Main Subject - Business

How can you find out the group loyalty requirements before you venture forth?

Many groups have l

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

oyalty requirements in order to make sure that the leads you generate are exclusively for the mem

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

Examples of combination products may in

bers of the group. It is important that you make sure you know everything about the group before

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

you join, and loyalty requirements can put a damper on other activities you have planned. If you

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

ind a group that does not have any requirements for loyalty, then you will have to interview memb

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

Combination pro

ers to see what other groups they belong to. If there is no focus on your group, then the leads w

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

ill likely be watered down. Loyalty that excludes organizations such as Chamber membership or spe

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

aking groups should not be on the list of acceptable groups to join. Loyalty should be restricted

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

to other leads groups. Make sure that others who belong to the group do buy into the loyalty issu

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

e. Often when there is a rule, someone will take advantage and belong to other groups in a differ

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

ent area. Loyalty will prove to be the making or breaking of any group.

If you do business with

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

Following aspects would a

members of other groups, then you should make sure that they do not have restrictions with whom t

dd to the challenges in developing combination products:

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

ey may do business with. Some groups restrict using an outside source for some services from memb

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

ers. In my experience, to join one of the groups I was considering, members joining were required

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

to drop their current printer service and give business to the member printer. It is NEVER wise

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

to lose good business relationships through group loyalty requirements.

Loyalty in theory is sup

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

Professional from academic institutions, pharmaceutical industries, health care indust

osed to lead to a closed group that supports your business and the other members. It does not nec

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

essarily mean that you cannot do business outside the group (you will have to make sure that this

.

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

is not a requirement). Loyalty is often only one of the criteria for membership; you may also ha

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

Companies that provide selfless information through particip

ve an attendance factor, and a fee. In light of the criteria, you still have to measure the value

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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Planning to be an accountant doesn't have to be a tedious and difficult chore. It does, however, require you to explore and do your homework ahead of time.

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