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SEVER HALL CONSULTING GROUP Instrumentation Laboratories Medical Device Manufacturing Process D ecember 9, 2010 Presented by: Sever Hall Consulting Group.

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Presentation on theme: "SEVER HALL CONSULTING GROUP Instrumentation Laboratories Medical Device Manufacturing Process D ecember 9, 2010 Presented by: Sever Hall Consulting Group."— Presentation transcript:

1 SEVER HALL CONSULTING GROUP Instrumentation Laboratories Medical Device Manufacturing Process D ecember 9, 2010 Presented by: Sever Hall Consulting Group Rita Distel Dustin Esposito Kathryn Holmes Winston Kuo Michael Snitkovsky Davide Zocco

2 SEVER HALL CONSULTING GROUP Instrumentation Laboratory (part of Werfen Group) Headquartered in Bedford, Massachusetts. Founded in 1959 has operations worldwide. Market leader in diagnostic instruments for real-time blood testing - 40% market share. Primary stakeholders are hospitals. Innovative technology - GEM Premier 4000 cartridges. 285,000 GEM 4000 cartridges projected to be sold in Background

3 SEVER HALL CONSULTING GROUP Background: GEM 4000 cartridges are used during surgery to measure patients physiological parameters and provides real-time information to a surgeon. Scope: Identify the root cause of the source(s) of fiber contamination of cartridge. Propose solution(s) to mitigate fiber contamination. Project Scope

4 SEVER HALL CONSULTING GROUP Impact of defective cartridge Actual incident: 10/16/2010: Infant at local hospital was intubated due to a cartridge malfunction – improper/inaccurate Oxygen reading. Cartridge evaluation: Fiber contamination on Oxygen sensor.

5 SEVER HALL CONSULTING GROUP Impact of Fiber Contamination Cartridges returned by costumer (35%) Cartridges manufactured/yr: 285,000 Defective cartridges/yr: 99,750 Defective cartridges due to fiber contamination/yr: 24,938 Loss: $ 2M/year $80.20/cartridge

6 SEVER HALL CONSULTING GROUP Stakeholders

7 SEVER HALL CONSULTING GROUP NameInterestInfluence Project Support (Verbally) Project Support (Actions) Project Support (Desired)Expectations Ways to Manage Expectations Michael Project ManagerHigh Strong Plan, schedule and coordinate detailed phases of the engineering work in a multi- departmental initiative to reduce manufacturing variability and increase quality. Mark Director of Operations High Strong Needs to gain influence with engineers to validate proposed changes and provide support to obtain financial backing. Doug VP of Operations High StrongWeakStrong Provide financial backing and influence from company owners Need to find a more effective method to show a need to spend money to improve the process. Doug expressed strong concerns about the quality but feels that R&D is responsible to propose changes. R&D is currently running an 18-month study. Werfen Group Parent Company, Sponsor HighMediumStrongWeakStrongProvide financial backing The company is financially stable and profitable. NameInterestInfluence Project Support (Verbally) Project Support (Actions) Project Support (Desired)Expectations Ways to Manage Expectations Michael Project ManagerHigh Strong Plan, schedule and coordinate detailed phases of the engineering work in a multi- departmental initiative to reduce manufacturing variability and increase quality. Mark Director of Operations High Strong Needs to gain influence with engineers to validate proposed changes and provide support to obtain financial backing. Doug VP of Operations High StrongWeakStrong Provide financial backing and influence from company owners Need to find a more effective method to show a need to spend money to improve the process. Doug expressed strong concerns about the quality but feels that R&D is responsible to propose changes. R&D is currently running an 18-month study. Werfen Group Parent Company, Sponsor HighMediumStrongWeakStrongProvide financial backing The company is financially stable and profitable. NameInterestInfluence Project Support (Verbally) Project Support (Actions) Project Support (Desired)Expectations Ways to Manage Expectations Michael Project ManagerHigh Strong Plan, schedule and coordinate detailed phases of the engineering work in a multi- departmental initiative to reduce manufacturing variability and increase quality. Mark Director of Operations High Strong Needs to gain influence with engineers to validate proposed changes and provide support to obtain financial backing. Doug VP of Operations High StrongWeakStrong Provide financial backing and influence from company owners Need to find a more effective method to show a need to spend money to improve the process. Doug expressed strong concerns about the quality but feels that R&D is responsible to propose changes. R&D is currently running an 18-month study. Werfen Group Parent Company, Sponsor HighMediumStrongWeakStrongProvide financial backing The company is financially stable and profitable. NameInterestInfluence Project Support (Verbally) Project Support (Actions) Project Support (Desired)Expectations Ways to Manage Expectations Michael Project ManagerHigh Strong Plan, schedule and coordinate detailed phases of the engineering work in a multi- departmental initiative to reduce manufacturing variability and increase quality. Mark Director of Operations High Strong Needs to gain influence with engineers to validate proposed changes and provide support to obtain financial backing. Doug VP of Operations High StrongWeakStrong Provide financial backing and influence from company owners Need to find a more effective method to show a need to spend money to improve the process. Doug expressed strong concerns about the quality but feels that R&D is responsible to propose changes. R&D is currently running an 18-month study. Werfen Group Parent Company, Sponsor HighMediumStrongWeakStrongProvide financial backing The company is financially stable and profitable. NameInterestInfluence Project Support (Verbally) Project Support (Actions) Project Support (Desired)Expectations Ways to Manage Expectations Michael Project ManagerHigh Strong Plan, schedule and coordinate detailed phases of the engineering work in a multi- departmental initiative to reduce manufacturing variability and increase quality. Mark Director of Operations High Strong Needs to gain influence with engineers to validate proposed changes and provide support to obtain financial backing. Doug VP of Operations High StrongWeakStrong Provide financial backing and influence from company owners Need to find a more effective method to show a need to spend money to improve the process. Doug expressed strong concerns about the quality but feels that R&D is responsible to propose changes. R&D is currently running an 18-month study. Werfen Group Parent Company, Sponsor HighMediumStrongWeakStrongProvide financial backing The company is financially stable and profitable. Impact of Key Stakeholders

