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Let's face it, there are things that we don't always enjoy doing in our day-to-day business routines. Perhaps you are confused by accounting and have papers strewn all over your desk or stuffed in a drawer. Maybe you're afraid to pick up th

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

e phone and call potential clients, even though you know it will result in some much-needed sales. Or you know you need to hire an assistant, but you cringe at the thought of turning over the "controls" to someone else.

All of us have the

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

Examples of combination products may in

tendency to form "comfort zones" around ourselves: boundaries between what makes us feel comfortable, and uncomfortable. Comfort zones are not always bad. Sometimes they can prevent us from doing something stupid or reckless. Most often, ho

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

ever, our comfort zones are built on a belief that may or may not be true. If you've experienced a particularly painful rejection in the past, you might create a comfort zone that will prevent you from "sticking your neck out there" and bei

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

ng rejected again. In this case, the comfort zone itself isn't the problem. The underlying belief that you will be rejected again is the problem.

Just because you've been rejected in the past does not mean you will be rejected again in the

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

Combination pro

future. That particular comfort zone will cause you to act in ways that are counterproductive to your own success. You will dread approaching new clients, networking, or any type of public activity involving your business. Deep inside, part

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

of you will be expecting to be rejected again, and you will do whatever you can to limit the possibility of that happening. Pain isn't fun to experience, and it's amazing how our minds will avoid it at all costs!

Maybe you're not even awa

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

re of most of your comfort zones. Take a look at your business as it is right now. Are you making as much money as you'd like? Are you moving forward with new projects and goals without a problem? Do you love meeting new people and getting

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

o know them? Is your business well-organized and efficient? If you answered yes to these questions, you probably aren't being hindered in any way by your comfort zones. If you answered no to any of these questions, you might have some issue

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

s to work through.

Here is a simple way to discover if your fears are holding you back: make a list of the worst possible things you can imagine for your business. What are your deepest fears? What aspects of your business don't you enjoy?

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

And why? If you don't enjoy networking, ask yourself why that is. What is the worst thing you can imagine happening regarding networking? Be honest with yourself. You don't have to show this list to anyone.

Once you know what you are truly

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

Following aspects would a

afraid of, ask yourself what the consequences would be if your worst fear were to be realized. And could you live with those consequences? Using the rejection example again, what would be the consequences of being rejected again? Would you

dd to the challenges in developing combination products:

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

be able to live with that? I think you'll be surprised at how small most of the consequences are, and how easily we could live with them if we had to.

Fear has a way of making itself much bigger in our minds than it is in reality! We work

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

ourselves into a sweat, terrified of the "what ifs" -- when in fact, the outcome would be no big deal really. As with most other things, we'd simply pick ourselves up and continue on our way.

Once you know what your fears are, and you unde

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

rstand and accept the consequences, immediately do the thing you fear most. Yes, that's right, I'm encouraging you to step out of your comfort zones! Refuse to let fear control you. Tell your fear, "Thanks for trying to protect me, but I'm

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

oing to do it anyway." And then just do it. Then do it again. And again. The first few times you step out of your comfort zones, you WILL be uncomfortable. Expect that and accept it. Fear won't vanish overnight. But it will go away after yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

ur mind understands that the fear is groundless.

Now, just because you conquer your fears and expand your comfort zones doesn't mean you should become reckless either. There is a big difference between blindly leaping into the unknown and

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

taking a calculated risk. Before acting, take a few minutes to think about the action you want to take, consider the consequences, and ask if you're willing to accept them. If you are, go for it. If you're not, that's all right! Don't feel

.

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

ike you have to push yourself beyond what you'd be willing to accept. You can put the issue on the back burner for awhile and reconsider it later.

The point is to stop letting fear make your business decisions, and start making them yourse

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

Companies that provide selfless information through particip

lf. It will take some time to get used to this new way of thinking, but before long you'll automatically begin questioning your fear and stop letting it control you. Once that happens, there is no telling the levels of success you can reach

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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