Reducing Time to Market while ensuring Product Quality and Reliability to Gain Customer Preference and Meet Company Demands

Reducing Time to Market while ensuring Product

Quality and Reliability to Gain Customer Preference

and Meet Company Demands

Reducing Time to Market while ensuring Product

Quality and Reliability to Gain Customer Preference

and Meet Company DemandsSharon Rozzi

Lean Six Sigma Master Black Belt

January 15, 2009

Sharon Rozzi

Lean Six Sigma Master Black Belt

January 15, 2009

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AgendaAgenda

1. About Boston Scientific

2. Our Lean Six Sigma Strategy in R&D

3. Leading with Lean

4. Delivering results with Six Sigma

5. Institutionalizing Lean with DFSS

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Boston Scientific Corporation Profile

General Facts:

• Founded in 1979 with 38 employees and $2 million in sales

• Now a global leader in cardiovascular medicine and one of the world’s largest medical device companies

• Portfolio of approx. 13,000 products, many with market leading positions

• The TAXUS® drug-eluting coronary stent was the most successfully launched product in the history of the industry

• Added Cardiac Rhythm Management Group through acquisition of Guidant Corporation in April 2006

• Corporate HQ: Natick, MA

• Regional HQs: Paris, Tokyo, Singapore

• Website: www.bostonscientific.com

Product Innovation:• 13,818 Patents issued worldwide• $1.1 Billion invested in R&D (’07)• $475 Million invested in 20 alliances/

acquisitions (’07)

Financials:• $8.4 Billion Revenue (’07)• 25% CAGR1 (’03-’07)• $1.2 Billion Net Income2 (’07)• NYSE: BSX

Demographics:• 25,000 Employees• Dedicated marketing and sales force in

more than 45 countries• 37 manufacturing, distribution and

technology centers worldwide

1. Compound Annual Growth Rate2. Excluding acquisition, litigation,

divestiture, restructuring, and other charges

Boston Scientific is a global, Fortune 500 company focused on innovative medical devices and proceduresBoston Scientific is a global, Fortune 500 company focused on innovative medical devices and procedures

4

Boston Scientific’s mission is to improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less-invasive medical devices and procedures.

Boston Scientific’s Mission Statement

Boston Scientific’s mission is to improve the quality of patient care and increase health care productivityBoston Scientific’s mission is to improve the quality of patient care and increase health care productivity

This is accomplished through the continuing refinement of existing products and procedures and the investigation and development of new technologies that can reduce risk, trauma, cost, procedure time and the need for aftercare.

5

Boston Scientific is advancing patient care across a broad range of medical specialtiesBoston Scientific is advancing patient care across a broad range of medical specialties

PERIPHERAL VASCULAR

PAIN MANAGEMENTELECTROPHYSIOLOGY

GYNECOLOGY

NEUROVASCULAR

UROLOGY

CARDIAC RHYTHMMANAGEMENT

GASTROENTEROLOGY

ONCOLOGY

INTERVENTIONALCARDIOLOGY

INTERVENTIONALRADIOLOGY

INTERVENTIONALBRONCHOSCOPY

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Sampling of Boston Scientific’s Product Portfolio

29 years of innovation have led to a broad and deepportfolio of more than 13,000 products29 years of innovation have led to a broad and deepportfolio of more than 13,000 products

Stents Embolic ProtectionBalloons Catheters / Guidewires Ultrasound Imaging

Lithotripsy SystemsStone Retrieval Enteral FeedingEmbolicsBiopsy Systems

Pacemakers / ICDs Detachable CoilsAblation Peripheral Dilatation Neurostimulation

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AgendaAgenda

1. About Boston Scientific

2. Our Lean Six Sigma Strategy in R&D

3. Leading with Lean

4. Delivering results with Six Sigma

5. Institutionalizing Lean with DFSS

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Boston Scientific Corporation Confidential 8

Our Lean Six Sigma Strategy in R&DOur Lean Six Sigma Strategy in R&D

Our Mission: Boston Scientific’s mission is to improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less-invasive medical devices and procedures.

