Advice You - Business

Selling is a little like being drunk.

You say and do things in the heat of the mo

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

ment that might come back to haunt you.

For instance, it’s easy to make grandiose

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

Examples of combination products may in

promises, vague pronouncements such as: “We stand behind our products 100%!”

Of

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

ourse you do; otherwise, you might stand beside them or in front of them, obscurin

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

g everyone’s view.

To prospects, it sounds like you just made an unconditional gu

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

Combination pro

rantee.

What if your widget breaks or your gizmo grinds to a halt, say five years

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

down the line? Where are you going to be standing, then, in the defendant’s box 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

n court, disclaiming responsibility?

I know, some buyers are influential and char

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

ing and disarming.

Full of smiles, being ultra-nice, as he asks for a discount, y

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

ou might be tempted to reciprocate and be a good old boy and collapse your margins

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

or commissions right there, on the spot.

“Why did I agree to that?” you wonder la

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

Following aspects would a

ter on, in the bright glare of your office’s overhead lights.

You might con yours

dd to the challenges in developing combination products:

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

elf with the thought, “Sure, I’m losing money on this unit, but I’ll make it up on

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

volume!” or “This one will make a fine testimonial and by selling her, the rest in

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

her industry will follow!”

Of course, it’s nonsense. In bar-speak, you’ve had 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

e than one too many.

So, how can you avoid this occupational hazard?

Try this: W

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

Professional from academic institutions, pharmaceutical industries, health care indust

hen you’re really starting to feel loose in front of a prospect, pull yourself tog

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

ether. Be your own designated disciplinarian.

Shake yourself, and say, "Hey, bud,

.

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

it’s closing time!"

Ask for the deal, right then and there.

If you hang around a

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

Companies that provide selfless information through particip

ny longer, you’re going to say something you’ll regret, and probably blow the deal

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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