Top Adding - Business

Once upon a time, when I was a front line employee at a food manufacturing plant, I had a supervisor, I'll call him "Fred" who intimidated most of his employees. When anyone called in sick, Fred would slam down the phone befo

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

re the conversation ended. To most of us line workers, it seemed that this was his way of punishing anyone who tried to get by with calling in sick or playing hookey.

Fred also used other intimidation tactics to control his

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

Examples of combination products may in

workforce. When someone approached him with a complaint, he made no bones about expressing his irritation: In a raised voice he would say, “That’s just the way it is.” In most cases his tactics worked. His employees learned

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

not to express grievances because it was a no-win situation.

Fred also had two other sayings in his back pocket. Any time a brave employee would try to question the status quo, Fred would say, "I didn't ask you to work here.

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

" If that didn't work his final retort was, "If you don't like it find yourself another place to work."

These statements accomplished Fred's goal of closing the subject, but it did little for teamwork and productivity.

Fred

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

Combination pro

never connected the dots that the reason the line went down for two hours was often because of a complaint that went unanswered or an employee with a bad attitude wanted revenge.

I'll never forget one time getting the courag

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 to confront my bosses’ attitude. I explained to him that when he hangs up on others it is intimidating. His response was to tell me that I was the only one who felt this way since I was the only one to bring it up. His sec

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

nd response was to tell me that he never raised his voice it was only my perception. (Had he never heard of the theory that my perception is my reality?) He then justified his behavior by paraphrasing Eleanor Roosevelt, “No

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

one can make you feel anything without your approval.”

Looking back on this situation I realize that there are two philosophies when it comes to attitude: The idealistic philosophy and the realistic philosophy. The idealis

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

ic approach is that each person is responsible to choose his attitude no matter how someone else treats you. The idealistic approach goes along with Eleanor Roosevelt’s saying” No one can make you feel anything without your a

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

pproval.” A minor flaw in this way of thinking is that there is a difference between knowing and doing. Most of us know that we are totally responsible for how we feel, but we are more used to reacting than we are to choosing

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

Following aspects would a

consciously.

The realistic approach is more of a William Penn philosophy: “No man is fit to command another who cannot command himself.” The realistic philosophy embraces the concept of personal choice but acknowledges the

dd to the challenges in developing combination products:

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

truth that we are often influenced by each other. Some people just make it easier to choose a good attitude.

For example, it’s easier to choose a good attitude when the boss has a great attitude. It’s easier to choose a goo

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

d attitude when others welcome you with open arms. It’s easier to choose a good attitude when you feel like a valued customer.

Recently I tried a brand new restaurant in town. Several minor mistakes were made. Just when I

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

as thinking that I might never return, the manager approached my table and told me the meal was on the house. The manager realized a profound business truth: If the customer leaves with a good attitude she will return again

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

and again.

Think about the times you have been to the grocery store and you walked away frustrated. Chances are someone was rude to you, you didn’t get help out with the groceries, the place was a mess or they were out of th

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

Professional from academic institutions, pharmaceutical industries, health care indust

advertised specials. Perhaps you kept your attitude in check, but I’ll bet that you stopped shopping there nonetheless.

If you attend a new networking group and you are not greeted or made to feel welcome, it influenced you

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

r attitude. You might have silently quoted Eleanor Roosevelt, while you researched other networking groups to join.

If you are a leader in any sense of the word, you must never forget the influence you have over others. Acco

.

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

ding to Jim Loehr and Tony Schwartz in their book Power of Full Engagement, “Leaders have a disproportionate impact on the productivity of others.”

None of us work in a vacuum. Attitudes cause a chain reaction. As a boss, y

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

Companies that provide selfless information through particip

our attitude affects your employees. Your employee’s attitudes affect your customers, and your customers are the lifeblood of your business. The result of bad attitudes whether it be yours of your customers, is lost business

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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I flew to Fiji from Singapore via Australia, requesting vegetarian meals throughout. But not a single vegetarian dish was provided.

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