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MEDICAL
Additive Manufacturing Hub case study: Vesticam Vesticam is an Australian medtech startup company that has developed an accessible device to help with the diagnosis of causes of dizziness, vertigo and balance disorders. Vesticam evolved from the clinical need for simple, portable and affordable infra-red video goggles to record of eye movements during oculomotor tests. It is an innovative modification of existing trialled and tested equipment, making it portable, fully adjustable and accessible for widespread use. Vesticam’s product records eye movement (nystagmography) during over 15 standard bedside oculomotor tests, including tests that can only be done in the dark (with vision denied). The video and audio recordings can then be reviewed, stored or sent for second opinion. Prior to Vesticam, no existing IR video goggles met all of the required clinical parameters of being fully adjustable, easy to focus, light and comfortable for patients to wear, completely light-tight, and able to switch quickly from vision-denied to with-vision. A large part of the original design (innovation patented) was for an adjustable means of positioning a camera at a target. The design of Vesticam version 1 (V1) allowed the subject/patient to have a frame on their head (goggles) with a camera and illuminator, and for the user/clinician to very easily position the camera manually. The V1 design allows five degrees of movement in a simple configuration of ball and socket combined with slider.
The challenge The V1 3D-printed version of the Vesticam IR video goggles was developed in 2018-19 by the company’s co-founder Burt Nathan with input from Suzanne Douglas, co-founder and Director. The final version of Vesticam V1 was trialled and went into production and sale in 2019. With approximately 150 units in clinical use, feedback from clinicians, production, manufacturing and marketing was collated. While the main clinical parameters had been met, there were significant issues to be addressed. These were: • Difficulty and inefficiency achieving light-tightness in the manufacturing and final testing stages. • A complete reliance on imported swimming goggles as a component. • The need for a simpler, user-friendly final product to meet the challenge of new competition. • The need for reduced manufacturing costs with less wastage. • The need for an ability to scale up and address higher volumes, with a view to meeting an increasing domestic and an export market. • A preference and ethic for on-shore manufacturing. • The need to be a certified medical device with future regulatory approval. • The desire for a more medical/clinical product aesthetic. The next iteration of the product was intended to be designed for higher-volume production utilising injection moulding techniques. Designer Don Silak from View 7 (Victoria) started development of version 2 of Vesticam (V2), with injection moulding as the designfor-manufacturing (DFM) approach. The injection moulded V2 design had ongoing inherent issues with basic parameters of eye spacing adjustment, goggle light tighness and camera adjustment. Followng review of the newly available possibility of multi jet fusion (MJF) additive manufacturing, the relatively small size of the niche market for this product, and the possibility of future modifications (for example, future embodiments may be WiFi-enabled), it was decided to move back to additive manufacturing and explore MJF as a manufacturing process.
AMT AUG/SEP 2021
Vesticam sought an additive manufacturing system based in Victoria with increased employees, use of local contractors, and minimal reliance on imported inputs. With this in mind, further research & development was needed to provide a design suitable to more advanced additive manufacturing that met the above requirements.
The solution In undertaking the project, the Additive Manufacturing Hub engaged the assistance of registered service providers Cobalt Design Pty Ltd and GoProto (ANZ) Pty Ltd. An additive manufacturing program using current 3D printing techniques (including the more specialised MJF process) was identified as an excellent way to mitigate many of the above concerns. The project started off with a design concept phase with Cobalt, exploring the clinical needs and requirements of the product. The final product needed to keep within the proven clinical parameters of being fully adjustable to fit different face shapes and sizes; easy to focus; light and comfortable for patients to wear; completely lighttight; and able to switch quickly from vision-denied to with-vision. The product needed to be of medical standard, including having less cavities and being compatible with standard patient hygiene pathways. For marketing purposes, it had to have a medical look and feel. Design for Additive Manufacturing (DFAM) formed an important part of this phase. Initial designs with Cobalt were based upon the previous, incomplete design by View7, with attention to parameters and noted issues. Additive manufacture expedited development considerable flexibility to the design.
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The MJF process was an efficient way to produce high-quality prototypes. Using the MJF process, Vesticam could access prototypes and test them real time. The MJF process also allowed Vesticam to show prototype versions to other team members and customers for feedback about the design concept without undermining their overall opinion regarding the quality of the parts. Final design is yet to be completed and will culminate with a short manufacturing run to produce 5-6 working modules for extended testing. This phase will focus on refinement of the product and preparation for mass production. This will be undertaken after