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

SEVER HALL CONSULTING GROUP

Instrumentation LaboratoriesMedical Device Manufacturing

Process

December 9, 2010

Presented by:Sever Hall Consulting Group

Rita DistelDustin EspositoKathryn Holmes

Winston KuoMichael Snitkovsky

Davide Zocco

Page 2: SEVER HALL CONSULTING GROUP Instrumentation Laboratories Medical Device Manufacturing Process D ecember 9, 2010 Presented by: Sever Hall Consulting Group.

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 2010.

Background

Page 3: SEVER HALL CONSULTING GROUP Instrumentation Laboratories Medical Device Manufacturing Process D ecember 9, 2010 Presented by: Sever Hall Consulting Group.

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

Page 4: SEVER HALL CONSULTING GROUP Instrumentation Laboratories Medical Device Manufacturing Process D ecember 9, 2010 Presented by: Sever Hall Consulting Group.

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.

Page 5: SEVER HALL CONSULTING GROUP Instrumentation Laboratories Medical Device Manufacturing Process D ecember 9, 2010 Presented by: Sever Hall Consulting Group.

SEVER HALL CONSULTING GROUP

Impact of Fiber Contamination

Cartridges returned by costumer (35%)

Cartridges manufactured/yr: 285,000Defective cartridges/yr: 99,750Defective cartridges due to fiber contamination/yr: 24,938 Loss: $ 2M/year

$80.20/cartridge

Page 6: SEVER HALL CONSULTING GROUP Instrumentation Laboratories Medical Device Manufacturing Process D ecember 9, 2010 Presented by: Sever Hall Consulting Group.

SEVER HALL CONSULTING GROUP

Stakeholders

Page 7: SEVER HALL CONSULTING GROUP Instrumentation Laboratories Medical Device Manufacturing Process D ecember 9, 2010 Presented by: Sever Hall Consulting Group.

SEVER HALL CONSULTING GROUP

Name Interest Influence

Project Support(Verbally)

Project Support(Actions)

Project Support(Desired) Expectations

Ways to Manage Expectations

MichaelProject Manager High High Strong Strong Strong

Plan, schedule and coordinate detailed phases of the engineering work in a multi-departmental initiative to reduce manufacturing variability and increase quality.

MarkDirector of Operations

High High Strong Strong StrongNeeds to gain influence with engineers to validate proposed changes and provide support to obtain financial backing.

DougVP of Operations

High High Strong Weak StrongProvide 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 GroupParent Company, Sponsor

High Medium Strong Weak Strong Provide financial backingThe company is financially stable and profitable.

Name Interest Influence

Project Support(Verbally)

Project Support(Actions)

Project Support(Desired) Expectations

Ways to Manage Expectations

MichaelProject Manager High High Strong Strong Strong

Plan, schedule and coordinate detailed phases of the engineering work in a multi-departmental initiative to reduce manufacturing variability and increase quality.

MarkDirector of Operations

High High Strong Strong StrongNeeds to gain influence with engineers to validate proposed changes and provide support to obtain financial backing.

DougVP of Operations

High High Strong Weak StrongProvide 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 GroupParent Company, Sponsor

High Medium Strong Weak Strong Provide financial backingThe company is financially stable and profitable.

Name Interest Influence

Project Support(Verbally)

Project Support(Actions)

Project Support(Desired) Expectations

Ways to Manage Expectations

MichaelProject Manager High High Strong Strong Strong

Plan, schedule and coordinate detailed phases of the engineering work in a multi-departmental initiative to reduce manufacturing variability and increase quality.

MarkDirector of Operations

High High Strong Strong StrongNeeds to gain influence with engineers to validate proposed changes and provide support to obtain financial backing.

DougVP of Operations

High High Strong Weak StrongProvide 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 GroupParent Company, Sponsor

High Medium Strong Weak Strong Provide financial backingThe company is financially stable and profitable.

Name Interest Influence

Project Support(Verbally)

Project Support(Actions)

Project Support(Desired) Expectations

Ways to Manage Expectations

MichaelProject Manager High High Strong Strong Strong

Plan, schedule and coordinate detailed phases of the engineering work in a multi-departmental initiative to reduce manufacturing variability and increase quality.

MarkDirector of Operations

High High Strong Strong StrongNeeds to gain influence with engineers to validate proposed changes and provide support to obtain financial backing.

DougVP of Operations

High High Strong Weak StrongProvide 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 GroupParent Company, Sponsor

High Medium Strong Weak Strong Provide financial backingThe company is financially stable and profitable.

Name Interest Influence

Project Support(Verbally)

Project Support(Actions)

Project Support(Desired) Expectations

Ways to Manage Expectations

MichaelProject Manager High High Strong Strong Strong

Plan, schedule and coordinate detailed phases of the engineering work in a multi-departmental initiative to reduce manufacturing variability and increase quality.

MarkDirector of Operations

High High Strong Strong StrongNeeds to gain influence with engineers to validate proposed changes and provide support to obtain financial backing.

DougVP of Operations

High High Strong Weak StrongProvide 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 GroupParent Company, Sponsor

High Medium Strong Weak Strong Provide financial backingThe company is financially stable and profitable.

Impact of Key Stakeholders

Page 8: SEVER HALL CONSULTING GROUP Instrumentation Laboratories Medical Device Manufacturing Process D ecember 9, 2010 Presented by: Sever Hall Consulting Group.

SEVER HALL CONSULTING GROUP

Project Timeline and Tasks

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

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

Page 10: SEVER HALL CONSULTING GROUP Instrumentation Laboratories Medical Device Manufacturing Process D ecember 9, 2010 Presented by: Sever Hall Consulting Group.

SEVER HALL CONSULTING GROUP

Process Mapping

Page 11: SEVER HALL CONSULTING GROUP Instrumentation Laboratories Medical Device Manufacturing Process D ecember 9, 2010 Presented by: Sever Hall Consulting Group.

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

Page 12: SEVER HALL CONSULTING GROUP Instrumentation Laboratories Medical Device Manufacturing Process D ecember 9, 2010 Presented by: Sever Hall Consulting Group.

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

Page 13: SEVER HALL CONSULTING GROUP Instrumentation Laboratories Medical Device Manufacturing Process D ecember 9, 2010 Presented by: Sever Hall Consulting Group.

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%)

Page 14: SEVER HALL CONSULTING GROUP Instrumentation Laboratories Medical Device Manufacturing Process D ecember 9, 2010 Presented by: Sever Hall Consulting Group.

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

Page 15: SEVER HALL CONSULTING GROUP Instrumentation Laboratories Medical Device Manufacturing Process D ecember 9, 2010 Presented by: Sever Hall Consulting Group.

SEVER HALL CONSULTING GROUP

Questions?


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