Advice You - Business

I was recently the fly on the wall at a negotiation. The negotiation itself is a result of longterm planning in most cases. This article details what to d

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

o before entering a business negotiation.

Step One:

Do your homework. That means research anything that may come up in advance of the business negotiatio

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

Examples of combination products may in

n. Absolutely, have a few notes there to back up your viewpoint. If you don't have that research, you are at a disadvantage.

Step Two:

Consider jotting

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

down notes of what you intend to get out of the negotiation. Include things like points that are absolute deal breakers. Include points that you are likel

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

y to compromise on.

Additionally, draw or sketch out what the final deal will look like. Include financial numbers to give you an idea of what ballpark yo

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

Combination pro

want to end up in as a result of this business negotiation. Ie. People who are successful at business can see into the future for longterm rewards as much

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

as they can see into the future for shortterm rewards. But clearly, having a map drawn of where your headed is valid before entering negotiation. It will

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

also help you to be firm in your negotiation, knowing what you may be foregoing.

Step Three:

Do some market research. I know that companies can charge y

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

ou millions of dollars for a simple study of getting people's opinion on something. If this business negotiation affects people, find out from people what

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

they think. Don't limit yourself to two or three of your closest managers or friends. Extend that. Show up at a mall. Ask if you can have a minute with

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

eople. Dress appropriately to break down the barriers. People are flattered when you are seeking their opinion so to be fair, treat them appropriately and

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

Following aspects would a

explain how their opinion will have some affect.

I have a friend in the natural concoction business. Before working on a new product, she phones up a lis

dd to the challenges in developing combination products:

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

t of customers who are agreeable and asks them about the future product. It may be well into the future but she gets the goods on the interest long before

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

she undertakes it. Such is the case with a negotiation.

Absolutely, do your market research. Some things look good on paper but never go anywhere in the

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

real world. For example, if you're the marketing guru behind The Clapper you would have researched this product in advance and how agreeable people would b

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 buying it. But say, you invented something similar like The Sneezer, then tried to market it without asking people how hard it would be, how useful it

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

Professional from academic institutions, pharmaceutical industries, health care indust

would be to them. You would undoubtedly lose your shirt.

Step Four:

Set down in advance what you as a company stand for and who you're willing to negotia

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

te with well in advance. For example, if you believe in only dealing with union shops, then make sure you write that down and stick to it before any negoti

.

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

ation. There's a phrase that if you don't stand for anything, you will fall for everything. By having principles, you are already on your way.

Step Five:

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

Companies that provide selfless information through particip

Enter the negotiation with a window of time that you will allow before making any final decisions. This prevents an emotional response to the negotiation

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 - Before Negotiation

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