Product Planning And Development Process

Hans Hjort Hans Hjort Consulting

hhjort@cinci.rr.com

Typical Product Development Review structure

Typical Phases User Needs Design Planning Design Input TDR I Design Output TDR II
Process Design Completed VOC Defined VOC Approach proposed Performance Requirements defined Product Concept proposed

Technical Design Reviews

Opportunity

Management Reviews

MK
Gate 1 Gate 2

M0
M1

Product Design completed Process Concept proposed

Gate 3 Design Verification & Validation Design Transfer

Verification and Validation Prototypes built Test Plan proposed

TDR III
Product Released and Launched

Gate 4
Ship to Volume

Post Launch Review

On-going Commercialization
Copyright 2001, Hans Hjort Consulting.

Product and Product and technology Planning

Technology Planning

Business Vision/Mission

1. 1.

PP 5.

Job 2 Job 1

Customers
Job 3 Job 5

Job 4 Job n

2.
5. 3.

Innovation Process

Solutions Bookshelf

Potential Technologies

TP

4.
Potential solutions

Early Marketing and ClinicalDefine Roles

Seminal Idea

Marketing takes the lead on identifying jobs and collecting data (imp. & sat.) from customers
Job 2 Job 1 Job 4 Job n

Customers
Job 3 Job 5

Jobs can be: Clinical Operational Social Economic Etc.

Business/Marketing are involved in selecting attractive jobs for plannedt effort.

Job 3

Job 5

Attractive jobs could be new outcomes, jobs that we do not currently address, jobs that are important but nobody has been able to satisfy well, or jobs where we have a distinct competitive disadvantage

Business Case/Project Charter 4

Opportunity Space
(US, Europe, and Japan)
Customer Jobs
Endoluminal Surgery CR (Lap & Open) IC (Lap & Open) CC (Lap & Open)

Open JejunoJejunostomy
Open Gastrojejunostomy Laparoscopic JejunoJejunostomy

Laparoscopic Gastrojejunostomy
Park BAR Sutures Glue Staples

Customer Groups

(Surgeons)

1
Technologies
Copyright 2001, Hans Hjort Consulting.

2
Initial Focus

Next Potentials

Customers

Process Map
Validation

Input

System

Subsystem

Component

Process

Copyright 2001, Hans Hjort Consulting.

To Satisfy The Customer...

Customers
Performance Parameters. V O C Market Strategy

Business Case/Project Charter

Regulatory requirements

Basic Expectations

Techn. Targets Critical Parameters

80/20
Internal Standards
Non-Critical Parameters

A B
Concept Evaluation

System Requirements

Best Concept

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Product Planning

Plan
VOC Needs & Wants

Evaluate / Select
Performance Parameters

Deploy

Plan
Sub-system 1

Relative importance/satisfaction of needs Alternative Concepts Sub-systems Sub-system 2

System Targets

Internal Business Criteria Sub-system n Selected System Level Concept(s) Prioritize Sub-systems

Etc.
Copyright 2001, Hans Hjort Consulting.

System level Planning matrix

Scorecard
System Planning Matrix (VOC Based)
System Name:
Product Level Requirement CTQ Sedation Delivery System Target Value Owner Lower Upper Other Other Other Capability Capability Capability Mean Std. Dev. Cpk/Reliability Method Mean Std. Dev. Cpk/Reliability Method Mean Std. Dev. Cpk/Reliability Method Measurement System Analysis Design Prediction SDS100/SD

Product Code: SD01

Owner:
Design Verification Process Validation Data

Date: 5/29/2003

System Parameters

NUD

Limit Nominal Limit

Level of Automation

Market Strategy

The system will automatically detect when respiratory rate is "0" for 30 sec. 99.99% of the time. Accuracy of Monitoring System Respiratory Rate EtCO2 Accuracy # of User Interaction steps/time 19/20 of the trained users shall change infusion rate within 3 sec. while at equipment. 19/20 of trained users shall be capable of a total procedure setup time (up to drug start) <45 sec. End case turn-around: 19/20 of trained users shall be capable of the following interaction times: Total procedure removal time < 45 sec., Total recovery removal time <1 min.,(< 1.5 min when patient connected to entire system at once)"

0.9999

Y Y

3 bpm 12%

Y Y

3 seconds <45 seconds

<45 seconds

Customer Needs (VOC)

Vital few (CTQs) to support market strategy

Technical Strategy (parameters targets)

Most significant Parameters to satisfy the needs Significant System Parameters and Targets (requirements)

Copyright 2001, Hans Hjort Consulting.

