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This morning my 8 year old son Euan was eating his chocolate crispy thingies at breakfast when he

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

suddenly announced to his mum.

“Mum, don’t think I’m being rude, but do you mind if Dad takes us

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

Examples of combination products may in

o school this morning?”

Now how do you feel my wife felt? She felt hurt. Not because she didn’t

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

want to take him to school because she’s always got a thousand things to do. Not because of being

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

refused. The reason she felt hurt is because she was asked to think that Euan was going to be rud

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

Combination pro

e and before she even heard him, she’d convinced herself that he was going to be rude.

And when h

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

wasn’t it didn’t matter. She’d convinced herself that whatever he was going to say, he was going

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

to be rude.

Strange that. But logical.

You see if I ask you not to do something, the way we pro

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

ess this in our heads is to think of the thing we’re not going to do first, then we think of not d

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

oing it, as instructed. The net result, we think of doing it.

Don’t think now of a giant flying

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

arrot.

And what do you think of? A flying carrot

Keep an eye on your conversation over the next

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

Following aspects would a

day or so and listen out for the “don’ts” and “nots”. Most of us, me included, sprinkle our langu

dd to the challenges in developing combination products:

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

ge with them.

In sales this can be disastrous.

“Don’t worry about the price yet” “It doesn’t ma

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

tter that we can’t deliver on that day because we can…” “With our product, you won’t ever need to

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

worry about competitor’s products”

But you can use this to your advantage.

“Don’t think for a mo

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

ent you need to make a decision right now to buy this product”

Is quite harmless and will subtly

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

Professional from academic institutions, pharmaceutical industries, health care indust

uggest they should make a decision right now. “You don’t have to stop right now if you don’t want

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

to”

Will confuse any browser to stop and listen to you as their brain interprets what you mean.

.

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

Say it with a lovely tone and you’ve broken the ice without being pushy.

I know you’re busy right

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

Companies that provide selfless information through particip

now, so you don’t need to worry about remembering this anymore.

I reckon you’ll not forget though

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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The one area in small business where there is still an opportunity to have a huge advantage over your competition is in marketing. In almost every industry all other competitive advantages have all but gone away, however the use of proper marketing can give you ten, one hundred and sometimes a thousand percent leverage over your competitors.

If you are charging by the hour and you own a creative business or freelance in a creative industry, then you are LOSING MONEY and not making the amount of money you deserve for your creative talents. Find out how to charge for what you are worth!

Because holding on to prejudices and judgments can seriously undermine your effectiveness as a manager, your challenge is to let go of them. Prejudices can take many forms, but generally are the result of your expectations, personal philosophy, experiences, life outlook, and personal agendas.

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