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Digg It - Attain The Nirvana Of Low Fixed Overheads Through Outsourcing
The way forward for most organisations is not only to be lean and mean, but to be
fl
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
exible. Dell Computers and Nike have demonstrated the power of flexibility and speed
; 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
through outsourcing. It is not just the fast that will eat the slow, but the flexible
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ones will
be able to beat the inflexible. One of the most effective ways to stay fle
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ible is to
outsource most of the functions. For instance, Dell Computer and Nike no
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
longer
manufacture most of the parts or components they need. Rather, these are outs
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
urced.
These companies do away with the traditional supply chain network and can be v
These companies do away with the traditional supply chain network and can be v
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
ery
nimble to change parts and components in order to meet customers’ specifications
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
without ending up with huge stocks and factory overheads. However, these companies d
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
o
not outsource everything. For those parts and knowledge that are critical to the
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
companies, they are kept in-house. For example for Nike, the sole of the shoes is stil
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
designed in the United States.
Organisations are moving towards the virtual organi
Organisations are moving towards the virtual organi
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
sation concept, using networks
linking people, assets and ideas to create and distri
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
ute products and services without
being limited by ownership of fixed assets and inc
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
urring fixed overheads. A virtual
organisation is virtually unbeatable and is the ni
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
vana of every accountant for it carries
little fixed overheads. This is why outsourc
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
ing is becoming very popular, although it may
not necessarily translate into lower o
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
erall costs but it certainly lowers the fixed
overheads and gives the company more f
.
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
lexibility to change with the market dynamics.
A final word is that outsourcing is no
A final word is that outsourcing is no
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
a cure-all. It has to be managed properly to ensure that there are no costs over-run
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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