Advice You - Business

In any conversation with two or more people, there is a tendency to want to talk all the time

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

to fill any awkward silences or gaps that appear in a conversation.

However, if you think of

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

Examples of combination products may in

he conversations that you have with your closest friends or family, you will notice that there

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

isn't the same need to fill these gaps, as silences between you are comfortable. This is gener

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

lly because you know the other person and the type of character that they are.

Now, if we cha

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

Combination pro

ge this scenario to the sales process you will see that it is a completely different feeling t

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

o the one above. Suddenly silence is your worst enemy, the one thing to be avoided during nego

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

iations, the realisation that you are losing the sale.

Well actually, that last statement is

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

ompletely wrong!

Because a person does not say too much during negotiations does not mean tha

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

you are losing the sale. Yes, silence can be awkward to some but to those of you who want to

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

in, silence can be your best friend.

During the negotiations, you will ask your customer a nu

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

Following aspects would a

mber of open questions and that is absolutely the right thing to do. However once you have as

dd to the challenges in developing combination products:

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

ed the question, DO NOT fill the space! Resist the temptation to put words into their mouth.

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

n other words:

"Ask your open question and then say absolutely nothing until they have replie

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

"

No matter how awkward it becomes or how uncomfortable it may seem, leave your customer to r

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

ply. If it takes 5 minutes then so be it. They MUST be allowed to reply in their own time with

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

Professional from academic institutions, pharmaceutical industries, health care indust

out any help from you.

The reason I am pushing this point is that customers (and people in ge

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

eral) do not like silence. They particularly do not like long silences and they feel that they

.

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

have to fill the space up with words. Before you know it they have committed to all sorts of t

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

Companies that provide selfless information through particip

ings.

So, don't be afraid of the silence and let your customers talk their way into your sale

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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Advice You - Don't Be Afraid Of Silence

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