Useful Advices - Business

When Merriam-Webster assembled their list of most searched definitions for 2005, they could easily reason why certain words would make the list. Levee, tsunami, filibuster, and refugee were tied to events during the year. Even insipid was explainable due to the timing of the hits and co

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

mments made by Simon Cowell of wannabe singers during American Idol. Yet one word, the top word, seemed to be more wide-spread than caused by a single event. The word: Integrity.

More people searched for the definition of integrity than any other word during the year. The sear

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

Examples of combination products may in

hers were potentially hungering for the days when one’s words coincided with their actions under an umbrella of honesty and morality. There was a day when one could trust their supervisor to have concern for their interests and for the heads of the organization to be concerned about the

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

uture of the people working for them. You could work for a company your entire life and depend on them in retirement.

Yet in 2005 we saw cuts in pensions for retirees, the threat of double digit pay cuts, and hefty benefit reductions for workers across industries and supply channels. Ev

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

n former lifelong employers like Ford, Sears, GM, Kmart, and others announced new layoffs while upper management seemed oblivious to the hardships created for their employees.

For Baby-Boomers, integrity in the business world seems to have vanished - evaporated from a glass once half-ful

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

Combination pro

l.

People want to trust their customers, employees, and employers. At the same time employee theft is on the rise, pension funds are being raided, and customers are increasingly treated as interruptions.

Integrity slips away quietly even under the loud cries of those that inevitably se

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

it happening. Customers complaints silenced by uncaring frontline employees or deaf managers and owners. Leaders isolated from the frontlines of the operations. Employees seeing owners buying beautiful new cars and homes while payroll and benefit deductions are reducing discretionary in

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

ome.

A Life Lesson from Kmart

Failed integrity is often the result of good intentions derailed by business needs. While working at Kmart in the mid-1990s there was heavy investor pressure to the number of out-of-stock items in the stores. Wall Street was bitterly complaining

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

bout Kmart’s slumping market share, blaming the empty store shelves as a customer turn-off. Anderson Consulting had been brought in to assist in determining a way to get the merchandise on the shelves, especially during ads. At first the program had noble intentions.

A vendor report car

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

d would show each manufacturer which shipments were late so that supply chain impediments could be identified and eliminated. Unfortunately red ink was beginning to show on initial balance sheets and the scorecard became a way to generate revenue through penalties. Kmart’s president at

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

he time had used the same tactic to save a supermarket chain ad previously led from almost certain bankruptcy. Before long the program was assigned huge income goals which destroyed many longtime vendor relationships.

As the manager of vendor development, I had been the most visible exe

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

Following aspects would a

utive on the program in its early days, teaching vendors how to use the scorecard. As pressures built to generate revenue from the scorecard through vendor fines, I resisted. As the face of the scorecard, upper management spun off the compliance program and left the scorecard and traini

dd to the challenges in developing combination products:

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

g program under my responsibility while a different team was chosen to automate and expand the compliance program. As it grew to a nine figure income stream, my continued training and consulting duties solidified vendor thoughts that it was still my program.

Knowing what I know in hinds

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

ight, integrity would have taken me down a different road.

So it is with integrity. People do not judge your integrity by motives or intensions. They discern your integrity by outcomes.

My experience, exhaustive research, and interviews with experts, I developed a concept I call Trust

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

Ball™, a vivid correlation of integrity, honesty, and trust built on the game of baseball. It follows a simple notion that trust is disciplined game with procedures and rules that make it easier to follow and understand. Just as in baseball, you get to go straight to the batter’s box wh

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

n you first encounter a new individual or team. If your initial impression conveys honesty, integrity, and trust, you get to move to first base. Specific attitudes and actions will allow you to move around the bases, one at a time, until you eventually score a home run. If at any time

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

Professional from academic institutions, pharmaceutical industries, health care indust

ou break one of the tenets of trust, it constitutes an out and you must return to the dugout. No longer can you simply go to the batter’s box, from this point on you must make a stop at the on-deck circle before you can get back into the game.

Five Important Questions

When you a

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

re faced with a new situation, policy, procedure, or opportunity (which I’ll refer to singularly as an “event”) ask yourself these questions:

1. How does this event apply to my personal belief system?

2. How will others view this in hindsight when the event is over?

3. If something goe

.

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

wrong or is changed/expanded/shifted in mid-stream, how will others in hindsight view me?

4. What can I do in advance to prevent a negative impression of my integrity and honesty when the event is occurring and when it is completed?

5. Is the price worth it?

Integrity is an essential

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

Companies that provide selfless information through particip

eadership quality. What are you doing in your day to destroy trust? Are your words consistent with your actions? Do you catch others off guard or do they know what to expect from you? Master integrity and you will build relationships stronger and faster than you ever imagined possible

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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When you are off to your first seasonal summer job, picking strawberries or helping the farmer with other summer fruits, you should what the work will take all in all and be prepared for it right away.

The Business Model is simply how an enterprise will organize processes to make money. The ability to adjust, change, innovate, learn the lessons of history while looking ahead and streamline systems is the best way to describe this crucial element of business development.

Do you ever wonder if you will really succeed with your small business? You may have a number of special traits, but how well developed are they? Ask yourself these questions to see if you have what it takes.

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