Sustaining Capability from Design to Launch

Sustaining Capabilityfrom Design to Launch

Bruce K. JankowskiBruce K. JankowskiGlobal DirectorGlobal DirectorProduct Development ExcellenceProduct Development ExcellenceTyco HealthcareTyco Healthcare

Tyco Healthcare

• Tyco Int’l Splitting Into Three Separate Companies (2007)– Healthcare– Fire & Security– Electronics

• Tyco Healthcare - $10 Billion Company Poised for Accelerated Growth

– Healthcare• Medical Devices• Pharmaceuticals & Imaging• Medical Supplies• Retail

• Tyco Healthcare Portfolio Diversity & Resources– 50,000 Discrete Medical Products – 43,000 Employees World Wide

Tyco Healthcare…

US Surgical & Valleylab A leading manufacturer of innovative

wound closure products and advanced surgical devices available through the Auto Suture Division which offers a complete line of surgical devices and laparoscopic instrumentation and the Sutures Division, Syneture.

Mallinckrodt Imaging Mallinckrodt, an industry leader in imaging

provides a full line of contrast media and delivery systems, radiopharmaceuticals, and urology imaging systems for the diagnosis and treatment of disease in many imaging procedures.

Retail The Retail division develops, manufactures and

markets a wide variety of retail brand (private label) products for the retail markets.

Nellcor & Puritan Bennett Nellcor and Puritan Bennett products

include respiratory, oxygen and temperature monitoring devices.

Kendall Kendall manufactures and markets a broad range

of wound care, needle and syringes, vascular therapy, urological care, incontinence care, sharps disposal and nursing care products. Kendall's DOVER

Silver Foley Catheter

Pharmaceuticals Mallinckrodt’s many products offering supplies a wide

range of inactive ingredients used in countless other pharmaceuticals. Almost every tablet made in the US contains at least one Mallinckrodt product.

Measuring the Success New Product Development

New Product Metrics

Successful New Products: Achieve Targeted ROI Payback Periods Less Than 2 Years Achieve Targeted Market Share

Sustaining Performance Through Capable Production Leads to Improved Customer Satisfaction Resulting in High ROI

New Product Metrics …

Product Development Excellence

49% of Sales Derived From New Products

1 Out of 3.5 Product Ideas Executed to Launch

Where do you stand?

Product Development Norm

25.2% of Sales Derived From New Products

1 Out of 8.4 Product Ideas Executed to Launch

Voice of the Customer

& Product Development

Key Components of Product Development

DFSSTOOLS

ORGANIZATION& PEOPLE

TECHNOLOGY

ENABLERSENABLERS

Customers & Market Environment

Lean Design Product Development Process

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A Broad Approach for Collecting VOC

“Success”Customer Satisfaction

What Customers Say(Interviews)

What Customers Do(Appropriate Inquiry)

What Customers Create(Applications / Value)

A Comprehensive VOC Leads to Successful Development

How do you get your VOC?

Product-Out Organizations

● Make Product Decisions Using Internal Knowledge

● Believe Customers Don't Know Enough, or Aren't “Expert" Enough to Guide Company Decisions

● Get Customer Feedback Late in Product Development Cycle and Response is Gamble

Market-In Organizations

● Use Customer Data to Guide Decisions

● Solicit Customer Input Throughout Product Development Stages

● Involve Many Functions in Customer Interaction (e.g. Mktg., Eng., etc.)

● Obtain True Response From Market and Use Response to Guide Subsequent Product Releases

Most Companies Use a Mix of VOC Activities

Voice of Customer Translation & Application

Physical / FunctionalProperties

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Objective Measures

Objective Measures

Objective Measures

Objective Measures

Requirements & Specifications Flow

CTQs Identified at Each Level

Critical to Quality Characteristics & Capability

Effects of Variation Flow Up…

Product Functional Requirements

ProductSpecifications

Material & Process Specifications

CTQ Sensitivity

CTQ Requirements Flow Down – CTQ Variation Flows Up

CTQ Management Process

Develop Monitoring Plan for Key CTQs

Engineering & Manufacturing Investigations & Corrective

Actions

Develop plan to complete actions

Assign and Complete Projects

Process Control issue (special

causes)?

Yes

Continue Monitoring Mfg and Field Data

Reprioritize CTQs to Monitor and/or reduce sampling frequency with

evidence of quality

No

Analyze / Prioritize Top CTQs in DFSS Scorecard

Collect and Analyze Process Data (CTQ’s)

Collect and Analyze Field Data

Complete Analysis to Understand Current

CapabilityUpdate Scorecard

Complete / Update Measurement System

Analysis

CTQ Monitoring

Y = f (x1, x2, x3, x4, . . . xn)

CTQ Scorecard

DFSS-Critical Parameter Management Score CardProduct Spec -to- Process Spec Mapping

Product - Critical Specification:

Process - Critical Specification:

Measurement Technique: Target USL LSL %P/T Mean Std Dev Cp Cpk δProd/δProc

• Keeps Track of Important Information for Critical X’s:– Target Value and Spec Limits (USL, LSL)– Measurement System Capability (%P/T)– Process Capability (Mean, Standard Deviation, Cp, Cpk)

– Effect on Y’s (δProd/δProc)

If You’re Not Keeping Score – You’re Just Practicing