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INDUSTRY 4.0
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,
AMT AUG 2022
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
