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Is commitment something you gain on the way, or do you need it right from the

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

start?

Many projects and business activities fail because of a lack of comm

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

Examples of combination products may in

itment. Some of these activities stop halfway others near the end – when most

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

commitment is needed – and others do not even get really started. It?s all i

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

the emotion around it. People can be sceptic at first, they are insecure (I

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

Combination pro

know I am) and they wait what others do before they step in.

Even in persona

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

l relations you cannot do without commitment. Or put it another way; personal

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

relations are relations because of the commitment. You said ?yes? at one poi

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

t at time. It is possible that commitment fades away down the road. But this

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

is another topic. Any relation starts after commitment.

Commitment is not so

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

mething you gain over a period of time. You need it at day one. Project manag

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

Following aspects would a

ers know this and the first step they take in accepting (an existing or new)

dd to the challenges in developing combination products:

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

roject is to check the commitment as part of an intake. They know whether a p

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

roject is viable or not.

What you should never do is, if you reckon that the

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

re is no commitment, try and pull or push in the hope you will receive it soo

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

n. You should rather start with it. Commitment is like a door that should ope

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

Professional from academic institutions, pharmaceutical industries, health care indust

. And if it doesn’t you have a problem. This is where sales comes in. Sales r

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

epresentatives know how to deal with this aspect. They might give something a

.

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

way to let you feel good. After which the barrier should fall. The door gets

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

Companies that provide selfless information through particip

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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