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Red flags. Warning signs. Flashing lights. Shrieking Alarms. Any time you are negotiating and you realize you're making one of the following mistakes STOP ... take a deep breath ... and collect

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

your thoughts. You may be on the slippery slope to a really poor agreement.

Mistake #1 Wanting Something Too Much

If you give the impression that your life depends on getting

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

Examples of combination products may in

that job, or car, or house, or business deal, you are in trouble. Once your counterpart gets a hint of your desperation, you're dead. Remember "the person who cares least about the outcome alway

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

s gets the best deal."

Mistake #2 Believing Your Counterpart Has All The Power

This is rarely, if ever, true. Remember, all parties want something, or they wouldn't be at the

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

bargaining table. Ask yourself, "Why are they negotiating with me?"

Mistake #3 Failing To Recognize Your Own Strengths

Always try to determine your negotiating strength before

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

Combination pro

you sit down at the bargaining table. The key to assessing your strengths and weaknesses is to know where you stand. Information of this kind is the true power in any negotiation.

Mist

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

ake #4 Getting Hung Up On One Issue

This is called fixed-mind negotiating. When our counterpart uses this approach it's usually the old "red-herring". When we fall into this pattern it

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

is usually a "pet-peeve". In any event, virtually no negotiation involves one and only one issue. If you think yours does ... you are making a big mistake.

Mistake #5 Failing

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

to See More Than One Option

Seldom do negotiations break down to only one option. There are almost always several choices of action. Creativity is the key to avoiding the "one-option" mistake.

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

Mistake #6 Adopting A Win-Lose Mentality

Mutual benefit is the name of the game when the Pros negotiate. If both parties are not happy, then performance becomes the problem. A

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

yone can shake hands on a deal. Performance only follows if benefit is derived. Otherwise, "unilateral renegotiation" is the result. Not Good!

Mistake #7 Too Much Grinding

Neg

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

Following aspects would a

otiation is a skill and an art. Understanding and using tactics is relatively simple. The real distinction between the Pro and the amateur is the judgment call to end the give-and-take and proce

dd to the challenges in developing combination products:

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

ed to performance ... that is the art.

Mistake #8 Short Term Thinking

Some negotiators go for immediate payoffs, rather than seeking a long-term relationship. Long-term doesn'

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

t necessarily mean over a lifetime. It can show up later in the same negotiation session. Be careful about grinding someone down on one point. They will get you back on another issue.

M

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

istake #9 Accepting Opinions, Feelings and Statements As Facts

"Our client would never agree to a proposal such as this" ... "We don't feel we can pay more than $1,000 for your product

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

" ... "Our budget doesn't provide for an additional installation fee". An opinion, a feeling, a statement ... None are facts. Don't be fooled.

Mistake #10 Accepting Firm Positi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ons

"This is our final offer." Everyone who has any level of experience has said this ... and then made another offer. Don't buy it!

Mistake #11 Believing That Having More Aut

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

hority Gives You More Negotiating Power

It is quite convenient to be able to say "I'd love to be able to work with you on these figures, Mr. Buyer. But all our prices are determined at our head

.

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

quarters in Boise, Idaho. I'm afraid nothing short of a coup is going to change them."

Everyone makes mistakes. The value of becoming a student of the art of negotiation is that most of us can

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

Companies that provide selfless information through particip

reduce the frequency of our mistakes and increase the frequency of optimum returns. With a little diligence and practice anyone who is committed can Negotiate Like The Pros.

Bio

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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