for us to provide quality input. 

• Matching an idea to identifying the need is not enough. Identifying the need or problem is necessary to go in the right direction. But remember this is just the beginning and when dealing with game change innovations you need to match this need with not just the resources and expertise of your partners but also their incentives. 

• MSF needs to be better at dealing with partners. This is why we started the Innovation Partnership Project, to better investigate how we could make the most out of partnerships.