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If you think that negotiating is something only a buyer will do, you’re very much mistaken. Even a

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

s a home seller, you will, at some point in time, negotiate with your potential buyer. Remember th

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

Examples of combination products may in

t, negotiation is a two way street.

When you are negotiating, make sure that you remain detached

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

from the entire transaction emotionally. Bear in mind that this is a financial matter and, when de

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

ling with money, it’s always better to think with a clear head. Don’t look at your house as the ho

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

Combination pro

me that sheltered you through many storms in your life, but view it objectively as a solid structu

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

e made of stone, timber and mortar.

It is also important that when you are negotiating (or presen

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

ting a counter offer to your buyer) you don’t just think of the actual money changing hands, but t

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

e “net” profit. Take into consideration all the costs that you (or the buyer) will shoulder. The m

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

oney you get from the buyer who offers to pay a little less than what you’re asking for and also s

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

oulder all other incidental expenses may be more than the total net amount you’ll get from a buyer

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

Following aspects would a

who will pay your asking price but will leave all incidental costs for you to settle.

Keep mum ab

dd to the challenges in developing combination products:

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

out the lowest price you are willing to accept. Don’t tell anyone, even your friends and family (e

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

cept your partner, of course). By letting buyers know that you’re willing to settle for far much l

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

ess, expect them to haggle in order to get that amount (or even lower). Just accept the offers tha

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

come in and negotiate if you don’t find them suitable.

Finally, you should always keep your temp

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

Professional from academic institutions, pharmaceutical industries, health care indust

er in check and practice utmost decorum and tact at all times. You cannot raise your voice or utte

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

sarcastic remarks as these will turn your buyer off and leave you with a bad reputation. Negotiat

.

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

ion is all about reaching a compromise, and this cannot be done if you enter the battleground with

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

Companies that provide selfless information through particip

a hot head and a short temper. Be patient and amiable, and eventually, you’ll settle things nicely

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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Many professionals and managers are so involved in day-to-day crises and fighting fires that they forget about a key leadership characteristic: self-management. It’s too late to figure out what’s next for you once your company has merged, had lay offs, changed strategy or whatever. Rather, start taking control of your career now.

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