Main Subject - Business

If you are like most people, it will not take long to encounter a situation where you feel slighted in one way or another by someone you are trying to do business with. When these si

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

tuations arise, it is helpful to know how to approach the problem in a way that results in getting the results you want without throwing gasoline on the flames. With a careful choice

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

Examples of combination products may in

of wording, you can turn a negative into a positive, and get the offending party to tumble over themselves to make things right.

To illustrate this point, I will use a simple example

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

of a situation I encountered recently in a fast food establishment. A friend of mine went to the counter and ordered a sandwich. He paid for the item, and went to a table in the din

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

ng room. When he looked at the sandwich, I saw him frown and hesitate to begin eating. I asked him what was wrong, and he told me the sandwich was not prepared the way he requested.

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

Combination pro

I then asked if he was going to take it back to the counter, and I saw another look of pain on his face. He told me the clerk had been so pleasant, he hated to go back and confront

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

he person with the information that they had made the mistake of not putting enough extra pickles on the sandwich as he had asked, but he also did not want to eat the sandwich because

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

it was not right. My friend struggled with whether or not to accept the error, and asked me how he could get the employee to correct the problem without having to offend the person b

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

telling them they had made a mistake.

My response was to return to the counter and say to the cashier, “Excuse me, could I trouble you for some extra pickles?” My friend was up lik

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

a shot and said exactly what I instructed him to say. Moments later, he returned to the table beaming and carrying a cup filled with more pickles than he wanted to eat, with a smile

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

and wave from the happy restaurant cashier. In this encounter, there was no mention that any mistake had occurred, and nothing said to trigger any kind of negative reflex defensive r

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

Following aspects would a

action from the restaurant employee. All too often, people follow their first impulse to lodge a complaint and turn a minor issue into a needless argument or embarrassment. Using th

dd to the challenges in developing combination products:

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

softer calculated approach I recommended, my friend got what he wanted, and the cashier was more than happy to fill the request. The situation was settled without accusations or ruf

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

led feathers, and nobody came away feeling uncomfortable from dealing with a confrontation.

Though this incident was a minor example for how to develop an instinct for a positive app

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

oach, the same technique will serve equally well in more important encounters. If you take the time to consider what you want, and approach the situation with a friendly, non-accusin

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

attitude, you can set the stage for easily accomplishing the objective. It is rarely necessary for you to include the mention that someone is responsible for making a mistake in ord

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

Professional from academic institutions, pharmaceutical industries, health care indust

r to accomplish your true objective. Even when someone is clearly at fault in causing a situation, telling them they have done something wrong sets their mind toward attempting to ju

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

tify themselves, and causes them to think more about why they did not make a mistake than how to correct the problem. The alternative is to ask for help, which instinctively causes m

.

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

st people to do their best to fulfill the request, especially if they believe they will please you by doing what you ask. The next time you feel something needs to be corrected, look

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

Companies that provide selfless information through particip

past any initial anger the situation causes, and see how effectively this simple approach will get the results you want. These techniques work well on both sides of the sales counter

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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If you were not born to be a leader, you still can be one at your field of expertise. All you need is to have your leadership skills developed to be able lead. If you cannot build your leadership skills, then simply don’t lead, just follow.

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Change can be pretty scary but it is inevitable. Find out the MAIN reason which makes dealing with change difficult.

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