Goals: To be our customers’ first choice

Strategy: Rapid delivery of Exceptional Products

Tactics: • Lean

• Six Sigma DMAIC

• Design for Six Sigma

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Moving towardLeadership…

DFSSDesigning new products with exceptional

capability for meeting customer needs

DMAICReduce variation, Shift performance

Lean(Speed)

Identify value, eliminate waste, Create flow, pull instead of push

Pro

cess

Impr

ovem

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Custom

er Responsiveness

Six Sigma Capability

We believe Lean Six Sigma will help us serve our customers better and make us a marketplace leaderWe believe Lean Six Sigma will help us serve our customers better and make us a marketplace leader

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AgendaAgenda

1. About Boston Scientific

2. Our Lean Six Sigma Strategy in R&D

3. Leading with Lean

4. Delivering results with Six Sigma

5. Institutionalizing Lean with DFSS

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Leading with LeanLeading with Lean

• Key Lean principles:

– Specify Value

– Identify the Value Stream

– Make the value-creating steps Flow continuously

– Let customers Pull value from the enterprise, rather than push

– Drive to Perfection with continuous improvement

Original Lead Time

Value Added Non-Value Added

Typical Process

Traditional Improvement

Lean Improvement

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There is growing recognition that Lean can be applied to Quality SystemsThere is growing recognition that Lean can be applied to Quality Systems

October 2008

Extending ‘Lean’ Principles to Quality Systems How Physio-Control, Osmetech and Kyphon Ues “Lean quality” to Beat Problems

ADOPTING "LEAN" MANUFACTURING may be an option for some device firms as they cut costs during rough economic times, but the concept should be extended to their quality systems to prove truly effective, experts say. "Don’t make quality lean, but integrate quality throughout your lean process," says Linda Lovett, a consultant who implemented lean quality methods at Abbott Laboratories and Medtronic subsidiary Kyphon. Meanwhile, another Medtronic division, Physio-Control, is optimistic it will soon clear up its FDA compliance problems in part because it is adopting lean quality, and small manufacturer Osmetech says it now closes CAPAs quicker because of the technique. "By applying that tool, I’m able to have regularly scheduled meetings for CAPAs," says Bob Dicheck, VP of quality & regulatory for Osmetech.

Extending ‘Lean’ Principles to Quality Systems How Physio-Control, Osmetech and Kyphon Ues “Lean quality” to Beat Problems

ADOPTING "LEAN" MANUFACTURING may be an option for some device firms as they cut costs during rough economic times, but the concept should be extended to their quality systems to prove truly effective, experts say. "Don’t make quality lean, but integrate quality throughout your lean process," says Linda Lovett, a consultant who implemented lean quality methods at Abbott Laboratories and Medtronic subsidiary Kyphon. Meanwhile, another Medtronic division, Physio-Control, is optimistic it will soon clear up its FDA compliance problems in part because it is adopting lean quality, and small manufacturer Osmetech says it now closes CAPAs quicker because of the technique. "By applying that tool, I’m able to have regularly scheduled meetings for CAPAs," says Bob Dicheck, VP of quality & regulatory for Osmetech.

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Examples of Waste in Product Development CompaniesExamples of Waste in Product Development Companies

Defective Products • Drawing or code errors• Work does not match customer needs

• Excessive changes, scrap• Rework, scrap, warranty

Over Production • Working w/ incomplete requirements• Not using standard parts and subs• Extra software features customer doesn’t want

• Queue time drives lead-time• No re-use of knowledge• Drives supply chain variation

Excessive Inventories

• Projects ≠ desired future business• Work-in-process exceeds capacity• Partially done work

• Long lead-time, rework• Investment not realized

Excessive Motion • Excessive engineering changes• Requirements change impact design• Moving info from one person/ group to another

• Barriers to adding value• Capacity consumed by rework

Excessive Processing

• Unnecessary items specified• Too may approvals required• Too much “paperwork”

• Ineffective use of skills• No decision rules• Drives rework and inflexibility

Transportation • Excessive approvals and controls• Process monuments• Task switching on multiple projects

• Queue time, work-arounds• Batch processing, no flow

Waiting • Workload ≠ capacity• Excessive multi-tasking• Delays due to reviews/ approvals/ testing/

deployment/ staffing/ workload

• Project sits for next “event”• Not cost effective• Inefficiencies built-in

Waste Category Example Implication

Lean helps us see what is slowing down product developmentLean helps us see what is slowing down product development

