Science Careers within the
Medical Device Industry
MVHS Explore Careers
Feb 9, 2016
Medical Device
Industry
In-Vitro Diagnostic Products
Products intended for use in diagnosis
of disease or other conditions.
Strep Throat
Cancer
High
Cholesterol
Diabetes
Hologic, Inc. is a leading developer,
manufacturer and supplier of premium
diagnostic products, medical imaging
systems, and surgical products, with an
emphasis on serving the healthcare
needs of women throughout the world
2.7B in Sales in 2015
5,500 Employees Worldwide
My Background
• Raised in Cupertino
• 2 years at DeAnza
• CSU Chico
– B.S. Microbiology
– Minor in Chemistry
• Employed since 1989
• Career Pathway:
Product Development
Scientist
Program Manager
What Lead me into a Career in Science?
• A subject I enjoyed in school
• Up and coming field = JOBS!
Adeza Biomedical Founded in 1985
Focus on Maternal & Fetal
Health
Mission: Identify women
at risk for Preterm Birth
Global burden of preterm birth
9
Preterm birth is major cause of
morbidity and mortality
•
15M
1.1M
75%
preterm births
every year
deaths from preterm
birth complications
deaths that could be
prevented
Born Too Soon: Global Action Report on Preterm Birth, WHO, 2012
10
Causes & Mechanisms for Prematurity
Activation of
Maternal/Fetal
HPA Axis
 Maternal/Fetal
stress
Inflammation/
Infection
 Chorio-decidual
 Systemic
Decidual
Hemorrhage
 Abruption
Chorion
Decidua
Uterine Contractions
Cervical Change
Preterm PROM
Preterm Birth
Lockwood CJ, Kuczynski E. Paediatr Perinat Epidemiol. 2001;15(suppl 2):78-89.
Pathological Uterine
Distension
 Multifetal pregnancy
 Polyhydramnios
 Uterine abnormality
fFN as Predictor of Preterm Birth
•
Fetal fibronectin (fFN), or oncofetal fibronectin, is a glycoprotein expressed at the
interface between the mother and fetus and is detected in cervico-vaginal secretions
•
Plays a role in adhesion of fetal membranes to wall of uterus
12
fFN Levels In Pregnancy
•
The Fetal Fibronectin Test is taken between weeks 22–35 of pregnancy when
levels should be low
Relevant Time-Frame
700
fFN (ng/ml)
600
500
400
300
200
100
0
16
20
24
28
32
Gestational Age (Weeks)
13
36
40
Fetal Fibronectin Testing
HOSPITAL MARKET
Women with Signs and Symptoms of Preterm Birth
STAT
Crisis Patient
Triage Decision
Hospital Lab
Admit / Release Patient
• fFN Test run during evaluation period prior to admission
• Prior to use of the fFN test, most women with signs and
symptoms were admitted to hospital
• Negative test provides 99.5% assurance that patient will not
deliver in next 7 days
• Reduces hospital admissions
• Avoids inappropriate drug treatments
14
TLiIQ System / fFN Test
15
Product
Development
Scientist
B.S., M.S., PhD Science
What detector chemistry?
What antibodies to use ?
Best Storage Conditions?
How much detector?
How much antibody ?
What solid phase?
Stability of chemistry?
How much antibody ?
Market
Evaluation
Product
Requirements
Build your
product
Did you build
what you
planned to
build?
Monitor for
Problems
PRODUCT
DEVELOPMENT TEAM
Marketing
Regulatory
Affairs
Development
Scientist
Program
Manager
Clinicals
Tech Service
Engineers
Manufacturing
Quality
Assurance
Market Evaluation
Marketing Associate
B.S. Science + M.B.A.
“How would you use this
new test?”
40,000
35,000
30,000
4M
25,000
1.2M
20,000
0.8M
15,000
10,000
500K
5,000
2016
WW Revenue
2017
2018
North America
2019
2020
Europe
fFN
Total pregnancies
Sym
Asym, at risk
Product
Development
Scientist
B.S., M.S., PhD Science
What detector chemistry?
What antibodies to use ?
Best Storage Conditions?
How much detector?
How much antibody ?
What solid phase?
Stability of chemistry?
How much antibody ?
Intellectual Property
Point of care diagnostic systems
US 20040241752 A1
Patent Attorney
B.S., M.S., PhD Science
+ J.D.
Production
Performing latex
conjugation
Measuring pH of
solution
Formulations
Chemist/Manufacturing
Supervisor
B.S., Science
APPROVED
Clinical Trial Process
Clinical Research
Associate
B.S., M.S. Science
Hypothesis
What diagnosis do
you think your test
can do?
Gather test data on
real patients
Statistician
B.S. Science +
M.S. Statistics
Analyze data and
make statically
sound conclusions
Is your test SAFE and EFFECTIVE?
What characteristics do we look for in
a new hire?
Smart – can you talk about the science
Logical Thinker
Hard worker
Team Player
Communicator
Honest
Personality fit with company culture
Bottom Line: We hire based on what type of person
you are, not based on where you went to college
and not your GPA.
Career Ladder
Scientist
Research Associate
(BA/BS, no experience)
$55K
(Scientist II, BS + 8 yrs
experience, $95K)
Manager
(Sr. Manager, BS + 25
years experience,
$150K)