Voice of Customer (VOC)

What is a VOC ? Customers
Start with long list of customer issues (mix of needs and features from different sources)
Customer interviews and observations

Then rephrase, eliminate, transfer issues to result in manageable list (10-25) For example:
I need the patient to receive the exact prescription that was ordered by the doctor.

Not how it may be accomplished:

I need the pump to be able to be programmed automatically from the pharmacy system

Not to be included in the VOC list:

Givens (or basic expectations) Regulations and standards VOB (Voice of Business)

The list of VOCs defines our opportunity for competitive advantage

Market Strategy

79 customer issues (mix of needs and features from different sources

25 customer needs (VOC) 6 CVOC

Opportunity Space Market strategy (Spider Chart)

5 4 3 2 1

Team members know what to accomplish for customers and why

Copyright 2001, Hans Hjort Consulting.

Needs vs. Customer Satisfaction (Kano)

Very Satisfied

Customers

Latent Needs

Articulated Needs

Did not Address Customer Need at all

Fully Supplied Customer Need

Basic Expectations

Very Dissatisfied Customers

Copyright 2001, Hans Hjort Consulting.

Voice of Customer (VOC)

What do we need to know about the VOC ?

Importance:
Is this issue (VOC) important enough to the customer to be recognized if satisfied better by us than our competitors?

Satisfaction:
How well does the customer feel our current product satisfies each VOC?

How well does the customer feel ours and our competitors products satisfies each VOC?

By collecting these perceptions from the customers we are able to understand the landscape that we are trying to influence to achieve the results identified in the project charter

Product Requirement
What converts a VOC to a product requirement?

Desired/Future Satisfaction:
Knowing the current situation surrounding the VOCs, the development team assigns the satisfaction profile that must be achieved to gain the desired competitive position The desired satisfaction profile is based on the teams assessment about current state of technologies as well as the product/company image that must be reinforced. The team also considers potential competitor moves prior to launch

Product Requirement:
A product requirement is the VOC supplemented by the satisfaction goal assigned by the team and approved by management This can be communicated by means of a Spider chart (or Radar chart)

Competitive Market Position (Trocars)

I do not want the internal cannula to be in the way, i.e. it prevents sword fighting

I always want the right trocar configuration to be available to me.

I do not want interference with my external range of motion

I want to minimize the risks of incisional herniation

I want it to stay where it is placed and not slip in or out

I want to be able to do one-handed instrument exchange

I want to be able to access tissue deep in the body

Ours Importance 15

Comp #1 Satisfaction

Comp #2

Planned Competitive Position (Comp #1)

I do not want the internal cannula to be in the way, i.e. it prevents sword fighting

I always want the right trocar configuration to be available to me.

I do not want interference with my external range of motion

Gold Space Competitive Advantage

I want to minimize the risks of incisional herniation

I want it to stay where it is placed and not slip in or out

Red Space Current Competitor/us

I want to be able to do one-handed instrument exchange

White Space Future opportunity

I want to be able to access tissue deep in the body

Comp #1 Importance 16 Satisfaction

Our New

Market Strategy
(Survey) I want to bring my next patient into the procedure room as soon as possible

Once I start a procedure, I don't want to be distracted

Gold Space Competitive Advantage I want a system that can be set-up fast I always want to be able to override a system's actions

I want the system that can be moved easily between procedure areas I want to avoid adverse events

Green Space Current Situation

I want detailed timely record keeping of procedure events whenever requested Importance 17 Satisfaction Current

White Space Future opportunity Planned Satisfaction

Planning Matrix (House of Quality)

How Interdependencies

How List Performance Parameters

W h a t L i s t
Relationships 1 = Mild Link 3 = Moderate Link 9 = Strong Link

Whys
Market perception

V O C

Whys vs. Whats

How Muches

How vs. How Muches

Technical reality and priority

Copyright 2001, Hans Hjort Consulting.