8 SEVER HALL CONSULTING GROUP Project Timeline and Tasks

9 SEVER HALL CONSULTING GROUP High Risk Identify root cause but not able to determine satisfactory solution. Resource constraints to identify and complete testing. Medium Risk Failure to identify root cause of fiber contamination. Not able to complete the project within the required timeline. Low Risk Identify root cause but not able to obtain financial support to implement the changes. Training required to implement changes maybe too time consuming or IL may be required to modify employees' skill set. Automation equipment does not exist in market place and would need to be custom designed. Required changes may render product no longer financially feasible. Project failure may lead to loss of Market Share Risk Analysis

10 SEVER HALL CONSULTING GROUP Process Mapping

11 SEVER HALL CONSULTING GROUP Performance Metrics What do we measure? Fibers Colorful Clothes Cardboard boxes Workers (hair, make-up etc..) Transparent Manufacturing process Dust Ventilation system

12 SEVER HALL CONSULTING GROUP Phase I - Hygiene & Work Environment Hypothesis: Colorful fibers from clothing and paper fibers from cardboard boxes are transferred to the product Wear jump suits instead of lab coats Gloves must be worn at all times No make up/lotions policy Beard nets Cardboard boxes cannot be stored near the cleanroom Sweaters and jackets cannot be stored near the cleanroom Phase II - Work Environment Hypothesis: Frequently opened door allows dust particles to enter the cleanroom and contaminate product Process glass disks in the hood Relocate operation further away from the door Phase III - Process Change Hypothesis: Operators are rushed which may negatively impact quality Decrease batch size by 10% Eliminated rejects due to colorful fibers during in-process inspection Significantly reduced rejects due to dust particles during in-process inspection, from 5.5% to 1.2% The reject rate during in-process inspection increased by 11% Implemented Pilot Testing

13 SEVER HALL CONSULTING GROUP Impact of short-term pilot study Cartridges returned by costumer (35%) $ 2M/year (loss)$ 1.66M/year (loss) Overall fiber contamination rate decreased by 17% upon testing by the simulation lab, translating into potential ~$340,000 annual savings. Defective cartridges due to fiber contamination/yr: 24,938 (8.8%)/ (20,699)(7.3%)

14 SEVER HALL CONSULTING GROUP Retraining of personnel Review current inspection criteria (quality control) and modify SOP/workstation based on more data in conjunction with quality control department Modify new employee application guidelines Conduct brainstorming exercise to identify further process improvement opportunities Follow-up

15 SEVER HALL CONSULTING GROUP Questions?


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