Digg It - Business

Most leaders want to improve their business. After all, these impro

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

vements lead to increased profits through greater productivity and

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

Examples of combination products may in

fficiency.

Sometimes clues to important improvements lay hidden in

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

events that everyone takes for granted.

For example, how well do y

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

u score on the following quiz about your meetings?

* How much time

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

Combination pro

do you spend in meetings?

0% - - | - - 25% - - | - - 50% - - | -

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

75% - - | - - 100%

* How productive are your meetings?

0% (terri

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

le) - - | - - 25% - - | - - 50% - - | - - 75% - - | - - 100% (effec

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

ive)

* What do meetings cost your business?

* How much do meeting

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

s earn for your business?

* What would you work on if you spent le

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

s time in meetings?

My surveys show that (on average) people spend

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

Following aspects would a

40% of their time in meetings that they rate 50% effective. That tr

dd to the challenges in developing combination products:

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

nslates to wasting 20% of their time in meetings.

This is equivale

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

nt to spending a full day each week doing nothing. It also represen

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

s a monstrous lost opportunity because that day could be spent work

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

ng on things that make money for the business.

But most executives

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

Professional from academic institutions, pharmaceutical industries, health care indust

dismiss meetings as just another business activity. They say, "It’s

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

okay, I’ve learned to live with it."

In fact however, fixing thei

.

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

meetings represents the most significant improvement that they cou

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

Companies that provide selfless information through particip

d make on their business. Call if you want to improve your meetings

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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