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Medical Device Outsourcing & the Role of Regulatory Compliance Scott Pletzer President MEDICAL DEVICE OUTSOURCING SOLUTIONS.

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Presentation on theme: "Medical Device Outsourcing & the Role of Regulatory Compliance Scott Pletzer President MEDICAL DEVICE OUTSOURCING SOLUTIONS."— Presentation transcript:

1 Medical Device Outsourcing & the Role of Regulatory Compliance Scott Pletzer President MEDICAL DEVICE OUTSOURCING SOLUTIONS

2 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, The Tech Group)13 yrs industry experience (Boston Scientific, Becton Dickinson, C.R. Bard, The Tech Group) Founded CARZER Technologies 2003Founded CARZER Technologies 2003 American Society for Quality (ASQ)American Society for Quality (ASQ) Residing in Arizona since 1998Residing in Arizona since 1998

3 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.

4 2007 CARZER Technologies, LLC All Rights Reserved CARZERs 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

5 2007 CARZER Technologies, LLC All Rights Reserved Outsourcing Reaches the Entire Biomedical Industry AcademiaAcademia EntrepreneursEntrepreneurs Biomedical organizationsBiomedical organizations Funding organizationsFunding organizations Legal counselLegal counsel

6 The question for device makers is not whether to outsource--it's what to contract out, where to do it, and how to begin. Source: MDDI-March, 2003

7 2007 CARZER Technologies, LLC All Rights Reserved Todays Outsourcing …Its about systems and infrastructure, training and awareness, design houses for prototyping, contract manufacturing, third party testing and clinical services, regulatory representation, experienced and skilled personnel, without permanent salaries. Its more than consulting as we know it…

8 2007 CARZER Technologies, LLC All Rights Reserved Factors Driving Outsourcing Cost effectivenessCost effectiveness ResourcesResources Speed to marketSpeed to market ExpertiseExpertise Competitive edgeCompetitive edge CapacityCapacity

9 2007 CARZER Technologies, LLC All Rights Reserved Top Device Manufacturers 1.Johnson and Johnson ($20.3B) 2.GE Healthcare ($16.6B) 3.Medtronic ($11.3B) 4.Baxter International ($10.4B) 5.Siemens Medical Solutions ($10.1B) 6.Cardinal Health ($10B) 7.Tyco Healthcare ($9.6B) 8.Philips Medical Systems ($8.5B) 9.Boston Scientific ($7.8B) 10.Becton Dickinson ($5.8B) Source: MPO magazine, July/August-2007

10 2007 CARZER Technologies, LLC All Rights Reserved What Manufacturers Outsource Source: MDDI-March, 2007

11 2007 CARZER Technologies, LLC All Rights Reserved Contract Manufacturing Market Size Source: Medical device market size and gross profit from IBISWorld estimates. Contract manufacturing market size based on consensus among Frost and Sullivan, Millennium Research, MedTech Insight and Accellent estimates.

12 2007 CARZER Technologies, LLC All Rights Reserved Top Contract Manufacturers Accellent Inc. (12%)Accellent Inc. (12%) Symmetry Medical (6%)Symmetry Medical (6%) Greatbatch (5%)Greatbatch (5%) Heraeus, Avail (4% each)Heraeus, Avail (4% each) The Tech Group, Lake Region, Fort Wayne Metals (3% each)The Tech Group, Lake Region, Fort Wayne Metals (3% each) Orchid International, Doncasters Medical Technologies (2% each)Orchid International, Doncasters Medical Technologies (2% each) Source: MPO-July/August, 2007

13 2007 CARZER Technologies, LLC All Rights Reserved Geographical Opportunities Idaho - Showing entrepreneurs the moneyIdaho - Showing entrepreneurs the money Arizona - Building more technology centersArizona - Building more technology centers Wisconsin - A partnership powerhouseWisconsin - A partnership powerhouse Ohio - Rich in researchOhio - Rich in research South Carolina - Legislating life science successSouth Carolina - Legislating life science success Traditional - San Francisco, San Diego, Boston, MinneapolisTraditional - San Francisco, San Diego, Boston, Minneapolis Source: MPO-July/August, 2007

14 2007 CARZER Technologies, LLC All Rights Reserved Factors Driving Contract Manufacturing Source: MDDI-March, 2003

15 2007 CARZER Technologies, LLC All Rights Reserved Whats Important When Outsourcing? Source: MDDI-March, 2007

16 2007 CARZER Technologies, LLC All Rights Reserved What are the Challenges? Source: MDDI-March, 2007

17 2007 CARZER Technologies, LLC All Rights Reserved Achieving Contract Manufacturing Success Source: MDDI-March, 2003

18 2007 CARZER Technologies, LLC All Rights Reserved Outsourcing Partner Considerations Identify the companys specialty areaIdentify the companys specialty area orthopedics, cardiology, interventionalorthopedics, cardiology, interventional Device classification (I, II, or III)Device classification (I, II, or III) affects the development strategy, regulatory pathway, finances, product liability, etc.affects the development strategy, regulatory pathway, finances, product liability, etc. Assess the gapsAssess the gaps engineering, supply base management, packaging, manufacturingengineering, supply base management, packaging, manufacturing

