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While this might sound like a bold claim, it is true. After years

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

of trying nearly everything out there, I can say without reservat

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

Examples of combination products may in

ion that the key to investment success no matter the market or tim

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

e frame is the ability to recognize technical divergence.

They sa

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

y there are no "leading indicators." Actually, this is not true.

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

Combination pro

Momentum indicators properly configured can show divergences from

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

price which often forecast a price change in the direction of the

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

divergence. This is not 100% foolproof. There is no "holy grail

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

" out there. However, this kind of divergence does accurately pre

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

dict short-term direction about 70 - 80% of the time. And this is

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

enough for a well-constructed investment plan to make some serious

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

Following aspects would a

hay from!

Of course, since it isn't foolproof, it is of critical

dd to the challenges in developing combination products:

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

importance to use stops. Stops keep you in the game. Over time,

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

the positive expectation of a technical divergence strategy can m

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

ake one a lot of money. However, the key is patience. Don't try

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

to "see" a divergence that just isn't there. Jumping the gun and

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

Professional from academic institutions, pharmaceutical industries, health care indust

taking false signals will only decrease your winning % in the long

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

term.

Over time, as you get more practice, you'll begin to see t

.

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

hese divergences in all types of markets. Spend time learning to

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

Companies that provide selfless information through particip

see the divergences and act on them. They will lead you to wealth

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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