Main Subject - Business

By now you've been more aware of the times when you are in a negotiation with someone, whether it be a customer, co-worker, vendor, or someone at home. You've no doubt had one or two

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

outcomes that were very different than what was available to you before the win/win training. You also probably had many negotiations that didn't result in win/wins, that went as 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

y have in the past, or perhaps worse than usual as you tried new things. Remember, to be a successful win/win negotiator, you must:

A. Have the knowledge, which you now have and can

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

reinforce and strengthen by review of the training materials in your manual and in the book, Getting to Yes.

B. Have the desire to be a great negotiator. This includes seeing yourse

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

f as a businessperson, providing leadership for others and not simply focusing on tasks alone.

C. You must practice. Each unsuccessful negotiation or failed attempt to create a spir

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

Combination pro

t of collaboration can be used and learned from. Rather than take the position that what you are doing doesn't work or some other defeatist attitude, look at what you learned from yo

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

r success and failures, what you could have done to have a different outcome, and begin experimenting and trying different things. Negotiations, like many skills, require practice da

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

ily. Let's review:

Separate the people from the issues. You must be soft on the people but tough on the issues. This means also creating a spirit of collaboration and not saying thi

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

gs that could be taken as offensive. For example: I feel pressure rather than you are pressuring me. Set the tone of collaboration early on in the discussion!

Uncover interests. Pos

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

tions are solutions. Interest are the needs behind those solutions, not only being aware of your interest but also asking questions to uncover the other party's interests.

Creating

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

ptions. When working with customers, you may need to create some commitment. For example, "We certainly want to see, Mrs. Jones, that whatever we do meets with your needs and require

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

Following aspects would a

ents. Here are a few options of ways we may go about doing that..." Do not try to rush this part of the process. Often times you can create solutions that are better than either part

dd to the challenges in developing combination products:

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

would have dreamt of.

BATNA. Remember to have a backup, an alternative to negotiated settlement. This is not your bottom line in negotiation, rather it is what you can do without t

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

e other party if you cannot reach a negotiated agreement with them.

Use objective criteria or an objective process for reaching a decision. The classic example here is if your car i

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

s stolen, what should the insurance company pay you. Is it wholesale, retail, is it what's remaining on the financing, is it what's in the paper on Sunday on similar vehicles, etc. Y

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

u will want to forward the objective criteria that helps persuade the other party and that creates a foundation of fairness for both parties.

Relationship. One of the truest tests o

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

Professional from academic institutions, pharmaceutical industries, health care indust

the successful win/win negotiation is that the parties will want to negotiate again. There may be some upsets along the way during the negotiation, but the primary results of the ne

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

otiation in terms of the value provided for each party, and the state of the relationship at that point, is what really counts.

Commitments. What are all the factors to be included

.

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

n a negotiated agreement. Never make a negotiation about one issue because then it becomes a battle of wills. Rather than have inflexible criteria for the ending of the negotiation,

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

Companies that provide selfless information through particip

his part of the process involves you in thinking about all the things that need to be considered for an agreement to be complete and to be followed through by each party successfully

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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My clients have grown to love the fact that I’m available quickly. If they e-mail me, chances are great that I’ll be sitting at my PC ready for their e-mail and in most cases; I have an e-mail back to them within five-ten minutes. My clients have always commented on this ability of mine and how much they appreciate my responsiveness and timeliness. So, how can you achieve this for your own business? It’s easy!

Hey, as business owners we CAN'T be all things for all customers. I mean it would be fantastic if we could, however, you just can't meet the needs and wants of everyone, you would run yourself ragged trying :o(

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