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Values have been described as personal--or organizational--North Stars. Having values means we have a constant fixture to guide us in the face of uncertainty. In

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

the Northern Hemisphere, as long as you can see the North Star, you can navigate successfully, whatever the circumstances, and arrive at your intended destinati

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

Examples of combination products may in

on. Similarly, the presence of corporate values enables employees to make good decisions if no leader or other source of guidance is available.

Our culture tod

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

y often scoffs at the “antiquated” notion of values. On television and in print, we see daily examples of the degradation of fundamental values. Some in our soci

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

ety believe that having the basic freedoms we have means they can do whatever they want, whenever they want to. People behaving badly receive attention and recog

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

Combination pro

ition in our news media. Consider music videos that are less about music and more about sex. Or Wall Street traders who are concerned less about shareholder valu

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

e than about their own net worth. Even some church leaders have made news for adhering to a standard of self-preservation rather than the standard of a higher ca

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

ling that embraces honor and respect.

In the business world, values also receive short shrift. Managers thrive on metrics and measurement. Theirs is a world of

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

spreadsheets and cash flow projections. A boost in share price may be well worth cutting a few corners. When people do talk about values, perhaps in a strategic

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

lanning session, it’s a quick and perfunctory conversation, held to get the check mark for having talked about Values in order to move on to Action Planning. Man

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

agers cannot apply Total Quality Management and Six Sigma to values. Values cannot be subjected to re-engineering. They are not quantifiable, and in the business

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

Following aspects would a

world, some say, “If you can’t measure it, don’t bother with it.”

Values, too, can be dicey to talk about. People get uncomfortable, possibly because they are

dd to the challenges in developing combination products:

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

nsure of their own values, or they’re worried about the potential of a clash with someone else’s values--or because they have never heard of a workplace having v

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

alues, and they don’t know what it means. Employees at lower levels don’t concern themselves with values because those were crafted somewhere “on high;” lower-le

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

el workers don’t own a piece of them. It is imperative that senior leaders invest time to define and explain the values of the firm to these, and all other, empl

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

oyees.

On the job, leaders have the opportunity to talk about values whenever they are coaching or reinforcing behavior. Rather than simply telling someone he/s

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

Professional from academic institutions, pharmaceutical industries, health care indust

e did something wrong, it is far more effective to explain why the mistake is inconsistent with the company’s values. Armed with this deeper understanding, the e

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

mployee is able to make better decisions in the future.

If the leaders of your firm don’t talk about and model the firm’s values, how are your employees going t

.

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

learn what they are? If you want your employees to understand what you expect of them, you need to explain it to them. If you want them to act a certain way, gi

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

Companies that provide selfless information through particip

ve them a code of conduct--a system of values--to enable them to act decisively and in the best interests of the group

© 2006 FireStarter Speaking and Consultin

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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No matter if you are a seasoned trade show exhibitor or a newcomer, do not exhibit until you read and apply these timeless tips. These following tips and training resources will save you aching back, wasted money and increase your sales – guaranteed! If you don’t take this 7-second questionnaire, you will be like most trade show exhibitors. You will leave the trade show exhausted and wondering why you spent thousands of dollars for little or no results. Trade show marketing is a big investment of your time and money. Follow these simple tips and tools and you’ll prosper.

Testimonials are a wonderful way to market yourself. They give you credibility—a third-party endorsement. It is no longer you alone saying that you and your company and products or services are phenomenal—it is someone else saying that they are phenomenal! When you place an ad, everyone knows that you have paid for it. It is you “tooting your own horn.” Much more believable and credible is someone else “tooting your horn!” Use testimonials in your marketing materials, use them on your web site, use them in advertisements, use them in your media kits, put them on business cards and make sure to use them in your sales presentations and/or on the telephone as success stories.

We miss opportunties in sales when we are too tired to listen and we need to recharge our batteries. The focus and attention to detail is critical to our sales success.

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