Start-up helps manufacturer navigate IoT for the medical industry

Picture credit: Cook Medical

Manufacturers’ Monthly speaks with Neil Baker, CEO and co-founder of Medulla and Dr Alex Buddery, Continuous Improvement Manager at Cook Medical Australia, about digitising paper-based processes.

In a post COVID-19 manufacturing resurgence, the ability to quickly access production data through digital platforms is becoming increasingly important as companies continue to work remotely with less direct visibility of their production lines.

For smaller businesses, however, there remain few cost-effective options for capturing workflow data directly from production lines.

Until recently, SMEs wanting to implement data capture and workflow management on their production lines had to follow a DIY path and build custom in-house solutions. These would typically start as macro-enabled spreadsheets or ad-hoc databases that over time end up costing far more to maintain than first estimated.

Medulla, a cloud-based manufacturing workflow management platform, was co-founded in 2017 by former Cochlear engineers Neil Baker and Kurt Friday to address this critical gap in the manufacturing sector.

The company set about building a cloud-based system that connects manufacturers directly to their production lines. The platform is able to pull production related telemetry directly from the manufacturing equipment or from the product itself, allowing clients to monitor and analyse the state of production as it happens in real time.

“At the very high end of manufacturing, large companies like Coca Cola, Boeing, or Johnson & Johnson, use complex systems provided by the likes of Oracle, SAP or Siemens,” Baker said. “These are very high-end systems, but they’re also really expensive. Especially when it comes to integration. We found there was a big gap between the in-house DIY systems and these enterprise solutions.”

Managing traceability 

One such company to benefit from Medulla’s services is Brisbane-based Cook Medical Australia. Cook Medical Australia’s parent company is Cook Medical, a global family-owned company that specialises in minimally invasive medical devices, headquartered in the US.

Traceability is important for manufacturers, especially in the highly regulated medical manufacturing sector. For Cook Medical, who use paper-based processes to meet their regulatory obligations around traceability, the digitisation provided by Medulla’s platform enables traceability to be captured and reported in a much more efficient way.

“Our platform caters particularly well to manufacturers who have regulatory obligations around traceability,” Baker said. “But Medulla also provides detailed reports and analytics related to production and product data.”

While digitisation is a much-discussed topic in manufacturing, getting started is often a difficult path to navigate. This is where Medulla’s cloud platform greatly simplifies implementation.

Baker explained that although the Operations or Production teams are the key benefactors of digitised manufacturing processes, the responsibility for implementation and upkeep of conventional on-premise Manufacturing Execution Systems (MES) is often deferred to the onsite IT department. He can recount numerous situations where this delineation of ownership has led to confusion or conflict over ownership and the expected value of the system is not realised in these situations.

He said the advantages of having its online system capture and manage production data are three-fold – it does not require any complex IT infrastructure, it allows data captured across different manufacturing locations to be consolidated in a single platform, and it allows the intended end users to take full ownership of the system and its data.

It can connect to production lines that are distributed across different geographies with ease to provide one centralised dashboard to view all operations. The system is not dependent on costly IT infrastructure. It can be configured and maintained entirely by the production engineers and managers, meaning there can be a clear delineation of ownership between operations teams and the IT department.

“Medulla’s cloud platform is targeted for ease of integration by the intended user, typically operations or production managers. When a clients’ IT department needs to be involved, we are happy to work with them directly in order to smooth out the integration and handover process”.

Compared to traditional on-premise systems, which can cost millions up-front to set up and almost as much per year on in-house IT resources simply to maintain, Medulla’s subscription model charges a monthly flat rate per workflow.

At Cook Medical, Medulla has been deployed to a pilot line where it actively tracks the product through every step in the manufacturing process. Visual dashboards display information that includes how much time each process took and highlights any peculiar activity that may need further investigation to improve efficiencies.

“Cook is experiencing much better real-time visibility into the state of that production line, with on-demand reports showing product performance, throughput and the transaction time at each process step. While working remotely, they are able to monitor production equipment or generate traceability information without having to be on-site, sifting through piles of paperwork,” Baker said.

“Moving forward, we’re looking to expand that pilot project into other areas of their manufacturing process.”

Baker explains that one of first and most critical stages of the partnership is working directly with the client to map out their current manufacturing workflows. This allows Medulla to understand how products move through assembly lines and where parts and materials are consumed in the process.

“We create a digital representation of that production line, factoring for raw material consumption and enforcing quality control gates at each process step,” Baker said.  “Where existing equipment isn’t built for talking over the internet, we can install a simple digital ‘supervisor’ such as a Raspberry Pi or something more industrial where needed to interface with the local equipment, pull telemetry from it and post it to our cloud application.  For process steps that are more manual, operators interact with a touchscreen or mobile device that calls dynamic data collection forms. These simply replace paper-based forms. This allows the platform to maintain real-time oversight of the end-to-end process.”

Getting past challenges in data flow

Cook Medical connected with Medulla initially through the Australian Research Council’s (ARC) Advanced Manufacturing of Medical Devices (AMMD) Industrial Research Hub and was impressed by Medulla’s industry knowledge and experience.

The AMMD hub, where Cook Medical is a collaborator, brings research and industry partners together to develop and apply advanced manufacturing technologies.

Due to the complex and highly regulated nature of the medical manufacturing industry, detailed record keeping is critical. Hence, the importance of data integrity. Cook Medical manufactures its product through various stages of assembly, using various equipment including ovens, flow meters, and sterile pack sealers. To ensure the best quality, detailed process monitoring throughout assembly is necessary.

Engineers can gain better insight into the assembly process with accurate data from the manufacturing line. With the right workflow management system, the performance of assembled product can be tracked against the manufacturing metadata captured from each machine.

Dr Alex Buddery, Continuous Improvement manager at Cook Medical, said by partnering with Medulla, it has been able to add more process data streams to the cloud to manage workflow.

“We discussed a few of the challenges we had been experiencing with the IoT rollout and Medulla had already solved or were developing solutions for a lot of them,” Buddery said.

At the start of the partnership, Cook Medical was surprised at the lack of standardisation in communication protocols between different equipment, PLCs and software.

“We quickly realised this is one of the biggest barriers to an effective cloud-based workflow management system,” Buddery said. “This is data that may have been handled by a machine locally with alarms or other local controls to raise exceptions. By adding these data streams to a centralised workflow, it allows us to more efficiently demonstrate compliance and provides a powerful platform for process improvement.

“Pulling data from different equipment and systems into one place really enables data analytics at your fingertips with clear visual workflows,” Buddery said.

“This allows you to make decisions much quicker and makes compliance reporting a lot more efficient. Centralising all our process data into the product workflow allows us the flexibility to build in more robust logic to manage the workflow more effectively so that exceptions can be dealt with quickly.”

Buddery explained that Medulla has been very effective at retrieving data required by the platform from Cook Medical’s existing systems, without impacting the compliance of those systems.

“For equipment used to manufacture the devices, the problem is it tends to be either not IoT-enabled or set up to interface with the equipment manufacturer’s analytics system only,” he said. “Medulla have been able to pull data from many different production machines into the cloud, which were not IoT enabled.”

Having all the equipment feed information into a centralised cloud platform is the practical way to manage many different types of production equipment along with all other data flows.

“This has been a real strength of the partnership,” Buddery said.

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