Advice You - Business

The other day I was driving my wife to the super Wal-Mart that she likes to visit. On

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

the way I said, "Let me show you a short cut that will cut off about 2 miles and maybe

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

Examples of combination products may in

or 6 minutes of driving time each way."

I then proceeded to turn down this obscure ro

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

d and in just a few seconds we re-entered the main road. We had indeed cut off about 2

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

miles of driving. My wife said, "Do you just drive around looking for strange roads a

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

Combination pro

d follow them to see where they go." "No", I said, "But I do pay attention to road sig

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

s and when I see two that appear to be the same road, I will make an educated assumptio

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

n that the road will lead to the same place where I saw the other sign."

Business is m

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

ch like this. We must keep our eyes open and look for the relationship between signs.

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

When we see them we can feel reasonably sure that the two are connected. By looking fo

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

these short cuts in business we can leap ahead of our competition.

Here is an example

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

Following aspects would a

of what I mean. Suppose you had an Automobile Window Tinting shop. You could spend th

dd to the challenges in developing combination products:

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

usands of dollars on various advertising to get a new customer to come through the door

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

or you could look for the connecting signs. A Windshield Repair shop probably meets wi

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

th the same types of customers that you meet with. If you could establish a relationsh

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

p with the Windshield Repair business so that they would refer their customers who need

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

Professional from academic institutions, pharmaceutical industries, health care indust

window tinting to you, and you would in turn, refer those who need windshields repaired

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

to them, do you think your walk in business would improve? Probably, and how much woul

.

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

it cost? Nothing more than a few business cards and a solid business relationship bet

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

Companies that provide selfless information through particip

een the two companies.

That's how you connect the signs in business.

To Your Success

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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