A New Phase- Lorena Banda

A new six weeks began, therefore a new phase had risen, which is the Deliverable Two Design Proposal. This is another step to the tool up section. Unlike the Memorandum, which was part of the imagine phase and was used to introduce the team and the problem, the purpose of the deliverable is to communicate to the public on the product design and development, in order to convince the relevant decision makers to allow the design to be made. We now are directing ourselves more to the pathway of comfort and effectiveness. The deliverable two is a written report that should include: a title page, executive summary, table of contents, statement of problem, technical background: physiological and biomedical aspects, technical background: materials research and/or applicable standards, design objectives, design development overview, proposed design, project management plan, conclusion, and references. These are a lot of sections we have to cover, but it’s a good thing we have other people to work with. We assigned each section according to a section that was similar to the ones from the memo. For example Maria, since she was in charge of the introduction in the memo, she will be doing the executive summary.

In our group we have two engineering and two biomedical students, so we decided to split up the technical background according to the pathway it corresponded to. Maria and I, engineering students began to look into the materials and the FDA regulations. From the FDA website, we were able to determine that our product, a mask is indeed a medical device.

medical device
Source: Screenshot of http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm

I began looking into the FDA website more and started to look into their databases. In the databases, they have information on medical devices that have been classified, medical and non-medical products that emit radiation, medical devices that have caused deaths or serious injuries. This website is a very helpful resource that we can use to look into type of surgical masks and use those to improve our design. I looked more into the classification of medical devices and found a surgical mask that has been classified.

Source: Screen shot of http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=2550
Source: Screen shot of http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=2550

This surgical mask shows a basic design of what we want. But we don’t want to make an ineffective mask, we want to really make sure we meet the customers desires. To do so, we have to make sure the fabric is of good quality, the bands or ties securing the mask are comfortable, and that the nose piece sits well to every nose. Once we have a better understanding on the materials we want to be able to use, we will be able to sketch out our design on AutoCad or Google Sketch up. This is a task that the engineers will have to do, and it’s something I am looking forward to doing.

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