19 2007 CARZER Technologies, LLC All Rights Reserved Outsourcing Relationships Preferred Outsource Established Partnership Strategic Alliance Initial Contact

20 2007 CARZER Technologies, LLC All Rights Reserved Achieving Outsourcing Success Begin earlyBegin early Due diligenceDue diligence Common objectivesCommon objectives CommunicateCommunicate Trust and respectTrust and respect

21 2007 CARZER Technologies, LLC All Rights Reserved Regulatory Compliance FDA & ISO

22 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

23 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

24 2007 CARZER Technologies, LLC All Rights Reserved Compliance Deficiencies Company A Failure to adequately validate the manufacturing process with a high degree of assurance, approve, and document the results of the validation activities to ensure that product specifications can be consistently met, as required by 21 C.F.R. § (a). Source: FDA Warning Letter Dated 19Jan07

25 2007 CARZER Technologies, LLC All Rights Reserved Compliance Deficiencies Company A Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria prior to releasing the devices for distribution, as required by 21 C.F.R. § (d), and failure to maintain acceptance records, as required by 21 C.F.R. § (e). Source: FDA Warning Letter Dated 19Jan07

26 2007 CARZER Technologies, LLC All Rights Reserved Compliance Deficiencies Company A Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 C.F.R. § (a) through (j). Source: FDA Warning Letter Dated 19Jan07

27 2007 CARZER Technologies, LLC All Rights Reserved Compliance Deficiencies Company B A medical device manufacturer that ignored FDA regulations by selling unapproved medical devices to doctors treating children with heart problems agreed to plead guilty to four misdemeanor charges in federal court and pay $4.5 million in fines. Source: MPO-July/August, 2007

28 2007 CARZER Technologies, LLC All Rights Reserved Compliance Deficiencies Company B The plea agreement ends a three- year criminal investigation of XYZ Medical, Inc. of New York and its founder and president John Doe by the U.S. Attorney that began amid charges of improper conduct by doctors at Anytown Hospital for Children. Source: MPO-July/August, 2007

29 2007 CARZER Technologies, LLC All Rights Reserved Compliance Deficiencies Company C Failure to implement complaint handling procedures to ensure that all complaints are evaluated to determine whether the complaint represents an event that must be filed as a Medical Device Report under 21 CFR Part 803, as required by 21 CFR (a)(3). Source: FDA Warning Letter Dated 03Jul07

30 2007 CARZER Technologies, LLC All Rights Reserved Compliance Deficiencies Company C Failure to submit MDR reports within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury, as required by 21 CFR (a)(1). Source: FDA Warning Letter Dated 03Jul07

31 2007 CARZER Technologies, LLC All Rights Reserved Compliance Deficiencies Company C A correction or removal conducted to reduce a risk to health posed by a device was not reported in writing to FDA, as required by 21 CFR (a)(1). Source: FDA Warning Letter Dated 03Jul07

32 2007 CARZER Technologies, LLC All Rights Reserved Compliance Deficiencies Company D Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of 21 CFR Part 820 and the firm's established quality policy and objectives, as required by 21 CFR (c). Source: FDA Warning Letter Dated 25Jan06

33 2007 CARZER Technologies, LLC All Rights Reserved Compliance Deficiencies Company D Failure to review, evaluate, and investigate any complaint involving the possible failure of a device to meet any of its specifications, as required by 21 CFR (c). Source: FDA Warning Letter Dated 25Jan06

34 2007 CARZER Technologies, LLC All Rights Reserved Compliance Deficiencies Company D Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure complaints are processed in a uniform and timely manner, as required by 21 CFR (a)(1). Source: FDA Warning Letter Dated 25Jan06

35 2007 CARZER Technologies, LLC All Rights Reserved Compliance Deficiencies Company D Failure to establish and maintain procedures to address the identification, documentation, evaluation, segregation, disposition and investigation of nonconforming product, as required by 21 CFR (a). Source: FDA Warning Letter Dated 25Jan06

36 2007 CARZER Technologies, LLC All Rights Reserved Violators Profiled Company ACompany A Startup in 2005Startup in 2005 Naïve and unaware of regulationsNaïve and unaware of regulations Company BCompany B Doing business since 1982Doing business since 1982 Self proclaimed worldwide leader in the fieldSelf proclaimed worldwide leader in the field Claimed device benefits outweighed violationsClaimed device benefits outweighed violations Companies C & DCompanies C & D Within top ten device manufacturersWithin top ten device manufacturers When does naivety become deceit?When does naivety become deceit?

37 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 wasnt written…it didnt happenIf it wasnt written…it didnt happen

38 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

39 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

40 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

41 2007 CARZER Technologies, LLC All Rights Reserved Additional Resources fda.govfda.govfda.gov iso.orgiso.orgiso.org devicelink.comdevicelink.comdevicelink.com mpo-mag.commpo-mag.commpo-mag.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)

42 2007 CARZER Technologies, LLC All Rights Reserved Questions MEDICAL DEVICE OUTSOURCING SOLUTIONS


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