BIOE 483 “What Else Bioengineers Should Know When Entering Industry” February 19, 2007 Scott Pletzer MEDICAL DEVICE OUTSOURCING SOLUTIONS

2007 CARZER Technologies, LLC All Rights Reserved Who Am I? B.S. Mechanical Engineering, West Virginia UniversityB.S. Mechanical Engineering, West Virginia University M.S. Bioengineering, Clemson University (Dr. Shalaby)M.S. Bioengineering, Clemson University (Dr. Shalaby) 13 yrs industry experience (Boston Scientific, Becton Dickinson, C.R. Bard, West Pharmaceuticals)13 yrs industry experience (Boston Scientific, Becton Dickinson, C.R. Bard, West Pharmaceuticals) American Society for Quality (ASQ)American Society for Quality (ASQ) ASQ Certified Quality Engineer (CQE)ASQ Certified Quality Engineer (CQE) Residing in Arizona since 1998Residing in Arizona since 1998 Founded CARZER Technologies 2003Founded CARZER Technologies 2003

2007 CARZER Technologies, LLC All Rights Reserved Who is CARZER? CARZER Technologies has over 20 years experience in the medical device industry. We provide solutions to organizations regulated by ISO standards and/or FDA regulations.

2007 CARZER Technologies, LLC All Rights Reserved CARZER’s Services Quality management systemsQuality management systems ComplianceCompliance Training & developmentTraining & development Contract engineering & manufacturingContract engineering & manufacturing Regulatory preparation & submissionRegulatory preparation & submission Supply base managementSupply base management

2007 CARZER Technologies, LLC All Rights Reserved Bioengineering Career Path Step 1 – Get the jobStep 1 – Get the job Step 2 – Keep the jobStep 2 – Keep the job Step 3 – Repeat steps 1 & 2Step 3 – Repeat steps 1 & 2

2007 CARZER Technologies, LLC All Rights Reserved Getting The Job… …the easy step

2007 CARZER Technologies, LLC All Rights Reserved Define Your Expectations Separate needs and wantsSeparate needs and wants Plot your career pathPlot your career path Research company culturesResearch company cultures Establish geographical boundariesEstablish geographical boundaries Understand total compensationUnderstand total compensation

2007 CARZER Technologies, LLC All Rights Reserved Network Early, Often, and Continuously ColleaguesColleagues AlumniAlumni InternshipsInternships RecruitersRecruiters Professional societiesProfessional societies Trade shows and conferencesTrade shows and conferences You’re entering an intimate communityYou’re entering an intimate community

2007 CARZER Technologies, LLC All Rights Reserved What is the Company Offering? The Tangible… Salary / Bonus Insurance Time off Company equity Other perks The Intangible… Your overall fit with the organization will determine your satisfaction and residence time with that organization

2007 CARZER Technologies, LLC All Rights Reserved Keeping The Job… …the challenge

2007 CARZER Technologies, LLC All Rights Reserved What’s in a Title?

2007 CARZER Technologies, LLC All Rights Reserved Your Actions Speak Louder Than Your Words Your actions have a priceYour actions have a price Materials & timeMaterials & time Resources & equipmentResources & equipment Functional groups affectedFunctional groups affected R&D is overhead and adds nothing to the bottom-lineR&D is overhead and adds nothing to the bottom-line

2007 CARZER Technologies, LLC All Rights Reserved If You Don’t Manage Your Career, Somebody Else Will Communicate your expectationsCommunicate your expectations Negotiate reasonable goalsNegotiate reasonable goals You will have a bad supervisorYou will have a bad supervisor Be careful what you wish forBe careful what you wish for

2007 CARZER Technologies, LLC All Rights Reserved Keep Your Tools Sharp & Your Toolbox Full Don’t ever stop learning internally and externallyDon’t ever stop learning internally and externally CertificationsCertifications JournalsJournals Continuing educationContinuing education

2007 CARZER Technologies, LLC All Rights Reserved The Hardest Lessons are the Most Memorable Understand other’s perception of youUnderstand other’s perception of you Admit and correct your errorsAdmit and correct your errors Learn from your mistakesLearn from your mistakes Practice preventionPractice prevention

2007 CARZER Technologies, LLC All Rights Reserved Flexibility & Versatility Make a Good Bioengineer Expect to wear many hatsExpect to wear many hats Supervision, purchasing, budgetsSupervision, purchasing, budgets Presentations, training, negotiations, selling your ideas and selfPresentations, training, negotiations, selling your ideas and self Remember why you became a bioengineer?Remember why you became a bioengineer?

