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We use a convenient laundry service that picks up our dry-cleaning and

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

delivers.

A new pair of fashion pants came back from the cleaner utt

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

Examples of combination products may in

rly destroyed. The cloth had bubbled and buckled and almost torn apart

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

Next to the telephone number on the laundry receipt was a small note

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

‘Liability may be limited to the cost of dry-cleaning.’

With concern

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

Combination pro

in my voice, I called the proprietor of Laundry Unlimited. To her cred

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

t, she listened to my report and immediately replied, ‘Well, it sounds

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

like we need to buy you another pair of pants without delay.’

Dry-cle

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

ning cost? $7. New pants? $150.

It will take many dry-cleanings for L

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

undry Unlimited to earn back the money spent replacing our pants. But

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

inda has earned our loyalty for many years to come.

She deserves the

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

Following aspects would a

profits she will make.

Key Learning Point
---------------

dd to the challenges in developing combination products:

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

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

hen things go wrong, don't hesitate to spend money setting things righ

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

. It isn't money spent at all; it's money wisely invested.

Acti

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

Professional from academic institutions, pharmaceutical industries, health care indust

-----------------------
What is the `cash value' of things that b

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

eak, malfunction, get lost or otherwise go awry for your customers? Ar

.

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

you ready to spend that amount - immediately - to set things right?

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

Companies that provide selfless information through particip

or a lifetime of customer loyalty, are you willing to invest even more

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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Credit card processing costs can add up but cannot directly be passed on or down to customers. While business owners should include the cost to process credit cards when determining fees, they cannot surcharge customers for using credit cards -- at least in most scenarios.

It is true that most interviewers are too busy to play games with you, but every now and then up pops one of these questions and delivers the knock-out blow. They sound almost innocuous and really quite so straightforward that you might just jump straight in with your answer. However if you do, you might not spot the concealed trap until it's too late.

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Digg It - Laundry Unlimited 'Bounces Back'

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