+ 4602 BMED

. .
on es
Capstone

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Design Inputs

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Asked questions, translate answers

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Profs. Stubbs & Rains

+
ANNOUNCEMENTS

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Grady badges are good everywhere in Grady (unlike Emory)

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
No need to specify where you plan/will go

di or


Do NOT attempt to go into clinical areas (patients) WITHOUT your

re d


r va
clinical sponsor/advisor or their designee. Puts credentialing at
risk.

fo al
nt f S
Emory requires you to provide clinical areas you will visit
ea o


m rty

 Security access to be provided based on requested areas

ot e
N rop

 Keep track of your clinical observation hours using online

form
P
 +

stiff
Implant
needs to be
P
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+

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The Section Modulus needs

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to be greater than 379 N*m2

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Implant needs

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to be stiff

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+ Design Inputs

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Design inputs should identify all of the

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desired performance, physical, safety

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and compatibility characteristics of the

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proposed device and, ultimately, the

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finished device.
nt f S
Is that all??
ea o

Also includes requirements for labeling,

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packaging, manufacturing, installation,

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maintenance and servicing.

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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u
cm070642.pdf
+
Design Inputs

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Should provide enough clarity and

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detail that an outside design firm

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would have enough info that they
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could develop an adequate solution.
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+
Design Inputs - Questions

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1. What is the real need for the new device?

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2. Where will the new device be used?

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3. Who will use the new device?

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4. How will the new device be used?
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5. With what devices will the new device be used?
ea o

6. Other questions related to the specific device to

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be developed.
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u
cm070642.pdf
+
Scope and Level of Detail

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1. Functional Requirements

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• What the device does

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• Operational capabilities, processing of inputs,

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and resultant outputs

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2.
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Performance Requirements
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• Specify how much or how well device must
ea o

perform
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• Speed, strength, response times, accuracy, etc

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• Reliability and safety

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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u
cm070642.pdf
+
Scope and Level of Detail

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Functional Requirements

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1.

di or
2. Performance Requirements

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Interface Requirements
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3. nt f S
• Characteristics that are critical to
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compatibility with external systems

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• User interface/Patient interface

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+ Design Input Review

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 Should be unambiguous

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 Can be verified by an objective method of

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analysis, inspection, or testing

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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u
cm070642.pdf
+ Design Input Review

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 Should be unambiguous

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 Can be verified by an objective method of

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analysis, inspection, or testing

di or
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Example
fo al
 Catheter must be able to withstand repeated
nt f S
flexing
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 Catheter should be formed into a 50mm

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diameter coil and straightened out for a total of

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50x with no evidence of cracking or deformity

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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u
cm070642.pdf
+
Design Input Review

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 Should be self consistent

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 Resolve conflicting requirements

di or
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 Characterize the environment where the

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product’s intended use is
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 High and low temps Also storage & transit
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 Relative humidity (don’t forget trunk stock!!)

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 Use appropriate industry standards

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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u
cm070642.pdf
 P
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 +

P
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 +

P
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 P
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+ Case Study

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+ Case Study

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User Needs: Design Inputs:

ti id
bu st
More Memory

ri ri
Size//Thinner

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Long Battery Life

di or
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Headphone compatible

r va
Speakers

fo al
Faster Download
nt f S
Waterproof
ea o
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ot e
N rop
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 P
N rop
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+ Case Study

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nt f S
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. .
video
+
User Needs

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 Light weight

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di or
 Equivalent speeds to competitors

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 Suction/Irrigation

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 Doesn’t get too hot
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 Not too loud

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 Does not interfere with OR equipment

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+
Design Inputs

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Light weight

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Weight ≤ 650 grams

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

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Equivalent speeds to competitors
ea o

 Speed 4,000 – 30,000 RPM

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 Increments of 1,000 RPM

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+
Design Inputs

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Suction

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100 mm Hg

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

fo al
Irrigation
nt f S
500 ml/min
ea o


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 Adjust levels in 10mL/min increments

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+
Design Inputs

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Doesn’t get too hot

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Surface temperature < 55° C

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

di or
WAIT!
• Use animations to improve delivery,

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• BUT use simple “appear”
Not too loud
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 Operating sound < 55 dB
ea o
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Does not interfere with OR equipment

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IEC 60601 (safety & performance of

P


medical electrical equip.)
 +

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TREAT METACARPAL FX

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User Needs

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 Stable enough to support healing

