Trailblazing at Herston Biofabrication Institute

Navigating robotic surgery and regulatory changes with patient-matched manufacturing.

Point-of-care manufacturing promises a path to locally produced devices custom-fit to patient features. It encapsulates many of the latest trends - industry 4.0 connectivity, additive manufacturing, advanced imagery, and uses a logistic-friendly distributed manufacturing model. The devices produced build on significant technological advances to support clinical intervention including robotic surgery. While the promise is strong, it is important to get it right: patient health is on the line therefore the device produced must still meet the same safe and effective standards as mass produced items. The goal of medical device regulation is safe and effective products. Typical regulation is often framed around tight quality control of massproduced validated designs whereas personalisation was often enabled through custom-made exemptions. New, readily available advanced manufacturing tools are enabling mass customisation alongside measurable processes allowing products that greatly exceed the prior custom low-volume artisanal scale. In recent years there was rapid increase in volume of custom-made products. Since the custom-made exemption pathway provided limited regulatory oversight, regulators identified a need for novel ways to navigate this new manufacturing landscape. They identified a new class of device, patient-matched, where the intended purpose of the device is the same while the controlled production process has steps that are adapted on the individual patient level prior to manufacture. The overall goal was to enable mass personalisation of devices along with their potential health benefits while maintaining low risk levels. Australia is a good place to be developing point-of-care manufacture pathways with its fast response to regulatory path changes as well as its participation in global additive manufacturing standards development in ISO/TC 261. Australia through the Therapeutic Goods Administration (TGA) is a leading player in patient-matched regulation reform. Australia has already begun implementation of reforms which largely follow the 2020 published global harmonisation approach. While other areas such as the USA’s Food and Drug Administration (FDA) have published guidelines for additive manufacturing devices and are consolidating feedback from their discussion paper on possible point-of-care implementation models. It appears the FDA may still be some time away from legislating regulatory changes. Many stakeholders are watching to see how the different models perform as people work to develop effective pathways together. Herston Biofabrication Institute (HBI) in Brisbane is one of the Australian groups ‘trail blazing’ to set up systems, processes and testing to find a path through the developing regulatory landscape in a healthcare setting. Currently, HBI through Metro North Health have set up systems to deliver custom-made devices, radiation therapy boluses (ARTG: 355606), anatomical models (ARTG: 355288) and have others in the pipeline including surgical guides and brachytherapy devices. If process, knowledge, and risk are managed well, excellent state of the art results can be achieved as demonstrated recently with a robotic surgery case. A young patient had a large tumour on their kidney that was sitting precariously close to significant blood vessels. Without clear knowledge of the relative locations of the kidney, tumour, and vasculature, there was substantial risk of compromising the blood vessels during surgery and leaving cancer cells behind. Robot-assisted surgery is a fascinating technology where robotic arms that hold cameras and surgical instruments are inserted in a patient and a surgeon controls the robotic arms while seated at a computer console near the operating table to perform a procedure. Robotic surgery enables many benefits such as enhanced dexterity,

Creation of the digital 3D anatomic model showing the patient’s anatomy from the MRI scan in the 3 anatomic planes and a sliced 3D representation in the bottom right. Kidney (yellow), arteries (red), veins (blue), tumour (green).

greater precision with faster recovery and minimal scarring. While use of the robot during kidney surgery offers these benefits, there are still challenges of limited tactile feedback for identification of pulsating arteries, the ever-present challenge of distinguishing normal from pathologic tissue, and the identification and dissection of the renal artery are performed without anatomical landmarks. To overcome these limitations, the current standard of care relies heavily on a surgeon’s skill in mentally reconstructing the twodimensional pre-operative images into a 3D space and their ability to recall and align the mental model during the operation. Use of patient-matched devices could support the surgeon in this challenging task. Anatomic models are 3D representations of human anatomy and are one of the most prevalent patient-matched medical devices. They offer non-controversial benefits in enhanced visualisation, inform surgical approach, improved patient-clinician communication, and increased patient understanding. Given the complex location of the patient’s tumour it was decided to use an anatomic model to enhance surgical visualisation of the specific anatomy. HBI designed and produced the kidney models by first transforming the patient CT images into a 3D virtual model using Mimics, a state-of-the-art software in medical design and visualisation. From the digital model they brought the device from the digital world to the physical by 3D printing the model using the Stratasys J750 3D printer. The successful point-of-care development, supply, and use of the kidney anatomic model for the robotic surgery is a demonstrator that navigation of the changing regulatory environment can lead to clinical success. For these benefits to spread across further surgical platforms, there is a clear need for transparent exploration of solutions for regulatory conformity. This must involve diverse input from health providers, manufacturers and the regulatory bodies during this time where novel regulatory paths for point-of-care manufacture are being forged. When acceptable paths are found there is an imperative to communicate them, so others might follow safely. Ultimately this knowledge sharing may fast-track improved patient care through mass personalisation. If we can continue to navigate the regulatory landscape effectively and efficiently, it can unlock patient benefits such as those seen through the enhanced navigation for robotic kidney surgery.

herstonhealthprecinct.com.au/partners/herston-biofabricationinstitute

Key to unlocking maximum value from Industry 4.0

Combining IT and operations will shake out performance, results and value.