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1. About Boston Scientific

2. Our Lean Six Sigma Strategy in R&D

3. Leading with Lean

4. Delivering results with Six Sigma

5. Institutionalizing Lean with DFSS

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Delivering Results with Six SigmaDelivering Results with Six Sigma

• Implementing Lean Solutions is not enough

• Cycle time to show better products getting out the door faster is too long

• Need earlier feedback

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• Six Sigma DMAIC can …– Identify root cause of the waste

that is slowing down product development

– Simultaneously improve speed and quality

– Provide early feedback that the lean approaches are working

– Create accountability

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Six Sigma DMAIC keeps Counter-balancing Measures Front and CenterSix Sigma DMAIC keeps Counter-balancing Measures Front and Center

Reduce Cycle Time

Reduce Effort

Improve Quality

Process

Counter-Balancing OutputsInputs

• Quality• Cycle Time• Effort

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Example: Reducing ReworkExample: Reducing Rework

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Example: Increasing ReuseExample: Increasing Reuse

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Other Examples of Six Sigma DMAIC Project Objectives we are driving in R&DOther Examples of Six Sigma DMAIC Project Objectives we are driving in R&D

Increase Knowledge Capture and Reuse

Increase Report Utility

Reduce Cycle TimeReduce Effort

Improve theon-boarding

process

Reduce Testing Cycle Time for earlier feedback

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1. About Boston Scientific

2. Our Lean Six Sigma Strategy in R&D

3. Leading with Lean

4. Delivering results with Six Sigma

5. Institutionalizing Lean with DFSS

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Defining Design for Six SigmaDefining Design for Six Sigma

• Design for Six Sigma (DFSS) is a methodology for developing new products with exceptional capability for meeting customer needs.

• DFSS is inherently anti-waste because it focuses on delivering customer value and preventing defects

• DFSS supports the Lean Product Development System

LSL USL

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The Lean Product Development SystemThe Lean Product Development System

Set-based Concurrent Engineering

Expert Engineering Workforce

Responsibility-based

Planning &Control

System Designer

Entrepreneurial Leadership

Operational Value Stream

to the Customer

The Lean Product Development System has little waste, and good flow of value-creating activities

The Lean Product Development System has little waste, and good flow of value-creating activities

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The Lean Product Development System is a Paradigm ShiftThe Lean Product Development System is a Paradigm Shift

From

• Highly structured PDP

• Detailed task/ procedure descriptions

• Early component specification definition

• Manager as administrator

• Detailed project plans

To

• Knowledge-based product development

• Detailed quality standards for the work product

• Just-in-Time

• Engineering expert/ mentor

• Firm integration dates

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The DFSS toolkit helps institutionalize the Lean Product Development SystemThe DFSS toolkit helps institutionalize the Lean Product Development System

Set-based Concurrent Engineering

Expert Engineering Workforce

Responsibility-based

Planning &Control

System Designer

Entrepreneurial Leadership

Operational Value Stream

to the Customer

• Voice of Customer

• KJ Analysis• House of Quality• Pugh Concept

Selection• DFMEA• Capability

Studies• Factorial

Designed Experiments

• Response Surface Methodology

• Measurement System Analysis

• Critical Parameter Management

• Control Plans

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Our Results with Lean Six Sigma in R&DOur Results with Lean Six Sigma in R&D

• In 2008 we introduced COGNIS™ Cardiac Resynchronization Therapy Defibrillator (CRT-D) and TELIGEN™ Implantable Cardioverter Defibrillator (ICD)

– The smallest, thinnest, high-energy CRT-D and ICD in the world– These full-featured devices were designed, built and tested with patient

safety, quality and reliability in mind.

• 3-7% YOY Productivity Improvement

Moving towardLeadership…

DFSSDMAIC

Lean

Pro

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Six Sigma Capability

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SummarySummary

• Lean is helping us see what is slowing down product development (the “waste”)

• Six Sigma DMAIC is helping us identify root cause of the waste, and simultaneously improve speed and quality. It is also creating early proof that the lean approaches are delivering results.

• The Design for Six Sigma toolkit is helping us institutionalize a Lean Product Development system

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