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Just Other Articles - Innovation Management - how will we make the go or kill decisions?
Creativity can be defined as problem identification and idea generation whilst innovation can be defined as idea selection,
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
development and commercialisation.
There are distinct processes that enhance problem identification and idea generation and
There are distinct processes that enhance problem identification and idea generation and
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
similarly, distinct processes that enhance idea selection, development and commercialisation. Whilst there is no sure fire
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
oute to commercial success, these processes improve the probability that good ideas will be generated and selected and that
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nvestment in developing and commercialising those ideas will not be wasted.
One of the most important aspects of innovation
One of the most important aspects of innovation
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
management is the ability to know how and when to give further KILL or GO decisions once good ideas have been selected and a
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
e pushed into the pipeline, where they must measure-up alongside other good ideas.
The pipeline is also known as an idea fu
The pipeline is also known as an idea fu
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
nel or a stage gate system. These terms are useful as they address the fact that the good idea selection process continues i
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
the development stage.
The value of an idea is consistently changing and depends on where it is in the idea funnel process
The value of an idea is consistently changing and depends on where it is in the idea funnel process
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
Innovative firms accept that ideas have a high mortality rate and that GO or KILL decisions have to be made to focus resour
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
es on those ideas most likely to succeed.
As the idea funnel narrows, the requirement for staying in the funnel becomes mor
As the idea funnel narrows, the requirement for staying in the funnel becomes mor
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
rigorous – the process involves tinkering, experimentation, market research and prototyping. The issues raised include:
a)
a)
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
What are the criteria for staying in the funnel?
b) How long will development and experimentation be allowed before the KIL
b) How long will development and experimentation be allowed before the KIL
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
decision is made?
c) How should the KILL decision be made?
A balance needs to be struck. A company that allows the idea t
c) How should the KILL decision be made?
A balance needs to be struck. A company that allows the idea t
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
stay in the funnel longer and give it every chance to prove itself will use up valuable resources that could be allotted to
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
other good ideas. However, they have less chance of prematurely killing off a good idea.
These topics are covered in depth
These topics are covered in depth
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
n the MBA dissertation on Managing Creativity & Innovation, which can be purchased (along with a Creativity and Innovation D
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Y Audit, Good Idea Generator Software and Power Point Presentation) from http://www.managing-creativity.com.
You can also r
You can also r
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
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Kal Bishop, MBA
****************************
Kal Bishop, MBA
****************************
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
*****
You are free to reproduce this article as long as no changes are made and the author's name and site URL are retained
You are free to reproduce this article as long as no changes are made and the author's name and site URL are retained
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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