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One of the biggest deflators of an idea or a dream is when someone close to you dismisses it, or worse, laughs at it. We all know people like that. It’s especially difficult when these people are our

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

spouses, parents, or friends. Why is it that the very people we turn to for support and encouragement are often the ones who won’t provide it?

Of course, they offer support and encouragement when terr

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

Examples of combination products may in

ble things happen. If your house were hit by a tornado, they’d probably rush over to make sure you’re okay, and then they’d give you a place to stay, feed you, and possibly lend you money while you got

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

back on your feet.

But when you go to them with a positive idea, such as an idea for an invention or a business idea, they just can’t resist poking holes in it. Sometimes they’ll frame it as though th

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

ey’re trying to help you. “I’m just playing devil’s advocate,” they say. Or they might actually be worse, and just roll their eyes at you or laugh. They’ll say things like “If it were such a good ide

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

Combination pro

, someone else would already be doing it.”

Here are some strategies for managing these nay-sayers and preventing them from deflating your dreams.

1) The best strategy is to eliminate the really bad on

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

s from your life. Often, this isn’t possible. But occasionally, it is. If you can’t avoid someone entirely, do what you can to minimize the frequency of contact.

2) Use the person who always wants t

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

o play “devil’s advocate.” Don’t go to this person early on in the process. For instance, if you have a great idea for a business, don’t share it with this person right away. Flesh it out on your own

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

first. Do research. Put together a plan. Then go to the person who wants to play “devil’s advocate.” This person can help you identify problems or weaknesses in your plan. This doesn’t mean you sho

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

ld abandon your plan! It just identifies potential problems that you may not have considered. This is good because now you can address them and solve the problems as you proceed.

3) Don’t even bother

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

sharing your ideas and dreams with people who dismiss your ideas out of hand or laugh at them. It’s not worth the hassle. Talk to them about the weather instead.

What if the nay-sayer in your life is

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

Following aspects would a

someone from whom you really do need buy-in before proceeding? For example, what if the biggest nay-sayer in your world is your spouse? It would be very difficult to invest time and money into a grea

dd to the challenges in developing combination products:

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

idea without your spouse’s buy-in. Some of the best ideas in the world never saw the light of day because someone’s spouse said “Don’t be ridiculous,” or “That would never work,” and just left it at t

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

at.

If you’re married to a nay-sayer, you just have to work around him or her. Treat your spouse like the devil’s advocate in the second example above. Go as far as you can with the idea before telli

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

ng your spouse about it. Think through every possible pitfall and every obstacle. Then, by the time you tell your spouse about it, you’ll have an answer for every objection. Your spouse says it’s im

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

ossible? No, you’ve already done the research to prove that it isn’t. Your spouse says if it were a good idea, someone else would have already thought of it? Point out that if all good ideas have alr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ady been thought up by other people, nobody would have been motivated to invent the automobile, the transistor, those special diapers that toddlers could swim in, diet cola, you name it – if it’s been i

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

nvented, it’s because someone proceeded with an idea.

I’m not advocating keeping secrets from your spouse. I am, however, advocating managing the nay-sayers in your life, and if one of them happens to

.

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

be your spouse, then this requires management if you really want to try out your ideas.

And finally, don’t be a nay-sayer yourself. When someone comes to you with a seemingly ridiculous idea, resist t

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

Companies that provide selfless information through particip

e urge to dismiss the idea out of hand. If you can’t think of anything encouraging to say, simply say politely “I don’t see how it would work, but if you find a way, that’s great! Good luck with that.

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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