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1 Welcome to the Global Web cast on How To Overcome the Medical Devices V&V Triple Challenge Event Time: 11:00 12:00 hrs EST 08:00 09:00 hrs PST 16:00 17:00 hrs GMT 21:30 22:30 hrs IST Event Date : 9-March-2007

2 Speaker Introduction Dan M. Mihai Managing Consultant Prius Medical Systems LLC Venkatesan M. Head, Medical Devices Vertical HCL

3 Your Take-Away: The new role of V&V What is the V&V triple challenge How to overcome it Why HCL is best positioned to help you

4 The Medical Devices V&V Triple Challenge Dan M. Mihai Managing Consultant Prius Medical Systems LLC

5 Turning Point November 2, 1999 The warm and fuzzy climate of FDA's regulatory relationship with medical device manufacturers may be turning a bit chilly. Initiated by the Clinton Administration's "reinventing government" program and the agency's own complementary "reengineering" initiative at CDRH, and fostered by the FDA Modernization Act (FDAMA), the atmosphere of friendly cooperation is looking bleaker in the wake of November's record-setting consent decree with Abbott Laboratories. The $100 million decree exceeds the previous record of $61 million also against a device company dating from the 1993 C.R. Bard settlement. Abbott announced it was taking a $168 million charge against its assets to allow for lost sales and administrative costs it will incur in implementing the manufacturing and personnel changes required by the decree including FDA's costs for verifying corrections. What they're saying though not for attribution is that this case sends a signal to industry as a whole about the seriousness with which FDA views promises made to it by manufacturers within the inspection setting. - James G. Dickinson, MD&DI (December 1999 Issue)

6 The Other Shoe Drops June 29, federal agents seized more than 7,000 devices, mostly pumps, distributed from two of Baxter's suburban facilities. Defects in the pumps may have led to eight deaths and 16 serious injuries, the company and the FDA have said. Chicago Tribune Baxter Healthcare Corp. (Baxter) and two of its top corporate executives have signed a consent decree of condemnation and permanent injunction for certain infusion pumps made by the firm. They agreed to stop manufacturing and distributing within the United States all models of the Colleague Volumetric Infusion Pump (Colleague) and the Syndeo Patient Controlled Analgesic Syringe Pump (Syndeo) until they correct manufacturing deficiencies and until the devices are made in compliance with FDA's current good manufacturing practice (CGMP) requirements and the Quality System (QS) regulation for devices. FDA News Baxter said it intends to take a $70 million charge in the second quarter for remediation connected with the settlement. If Baxter fails to comply with tenets of the decree, the company could face penalties up to $10 million a year, the government said. Chicago Tribune

7 How Could This Happen? New rules: FDA QSR (21 CFR Part 820) June 1997 (vs. old GMPs) Enforcement lag until V&V and GDP / GLP - key elements of compliance Expanded area w/ specific new rules: Software V&V Grandfather clause: only if no change (improvement OR remedial) Change localization argument vs. baselining as precondition Bottom line for existing products: extensive DHF rework Business Impact: $$$ cost with no additional sales!

8 What Does This Mean To You? New expectations for detail and quality of formal documentation Formal process needs to be in place and institutionalized 510(k)s or PMAs are still relatively easy to get FDA Inspections, however, can be deadly! Product safety / effectiveness extrapolated from the quality of documentation and the degree of process control Inherent merits of product design are secondary (inferred) BOTTOM LINE: much higher cost ($$$) of doing business!

9 QSR, V&V, and GDP Quality Policy / Quality Manual / SOPs / WIs / Templates Personnel: Education / Experience / Training Design Control: Inputs / Outputs / Review / Changes / RHA / V&V Manufacturing: Process Validation / SPC / Calibration / DMR Facilities: Sanitation / Contamination / Monitoring Labeling / Packaging / Storage / Shipping Complaints / MDR / Service / Investigations / Recalls / CAPA Vendor Management: Supplier Qualification / Audits Internal Quality Audits / Management Review

