Product Planning And Development Process

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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)