Team:Dundee/Implementation/methodology

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             <p class="lead">How We Designed the Technology</p>
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To build the best device possible we took a professional approach to our design and development processes.
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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 society. To create a product that had a future in the real world we decided it would be best to talk to people we envisioned using it. 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.  
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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.
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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 of Standards (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”<sup>1</sup> 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 <a href='http://en.wikipedia.org/wiki/ISO_9000#Contents_of_ISO_9001'>9001</a> and <a href='http://www.iso.org/iso/catalogue_detail?csnumber=36786'>13845</a> as we could. Standard 9001 dictates the procedures for general quality management; giving standards a company should follow when developing a product. Standard 13485 expands on 9001 to specify how a medical device should be developed.  
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After obtaining a clear direction for our device from potential users, we spoke to representatives from relevant industries. In particular we contacted a local company that developed medical equipment; the <a href="http://www.imsat.org">Institute of Medical Science and Technology</a>. We were informed that the main body for devising procedures by which medical devices should be built is the International Organisation of Standards (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”<sup>1</sup> 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 <a href="http://en.wikipedia.org/wiki/ISO_9000#Contents_of_ISO_9001">9001</a> and <a href="http://www.iso.org/iso/catalogue_detail?csnumber=36786">13845</a> as we could. Standard 9001 dictates the procedures for general quality management; giving standards a company should follow when developing a product. Standard 13485 expands on 9001 to specify how a medical device should be developed. We followed these standards in the <a href="https://static.igem.org/mediawiki/2014/d/d8/ISOandtheLASSO.pdf">design and construction<sup>2</sup></a> of the L.A.S.S.O. wherever possible.
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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.  
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Following ISO development criteria compels the completion of a <i> Requirements Document </i> - documentation to show how we were meeting the users needs, the final aims of how the L.A.S.S.O. would operate and the functionality involved. Construction of the <a href="https://static.igem.org/mediawiki/2014/c/ca/V1RequirementsDocument.pdf">first version<sup>3</sup></a> of the Requirements Document was itself an iterative process, updated after feedback from our supervisors, patients and medical staff. This iterative authoring process was again in line with protocol dictated by ISO standards. This first version was  <a href="https://2014.igem.org/Team:Dundee/Implementation/realWorld">audited </a>by an approved Quality Manager for ISO 13845. A <a href="https://static.igem.org/mediawiki/2014/f/f5/V2RequirementsDocument.pdf"> second revision <sup>4</sup></a> was constructed based on  feedback from the audit and again in consultation with the CF community.  
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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 <i>Vibrio fischeri</i> and does not involve the Lung Ranger biological detection systems.
 
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             <h3>References</h3>     
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<sup>1</sup> International Organization of Standards <i>About ISO Standards</i> [Online] Available from: http://www.iso.org/iso/home/about.htm [Accessed: 10th July 2014]
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<sup>2</sup> <a href="https://static.igem.org/mediawiki/2014/d/d8/ISOandtheLASSO.pdf">https://static.igem.org/mediawiki/2014/d/d8/ISOandtheLASSO.pdf</a>
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<sup>3</sup> <a href="https://static.igem.org/mediawiki/2014/c/ca/V1RequirementsDocument.pdf">https://static.igem.org/mediawiki/2014/c/ca/V1RequirementsDocument.pdf</a>
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<sup>4</sup> <a href="https://static.igem.org/mediawiki/2014/f/f5/V2RequirementsDocument.pdf">https://static.igem.org/mediawiki/2014/f/f5/V2RequirementsDocument.pdf</a>
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Latest revision as of 00:42, 18 October 2014

Dundee 2014

Dundee 2014

Methodology

How We Designed the Technology

To build the best device possible we took a professional approach to our design and development processes.



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 potential users, we spoke to representatives from relevant industries. In particular we contacted a local company that developed medical equipment; the Institute of Medical Science and Technology. We were informed that the main body for devising procedures by which medical devices should be built is the International Organisation of Standards (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 a company should follow when developing a product. Standard 13485 expands on 9001 to specify how a medical device should be developed. We followed these standards in the design and construction2 of the L.A.S.S.O. wherever possible.

Following ISO development criteria compels the completion of a Requirements Document - documentation to show how we were meeting the users needs, the final aims of how the L.A.S.S.O. would operate and the functionality involved. Construction of the first version3 of the Requirements Document was itself an iterative process, updated after feedback from our supervisors, patients and medical staff. This iterative authoring process was again in line with protocol dictated by ISO standards. This first version was audited by an approved Quality Manager for ISO 13845. A second revision 4 was constructed based on feedback from the audit and again in consultation with the CF community.

References

1 International Organization of Standards About ISO Standards [Online] Available from: http://www.iso.org/iso/home/about.htm [Accessed: 10th July 2014]
2 https://static.igem.org/mediawiki/2014/d/d8/ISOandtheLASSO.pdf
3 https://static.igem.org/mediawiki/2014/c/ca/V1RequirementsDocument.pdf
4 https://static.igem.org/mediawiki/2014/f/f5/V2RequirementsDocument.pdf