10 V&V Is All-Pervasive Basic QSR concept: documented evidence QSR areas with high V&V content: Design Control Manufacturing Complaint Investigations / CAPAs Facilities - sanitation / contamination Types of V&V Activities Requirements Structuring / Traces Test Protocols (Studies) / Tool Validation / Process Validation Product Validation / Clinical Trials

11 Product V&V (Design Control) Customer Planning Design Inputs Design Review Development Design Verification Design Output Design Transfer Design Validation Finished Product

12 Software V&V ( V Model)

13 Before And After Pre-1997 GMPs: V&V effort (Design Control): 10-15% of total project cost Software V&V: 5-7% of total project cost No emphasis on usability testing Post-1997 QSRs: V&V effort (Design Control): 60-80% of total project cost Software V&V: 30-40% of total project cost Usability is a facet of effectiveness Product development cost has DOUBLED for the same functionality

14 The Triple Challenge Cost: Minimize non market value added V&V cost Schedule: Compress product release cycles HR: Absorb back-end loading of V&V resources by moving fixed cost to variable

15 Can You Have Your Cake and Eat It Too? Advantages of Strategic V&V Offshoring If Done Right: 50% to 70% cost savings Absorb large back-end resource loading demands Compress project schedules through parallelism Challenges of Offshoring If Not Done Right: Cost Overruns: scope definition / contract management Missed Expectations: culture / communication Schedule Delays: ability to scale / organizational match Intensive Rework: quality of deliverables / competencies Lack of offshoring experience = RISK

16 Cheap Development Services Available Right Now Dear Sir or Madam, We are glad to deliver cutting-edge solutions to your challenges at a quality that is equivalent or superior to that offered by domestic companies, but at a fraction of the cost of domestic development. We represent a number of well-established companies staffed with over 1000 qualified engineers with a record of successfully completing hundreds of small and midsize projects and tens of wide-scale projects for Fortune 100 corporations. Rates only $20 an hour! For more info...click HERE!!! Please include your phone number, and we will be happy to call you! Cost effective solutions Experienced teams of specialists Fair rates Should You Jump?

17 What The Experts Say 20-25% of all offshore outsourcing relationships fail in any 2-1/2 year period 50% of all offshore outsourcing relationships fail within 5 years - D&B Survey, 2004 Conclusion: if not done right and with the right partner (s), offshoring can carry a high risk!

18 Offshoring KSFs Organizational (yes, that s you!) Readiness (cultural / strategic / financial / risk) Crisp scope and boundaries definition Vendor selection process (fit / qualifications / track record) Governance (contract & program management, QA) Long-term (strategic) view Vendor-Specific FDA V&V expertise with proven track record for the specific device class (I, II, III) and type of V&V (SYS, SW, UI, Tools Validation, Process Validation, LIMS) CMMI Level 4 or 5 with the ability to tailor OR pass independent QSR audit Cost savings potential - at least 50%

19 ROS OLAM Process Framework

20 Conclusion: The Risk is Greater to NOT Offshore What is your competition doing right this instant? Have you looked at your opportunity cost? What areas are best suited for offshoring in your case? ROS OLAM Framework can help minimize you offshoring RISK No offshoring experience get help! Remember vendor selection is KEY Best-Of-Breed vs. One-Stop-Shop: both can work if done right Cost savings are secondary to quality of work products Adopt a long-term view to capture increased returns to scale

21 Medical Devices-V&V Off-shoring - A Service Provider s View-Point Venkatesan M. Head, Medical Devices Vertical HCL

22 The HCL Advantage Integrated Design and Test House Embedded Software Development Hardware Design Engineering Design Services Compliance Lab Proto Manufacturing Unit Partnerships with EMS Vendors Product Engineering 1500 Man Years of Product Development experience Class 2 and 3 Medical Devices Design to meet FDA / MDD Guidelines Seamless extension of Client s development group Process Compliance Medical Devices Practice Development Experience Medical Quality Management System ISO Certified 21CFR Part 820 Safety & Risk management : ISO14971 & IEC AAMI SW68:2001 Domain Expertise Embedded Systems Automotive Medical Industrial Aero Semi

23 Product Life Cycle Product Concept Requirements Definition System Architecture Product Development/ Re-engineering Product Sustenance & Enhancements Launch & Field Support Testing / Certification / Release Being an organization with significant product engineering strength, HCL can participate from Concept stage or from any Specific stage of the product life cycle

