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This is a very prosperous time for most people living in developed nations today. Consumers continue to desire the lat

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

est and greatest in virtually every economic sector. Could it be that this unprecedented prosperity is actually settin

; 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 many businesses for catastrophic failure?

There are those who believe that today's boom times will never end. Oth

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

rs believe we are nearing economic collapse. Both are extreme views and I personally subscribe to neither. I believe t

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

at business activity follows a cycle. Some so called experts try to predict when these cycles of boom or bust will end

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

Combination pro

. I can't predict when, but I will say that there will be some degree of contraction at some point. No one can predict

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

how dramatic the adjustment will be. But it will take place as it always has.

Here is the problem, as I see it now, i

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

the marketplace. Sales are so strong that many businesses no longer feel they need to 'earn' a prosp

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

ct's business or 'retain' a customer's loyalty for the future. I certainly recognize that there are m

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

any fine businesses, both large and small, that work tirelessly on providing great service and ongoing customer satisf

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

ction. Sadly, there are many more which do not.

So often today, business owners and managers feel that if a selling o

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

Following aspects would a

portunity to a prospect is mishandled or if the prospect is underserved, it doesn't really matter because there will b

dd to the challenges in developing combination products:

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

plenty more volunteers walking in shortly to eagerly part with their cash.

What else would explain the lack of prope

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

r and ongoing training in businesses of all types today. Even in places that have traditionally exhibited high standar

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

s, people will take your money without verbalizing a simple thank you before moving on to the next sale.

Businesses t

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

at don't sincerely respect their prospects and their customer base will find that when the economy retracts, as it sur

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

Professional from academic institutions, pharmaceutical industries, health care indust

ly will, prospects will take their business to operations that haven't lost sight of who it is that really pays them.

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

Businesses that have been sloppy by underserving prospects or that have lost the basic courtesies of business will be

.

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

lost in the contraction. Businesses that over promise while constantly under delivering will be footnotes in economic

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

Companies that provide selfless information through particip

istory. That's because they are losing sight of a basic consumer need. The need to be treated with respect and dignity

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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