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Instructor: John Desfardins BIOE 401: Bioengineering Design Theory BIOE 401 Final Exam December 11", 2012 11:30am-2pm or December 14", 2012, 7:30-9pm (150 pts) " alo ® Fillinthe aN NA team is a_sma\\_ number of people with complementary Shs who are committed to a common > and “weer aly for which they hol themselves Mob ally Atrountable_- (pts) @_ What is NOT an attribute of a good team leader? (1 pt) Keep purpose, goals, and approach relevant and meaningful . Manage relationships with outsiders Take credit for the success of the team Strengthen the mix and level of skills Build commitment and confidence f. Do real work @_ What is the term whose Definition is? (1 pt) “a specification of an object, manifested by an agent, intended to accomplish goals, in a particular environment, using a set of primitive components, satisfying a set of requirements, ‘subject t0 constraints" — ANSWE! ae - go a @ What can be Patented? Name the 3 requirements that must be satisfied by law to have a device considered for a patent. (3 pts) 7 ANSWE! s:_pevel “Ypevobvaus » - shits Q _ What type of IP do these images represent? (1 pt) QE CLEMSEN 5.5, narnia snag trademer £ Lie Instructor: John DesJardins Nabe Oxy Gand BIO wi: Bint Beige Thy i (B) What design tool is described as “The Voice of the Customer”? (1 pt) a. Quality Function Development Quality Function Deployment Z. Quality System Record A TRIZ © Use the concept of Synetics to brainstorm 5 possible things about a Christmas Tree that, could be applied to the design of a Rehabilitation Walker. List the Tree attribute, and then described your synetic link to the Walker with enough detail that a team of designers could begin working with your idea without further elaboration. (one or two good descriptive sentences of eack idea should be enough) (2 pts for each, 10 pts total) For Example (from last years’ class project): Christmas Parade and Vascular Stent ATTRIBUTE: A Christmas Parade has Floats in it. K: You could design a vascular stent that had floating components SYNETIC LI} on its surface it that moved with the pulsatile flow to optimize blood flow across the stent Atha bere? che stmes lights nt Colors Linkyeypabititabm alker oirere alt pots art took of in ‘ler’ “Sots retin /holder aad hattem oF Wee ink fo walker fo bap ne pobet Attribute Lintsbaicelets arourcle les fom falling . I dhitstros trees howe abote: ROB Mee a2 se GAD. OrcO BR Lsher arma omects Atirsdeote added fo Te walker Pos, ssorits Tet cor be funk: desan versed al ess ores Grater fe Cop ble, Ao troy ) ) apery on pret (onli kay cs Shed, loot Me tree doe} die Ferovab ie > replacable we wellcer doesat rer [0 > rs Ss Aitrigte busttes on Garctes 116 eam wren Component 4g De osvel® toda 7 eet come in yeas, HUET Sepes ptt nate: chi sgheres st / vat acjostodl® sues te hall civatenh fe seme Th already ‘ re mevket gov an re rvredbe (pretest den cel) eoadvry dence spear @qamtnce = dee Pes HE ame mete epee as deuce alrtetly om Te merle 7 5t3,_simnilar Ledenelsyy or Nw sehr Nat cles ner Cayst Ca] nes sweety pod ul Preditate device- a Swestetelly qevslot clevice ayeody ea THe“ wverker Thar ss You are working on a risk analysis for a new device. Two tools that will assist you in this, exercise are DFMEA and MAUDE. Define these acronyms (4 pts) and describe how each can contribute to the development of a risk analysis for a new device. (8 pts). Dever Fatore Mecrervams > Efbccts prolyss LOPMEA) 2 ondrstending uret Caures Po your devicy TH mechanm ay beth & Fas, ad mere far st Checls Te device perforce. leds desx9 senprave eat Tet con (tdece Failure nik, Ths POMS Maude - C& ara, mrerery Reduce 27 5 Ghai Instructor: John DesJardins BIOE 401: Bioengineering Design Theory G3 in the Robustness Strategy for Variation Reduction, there are 4 different levels by which a company can “deal” with variation. These are: n. Compensate the customers for their losses. (compensation) ©. Screen out defective devices (discard). P. Institute tighter tolerances through process control on the manufacturing line (inspect) 4. Change the nominal values of critical parameters such that the devices function becomes insensitive to the cause, namely, manufacturing variation. (design) Give an example of each with regard to the design/manufacturing/management of a potentially defective Heart Monitor Lead for a Pace Maker. (8 pts) N- Lied customas fe Ct F Me peer 2 PY Ac amedicat? costs BSS0CIO YA cate defective pofereonct € Mm acvice o- Tes delivery electrrcal choy e oer evict AnchnS before Thay leave Ne Prclecten Ine «Tos omey devices Thad clont Coork meperly Nacrov> Pm Measore yollege meynitue 7 DIOR ee assoueted oir ucltage megnihele, Devices Det Te accep re deliver & Volt close fy Me invented valer will he less likly Pe Beome aAcFtetve, Also aolyze produc fay mmetranisens ad try fp improve press flak cen Rvtt M aevice vacation, = st a metel (for Ne (oa) Tat bes an oper ae Lait (ense~ etd Px, ordee tivity so Nek wen Fa Hyer cvegt as olelevereal We leock evil net over- Stu late Tre patent q 18

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