Automated Audit Trail for Pharmaceutical Cold Chain & Healthcare

Monitoring pharmaceuticals from factory to patient

Delivering vaccines to all corners of the world is a complex undertaking. It takes a chain of precisely coordinated events in temperature-controlled environments to store, manage, and transport these life-saving products. This is called a cold chain.

When it comes to pharmaceutical cold chains, there are very clear regulations around the transport and storage processes, particularly within the European Union. Biomedicines such as vaccines must be continuously stored in a limited temperature range – between 2°C and 8°C – from the time they are manufactured until the moment of vaccination, because temperatures that are too high or too low can cause the vaccine to lose its potency. Once a vaccine loses its potency, it cannot be regained or restored.¹Pharmacies, hospitals, and distributors are required to monitor and audit cold storage of their biomedicines both during transportation and in stock.

These regulations may soon become even more stringent. Currently, GDP (Good Distribution Practices) make drug companies directly liable for medicine in the cold chain, from manufacturing all the way until it goes inside the patient. The new regulations, if passed, will mean the responsibility will fall on wholesale distributors to ensure that the quality and integrity of medicines is maintained throughout the supply chain. This is where Rebus Labs comes into the picture.

Rebus Labs’ plug-and-play solution addresses regulations, continuously taking periodic measurements of every kind of measurable environmental variable, including temperature, humidity, oxygen, C02, light, and location of medicine, either during transport or in healthcare institutions.

If there is a quality issue or if the set values are below or above requirements, an alert is sent to inform the responsible person on the end-user’s side in real time so they can take immediate action. This means medicine will not go to waste and anything that is being refrigerated will remain preserved for as long as possible.

The company’s ‘technology as a service’ includes the whole tech stack – electronics, embedded systems, cloud platforms, mobile applications, and telecommunication infrastructure in order to provide customers with a seamless, easy-to-use end-to-end system. And the Rebus solution is designed to be plug-and-play because the company wants it to be as easy as possible for customers.

“We work with doctors, hospitals, pharmacists, and distributors. They have direct exposure to regulations and by law they have to address them – but they usually don’t want to get too involved in the tech side of things. They just want things to work, so we make sure that that happens.”

Michael Boyman CEO & Founder, Rebus Labs

Technology & connectivity

Part of making the solution easy to use is ensuring that the connectivity works with whatever setup the organization has.

“This is why we chose GSM [Global System for Mobile communication],” says Michael Boyman. “We have all the technology inside the device, and you could say that basically, we provide a smart phone with sensors. Our devices support 2G, 3G, 4G, LTE-M, NB-IoT – and we cover all the wavelengths in the world for different GSM communication standards, from 833 MHz all the way to 2.4 GHz.”

Healthcare is of course a fast-growing area for IoT and technology in general and there are a lot of different solutions addressing different connected care challenges on the market. Could the Rebus solution be integrated with other connected care companies who are filling another space in the healthcare area?

“Absolutely! We have a platform where we can integrate devices that are not our own, where our platform can govern them,” says Michael Boyman. “We can host new firmware, data, reporting, invoicing, stockkeeping, etc. and we can provide security and communication.

“We already keep data in our internal system and have a lot of technical features in our system as well: where are the devices, who owns them, how many devices do they have, are they billed monthly or yearly – all of these can to be monitored.”

Challenges

Of course, few companies have avoided Covid-related challenges and Rebus is no different.

“Despite Covid seemingly like it would help healthcare applications, we had some challenges during the pandemic. Like a lot of other companies, it was, ironically enough, mainly supply chain issues, electronics sourcing. For two years it was a mess, but it also helped us find new ways of working and that has led to improvements.”

Why Tele2 IoT?

Connectivity is crucial to the Rebus solution, with roaming, a global footprint, and the ability to manage that connectivity effectively being important factors when choosing a provider.

We worked with several other operators, and it turned out Tele2 IoT was the easiest to work with – it really is as simple as that.

Michael Boyman

“It’s easy to communicate with people and when we ask questions we get fast responses, which is something that was very important to us. It really makes a difference, especially in Europe, where it feels like people are accustomed to getting an answer in a week. We try to reply to our customers in an hour and I like working with a company that has the same way of working with customer service.”

When talking about the technology stack, Rebus has direct access to the 2CONTROL (Cisco IoT Control Center) platform.

“We tried to integrate Control Center (2CONTROL) maybe three years ago. Back then it was quite closed, but we recently gave it another go. Right now, it’s a manual process. I login, I can see if there is an issue, I have set up different rules and I get alerts if a specific device uses more than the allocated data, so it works well.”

Healthcare & Security

No matter where you’re working in the healthcare, having strong security measures in place is crucial. Rebus has taken a number of measures to ensure their solution is secure, including developing its own communication protocol, where they use existing security protocols, such as APN, and add their own unique internal protocols on top.

“Every single one of our devices has the option to provide military grade encryption on a hardware level,” says Michael Boyman. “We had a customer where this was a requirement, so we decided to add this option. It allows every device’s protocol to be encrypted, which makes it difficult to gain unauthorized access – and even if you do manage to access the device it’s just that, one device, so your entire setup is not impacted.”

The Future

For Rebus, the next few years are all about growth. The company isn’t offering a ‘nice to have’ solution, it’s offering a ‘must have’ one, because everyone in the industry has to address regulations.

“Our solution works flawlessly, and it really helps our customers deal with something they absolutely have to deal with. You can’t avoid regulatory requirements, so we are helping our customers address regulations in an easy and effective way,” says Michael Boyman. “This is why, once we get a meeting, we have an 85% success rate and in five years of operation we have zero churn.

“In fact, Johannes Gutenberg University published a LinkedIn post saying how happy they were with our product. We were able to fully automate the cold-chain monitoring audit process in their pharmacies, necessary in numerous clinical trials funded by pharmaceutical manufacturers.”