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Competitive price

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

fo al
 Biocompatible material
nt f S
Not too stiff – Allows for micromotion
ea o


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 Wolff’s Law
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 Can treat 95% of human population

P
+
Design Inputs

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Stable enough to support healing

di or
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Stiffness ≥ 50 N*m2

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

fo al
 Withstand bending moment of 10 N*m
nt f S
with deflection less than 2mm
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 Withstand 100,000 cycles

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+
Design Inputs

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Stable enough to support healing

di or
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Stiffness ≥ 50 N*m2

r va


fo al
 Withstand bending moment of 10 N*m
nt f S
with deflection less than 2mm
ea o
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 Withstand 100,000 cycles

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Sidebar:
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• Careful on cycle requirements

• Test @ 5 sec/cycle x 100K cycles
P

• 139 hr for 1 sample!

 +

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+
Design Inputs

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Competitive price

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di or
 Manuf Cost ≤ $15

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 Note – R&D concerned with COGS not price, but if
fo al
cost too high, price not competitive!
nt f S
ea o

Biocompatible material
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 Pass ISO 10993, Biological Evaluation of Medical

ot e

Devices
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+
Design Inputs

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on es
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Not too stiff – Allow for micromotion

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di or
 Wolff’s Law

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r va
 Stiffness ≤ 75 N*m2

fo al
Compatible with 95% of human population
nt f S
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 Plate lengths up to 7cm

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+
Standards

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Documents produced by industry/gov’t

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

di or
 Provide reviews of methods/results

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 Make recommendations on testing and metrics

fo al
nt f S
ea o

 GT Resource:
m rty

http://libguides.gatech.edu/standards
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 +







ISO
IEC

MIL

IEEE
ASTM
P
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Standards

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 +







ISO
IEC

MIL

IEEE
ASTM
P
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Standards

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 ISO 10993 Standard: Biological evaluation of
+ medical devices

. .
on es
 Part 1:2009 Evaluation and testing in the risk management process

ti id
bu st
 Part 2:2006 Animal welfare requirements

ri ri
 Part 4:2002 Selection of tests for interactions with blood

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Part 5:2009 Tests for in vitro cytotoxicity

di or


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 Part 6:2007 Tests for local effects after implantation

r va
 Part 7:2008 Ethylene oxide sterilization residuals

fo al
Part 8:2001 Selection of reference materials
nt f S


Part 9:1999 Biological Framework for identification and quantification of potential

ea o


degradation products
m rty

 Part 10:2010 Biological Tests for irritation and delayed-type hypersensitivity

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N rop

 Part 11:2006 Tests for systemic toxicity

 Part 12:2007 Sample preparation and reference materials

P

 Part 13:1998 Identification and quantification of degradation products from polymeric

medical devices
+ Research Sources

. .
on es
 Engineering Handbooks (technical references)

ti id
 CRCnetBase, Referex, Knovel

bu st
 Material properties, equations, data tables

ri ri
 Methods for measurement, manufacturing, packaging, testing

st A
 Practical “how-to’s” and design guides

di or
 Engineering Research Articles (technical references)

re d
Engineering Village -> Compendex, Inspec (GT Library site)

r va


 IEEE Xplore

fo al
nt f S
 Medical/Science/Clinical Research Articles (medical references)
ea o

 PubMed, ISI Web of Science, ScienceDirect, Medline

m rty

 Material Databases (materials references)

ot e

 MatWeb: material property database http://www.matweb.com/

N rop

 Reaxsys: chemical structures, reactions, and properties; critically evaluated

data on physical, chemical, spectral, bioactivity, or toxicological properties
P

 Granta CES EduPack https://software.oit.gatech.edu

 +

P
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. .
+
This Week

. .
on es
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Translate User Needs into DI

ri ri


st A
di or
 Keep talking to Users

re d
r va
 Get competitive products
fo al
nt f S
 See problem in action
ea o
m rty
ot e
N rop
P
 +



P
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Next Week;

m rty
ea o
Dress for success!

nt f S
fo al
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di or
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bu st
Formal Design Input Presentations

ti id
on es
. .
+
Reimbursement

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Reimbursed 80% of approved expenses

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

di or
 Up to $500

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r va
Up to $1,000 for industry sponsored
fo al
 nt f S
 Will post process
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 +

P
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Team Evaluations

bu st
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3 opportunities in 4602

on es
. .
 +

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Questions??
m rty
ea o
nt f S
fo al
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di or
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. .