2. Definition
New product development (NPD) is the
complete process of bringing a new product to
the market till its consumption & feedback
from the end user of the business chain
through the systematic procedure &
parameter.
It may be a Consumable product, service or
idea.
3. Definition
New product development (NPD) is the
complete process of bringing a new product or
service to market.
New product development may be done to
develop an item to compete with a particular
product or may be done to improve an already
established product.
4. Examples
This type of development is considered the
preliminary step in product or service
development and involves a number of steps
that must be completed before the product can
be introduced to the market.
New medicine
New model of auto mobile
New cellular phone
6. Why New Products?
New product development is essential to any
business that must keep up with market trends
and changes.
Approximately one-third of the revenue a
business generates is coming from products
they did not sell five years ago
Changing environment creates new demands
and needs
7. Product Development
Must be alert to quickly develop opportunities
Focus on markets or product categories
consistent with organization’s objectives,
resources, capabilities and strengths
Securing a competitive advantage
8. Industrial New Product Ideas
Company sources other than R&D 36.2%
Analysis of the competition 27.0%
Research & Development 24.3%
Product users 15.8%
Supplier suggestions 12.5%
Product user research 10.5%
Published information 7.9%
9. New Products necessity
A way of getting new and keeping old
customers
Effective way of obtaining a competitive
advantage
Source of growth and excitement
10. New Product Categories
New to the world products
New product lines
Product line extensions
Improvements and revisions to existing
products
Repositionings
Cost reductions
12. Marketing
Very important to product development success
Key to successful marketing is imaginative,
effective, creative communication
Find a need and fill it.
Mutually beneficial exchange relationships
13. Market Opportunity and Threats
Economic Realities
•GNP
•Disposable Income
•Discretionary Income
Legal & Regulatory
Condition
•Laws
•Regulations
Societal Focus
•Population Shifts
•Values
•Attitudes
•Competition
•Trends
Technological
Development
•Advance in
technology
•Market receptiveness
to technology
14. Reasons For New Product Failures
Poor marketing research
Technical problems
Insufficient marketing effort
Bad timing
The wrong group was targeted.
Unrealistic forecast.
Insufficient level of awareness.
15. Summary
New product development drives growth.
Market research is critical to the success of a
new product launch.
Market research is a continuous process as
customer needs, your business and the
environment changes.
17. What is Fuzzy Front End?
Fuzzy Front end is defined as
Activities that come before the “formal and well structured”
New Product Development (NPD) Portion.
It is also described in literature as "Front End of Innovation",
"Phase 0", "Stage 0" or "Pre-Project-Activities"
Activities are less
structured and less
predictable.
Structured with a formulized
and précised set of activities and
questions.
18. Why Focus FFE?
Front End Innovation New Product Development
Nature of Work Experimental, often chaotic.
“Eureka” moments. Can schedule
work—but not invention.
Disciplined and goal-oriented with a
project plan.
Commercialization
Date
Unpredictable or uncertain. High degree of certainty.
Funding Variable—in the beginning phases
many projects may be
“bootlegged,” while others will
need funding to proceed.
Budgeted.
Revenue Expectations Often uncertain, with a great deal
of speculation.
Predictable, with increasing
certainty, analysis, and
documentation as the product
release date gets closer.
Activity Individuals and team conducting
research to minimize risk and
optimize potential.
Multifunction product and/or
process development team.
Measures of Progress Strengthened concepts. Milestone achievement.
20. Engine (Leadership, culture, and
business strategy)
The inner parts of the NCD are called
elements, as opposed to processes. A
process implies a structure that may not
be applicable and could force the use of
a set of poorly designed controls to
manage FFE activities. In addition, the
model has a circular shape, to suggest
that ideas are expected to flow,
circulate, and iterate between and
among all the five elements. The flow
may encompass the elements in any
order or combination and may use one
or more elements more than once.
21. Idea Identification:
The essence of this element is the sources and methods used to
identify opportunities to pursue. Opportunity identification in many
cases precedes idea generation and enrichment. It also may enable
linking unanticipated notions to business or marketplace needs that
were not previously known. Opportunity identification may occur
from a single person recognizing an unmet customer need or
previously undetected problem.
22. Opportunity Analysis:
Business capability and competency are assessed in this element,
and sponsorship for further work will be determined. However,
despite all of the effort, significant technology and market
uncertainty will remain.
In this element, an opportunity is assessed to confirm that it is worth
pursuing. Additional information is needed for translating
opportunity identification into specific business and technology
opportunities. This involves making early and often uncertain
technology and market assessments.
23. Idea Generation and Enrichment
The element of idea generation and enrichment concerns the birth,
development, and maturation of a concrete idea. Idea generation is
evolutionary. Ideas are built up, torn down, combined, reshaped,
modified, and upgraded. A new idea may also emerge outside the
bounds of any formal process—such as an experiment that goes awry,
a supplier offering a new material, or a user making an unusual
request.
24. Idea Selection
The problem for most
businesses is in selecting
which ideas to pursue in
order to achieve the most
business value. Formalized
decision processes in the
FFE are difficult due to the
limited information and
understanding that are
available early in product
development. Financial
analyses and estimates of
future income for ideas at
this early stage are often
wild guesses.
