Just Answers - Business

I use a credit card for many business purchases. Since I travel a lot, this means qui

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

te a bit of money is charged throughout the year.

Therefore, I was pleased when my b

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

Examples of combination products may in

nk had a local hotel deliver a ‘basket of goodies’ to our home during the holidays.

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

he card attached thanked us for our support, and looked forward to another year of pr

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

viding beneficial service.

Unfortunately, the basket included abalone, chocolate cak

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

Combination pro

and cookies. I am vegetarian (no abalone), we don’t eat much chocolate (no cake), an

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

we try to avoid extra sugar (bye-bye cookies).

I’m sure the hotel has other options

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

nuts, flowers, a voucher for dinner – any of which I would have appreciated more.

I

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

fact, I would have loved a phone call saying, ‘Hello Mr. Kaufman. On behalf of your

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

ank, we would like to send you a gift of your choice. Would you like wine, chocolate

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

ake and cookies? Or would you prefer nuts and a large bouquet of flowers? Or perhaps

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

Following aspects would a

voucher for dinner at one of our fine restaurants? Or shall we donate the cash value

dd to the challenges in developing combination products:

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

to a charity of your choice?’

The cost to the bank would have been the same. The dif

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

erence would be a phone call…and the desire to give customers what they want, not wha

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

you think they should want.

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

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

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Don't assume you know what you

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

Professional from academic institutions, pharmaceutical industries, health care indust

customer really wants. Find out. It doesn't take much effort: just a phone call, and

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

the right desire.

Action Steps
-----------------------------------------------

.

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

--------------------------------
Before launching your next customer promotion,

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

Companies that provide selfless information through particip

all your customers first and ask them what they think. Then, give them what they want

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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How to motivate yourself and your employees to do some spring cleaning of papers and such in the office!

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