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Are you ready for the changes that are coming or are you stuck in your paradigms refus

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

ing to see that there may be another way to look at things?

Let me give you 2 simple

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

Examples of combination products may in

examples:

1.The population is getting older. Over 70 million baby boomers are hitting

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

their fifties and sixties. What will they want, need or be interested in the next fe

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

w years? How will they want to buy? What will prevent them from buying? Example: Tech

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

Combination pro

nology is getting faster and faster and smaller and smaller. If hand-helds or telephon

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

es get any smaller, whew… I can hardly read the screens now, even with my glasses. If

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

my computer gets any faster my mind won’t be able to keep up with it. If the available

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

amount of information continues to increase, I won’t have enough time to have fun or

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

play tennis. So Tim, what’s your point?

These organizations are trying to shove spe

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

ed and smallness on a significant number of people (1/3 of the population) who will wa

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

Following aspects would a

nt slower and bigger in the next few years. Think I’m crazy? Hang around.

2.More wome

dd to the challenges in developing combination products:

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

n are staring new businesses today than men. Are you spending time understanding their

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

needs, buying style, prejudices, and concerns, or are you selling to them the same wa

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

y you have sold to the men? (This includes you also, ladies.)

How is your product/se

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

rvice positioned? Being sold? Are you taking into consideration your buyers or are y

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

Professional from academic institutions, pharmaceutical industries, health care indust

ou using arrogance (the fact that you know best what people should buy and how) to sel

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

l your wares?

It will be the savvy sales organization – that seeks to better understa

.

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

nd the needs, wants, agendas, and buying habits – who will succeed in the coming decad

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

Companies that provide selfless information through particip

e(s). The rest of you will spend a great deal of time wondering where you went wrong.

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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