Subjects - Business

I’m not really that old. At 54, I am surely not old enough to remember communicating by smoke signals or drums. But I am old enough t

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

hat while working for a huge engineering company, I was trained as a back-up for the regular telephone operator, and that meant learni

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

Examples of combination products may in

ng how to operate the old cord switchboard. When Centrex telephone system was introduced, I learned about that as well. Back then, w

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

men – even engineers – were all expected to type. And those in the clerical field were expected to learn at least enough about custom

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

er service, greeting customers face-to-face as a receptionist, and how to run a switchboard, that they could fill in if the regular re

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

Combination pro

eptionist or switchboard operator had to be away.

A few years later, I learned to send and receive telex messages. I remember well t

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

he clicking and clacking of that horrible machine. I also remember that not many in the clerical pool wanted to learn to use that mac

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

hine monster, and rightly so. I had nightmares about whether or not I could get the tape inserted properly and having to type without

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

error to be understood on the other end of the world.

Then came facsimile machines. A fax machine was often guarded by an executive,

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

and everyone had to make arrangements to use it in his office, when said executive was not in the midst of something top secret or mo

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

e important than having you transmit pages over the fax machine. While Mr. Executive waited impatiently, one had to try to send and r

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

Following aspects would a

eceive quickly. But fast was not how one would define the technology, when each page might take six minutes or more to transmit, all

dd to the challenges in developing combination products:

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

the while racking up long distance charges. If the recipient’s machine malfunctioned, you often did not realize that until it appeare

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

that the document had been totally sent and received. Time and again, we had to send and re-send, just to get an entire ten or twent

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

y-page packet to another company or a client.

Things have certainly changed for the better, as we have zoomed ahead with the types of

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

communication tools available to us today.

Still, there was something different about those “old days.” Back then, anyone who might

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

Professional from academic institutions, pharmaceutical industries, health care indust

work in “telecommunications” in any way was probably at least partially trained by the old Bell Telephone people. Customer service wa

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

s more important than actual technology knowledge.

There times have truly changed. Customer service and the old “the customer is alw

.

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

ys right” methodology has disappeared. And yet, a company that wants to succeed and thrive would be wise to institute some of those o

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

Companies that provide selfless information through particip

ld customer service practices. It could make a company stand out in today’s market, since it would be an oddity, rather than the norm

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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