25. Concept Definition
Concept definition is the final
element of the new concept
development model. This element
provides the only exit to the NPD or
technology stage gate (TSG). In
order to pass through the gate, the
innovator must make a compelling
case for investment in the business
or technology proposition. Some
organizations refer to this as a “win
statement.” Others call it a “gate
document.” The investment case
consists of both qualitative and
quantitative information, which the
gatekeepers use to make a
determination.
26. Influencing factors (the environment)
The FFE exists in an environment of influencing factors. The
factors are the corporation’s organizational capabilities,
customer and competitor influences, the outside world’s
influences, and the depth and strength of enabling sciences and
technology
28. WHAT IS NEW PRODUCT
DEVELOPMENT EXECUTION?
To create the next product in a company’s
product line a design team goes through
product development process steps.
Starting with a product idea, the team
moves through several stages to generate
all the details and documents needed to get
the product built. A NEW product
development (NPD) process goes through
the same steps, however as this product has
not been developed by the team before,
new risks and uncertainties are introduced
and often additional information is
documented and shared with
manufacturing.
29. STEPS OF NPD EXECUTION
There are five basic steps in a new product
development EXECUTION:
Concept
Ideation
Design
Test and
Release.
30. Concept :
The concept step sets basic
direction and boundaries for the
entire development process by
clarifying the type of product, the
problem the product solves and
the financial and technical goals
to be achieved by the product.
31. Ideation :
During the ideation step the
team brainstorms to discover
some of the many ways a
product can solve the problem
and meet internal goals. Ideas
are evaluated and the most
promising are selected for
further investigation.
32. Design :
It’s in this step that the
execution of the “best”
way to create and
construct the product
happens. Engineering
details are generated to
flesh out the high level
concepts from the
ideation stage.
33. Test :
Testing verifies if the
product meets the original
goals or if additional
refinement is needed.
34. Release:
Once testing has
confirmed that the
product solves the
problem and will
meet the company
goals; it is ready to
start the new
product
introduction (NPI)
process and get the
product built!
36. CLINICAL TRIALS :
A research activity that involves administration of a test
treatment to some experimental unit in order to evaluate
the treatment.
Clinical Trials
37. Clinical Trials
• Clinical trials are conducted only
when,
-Satisfactory information has been gathered
on the quality of the nonclinical safety.
- Health authority/ethics
committee approval is granted in the
country where approval of the drug is
sought.
• Clinical Trial is the mainstay for
bringing out New Drugs to the
Market.
38. Drug Review Steps
Preclinical (animal) testing.
An investigational new drug application
(IND) : outlines what the sponsor of a new
drug proposes for human testing in clinical
trials.
Phase 1 studies
Phase 2 studies
Phase 3 studies
Submission of New Drug Application
(NDA) is the formal step asking the FDA to
consider a drug for marketing approval.
FDA reviewers will approve the
application or find it either "approvable" or
"not approvable.“
Phase 4 studies
DRUG REVIEW STEPS :
Preclinical Data
IND Filing
IND Approval
Phase I
Phase II
Phase III
NDA Filed
NDAApproval
Marketing Permission
Phase IV
DCGI
Mandatory
Approval
Points
Sponsor
Go/No
Go
Decision
Points
40. Clinical
Trials
Major areas are:
• Pharmacodynamic studies in
vivo in animals, In vitro
preparation
• Absorption, distribution ,
elimination studies
(pharmacokinetics)
• Acute ,sub acute, chronic toxicity
studies (toxicity profile)
• Therapeutic index (safety &
efficacy evaluation)
PRECLINICAL TRIAL :
41. Phases Of Clinical
Trials
Focused on tolerability and safety.
12-30 (150) healthy people (often males).
Efficacy on biomarkers .
Single and repeated doses.
Increase dose levels.
Interaction with other drugs.
Pharmacokinetics.
Explorative.
Phase I
50-150
people
Phase II
100-200
people
Phase III
500-15000
people
Phase IV studies continue
PHASE 1 TRIAL :
42. Phases Of Clinical
Trials
Phase I
50-150
people
Phase II
100-200
people
Phase III
500-15000
people
Phase IV studies continue
PHASE 2 TRIAL :
50-1000 patients.
Extensive monitoring.
Safety and tolerability in patients.
Often complicated design, explorative.
Selection of optimal dose.
Pharmacokinetics in patients.
Effect in special populations.
Explorative.
43. Phases Of Clinical
Trials
Phase I
50-150
people
Phase II
100-200
people
Phase III
500-15000
people
Phase IV studies continue
PHASE 3 TRIAL :
500-15000 patients
Effect is verified in the target
population
Forms the basis of the NDA, New
Drug Application
Interactions between drugs start to
become measurable in the larger
population
Sub-groups start to be established
Special features and problems show
up
Confirmative
44. Phases Of Clinical
Trials
Phase I
50-150
people
Phase II
100-200
people
Phase III
500-15000
people
Phase IV studies continue
PHASE 4 TRIAL :
Often large 500-15000 patients
Further investigation of
efficacy and safety post approval
Special populations
New indications
Marketing