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 Diabetes High Cholesterol

2.7B in Sales in ,500 Employees Worldwide 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

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 10 Born Too Soon: Global Action Report on Preterm Birth, WHO, M1.1M75% preterm births every year deaths from preterm birth complications deaths that could be prevented

Causes & Mechanisms for Prematurity Chorion Decidua Uterine Contractions Cervical Change Preterm PROM Uterine Contractions Cervical Change Preterm PROM Activation of Maternal/Fetal HPA Axis  Maternal/Fetal stress Activation of Maternal/Fetal HPA Axis  Maternal/Fetal stress Inflammation/ Infection  Chorio-decidual  Systemic Inflammation/ Infection  Chorio-decidual  Systemic Decidual Hemorrhage  Abruption Decidual Hemorrhage  Abruption Pathological Uterine Distension  Multifetal pregnancy  Polyhydramnios  Uterine abnormality Pathological Uterine Distension  Multifetal pregnancy  Polyhydramnios  Uterine abnormality Preterm Birth Lockwood CJ, Kuczynski E. Paediatr Perinat Epidemiol. 2001;15(suppl 2):78-89.

12 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 fFN as Predictor of Preterm Birth

13 fFN Levels In Pregnancy The Fetal Fibronectin Test is taken between weeks 22–35 of pregnancy when levels should be low Relevant Time-Frame

14 Crisis PatientTriage DecisionHospital LabAdmit / Release Patient Fetal Fibronectin Testing 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 Women with Signs and Symptoms of Preterm Birth HOSPITAL MARKET STAT

15 TLi IQ System / fFN Test

Product Development How much antibody ? Stability of chemistry? What solid phase? What antibodies to use ? How much detector? What detector chemistry? How much antibody ? Best Storage Conditions? Scientist B.S., M.S., PhD Science

Product Requirements Did you build what you planned to build? Monitor for Problems Market Evaluation Build your product

Program Manager Marketing Development Scientist EngineersManufacturing Quality Assurance Tech ServiceClinicals Regulatory Affairs PRODUCT DEVELOPMENT TEAM

4M 1.2M 0.8M 500K “How would you use this new test?” Marketing Associate B.S. Science + M.B.A. Market Evaluation Sym Asym, at risk Total pregnancies fFN

Product Development How much antibody ? Stability of chemistry? What solid phase? What antibodies to use ? How much detector? What detector chemistry? How much antibody ? Best Storage Conditions? Scientist B.S., M.S., PhD Science

Intellectual Property Point of care diagnostic systems US A1 Patent Attorney B.S., M.S., PhD Science + J.D.

Measuring pH of solution Performing latex conjugation Formulations Chemist/Manufacturing Supervisor B.S., Science Production

APPROVED

Is your test SAFE and EFFECTIVE? Hypothesis What diagnosis do you think your test can do? Gather test data on real patients Analyze data and make statically sound conclusions Clinical Trial Process Clinical Research Associate B.S., M.S. Science Statistician B.S. Science + M.S. Statistics

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.

Research Associate (BA/BS, no experience) $55K Scientist (Scientist II, BS + 8 yrs experience, $95K) Manager (Sr. Manager, BS + 25 years experience, $150K) Career Ladder