User Based Approach

The L.A.S.S.O. is more than just the development of an idea; we wanted to see whether this device could be realistically implemented in practice. To create a product that had a future in a real-world situation, we decided it was vital to talk first to the people who would be using it: the patients and the CF healthcare team - people who understand the daily struggles and realities of treating cystic fibrosis. So we took a customer based approach by meeting with patients and medical staff to hear their view on how the L.A.S.S.O. should be designed to best meet their needs.

ISO Standards

After obtaining a clear direction for our device from possible future users we spoke to members of industry. In particular, we contacted a local company that developed medical equipment: the Institute of Medical Science and Technology. From this we found that the main body for devising procedures by which medical devices should be built is the International Organisation for Standardization (ISO). As we live in a global community where such standards are important to ensure that “products and services are safe, reliable and of good quality”¹ there are strict procedures that must be adhered to. During the development of the L.A.S.S.O. we attempted to apply as many of the points given in the quality management standards 9001 and 13845 as we could. Standard 9001 dictates the procedures for general quality management; giving standards that a company should follow when developing a product. Standard 13485 expands on 9001 to specify how a medical device should be developed.

This all led to us completing documentation to show how we were meeting the users needs - a requirements document; giving us the final aims of how the L.A.S.S.O. would operate and the functionality involved. It was an iterative process with the documentation being updated after feedback from our supervisors, patients and medical staff. A procedure that was in line with the ISO standards.

The first iteration can be downloaded here, and contains the version of the L.A.S.S.O. as if it were tested with the biological detection in place which produces a bioluminescent output. The second iteration can be downloaded here, and was used alongside our prototype device with tests based on luciferase production from Vibrio fischeri and does not involve The Lung Ranger biological detection systems.