Main Subject - Business

Learn to recognize potential problems before they threaten the survival of your business.

During the bleak days of the Depression, an aggressive politician from New York named Frankl

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

in Roosevelt made a bold promise that his administration would put “two chickens in every pot and a car in every garage.” As it turned out, this was one of the few times in history when a po

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

Examples of combination products may in

itical exaggeration was actually an economic understatement.

Today, poultry is so inexpensive that it is the most common meat used in pet food. And the automobile has become such a fixture

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

n the American home that owning just one is a handicap rather than a privilege. In fact, we have such an innate understanding of the internal combustion engine that most of us have a rough i

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

ea of how it works and why it sometimes doesn’t.

Unfortunately, many business people have not come quite as far since the Depression in their ability to discern what makes a company or orga

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

Combination pro

ization work and what needs to be done to ensure its survival. There are basically nine “danger signals” that indicate the strength and viability of a business.

1. Declining gross income, c

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

ombine with operating losses. In most instances, declining sales will not be targeted as a problem until operating losses deplete cash reserves. Normally, operating costs will remain high an

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

not be adjusted as sales decline. This creates the operating losses that eat up cash reserves.

2. The absence of an operating plan to guide the company. Most managers do not use a carefull

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

crafted planning procedure to create an ongoing validation system. It a planning document exists, it is often shelved and forgotten as day-to-day concerts take precedence over future goals.

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

When this happens, management has little or nothing to measure itself against and is oblivious to hidden dangers.

3. Breakdown in communications between upper management and the labor force

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

Failure to communicate vertically creates a situation where upper management cannot identify conflicts that exist in the on-going operation of the organization.

4. Inadequate cash flow. Th

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

Following aspects would a

e ability to generate cash flow is the key ingredient in a successful business operation. Without adequate cash flow, an organization is doomed to failure. While it is normal for most organi

dd to the challenges in developing combination products:

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

ations to have seasonal fluctuations, balancing these adjustments is critical for the survival of any organization.

5. Inability to convert accounts receivable to cash promptly. The slow co

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

lection process of accounts receivable can be a danger signal that poor job of screening accounts and granting credit has taken place.

6. Inability to convert inventory to cash promptly. A

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

low down in inventory may signal a problem in the quality of products shipped.

7. Cash tied-up in nonproductive assets. Investing heavily in new office building, equipment and personnel wit

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

out careful planning can be a nonproductive use of assets and can destroy a company.

8. Amounts owed to vendors. When an organization is unable to meet the payment terms of their vendors, n

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

Professional from academic institutions, pharmaceutical industries, health care indust

ot only does a serious cash-flow situation exist, the future credibility of the company is in doubt. Long-term business success depends on the goodwill a company is able to generate with its

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

creditors.

9. Low employee morale. Most employees truly want their organization to be successful. When a company is without solid direction, morale declines and with it goes productivity.

.

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

he natural tendency of most managers is to ignore potential problems until their urgency demands attention. By systematically—preferably on a monthly basis—reviewing the corporate goals and

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

Companies that provide selfless information through particip

valuating how successfully these goals are being achieved, management will maintain the fiscal vitality of their company and eliminate the anxiety that comes from last-minute problem solving

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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Let's start off with a given. The 2006 real estate market is tough and unlike anything we've seen in five years. The problem is if we go back five years, it was the advent of the Internet in residential brokerage. We're at an historical point in our business. While the go-go market was going on, real estate consumers changed. Now that we're in a more traditional market, we can't rely on our traditional habits of recruiting and training agents.

Marketers today focused on understanding the whole buying process rather than the final purchasing act. Each family member affects the purchasing behavior at different stages.

Forging partnerships to improve market penetration has become commonplace, particularly for “new economy” businesses. And, most companies proudly mention their many partnerships in their business plans.

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