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Every business has its life cycle that it undergoes during the course of its entire existence. It is widely accepted that businesses across the world experien

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

ce four principal stages of existence – Start-up Phase, Growth Phase, Maturity Phase and Decline Phase. Invariably, all businesses undergo these phases.

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; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

-up Phase:

Start-up phase is that phase during which a business comes into existence. It is during this phase that plans are conceptualized and implemented r

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

garding how the business should be set up, how it should be run, where to get the start up capital from and how to keep the cash flow going. During the start

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

p phase, legalities of setting up the business are taken care of. Every business, which is starting up will normally require a large investment of capital, lo

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

s of time and effort, setting up of good profitable and stable customer base, money to buy raw materials, manpower recruitment etc. Businesses usually arrange

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

for their own limited resources to run their activities. At first, demand is assessed and/or created for the products or services the business wishes to offer

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

. Then manufacturing facility and processes are established (if it is a business engaged in manufacturing) or processes for providing service are established

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

if the business will be service provider) or goods for sale are purchased (if it will be business engaged in trade).

Growth Phase:

During this phase of its

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

xistence, businesses experience expansion of its activities and enhancement of its customer base. It is an exciting period for the business. Its products and

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ervices are gaining acceptance in the marketplace and customers are patronizing them in increasing numbers. Profit margins also tend to increase during this p

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ase. During this phase, the business require infusion of additional capital to buy capital equipment to increase production (for manufacturing businesses), to

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

establish additional service network (for service providers) or procure more goods for trade (for trading businesses).

Maturity Phase:

This is the third sta

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

e of a business development. During this phase cash flows stabilize and establishment of marketing networks and operational channels are completed. The respec

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

tive brands become well known and there is a stable and faithful customer following. This is an ideal time for businesses to consider expansion or diversifica

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

ion.

Decline Phase:

This is the last phase of any business. It is also called the terminal phase. During this phase, the business experiences market pressur

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

s from all quarters, and are unable to handle them successfully. The inevitable is cash flow drying up and losses mount up. Most businesses fold up during thi

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

phase. There are resilient businesses that do survive this phase and go on to succeed on a new lease of life.

Business Support Software:

There are many sup

.

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

ort processes that any business would need during its existence. To support these business processes, softwares are hitting the market that cater to both new

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

nd experienced entrepreneurs. These softwares help business owners and managers to manage the business operations well. They are worth the money spent on them

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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