Advice You - Business

If we could absolutely know right away who was destined to buy from us, and distingui

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

sh these folks from non-buyers, selling would be a lot easier; don’t you agree?

Of c

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

Examples of combination products may in

ourse, we can’t be certain. There are always surprises, like prospects that seem to r

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

turn from the dead and suddenly buy without any fuss, and become profitable customers

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

.

QUALIFYING prospects is the process of determining whether people have the means,

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

Combination pro

he motivation, and the clout to buy.

Unfortunately, when qualifying is done, it usua

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

lly sounds brusque.

The car seller comes to mind, that upon first sighting a shopper

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

abruptly and condescendingly asks, “So, are you going to drive out of here in a new c

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

ar, today?”

One of best qualifying questions starts with the word, “When” as in “Whe

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

do you think you’re going to need a new car?”

Recently, I received a consulting inq

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

uiry and one of the first questions I heard was, “How soon can we get underway?”

Tha

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

Following aspects would a

t’s certainly a MOTIVATED buyer. Whether he has a senior enough rank to approve a con

dd to the challenges in developing combination products:

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

ract, as well as the funding, remains to be determined.

If you turn this around and

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

ask, “When would you like to get underway?” you’ll probably evoke information regardi

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

g MEANS and CLOUT.

If you don’t get these bits of information with due speed, you ca

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

n certainly ask: “Do you have a budget for consulting?” or “Is this a committee decis

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

Professional from academic institutions, pharmaceutical industries, health care indust

on, or do YOU have the green light to move forward?”

The “When” question is pivotal

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

because it pertains to TIME.

If there is no buying urgency, typically the prospect w

.

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

n’t mind wasting your time, and his or hers. If time is of the essence, this tells yo

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

Companies that provide selfless information through particip

u to stop the clock, give that prospect your complete attention, and ask for the 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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