From closed to open. Democratising medical devices using additive manufacture and open source development and distribution systems.

Pupils can provide important neurological information that can aid in the diagnosis of a range of conditions, including aneurysms, impending strokes and tumors in the lung (Gale, et al). In a research context, there is increasing interest in studying the intrinsically photosensitive Retinal Ganglion cells (ipRGC), which respond to intense blue light thanks to a photo pigment called melanopsin. Studying these cells could lead to a better understanding of sleep disorders and a range of optic nerve diseases. Although commercially available pupil testing devices do exist, all cost upwards of $10,000, and suffer from either poor portability or limitations in the tests they can perform. Specifically, the ipRGC require a specific intensity of blue light to be activated and measured, which most devices cannot produce.

In recent years, the open source movement has enabled users from around the world to freely collaborate on the development and distribution of their own products. At first, only software could be produced using this approach, however the continued improvement of 3D printing technology has enabled the same model to be applied to physical products as well. From a medical perspective, this is particularly exciting.

The aim of this research was to produce an inexpensive, open source pupilometer that runs on widely available components, can be distributed online and manufactured using 3D printing technology. In doing so, this thesis asks the question; How can an open source development and distribution model be used in conjunction with online 3D printing services and widely available parts and components to produce an inexpensive and open source pupilometer?

To answer this, a range of practice based methodologies, including research for design and research through design were used to explore this new potential. The resulting design proposal demonstrates how online file sharing platforms, in conjunction with distributed 3D printing services and online supply chains can be combined to develop new medical devices. The ability to collect pupil data using an open source pupilometer may lead to expanded data collection and diagnostic capabilities from doctors in a number of clinical settings, while a cloud based data collection system taking the form of a smartphone app will create a large biometric database and cooperative online research community.