No matter how efficient your production output is, if Industry 4.0 technologies are not used to capture and visualise the data of these processes, true manufacturing success cannot be realised. Established in 1965, MTM Pty Ltd is a proudly Australian familyowned parts manufacturer that supplies components to all parts of the globe. While the company is primarily an automotive parts supplier, it has expanded to cater for rail, recreation, water conservation and safety. “Our product range is vast and as our operations have grown, so has the need for an equally-advanced system to capture and visualise the data produced on the factory floor,” explains Darren Symington, MTM Information System Manager. For many years MTM relied on File Transfer Protocol (FTP) modules for data transfer. Here, they would manually connect to the Programmable Logic Controller (PLC) on the machine to create a file every time they made a part. Thereafter, data would be manually extracted and be used to populate the databases. This system, used for various processes such as making bookings and calculating cycle times, had many drawbacks. ‘That lightbulb moment’

The data collection and visualisation system was based on slow, unreliable industrial hardware and could only be accessed from outside the factory via a Virtual Private Network (VPN). It also occasionally impacted MTM’s production output. “If the FTP system failed to collect the data every two hours, we would end up with over 15,000 files to download at night, and it would take 5-10 seconds to download an individual file. Because a part would be completed on average every 4.5 seconds, the data collection process would not index this information in time and workers would still be trying to extract the previous night’s data when it would be time for the next run to begin,” Symington says. Darren describes the day that he met with Jim Wallace, Sales Manager of Balluff Australia as a ‘lightbulb moment.’ “We had been using a manual FTP integration for each line to accommodate each unique process. This was however inefficient, time-consuming and became increasingly complex as the company grew and we were required to look at up to 40 different portals to analyse the data.” Wallace, who is a member of the Industrial Internet of Things (IIoT) advocacy group Open IIoT, helped Symington and his team integrate the code that they had been running to transmit previously into Balluff’s Industry 4.0 technologies using JavaScript Object Notation(JSON). JSON automatically captured 10,000 records per second and uploaded the data to the database every five seconds. This meant that the database was being populated with real-time measurement and this data visualisation could be accessed from anywhere. Industry 4.0 implementation simplified operations

The first step in Industry 4.0 implementation at MTM required the team to transmit their existing data into easy-to-use, automated data capturing tools. “As part of Balluff’s Mold Tool ID system, we fitted a Balluff Radio-Frequency Identification (RFID) tag on each tool and a reader to each of MTM’s press machines. The system writes the number of operations to the tag so each tool knows exactly how many operations it has done, so if the tool is swapped out, this data is not lost because it is held in the RFID tag. As the press moves back and forth, the reader increments the number of operations count on the tag and then reads this back to make available to the controller dashboard and as a JSON file,” says Jim. “This data was then visualised by MTM in the form of a mobile app, allowing them to access a whole new range of insights into their business that they had not had previously.” The second major Industry 4.0 implementation involved the installation of a ‘Smartlight’ system on the factory floor (a part of the Mold Tool ID system supplied by Balluff) to alert operators when tools needed maintenance – turning a light orange when the time was approaching and red when maintenance was overdue. The Smartlight system was linked to a TV screen in the MTM Toolroom so that the staff could easily see where each tool was in the preventative maintenance cycle. The system is also linked to an email alert system to ensure efficiency. Automation ensures accuracy and reduces labour costs

“There are many benefits we’ve seen to our business since taking the plunge and starting the Industry 4.0 journey, but one of the most crucial benefits is that all our data capturing, recording and analysing processes are automated using a single system,” says Symington. “To add to this, manually entering data can have an inaccuracy rate as high as 38% but by automating the process we have 100% accuracy, reducing wastage and time spent on administration processes.” While MTM has operations in several different countries, design and advanced manufacturing still happens locally. As Australia has comparatively high labour costs, smart automation that reduced the reliance on physical manpower was needed to make local production financially viable and allow the company to continue to compete globally. “The Balluff Industry 4.0 implementation turned out to be less expensive than we’d originally anticipated, and it has already paid for itself in terms of improved production and reduced labour costs,” says Symington. Win-win across departments

“The benefits of the implementation have been felt across our entire business. The ‘Smartlight’ maintenance system has been great for factory operations and those of us in IT have loved the insights we can extract from the data – based on this success we’re going to prioritise IIoT integration across the plant,” he adds. Symington says that the detailed data insights have also been unexpectedly helpful for the sales department as it integrates into MTM’s Enterprise Resource Management (ERP) system. “We can tell how many actions each tool has performed thanks to the RFID reader and reference this back to our ERP system for sales reporting. The automated data capturing shows us exactly which customer has received what parts and enables us to alert a salesperson when a tool is nearing the end of its lifespan, allowing for better forward planning.” Finally, Symington recommends that manufacturers hoping to experience similar benefits from Industry 4.0 implementation begin by ‘automating their pain point.’ “The process isn’t as overwhelming or as expensive as it seems from the outset, so long as you have an experienced IIoT consultant such as Balluff to guide you along the way. Once you’ve decided what you’d like to get out of your data, they can help you find the IIoT solution to make this happen as simply as possible,” he concludes. mtmauto.com