Performance Parameters
What is a performance parameter? Performance parameter:
A definition of a tangible/measurable deliverable by the future product At this point, the future product concept may not yet have been defined The performance parameters becomes the mean by which we can influence satisfaction of the VOCs By delivering more or less of a parameter we will satisfy one or more VOCs more or less
Performance parameters such as Number of interactions/transactions between doctor and medication delivery and level of authentication for access to prescription would have an impact on the VOC I need the patient to receive the exact prescription ordered by the doctor

Once we assign a target to a performance parameter it becomes a system requirement

Planning Matrix-Performance Parameters

Consider product as a black box to focus on what a solution (product) should deliver (performance parameters) rather than what it is

PEI

Issues/needs

Parameters

It may be helpful to use a fishbone diagram to clearly identify which parameters are influencing which issues/needs.

Number of transactions between doctor and medication delivery) I need the patient to receive the exact prescription ordered by the doctor

level of authentication for access to prescription)

Copyright 2001, Hans Hjort Consulting.

Correlation between Performance Parameters and VOCs

Why correlation:
To understand the role of a parameter in satisfying a given VOC

To understand the role of a parameter in addressing all VOCs

To understand if all VOCs has been adequately addressed To deliver background for Prioritization of parameters

Typically restricted to Blank, 1, 3, 9

9 - This Performance Parameter could on its own deliver 75%-100% on this issue/need 3 - This Performance Parameter could on its own deliver 25%-75% on this issue/need, other variables are also needed to deliver on the issue/need 1 - This Performance Parameter have some effect <25% on delivery of this issue/need Blank - This Performance parameter has no effect on how this issue/need is satisfied

Correlation between Performance Parameters and VOCs

Number of transactions between doctor and medication delivery)

How is it captured and documented?

How Interdependencies

How List Performance Parameters

W

Why

h
V a t L i
Relationships 1 = Mild Link 3 = Moderate Link 9 = Strong Link

Why vs. What

I need the patient to receive the exact prescription ordered by the doctor

9
Relationships 1 = Mild Link 3 = Moderate Link 9 = Strong Link

s t

Identify CTQs
What is a CTQ?
As the name Critical to Quality implies, we must identify the performance parameters that will be critical to us achieving the level of quality that is desired. A commonly accepted definition of quality is its measure as customer satisfaction Critical to quality must then mean the performance parameters critical to achieve our desired level of customer satisfaction

How is the CTQ selected?

First, identify the VOCs that shows the largest increase/stretch in satisfaction (between how our customers currently are satisfied to how we plan to satisfy them) (CVOCs)

Then, select the parameters that strongly impact our ability to satisfy those CVOCs. These parameters will be our CTQs since they will be either New, Unique, or Difficult.
Additional CTQs could also be selected from compliance requirements if new regulations took effect. If not, we already are delivering on these.

Identify Significant Performance Parameters

What is a Significant Performance Parameter?
In addition to the CTQs we also want to identify the performance parameters that will have a major/ significant impact on how we satisfy the overall list of VOCs. These are then major contributors to our success.

This is where we utilize the planning matrix to allow us to generate a quantitative measure for the impact any parameter can have on the overall list of VOCs..
Number of transactions between doctor and medication delivery

Modified Importance

MI=Imp x future sat/current sat.

I need the patient to receive the exact prescription ordered by the doctor

40

I need to be confident that only my facility's prescribed medication will be administered

30.6

Overall Impact

452

Setting Targets for Performance Parameters

What drives the targets?

For CTQs and other significant Parameters:

The delivery of the parameter by our current product and by competitors products resulting in the corresponding level of satisfaction

Our target must show similar aggressiveness in the parameter delivery as shown for the correlated satisfaction stretch
Based on development time constraints, several targets may be identified (current project, 5 year out, ideal) Current project targets must be assessed to deliver on the desired satisfaction profile and future targets would identify potential future product requirements

Planning Matrix (House of Quality)

How Interdependencies

How List Performance Parameters

W h a t L i s t
Relationships 1 = Mild Link 3 = Moderate Link 9 = Strong Link

Whys
Market perception

V O C

Whys vs. Whats

How Muches

How vs. How Muches

Technical reality and priority

Copyright 2001, Hans Hjort Consulting.

Key Parameters - Trocar

Planned Improvement
Effective seal opening for specimen removal (TBD) Internal drag force (instrument to trocar) (.1-1.3 lbs)

Housing height (1.0-2.5 in.) Housing/obturator profile/geometry (ergonomics) (TBD)

Smoothness of internal passage (snag factor) (1-8) Diameter of Cannula (OD) (.5-.6 in.)

Effectiveness of internal seals (seal tear) (>25-0)

Ours

Comp. #1

Comp #2 Perimeter = Optimal Delivery

Planned New

Scale definitions in Parameter scale file (Excel).

