bioe 483 “what else bioengineers should know when entering industry” february 19, 2007 scott...

BIOE 483BIOE 483“What Else Bioengineers Should “What Else Bioengineers Should Know When Entering Industry”Know When Entering Industry”

February 19, 2007February 19, 2007

Scott PletzerScott Pletzer

MEDICAL DEVICE OUTSOURCING SOLUTIONS

2007 CARZER Technologies, LLC All Rights Reserved

Who Am I?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 13 yrs industry experience (Boston Scientific, Becton

Dickinson, C.R. Bard, West Pharmaceuticals)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


Who is CARZER?Who is CARZER?

CARZER Technologies has over 20 CARZER Technologies has over 20 years experience in the medical device years experience in the medical device industry. We provide solutions to industry. We provide solutions to organizations regulated by ISO organizations regulated by ISO standards and/or FDA regulations.standards and/or FDA regulations.


CARZER’s ServicesCARZER’s Services

• Quality management systems Quality management systems • Compliance Compliance • Training & development Training & development • Contract engineering & Contract engineering &

manufacturingmanufacturing• Regulatory preparation & Regulatory preparation &

submissionsubmission• Supply base managementSupply base management


Bioengineering Career PathBioengineering 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


Getting The Job…Getting The Job…

……the easy stepthe easy step


Define Your ExpectationsDefine Your Expectations

• Separate needs and wantsSeparate needs and wants• Plot your career pathPlot your career path• Research company culturesResearch company cultures• Establish geographical Establish geographical

boundariesboundaries• Understand total Understand total

compensationcompensation


Network Early, Often, and Network Early, Often, and ContinuouslyContinuously

• 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


What is the Company What is the Company Offering?Offering?

The Tangible…The Tangible…

Salary / BonusSalary / Bonus

InsuranceInsurance

Time offTime off

Company equityCompany equity

Other perksOther perks

The Intangible…The Intangible…

Your overall fit with Your overall fit with the organization the organization will determine your will determine your satisfaction and satisfaction and residence time with residence time with that organizationthat organization


Keeping The Job…Keeping The Job…

……the challengethe challenge


What’s in a Title?What’s in a Title?


Your Actions Speak Louder Your Actions Speak Louder Than Your WordsThan 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 R&D is overhead and adds nothing

to the bottom-lineto the bottom-line


If You Don’t Manage Your If You Don’t Manage Your Career, Somebody Else WillCareer, 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


Keep Your Tools Sharp & Keep Your Tools Sharp & Your Toolbox FullYour Toolbox Full

• Don’t ever stop learning internally Don’t ever stop learning internally and externallyand externally

• CertificationsCertifications• JournalsJournals• Continuing educationContinuing education


The Hardest Lessons are The Hardest Lessons are the Most Memorablethe Most Memorable

• Understand other’s perception of Understand other’s perception of youyou

• Admit and correct your errorsAdmit and correct your errors• Learn from your mistakesLearn from your mistakes• Practice preventionPractice prevention


Flexibility & Versatility Make Flexibility & Versatility Make a Good Bioengineera Good Bioengineer

• Expect to wear many hatsExpect to wear many hats• Supervision, purchasing, budgetsSupervision, purchasing, budgets• Presentations, training, negotiations, Presentations, training, negotiations,

selling your ideas and selfselling your ideas and self• Remember why you became a Remember why you became a

bioengineer?bioengineer?


When Companies & When Companies & Projects Go Bad…Projects Go Bad…

• ReorganizationReorganization• Reduction in forceReduction in force• RealignmentRealignment• RestructuringRestructuring• LayoffLayoff• AcquisitionAcquisition


Leave on a High NoteLeave 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


Regulatory ComplianceRegulatory ComplianceFDA & ISOFDA & ISO


Food & Drug Administration Food & Drug Administration (FDA)(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 Authority over company premises

and productand product• Applies to companies doing Applies to companies doing

business in the United Statesbusiness in the United States


The Meaning of BIOE 483The Meaning of BIOE 483

• FDA form number used to FDA form number used to document company document company noncompliances (aka 483s)noncompliances (aka 483s)

• Companies must respond to Companies must respond to 483s in a timely manner483s in a timely manner

• Multiple 483s can lead to Multiple 483s can lead to warning letters, product warning letters, product seizure, and shutdownseizure, and shutdown


International Organization International Organization for Standardization (ISO)for Standardization (ISO)

• Business orientedBusiness oriented• Promotes global harmonizationPromotes global harmonization• Regular standard reviews and Regular standard reviews and

revisionsrevisions• Applicable internationallyApplicable internationally


Compliance Governs The Compliance Governs The IndustryIndustry

• 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


Give Me an “A” for AuditorGive 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


When Your Ethics Come When Your Ethics Come Into PlayInto Play

• AlwaysAlways follow procedures follow procedures and and alwaysalways tell the truth tell the truth

• Make your decisions Make your decisions based on databased on data

• Bring about resolution Bring about resolution quickly, but correctlyquickly, but correctly

• You are accountable for You are accountable for your actionsyour actions


The Cost of ComplianceThe Cost of Compliance

• Compliance has Compliance has a pricea price

• Non-compliance Non-compliance has a much has a much greater pricegreater price


Additional ResourcesAdditional Resources• fda.govfda.gov• iso.orgiso.org• devicelink.comdevicelink.com• carzer.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)


QuestionsQuestions

MEDICAL DEVICE OUTSOURCING SOLUTIONS

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