2007 CARZER Technologies, LLC All Rights Reserved When Companies & Projects Go Bad… ReorganizationReorganization Reduction in forceReduction in force RealignmentRealignment RestructuringRestructuring LayoffLayoff AcquisitionAcquisition

2007 CARZER Technologies, LLC All Rights Reserved Leave on a High Note Exhaust your optionsExhaust your options Weigh your decisionsWeigh your decisions Present feedbackPresent feedback Don’t shut the doorDon’t shut the door Maintain professionalismMaintain professionalism No bridge is worth burningNo bridge is worth burning

2007 CARZER Technologies, LLC All Rights Reserved Regulatory Compliance FDA & ISO

2007 CARZER Technologies, LLC All Rights Reserved Food & Drug Administration (FDA) Motivated by public safetyMotivated by public safety Indifferent to company size or statusIndifferent to company size or status Enforces federal lawEnforces federal law Authority over company premises and productAuthority over company premises and product Applies to companies doing business in the United StatesApplies to companies doing business in the United States

2007 CARZER Technologies, LLC All Rights Reserved The Meaning of BIOE 483 FDA form number used to document company noncompliances (aka 483s)FDA form number used to document company noncompliances (aka 483s) Companies must respond to 483s in a timely mannerCompanies must respond to 483s in a timely manner Multiple 483s can lead to warning letters, product seizure, and shutdownMultiple 483s can lead to warning letters, product seizure, and shutdown

2007 CARZER Technologies, LLC All Rights Reserved International Organization for Standardization (ISO) Business orientedBusiness oriented Promotes global harmonizationPromotes global harmonization Regular standard reviews and revisionsRegular standard reviews and revisions Applicable internationallyApplicable internationally

2007 CARZER Technologies, LLC All Rights Reserved Compliance Governs The Industry 21CFR Part 82021CFR Part 820 ISO 13485:2003ISO 13485:2003 Procedure drivenProcedure driven Results documentedResults documented Failures must be addressedFailures must be addressed If it wasn’t written…it didn’t happenIf it wasn’t written…it didn’t happen

2007 CARZER Technologies, LLC All Rights Reserved Give Me an “A” for Auditor Expect to be part of auditsExpect to be part of audits FDAFDA ISOISO CustomerCustomer InternalInternal Be prepared to defend your workBe prepared to defend your work Less is always betterLess is always better

2007 CARZER Technologies, LLC All Rights Reserved When Your Ethics Come Into Play Always follow procedures and always tell the truthAlways follow procedures and always tell the truth Make your decisions based on dataMake your decisions based on data Bring about resolution quickly, but correctlyBring about resolution quickly, but correctly You are accountable for your actionsYou are accountable for your actions

2007 CARZER Technologies, LLC All Rights Reserved The Cost of Compliance Compliance has a priceCompliance has a price Non-compliance has a much greater priceNon-compliance has a much greater price

2007 CARZER Technologies, LLC All Rights Reserved Additional Resources fda.govfda.govfda.gov iso.orgiso.orgiso.org devicelink.comdevicelink.comdevicelink.com carzer.comcarzer.comcarzer.com ISO 13485:2003 (ISO requirements)ISO 13485:2003 (ISO requirements) 21CFR Part 820 (FDA regulations)21CFR Part 820 (FDA regulations) Medical Device & Diagnostic Industry (MD&DI)Medical Device & Diagnostic Industry (MD&DI) Medical Design & Manufacturing (MD&M)Medical Design & Manufacturing (MD&M)

2007 CARZER Technologies, LLC All Rights Reserved Questions MEDICAL DEVICE OUTSOURCING SOLUTIONS