Copyright 2003, Hans Hjort Consulting.

Technical Strategy
Most Significant Parameters
Level of automation of system activities Availability of recorded data Gold Space Competitive Advantage Change level Emergency Set-up # of interaction steps/time

Accuracy of alarms Reliability of systems/components Level to which programmed actions/functions are user definable/changeable

Level of compatibility with alternative technologies/systems/com ponents

Intuitiveness of controls

Green Space Current Situation White Space Future opportunity

Efficiency of connections between equipment and patient Existing New

Sub-System Phase Update

Copyright 2003, Hans Hjort Consulting.

Product Families

PROJECT CHARTER

Customer Function Market Definition

Same technology Same Targets Segment A Same Technology Different Targets Same Family Same Product

Different Technologies

Different products Segment B

Copyright 2001, Hans Hjort Consulting.

Technology Planning
Weight of Compressor

Scroll Technology Crank-Piston Technology

2015
PERFORMANCE GAP

2011 2007

EFFORT

Our Product Comp. 1 Comp. 2

CIRCUMFERENCE OF CIRCLE REFLECT TARGET VALUES

PERFORMANCE GAP IS A MEASURE FOR OPPORTUNITY AND VULNERABILITY

Copyright 2001, Hans Hjort Consulting.

VOC Cascading Process

Define Alternative Concepts and Select best
Brainstorm Solutions to Key System Parameter Targets

Givens

Filter
New concept 3

System Evaluation/Selection Matrix

New concept 1 New concept 2

Customer (VOC) driven

Significant System Parameters

Baseline

**

+ _

Relative Impact (a) normalized to 70 (c)

Internal Considerations
Business (VOB)

Importance of Internal criteria normalized to 30 (b)

Winning System Concept

Subsystem-1 Subsystem-2 Subsystem-3 Subsystem-4

Copyright 2003, Hans Hjort Consulting.

Concept Validation
Are we on the right track?

Customers
Best Concept 1

Best Concept 2

5 4 3 2 1

5 4 3 2 1

Concept results

Original Plan

Concept itself Lack of detail design Level of functionality of presented concept

Deploy The Voice Of The Customer...

Components /subsystems

Business Case/Project Charter

Product Specifications

Techn. Import. Non-Critical Components Most Important Components/ subsystems

80/20

Parameters.

A
Techn. Targets

B C

Design Evaluation

Use current design or Reverse engineer best in class design

Best design
Copyright 2001, Hans Hjort Consulting.

VOC Cascading Process

Create Deployment Matrix

Deployment Matrix
Subsystem-1 Subsystem-2 Subsystem-3 Subsystem-4

Relative Impact on VOCs

Key System Parameters

9 3 9 1 3 9

Subsystem impact (e) on delivering a given Parameter at the defined target

Relative Impact of each subsystem

Copyright 2003, Hans Hjort Consulting.

VOC Cascading Process (1)

Next level Planning Matrices Evaluation Matrices

New Concepts Planning Matrix Evaluation Matrix Deployment matrix New Concepts

New Concepts New Concepts Best Concept

New Concepts

Copyright 2003, Hans Hjort Consulting.

Best concepts

VOC Cascading Process (2)

System Subsystems Modules Components Processes

Copyright 2003, Hans Hjort Consulting.

Requirements Cascade
Business Case

leverage existing data for each Business Segment to evaluate Opportunities.

Seminal Idea

VOC
IMP/ SAT

ROB

Standards

Risk

Innovation Opportunities can occur at multiple points of the Cascade Process

HAZARDS ANAL

QFD

If the data does not exist, it will need to be generated.

DESIGN WORKSHEET
Transfer function

SYSTEM Planning Matrix DEPLOYMENT MATRIX

PUGH

1
4 5 6 3 7 2

SysFMEA iVOC iROB

SYSTEM CONCEPT (structure and function architecture, requirements)

Process Capabilities

Nominals & Tolerances

Reliability Predictions

VTests & GR&R

iSTDs

Mitigations and residual risk

SUBSYSTEM Planning Matrix

SUBSYSTEM PUGH
1 4 5 3 6 7

37
Baxter Confidential

SUBSYSTEM CONCEPT (structure and function architecture, requirements)

CONTINUED

For more information and discussions about this presentation contact:

Hans Hjort Hans Hjort Consulting Email: hhjort@cinci.rr.com Tel: 513-910-2687