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Jim thought he was organized. Everything was color coded, and there was a fil

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

e for every project he work working on – each with sub files, research files –

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

Examples of combination products may in

all neatly stored in state-of-the-art filing cabinets. So why can’t Jim find

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

anything?

One of the biggest frustration of being called “an organizing consu

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

tant” is that people assume you are always orderly (some would call it a “neat

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

Combination pro

reak!) Creative people often assume that “being organized” would cramp their s

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

tyle. Nothing could be further from the truth – at least in my case! Let me 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

lustrate.

Recently I came home from a shopping trip with several bags of groc

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

ries which I dumped on the counter. In the midst of unpacking them I decided

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

to bake the cake I was planning for dinner. In the middle of mixing the cake,

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

I realized there was more fresh coconut than I needed for the cake, so I deci

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

Following aspects would a

ed to make a pineapple coconut salad. While looking for the recipe, I found s

dd to the challenges in developing combination products:

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

everal other recipes I hadn’t used recently, so decided to leave those out so

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

could make a list of ingredients I needed to buy. Within an hour, the kitche

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

looked like a tornado had passed – and not the “white tornado” variety!

The

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

rest of the story: The phone rang with news that a friend wanted to bring his

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

Professional from academic institutions, pharmaceutical industries, health care indust

daughter over to see our house to get ideas for the house she was building! I

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

less than ten minutes, everything was put away – and not stuffed in a closet

.

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

out of sight.

The Productivity Principle: “A place for everything” makes “ev

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

Companies that provide selfless information through particip

rything in its place” a reality – not all the time, but at just the right time

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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