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Envision the scenario: You’ve just been asked at the last minute by Chris, the organizer of your local networking group, to replace the scheduled speaker at next month's meeting. You already have too many commitments on your pl

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

ate. Imagine your response:

You: “Well, I don’t think I’d have enough time to prepare. I’m awfully sorry—I wish I could help you!”

Chris: “Your last speech was super—maybe you c

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

Examples of combination products may in

ould just talk some more about that topic? I’d really appreciate it!”

You: “I’m glad you liked it--maybe I could do it…

Chris: “Oh that would be great! Just let me

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

know the title…” ...fade

How might you feel about doing this speech? You might feel stressed or resentful. You might not be at your best when you do the speech. Other work that you’d really like to be doing

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

might suffer.

Now imagine a different response:

You: ”No, I can’t be prepared on such short notice. I know how hard it is to find someone—Alex speaks on a variety of topics and I think she could fill in for yo

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

Combination pro

. I’ll give you her number.”

Chris: “Thanks! That will really help.”

This is a win-win-win: Alex gets an opportunity to speak (her specialty), Chris gets a speaker, and you ar

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

en’t saddled with a commitment you don’t want--plus, you’ve probably earned some good will from both Alex and Chris. What a difference!

Whether you are saying no to a collaborator asking you to do something, or saying no to a

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

potential client that you really don’t want to have, the ability to say no gracefully is a key skill when you are in business as a solo entrepreneur. Here are four quick steps to learning this skill:

1. Understand the reas

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

ons you say "yes", even when you don't really want to. Here are some common reasons; which ones apply to you?

-- You want to please people; you don't want to hurt anyone's feelings.

-- The customer is always rig

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

ht, you can't say no to the customer!

-- It's not polite to say no; if you say no you feel you are being self-centered.

-- You are flattered by the request.

-- You feel like you need the business!

-

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

You can't think of a nice way to say no fast enough.

--You think there might be other unforeseen negative consequences if you say no.

2. Recognize the good things that can come out of saying "no":

-- Y

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

Following aspects would a

ou have more opportunities to say "yes" to the right customer.

-- You have more time to do the things you *want* to do.

-- Saying no expresses how you *really* feel. You are taking responsibility for your own

dd to the challenges in developing combination products:

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

feelings and letting others take responsibility for theirs.

-- Someone else who really wants this customer's business, has a chance to get it

3. Learn how to say "no" gracefully:

-- "No, I can't do that.

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

" Don't beat around the bush-put "no" right upfront.

-- Use non-verbal cues to underscore the "no"-shake your head; use a firm and direct voice, use eye-contact.

-- Add an explanation if you want, but don't a

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

pologize: "I have another commitment." - even if that commitment is to yourself!

-- Be empathetic if the situation calls for it: "I know how hard it is to find a tax-preparer at this time of year."

-- Recommend an

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>alternative if one is available: "Let me refer you to..."

-- If you're not sure, it's always OK to ask for more time to think it over!

4. Practice your new skill:

-- Rehearse ahead of time if you think

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

Professional from academic institutions, pharmaceutical industries, health care indust

it will help. Role play with your business coach or a friend or colleague.

-- Choose a low-risk situation first. Practice on your significant other, family, friends. Or practice on strangers, if that's easier for

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

you: the salesclerk who wants to sell you one more thing, the telemarketer calling at dinner.

-- Work your way up to friendly clients. They are likely to appreciate the boundaries you are setting!

-- When you have the

.

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

courage to fire that client who hasn't paid and makes unreasonable demands-you'll know you've mastered saying "NO!" (Hint: refer them to someone else that is a better fit and help manage the transition!)

Saying "no" gi

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

Companies that provide selfless information through particip

ves you freedom. It is a way of honoring both yourself and the person you are saying "no" to. Learn to do it well, and you will earn the respect of others--and yourself!

Copyright 2004, Terri Zwierzynski, Accel Innovation, Inc

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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It is a better option to keep your business separate from your personal life, and the first step towards that is forming a business entity such as a corporation. Various states have various rules and Alabama is no exception regarding incorporation.

Do you need a consultant? How much will it cost? Hiring a consultant can save you money in the long term and get your business running better. But determining the who, what, when, where, and why of consultants can be a difficult task.

No matter what products your retail store offers customers, there will always be competition with the store next door or down the street.

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