Medical device design &

development
Wendy C. Newstetter
Jared Brown
Questions to drive your design
1. For which population are you planning to create value?
2. Why did you choose this population?
3. Describe the physiological challenge this population has to deal
with.
4. Draw a qualitative model/diagram of this physical challenge.
5. How will your device address this challenge?
6. What kind of data will your device need to collect to fulfill this
function?
7. What are the challenges collecting this kind of data?
Unmet
demand

Broad
Underspecified
Unconstrained Phase I

Phase II
Phase III
Proof of concept
Phase IV
 Unmet demand
70% of traumatic brain injury such as
concussions, hematomas and skull
fractures occurs among adolescents playing
sports . We need to prevent these.

Which sport?
Design a better way to Which age group??
prevent concussions in What kind of concussion happens
sports. in this sport?
What happens physiologically
when a concussion occurs?
Design concept How will ”better” be measured?
The image part with relationship ID rId3 was not found in the file.
 Physiology

Kleiven, S. (2013). Why most traumatic brain injuries are not caused by linear acceleration but skull fractures are. Frontiers
in Bioengineering and Biotechnology, 1, 15. http://doi.org/10.3389/fbioe.2013.00015
 TERMS TO USE
• Unmet demand: A societal need with broad application to
public health and quality of life
• User needs: Requirements or expectations of intended use
as defined from a customer’s point of view or language.
• Design input means the physical and performance
requirements of a device that are used as a basis for device
design which are written to an engineering level of detail.
• Design output is the results of the design generation
(ideation) effort. Phase I output.
Unmet
demand

Phase I

Phase II
Phase III
Proof of concept
Phase IV
Unmet need, user need or design input?
Design a flexible band that lights up when the athlete
receives a blow to the head.

Design a device that can measure rotational acceleration

within a range +/- 50 Gs.. 9

Reduce the number of head injuries associated with

heading the ball in soccer.

Design football helmet lining that increases the absorption

of linear acceleration by 5%.
User needs or design input?
• Febrile seizures, characterized by fever and often convulsive events,
are the most common seizure disorder in children from 6 months to 5
years of age. Our goal is to detect recurrent seizures, which take place
30-40% of the time, and assist in diagnosis of potential complications
by developing a portable device that detects abnormally high body
temperature and prolonged muscle contraction for everyday use.
• Recurrent
• Complications
• Portable
• Abnormally
• Prolonged
For toddlers aged 18 to 36 months, we will measure axillary body
temperature, and if above 101°F, monitor for a 10% increase from the
child’s baseline heart rate, in order to detect febrile seizures and alert a
caretaker of the child’s condition.

Concept Sketch
Design I: Sock EMG/Foot
Design a surface EMG that
can detect and measure the
duration of dyskinesia from
a frequency of 1-3 Hz in the
foot.

EMG surface
electrode
How about this?
• Problem Statement: Design a device that identifies tympanic
temperatures above 38.3℃ and high frequency oscillations
(200-500 Hz)[1] in brain activity; these thresholds indicate
seizure conditions in children.
Design II: How & Why?
Figure 2. displays the linear acceleration of

Signal/data measured: non-PD vs dyskinetic movement, from

“Journal Neurol, Neuros & Psyc”, 2000,

Acceleration of wrist movement in Manson A.J., DOI: 10.1136/jnnp.68.2.196

meters per seconds square (m/s^2)

and angular velocity of dyskinetic Non-
twisting (deg/sec). PD

How is the signal generated?

Muscle contractions in extremities

Dyskinesi
a

Figure 1. Displays gyroscope data from dyskinesia in the x, y, and z axes (left) and Dyskinetic
frequency (right). From “Conf Proc IEEE Eng Med Biol Soc”, 2012, Mera, T.O., DOI:
10.1109/EMBC.2012.6345894 twisting of arm
Value Propositions in Healthcare
•WHAT is the need
•WHO will buy it

•WHY will they buy it

Exact Sciences’ Cologuard – The Numbers

• Colorectal Cancer – 2nd Leading Cause of Cancer Death

• 1 in 3 People are not up to date

• 60% of deaths could be prevented with improved

screening
Exact Sciences’ Cologuard – The Problem

• Discomfort

• Lengthy/intrusive

preparation

• …Yikes…
Exact Sciences’ Cologuard – The Solution

• Minimally invasive

• No prep required

• Accurate

• Cheap
Exact Sciences’ Cologuard – The Value

People older than 45 are at risk for colorectal

cancer and will buy a cheaper, less intrusive,
accurate cancer screening method because it
will save them money, time, and discomfort.
Quantify the Value Added

• Patient (Primary User)

• Doctor (Secondary User)

• Healthcare System/Society (Tertiary Users)

 Adding Value in Healthcare
• Improving Outcomes (better results, faster healing, decreased complications, increased
compliance)

• Saving Money (fewer admissions, decreased material cost, etc.)

• Improving Workflow (fewer steps, fewer hands, fewer accidents)

• Expand Access
… There is A LOT of overlap in these categories but a perfect healthcare solution will hit all 4.

Audience participation: give examples of how Cologuard adds value in each of these 4 areas in quantified terms like specificity, mortality
rates, etc.
Functional flow diagram
What, how and why……
Bilateral Bracelets
Earpiece: Functional Flow Block Diagram

MASSETER INVOLUNTARY LEVEL 1

NERVOUS MUSCULAR MOUTH
SYSTEM MOVEMENT
MOVEMENT
- JAW
VOLUNTARY MANDIBLE TREMOR
MOUTH MOVEMENT +
MOVEMENT

LEVEL 2 SKIN SHAPE

FLEX CHANGE/BENDIN
SENSOR G

INTERPRET CONVEY
SENSORY
MICROCONTROLLER DATA RESULTS
DATA Log of tremors
Flex Sensor Frequency of voltage peaks Cloud