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Here's what to do if someone makes an amazing request.

1) Just agree. If someone offers a suggestion, comment, or complaint, sa

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

y, "Thank you. I'll note that and tell my boss." Never attempt to explain why the idea won't work because this will start an arg

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

Examples of combination products may in

ment. If appropriate ask for clarification or suggestions on how to implement the idea.

2) Avoid "Not." Negative talk encourage

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 arguments, counter attacks, and attempts to solve your problems. It also creates a negative impression. For example, when you

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

ay, "I can't," you appear helpless and ineffective. Instead, talk about what you can do and what you want to do.

3) Work at the

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

Combination pro

Ritz. That is, deal with impossible requests by 1) acknowledging the request, 2) empathizing with the other person's feelings,

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

) saying, "I wish I could . . . ," and 4) suggesting a reasonable alternative."

For example, imagine that you work at a resort

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

and it's raining. A guest walks up to you carrying a golf bag, slams it against your desk, and shouts, "This place stinks! I spe

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

t thousands of dollars coming here and it's raining."

Respond by saying, "You're right it's raining. And I know how upsetting i

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

t is to be stuck inside. I wish I could make it stop. In the meantime, you may want to visit our indoor putting center. Our golf

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

pro is offering instructions this afternoon."

4) Include them. Deal with difficult requests by 1) affirming your willingness to

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

Following aspects would a

help and 2) asking the other person to help you plan a solution.

For example, if your boss asks you to start another project, y

dd to the challenges in developing combination products:

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

ou could say, "I understand you want me to start a new project. And right now I'm working on another project. To help me set my

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

riorities, I wonder which one you want me to finish first."

5) Let them choose. If appropriate, offer choices that show the con

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

sequences of different options. This allows the other person to choose both the process and its impact.

For example, you can sa

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

, "That's a great idea. And there are different ways I can meet your request. We can use our existing supplies, which are free,

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

Professional from academic institutions, pharmaceutical industries, health care indust

or we can buy custom materials, which will cost $500. Which option would you prefer?"

6) Let them decide. Deal with complaints

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

y asking the other person to describe a fair settlement. You can say, "What do you want?" or "What would you consider a fair sol

.

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

ution to this?" or "What would make you happy?"

7) Smile. A smile makes you sound approachable, friendly, and helpful. When you

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

Companies that provide selfless information through particip

frown, other people hear caution, fear, and rejection. A smile (or at least a pleasant expression) encourages open communication

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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