Typical Product Development Review structure. Opportunity. On-going
Commercialization. Management Reviews. Technical Design Reviews. VOC
Defined.
Product Planning And Development Process
Hans Hjort Hans Hjort Consulting
[email protected]
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)