24 Product Development Service Map Hardware Engineering Architecture Board Design ASIC / FPGA System Engineering Test Jig Development Mechanical Engineering Industrial Design Engineering Design CAE Testing Reliability Analysis Integrated Design Services Software Engineering Architecture Device Drivers/Diagnostics RTOS/OS Porting GUI/PC based Software Product Specific Application Value Added Services PCB Design DFx Analysis System testing & validation Value Engineering Prototyping Product Testing & certification RoHS Services

25 HCL V&V Practice System Verification Environmental & Compliance Testing Mechanical Verification Tools Verification V&V Electrical Verification OTS / COTS Verification Software verification

26 Mechanical Verification Fatigue test Humidity test Vibration test Leakage test Altitude test Environmental tests Hot & Cold cycling Rain Chamber Dust Chamber UV Resistance Ozone resistance Rust Inhibition

27 Electrical Verification Hardware Functional Test Hardware Subsystem test Pre screening test Hardware Accelerated Stress Test ( HAST) Hardware Accelerated Lifetime Test ( HALT)

28 Software Verification Software Module Testing ( Unit Testing) Software Porting testing ( OTS/ COTS ) Software Integration Testing Software Subsystem Testing Software System Testing

29 Environmental Testing Product Validation -Test Lab Features Dry Heat Chamber: Ambient to 200 degree C Cold Chamber: Ambient to 65 degree C Thermal Shock chamber: - 65 degree C to +150 degree C Altitude Chamber: M to 25000M Climatic Chamber (2) :- -40 degree C to +200 degree C, 97% RH Humidity Chamber: 20% to 97% RH Salt Spray Chamber: For 5% to 30% salt and Humidity up to 97% RH Electro-dynamic Vibration and shock Table: Vibration 2000 kgf, max. G100, sine, random, shock, broad and short band Ultimate Testing Machine: Max. 40 T For Tensile, Compressive, Shear and torsion Hardness Tester: Shore, Vickers and Rockwell Solar Radiation Chamber: 1200 Watts / sq. m. intensity variable Dust & Rain Chamber: To conduct ingress protection test EMI / EMC Chamber 10 meter World Class Test Lab with an investme nt of $ 5.0 Million

30 Product Validation -Test Lab Snapshots Walk in Chamber Dry Heat Chamber Humidity Chamber 10 Meter Certification Facility Thermal Shock Chamber Vibration Chamber

31 Test Approach Test Planning Test Execution Product req. System level System test HW & S/W req Interface req. Component level HW & S/W Verification test Integration test Module req. Unit test : Work direction of Test specifications : Component parts of the tested unit

32 V&V Process flow Start Test Strategy Test Design(s) Test Protocol(s) Traceability Matrix Test Protocol(s) Dry run Yes Formal Test Execution Review Test results Test Pass? No Error in Protocol(s)? Yes Re-testing Required? Yes Approve Test record(s) No Log Defects No Correct Protocol(s) Regression Test Impact Analysis Yes Defect fix? No Test summary report Submit Documentation Done

33 Testing process work products Test management plan Test strategy document Test designs Test protocols Testing Traceability matrix Test execution plan Work instructions for Testers & Reviewers Test result review records Test log Test summary

34 Test Strategy Strategize test case design and execution Development of test cases Performance Functionality Boundary conditions Range, States Dependencies, Environmental Review and approval of test cases Execution of test cases Documentation of the test results Resolution of defects / issues found during execution Test Approach definition Various phases of test cycles involved

35 Typical Case Studies Sterilization Equipment Implantable Drug Delivery System Drug Delivery System Biopsy Systems Automated Test Equipment

36 Questions? The conference will now be in the Q/A mode. Please press 10 on your telephone keypad to alert the speaker that you have a question. You will be alerted with a beep when it is your turn to speak. Dan M. Mihai - Managing Consultant, Prius Medical Systems LLC Web: dan.mihai@priusmedical.com Venkatesan M. Head of Medical Devices Vertical, HCL Technologies Web: venkatm@hcl.in