Product Planning
And
Development Process
Hans Hjort
Hans Hjort Consulting
hhjort@cinci.rr.com
Typical Product Development Review structure
Typical Phases
Technical Design Reviews
Opportunity
Management Reviews
MK
User Needs
VOC Defined
VOC Approach proposed
Design Planning
Design Input
TDR I
Design Output
Performance Requirements defined
Product Concept proposed
Gate 1
M0
Gate 2
M1
Product Design completed
Process Concept proposed
TDR II
Process Design Completed
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.
Job 2
PP
Job 1
Customers
Job 3
Job 5
Job 4
Job n
5.
Solutions
“Bookshelf”
Innovation Process
2.
5.
3.
Potential Technologies
4.
TP
Potential solutions
3
Early Marketing and ClinicalDefine
Roles
Seminal Idea
Marketing takes the lead on
identifying “jobs” and
collecting data (imp. & sat.)
from customers
Jobs can be:
Clinical
Operational
Social
Economic
Etc.
Job 2
Job 1
Customers
Job 3
Job 5
Job 4
Job n
Business/Marketing are
involved in selecting attractive
“jobs” for plannedt effort.
Job 3
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
Job 5
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
Customer Groups
Park
BAR
Sutures
Glue
(Surgeons)
Staples
1
Technologies
Copyright 2001, Hans Hjort Consulting.
2
Initial Focus
3
4
5
Next Potentials
6
Process Map
Customers
Validation
Input
System
Subsystem
Component
Process
Copyright 2001, Hans Hjort Consulting.
To Satisfy The Customer...
Customers
Business Case/Project Charter
Performance
Parameters.
V
O
C
Regulatory
requirements
Techn.
Targets
Basic
Expectations
Market Strategy
Critical Parameters
80/20
Non-Critical
Parameters
Internal
Standards
A
B
Concept
Evaluation
C
System
Requirements
Best Concept
Copyright 2002, Hans Hjort Consulting.
Product Planning
Plan
Evaluate / Select
Plan
Deploy
VOC Needs & Wants
Sub-system 1
Performance Parameters
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)
SDS100/SD
System Name:
Product Code: SD01
Sedation Delivery System
Target Value
Product Level Requirement CTQ
System
Parameters
Owner Lower
NUD
Design Prediction
Owner:
Design Verification
Date: 5/29/2003
Process Validation Data
Upper
Limit Nominal Limit
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
Level of Automation
The system will automatically detect when respiratory
rate is "0" for 30 sec. 99.99% of the time.
Market Strategy
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)"
Y
0.9999
Y
Y
3 bpm
12%
Y
Y
3 seconds
<45
seconds
Y
<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 team’s 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
White Space – Future opportunity
Satisfaction Current
Planned Satisfaction
Planning Matrix (House of Quality)
How
Interdependencies
V
O
C
W
h
a
t
Whys
Market perception
How List
Performance Parameters
Whys
vs.
L
i
s
t
How
Muches
Relationships
1 = Mild Link
3 = Moderate Link
9 = Strong Link
How
vs.
How Muches
Whats
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
How is it captured and documented?
How
Interdependencies
How List
Performance Parameters
Number of transactions between doctor
and medication delivery)
Correlation between Performance Parameters and VOCs
Why
W
h
V
O
C
a
Why
t
vs.
L
Relationships
i
1 = Mild Link
3 = Moderate Link
s
t
I need the patient to receive the exact
prescription ordered by the doctor
9
What
Relationships
9 = Strong Link
1 = Mild Link
3 = Moderate Link
9 = Strong Link
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.
Modified
Importance
Number of transactions
between doctor and
medication delivery
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..
MI=Imp x future sat/current sat.
I need the patient to receive the exact
prescription ordered by the doctor
9
40
I need to be confident that only my facility's
prescribed medication will be administered
3
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
V
O
C
W
h
a
t
Whys
Market perception
How List
Performance Parameters
Whys
vs.
L
i
s
t
How
Muches
Relationships
1 = Mild Link
3 = Moderate Link
9 = Strong Link
How
vs.
How Muches
Whats
Technical reality and priority
Copyright 2001, Hans Hjort Consulting.
Key Parameters - Trocar
Planned Improvement
Internal drag force (instrument to trocar)
(.1-1.3
lbs)
Effective seal opening for specimen removal
(TBD)
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
Scale definitions in “Parameter scale” file (Excel).
Comp #2
Perimeter = Optimal Delivery
Copyright 2003, Hans Hjort Consulting.
Planned New
Technical Strategy
Most Significant Parameters
Level of automation of system activities
Availability of recorded data
Change level
Emergency
Set-up
Gold Space – Competitive Advantage
# 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
Copyright 2003, Hans Hjort Consulting.
Sub-System Phase Update
Product Families
PROJECT CHARTER
Customer Function
Market Definition
Same technology
Same Targets
Same Product
Segment A
Same Technology
Different Targets
Same Family
Different Technologies
Different products
Segment B
Copyright 2001, Hans Hjort Consulting.
Weight of Compressor
Technology Planning
Scroll Technology
Crank-Piston Technology
2015
PERFORMANCE
GAP
2011
2007
EFFORT
Our Product
PERFORMANCE GAP IS A MEASURE FOR
Comp. 1
OPPORTUNITY AND VULNERABILITY
Comp. 2
CIRCUMFERENCE OF CIRCLE REFLECT TARGET VALUES
Copyright 2001, Hans Hjort Consulting.
VOC Cascading Process
Define Alternative Concepts and Select best
Brainstorm Solutions to Key
System Parameter Targets
Givens
Filter
Significant
System
Parameters
**
New concept 3
New concept 2
Baseline
Customer (VOC) driven
New concept 1
System Evaluation/Selection Matrix
+ _
Internal Considerations
Relative Impact (a)
normalized to 70 (c)
Importance of Internal
criteria normalized to
30 (b)
Business (VOB)
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
Concept results
5
4
3
2
1
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
80/20
Most Important
Components/
subsystems
Parameters.
A
Techn.
Targets
B
Design
Evaluation
C
Use current design
or
Reverse engineer best
in class design
Best
design
Copyright 2001, Hans Hjort Consulting.
VOC Cascading Process
Create Deployment Matrix
Subsystem-4
Subsystem-3
Subsystem-1
Key System
Parameters
Subsystem-2
Deployment Matrix
Relative Impact on
VOCs
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
Deployment
matrix
Evaluation
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
Copyright 2003, Hans Hjort Consulting.
Processes
Requirements Cascade
Business Case
leverage existing data
for each Business
Segment to evaluate
Opportunities.
Innovation
Opportunities can
occur at multiple points
of the Cascade
Process
Seminal Idea
VOC
ROB
Standards
Risk
IMP/
SAT
HAZARDS
ANAL
QFD
If the data
does not exist, it will
need to be generated.
SYSTEM
Planning Matrix
PUGH
DEPLOYMENT
MATRIX
6
iVOC
7
iROB
Reliability
Predictions
VTests
&
GR&R
3
5
Transfer function
Process
Capabilities
2
4
DESIGN WORKSHEET
Nominals
&
Tolerances
SysFMEA
1
SYSTEM CONCEPT
(structure and function
architecture,
requirements)
iSTDs
Mitigations and residual risk
SUBSYSTEM
PUGH
SUBSYSTEM
Planning Matrix
1
4
5
37
Baxter Confidential
3
6 7
2
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