Useful Advices - Business

The responsibility for ensuring that every member of the sales team

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

is successful, lies entirely with management and below are the eig

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

Examples of combination products may in

ht reasons why sales people fail.

In fact, I usually ask just thre

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

e very straightforward questions, in order to identify why a salesp

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

rson is underachieving i.e.

• Are they visiting/talking to enough

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

Combination pro

clients/prospects?

• Are they talking to the right people within 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

hose client/prospect organisations?

• Are they saying/doing the ri

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

ht things?

However this list, whilst not exhaustive, remains extre

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

mely accurate and as I said earlier, management has total control o

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

ver each of these, including the last one!!

• Wrong or no selectio

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

process - The wrong person for the position

• Wrong or no trainin

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

Following aspects would a

g - Insufficiently developed

• Wrong or no planning - Expected to

dd to the challenges in developing combination products:

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

do all of their own planning

• Wrong or no supervision - Left with

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

out competent supervision

• Wrong or no motivation - Not properly

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

otivated to meet objectives

• Wrong or no stimulation - Not stimul

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

ated by appropriate incentives

• Wrong or no evaluation - Not regu

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

Professional from academic institutions, pharmaceutical industries, health care indust

larly appraised against a set of agreed objectives

• Wrong or no e

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

ecutive action - Not adequately supported by a competent manager

<

.

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

b>In Summary:

These then, are the "Eight Reasons Why Sales Peo

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

Companies that provide selfless information through particip

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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