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Design and development of a medical device for diagnosis of COPD

Eriksson, Sanna LU and Isaksson, Sofia LU (2015) MMK920 20151
Product Development
Abstract (Swedish)
Denna rapport redogör för design och utveckling av ett medicintekniskt instrument för diagnos av kronisk obstruktiv lungsjukdom (KOL) eller emfysem. Arbetet utgår ifrån en ny diagnosmetod och ett instrument i form av en funktionell prototyp som används för att testa den nya diagnosmetoden.
Med utgångspunkt i den funktionella prototypen har arbetet fokuserats kring att förstå vilka problem och utmaningar som finns för att kunna ta den funktionella prototypen till nästa nivå och för att bana väg för en framtida kortserieproduktion.
Det första steget i processen var att göra en litteraturstudie för att få en grundläggande förståelse för klinisk fysiologi samt aerosolteknologi och de specifika delinstrument som används i prototypen, följt... (More)
Denna rapport redogör för design och utveckling av ett medicintekniskt instrument för diagnos av kronisk obstruktiv lungsjukdom (KOL) eller emfysem. Arbetet utgår ifrån en ny diagnosmetod och ett instrument i form av en funktionell prototyp som används för att testa den nya diagnosmetoden.
Med utgångspunkt i den funktionella prototypen har arbetet fokuserats kring att förstå vilka problem och utmaningar som finns för att kunna ta den funktionella prototypen till nästa nivå och för att bana väg för en framtida kortserieproduktion.
Det första steget i processen var att göra en litteraturstudie för att få en grundläggande förståelse för klinisk fysiologi samt aerosolteknologi och de specifika delinstrument som används i prototypen, följt av insamling av rådata från användare och intressenter och tolkning av denna data i form av kundbehov. Produktspecifikationer skapades utifrån identifierade kundbehov så väl som utifrån litteratursökning och diskussioner med forskargruppen.
Vid konceptgenerering har prototyper varit ett mycket värdefullt verktyg. Genom att skapa fullskaliga pappmodeller av de viktigaste enheterna i den funktionella prototypen har konceptgenerering för placering av de olika enheterna gjorts. Prototyper har använts under hela projektet på flera nivåer och har varit en utgångspunkt för kommunikation med forskargruppen och andra personer som varit inblandade i projektet. Val av koncept har gjorts både genom test av prototyper samt strukturerade metoder från Ulrich och Eppingers generiska produktutvecklingsmetodik.
Valda koncept har vidareutvecklats med hänsyn till vad som är möjligt att producera i liten skala. För att främja reproducerbarheten har tillämpliga förändringar vad gäller ingående komponenter undersökts. En övergripande produktarkitektur har definierats och en helhetsdesign av instrumentet har tagits fram.
Den slutgiltiga utformningen av instrumentet som helhet presenteras med hjälp av 3D-renderingar i kombination med en fysisk prototyp som visar den övergripande designstrukturen. Det resultat som presenteras skapar en grund för detaljerad vidareutveckling för att kunna tillverka ett reproducerbart instrument inom en snar framtid. (Less)
Abstract
This thesis presents design and development of a medical device for diagnosis of emphysema or COPD by controlled lung deposition of nanoparticles. After purging the lungs with particle free air the subject inhales a controlled aerosol mixture and holds his breath for a determined period of time, before exhaling. The degree of lung disease is calculated by measuring and comparing the concentration of nanoparticles in the inhaled and exhaled breath, giving a value of the fraction of deposited nanoparticles in the subject.
With the starting point of the thesis project being a functional prototype, the work has focused around understanding the problems and challenges of the method as well as the current setup and what needs to be improved to... (More)
This thesis presents design and development of a medical device for diagnosis of emphysema or COPD by controlled lung deposition of nanoparticles. After purging the lungs with particle free air the subject inhales a controlled aerosol mixture and holds his breath for a determined period of time, before exhaling. The degree of lung disease is calculated by measuring and comparing the concentration of nanoparticles in the inhaled and exhaled breath, giving a value of the fraction of deposited nanoparticles in the subject.
With the starting point of the thesis project being a functional prototype, the work has focused around understanding the problems and challenges of the method as well as the current setup and what needs to be improved to take the device to the next level, and thereby make way for a future small size serial production.
To do so, the first step of the process was to make a literature study to understand the basics of medical devices, clinical physiology as well as aerosol technology and all the specific components used in the instrument. A substantial survey was carried out to collect data from users and stakeholders and interpret them in terms of customer needs. Product specifications were adapted from customer needs as well as from a literature search and discussions with the research group.
When generating concepts, prototyping has been the main tool. By creating a real size cardboard model of the main functional units in the device, concepts for placement of modules were generated. Prototypes have been used throughout the project at multiple levels and have been a basis for communication with the research team and other people involved in the project. Concept selection has been made both by means of trying the prototypes as well as structured methods derived from the generic product development process by Ulrich and Eppinger.
The selected concepts were further developed with emphasis on what is possible to produce. The final design is presented by means of 3D renderings as well as a prototype together with guidelines for further development. Renderings and prototypes show the overall design structure and creates a foundation for further detailed product development, in order to manufacture a reproducible device to a reasonable cost in near future. (Less)
Popular Abstract (Swedish)
Utveckling av ett medicintekniskt instrument med människan i fokus.
Please use this url to cite or link to this publication:
author
Eriksson, Sanna LU and Isaksson, Sofia LU
supervisor
organization
course
MMK920 20151
year
type
H2 - Master's Degree (Two Years)
subject
keywords
prototyping, ergonomics, product development, pulmonary function measurement, medical device
other publication id
15/5526
language
English
id
7456092
date added to LUP
2015-06-29 11:18:28
date last changed
2015-06-29 11:18:28
@misc{7456092,
  abstract     = {This thesis presents design and development of a medical device for diagnosis of emphysema or COPD by controlled lung deposition of nanoparticles. After purging the lungs with particle free air the subject inhales a controlled aerosol mixture and holds his breath for a determined period of time, before exhaling. The degree of lung disease is calculated by measuring and comparing the concentration of nanoparticles in the inhaled and exhaled breath, giving a value of the fraction of deposited nanoparticles in the subject. 
With the starting point of the thesis project being a functional prototype, the work has focused around understanding the problems and challenges of the method as well as the current setup and what needs to be improved to take the device to the next level, and thereby make way for a future small size serial production. 
To do so, the first step of the process was to make a literature study to understand the basics of medical devices, clinical physiology as well as aerosol technology and all the specific components used in the instrument. A substantial survey was carried out to collect data from users and stakeholders and interpret them in terms of customer needs. Product specifications were adapted from customer needs as well as from a literature search and discussions with the research group.
When generating concepts, prototyping has been the main tool. By creating a real size cardboard model of the main functional units in the device, concepts for placement of modules were generated. Prototypes have been used throughout the project at multiple levels and have been a basis for communication with the research team and other people involved in the project. Concept selection has been made both by means of trying the prototypes as well as structured methods derived from the generic product development process by Ulrich and Eppinger. 
The selected concepts were further developed with emphasis on what is possible to produce. The final design is presented by means of 3D renderings as well as a prototype together with guidelines for further development. Renderings and prototypes show the overall design structure and creates a foundation for further detailed product development, in order to manufacture a reproducible device to a reasonable cost in near future.},
  author       = {Eriksson, Sanna and Isaksson, Sofia},
  keyword      = {prototyping,ergonomics,product development,pulmonary function measurement,medical device},
  language     = {eng},
  note         = {Student Paper},
  title        = {Design and development of a medical device for diagnosis of COPD},
  year         = {2015},
}