Main Subject - Business

Have you ever hesitated to make a decision? Have you ever considered why? Some people spend their whole lives being cautious about the decisions they make concerning relationships, careers

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

, finances, education, even daily activities. They need to do things perfectly and the desire to control the outcome only keeps us stuck. It is like the story of the mules standing between

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

Examples of combination products may in

to bales of hay: unable to decide which one to eat, afraid of making the wrong decision, they starve to death. For many having to decide is risky and people fear risk.

Fear of making 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.

rong decision, is the reason people put off making a decision, instead they make biggest mistake of all: no decision and become stuck where they are. When we procrastinate about decision

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

making, it can be costly. It can cause people and companies to miss out on great opportunities. The fastest way for a company to grow is take risks. Often, that requires making a decision

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

Combination pro

o do something different and to be ready to accept the consequences. Anytime people are immobilized by the prospect of making a decision, they have forgotten the principle that says it is

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

ot the failing that makes a failure, it is the quitting. Failure is a prerequisite to invention. It is important to recognize that there are many types of decisions, specifically reversibl

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

and non-reversible ones. Move quickly on reversible decisions to avoid being left without, due to a change in circumstances. Take more time to consider the non-reversible ones, and rememb

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

r that a decision that seems right today may be wrong tomorrow.

It is important to consider all the options! Defining the alternatives available can be helpful when confronted with a prob

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

em or an opportunity Discuss the choices with people who are knowledgeable, supportive, and who will provide valuable feedback regarding the options. Choosing the right alternative at the

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

wrong time is not any better than the wrong alternative at the right time. Examine previous decisions, results and learn from them. Everyone makes some good decisions and everyone makes so

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

Following aspects would a

e bad decisions, but at least they made a decision. By accepting personal responsibility for our lives, we learn from choices we make and we gain wisdom.

Beware of protecting a bad decisi

dd to the challenges in developing combination products:

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

n. We only need to turn on the news or speak to a colleague to be reminded that some people become so invested in a bad decision that they stick with it regardless of the price they pay pe

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

sonally or professionally. I once heard the saying, “Never protect what you need to correct.” If a bad decision is made, quickly correct it let it go and move on. Once you have made the de

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

ision and have started what you are going to do, put the "what if's" aside stand behind it with commitment. Wondering what would have happened without the mistake focuses on the past. We

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

annot change the past nor can we control the future, all we can control is the moment and how we respond. So refrain from focusing on what should have been, and focus on what is happening

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

Professional from academic institutions, pharmaceutical industries, health care indust

now.

Some people expect correct decisions to keep us on course 100% of the time. Actually, correct decisions are exactly that: corrective moves we have made to either stay on course or to

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

get closer to our course. Pilots use instruments to keep the plane on course. If they veer off course due to weather then they simply make a correction to get back on course. Despite the c

.

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

rrections they may need to make, they are on track about 90% of the time. This reminds us that it isn’t the path from here to where we are headed that is important, it is what we do to cor

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

Companies that provide selfless information through particip

ect our errors and make better choices that will put on us the right path. Stay flexible, be willing to make decisions, and remember that sometimes, you will have to correct those decision

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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