Main Subject - Business

I once gave a presentation to a group of sales professionals about how belief patterns can take us "off our game." Afterwards, one of 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 audience members asked what he could do to notice when he is "not on his game." He said he could see where beliefs were likely a part

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

Examples of combination products may in

f this, but expressed frustration that he didn't always notice right away when something was off and now wanted to shorten his time to a

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

areness.

Being "on your game" is a great expression for that feeling we have when we are feeling good about what we're doing. During 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

ese times we typically feel more optimistic, more energized and often experience our greatest level of success and productivity. If you

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

Combination pro

ork at a job that requires leading a group or organization, or in sales where your relationship to prospects and customers is critical,

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

our ability to connect with people is often a key piece of your success. In situations like these, it's easy to see how being "off your

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

game" can interfere with your ability to relate to people in a way that allows them to experience the high value of your leadership or b

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

siness offerings.

The key to anyone's success and your #1 strategy for noticing when you are off your game is to simply stay connected

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

o yourself.

Taking stock requires a check-in with yourself - time to notice how you feel, your enthusiasm and energy level for where yo

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

are headed (yes, the vision!). And although it sounds simple, during those times when e-mail, cell phones, and Blackberries can put you

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

Following aspects would a

in overload, YOU are the one that you put on hold! YOU are likely the last one you check in with.

So, when you do check in with YOU, t

dd to the challenges in developing combination products:

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

e following signs are the ones to notice.

Seven Ways To Recognize You Are Off Your Game

You notice that:

Work or lif

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

seems to be requiring more effort than usual.

You're focusing more on what you don't have than the world of opportunities ava

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

ilable to you (the Glass-half-empty Syndrome).

You are questioning your decisions and hesitant to make new ones.

You

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

vision is feeling less like a vision and more like a "pipe dream."

Talking to prospects (job, sales, networking contacts) has

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

Professional from academic institutions, pharmaceutical industries, health care indust

you feeling like you're asking for a favor.

Even thoughts of success at work are leaving you feeling flat and unenthusiastic.<

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

/li>

Your perspective is one of scarcity as it's seeming that everyone else is getting theirs and you may be left out.

.

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

If two or more apply to you, you are likely "off your game" and not bringing the best of you to your work or life. Realizing that your e

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

Companies that provide selfless information through particip

ergy and perspective is off is the first step to making the changes you need in order to recharge and realign your self with your vision

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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