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No matter what you do, there will come a time when a cus

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

tomer will ask for a refund for some reason or another.

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

Examples of combination products may in

o you give it to them? That depends. If you have an unco

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

ditional money back guarantee, there's no question. Refu

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

d the money -- no questions asked. What if you have no s

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

Combination pro

ated guarantee? What would you do? How would you proceed

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

?

Your best course of action will normally be to go ahe

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

d and negotiate a refund. Perhaps it won't be a full ref

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

nd, but one that both you and your customer feel comfort

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

ble with. The time and effort you would invest to argue

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

ver it is most often not worth it. Consider this:

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

Following aspects would a

li> Determine how much one hour of your time is worth.

dd to the challenges in developing combination products:

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

Determine how many hours you've spent dealing with t

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

is person.

Do the math. Compare your total with the

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

price the customer paid. Is it worth it? You'll

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

spend tons more "money" in your wasted time and effort.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Neither of you will walk away happy. And don't forget th

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

t unhappy customers are the most vocal about the treatme

.

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

t they received.

Listen carefully to the feedback the c

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

Companies that provide selfless information through particip

stomer provides you and chalk it up to a business lesson

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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