1. Sever Hall Consulting Group
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

2. Background 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.

3. Project Scope
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.
Definition: Intubation is the process of inserting a tube, called an endotracheal tube, into the mouth and then into the airway. This is done so that a patient can be placed on a ventilator to assist with breathing.

4. 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. 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. Stakeholders

7. Impact of Key Stakeholders
Name
Interest
Influence
Project Support
(Verbally)
(Actions)
(Desired)
Expectations
Ways to Manage Expectations
Michael
Project Manager
High
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
Needs to gain influence with engineers to validate proposed changes and provide support to obtain financial backing.
Doug
VP of Operations
Weak
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
Medium
Provide financial backing
The company is financially stable and profitable.
Name
Interest
Influence
Project Support
(Verbally)
(Actions)
(Desired)
Expectations
Ways to Manage Expectations
Michael
Project Manager
High
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
Needs to gain influence with engineers to validate proposed changes and provide support to obtain financial backing.
Doug
VP of Operations
Weak
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
Medium
Provide financial backing
The company is financially stable and profitable.
Name
Interest
Influence
Project Support
(Verbally)
(Actions)
(Desired)
Expectations
Ways to Manage Expectations
Michael
Project Manager
High
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
Needs to gain influence with engineers to validate proposed changes and provide support to obtain financial backing.
Doug
VP of Operations
Weak
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
Medium
Provide financial backing
The company is financially stable and profitable.
Name
Interest
Influence
Project Support
(Verbally)
(Actions)
(Desired)
Expectations
Ways to Manage Expectations
Michael
Project Manager
High
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
Needs to gain influence with engineers to validate proposed changes and provide support to obtain financial backing.
Doug
VP of Operations
Weak
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
Medium
Provide financial backing
The company is financially stable and profitable.
Name
Interest
Influence
Project Support
(Verbally)
(Actions)
(Desired)
Expectations
Ways to Manage Expectations
Michael
Project Manager
High
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
Needs to gain influence with engineers to validate proposed changes and provide support to obtain financial backing.
Doug
VP of Operations
Weak
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
Medium
Provide financial backing
The company is financially stable and profitable.
Click through slides to see each row highlighted individually.

8. Project Timeline and Tasks
The first step in creating a accurate and achievable Project timeline was to define the Scope and determine Goals and Objectives. Having a solid understanding of what we were trying to accomplish allowed us to Detail out the requirements and test plan. Using these documents we were able to capture the necessary tasks, assign resources and ensure the schedule was realistic.
The team reviewed the timeline in detail internally and with the customer. This limited the risk of scope creep. The team stayed focused on the Critical Path to ensure we met our objectives.
Because we took the time up front to plan the work we had no changes to schedule and there fore no Change Management. The project stayed on track, within scope and met the deadlines. 8

9. Project failure may lead to loss of Market Share
Risk Analysis
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

10. Process Mapping

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

12. Implemented Pilot Testing
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%

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

14. Follow-up 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

15. Questions?