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Imagine if every morning when you awoke, there was a card table with a mound of jigsaw puzzle pieces on it. And your job every day was to put those pieces together to create a fi

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

nished puzzle. And tomorrow morning when you awoke, there would be another new mound of pieces to add to today’s.

Only, you have no idea what the final picture is supposed to lo

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

Examples of combination products may in

k like, because they didn’t give you the box with the finished picture on it! How would you proceed? How would you know how far you had to go to get done? How would you know when

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

you were done?

This is life without a plan, life without a Preferred Future. And the law of this life is this: “If you don’t know why you’re doing what you’re doing, you’ll neve

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

r have enough time to get it done.” Our personal life and our work are both a series of choices – choices of activities that we will perform next. The activities that we choose

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

Combination pro

to perform determine our results. And the choice we have is between a future and a Preferred Future. If the culmination of the activities we perform is automatically a future, wh

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

not have those activities culminate in a future we prefer? If life is like assembling the pieces of a jigsaw puzzle, why not have the final picture be something we’d like it to

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

be?

We can.
The secret of achieving your Preferred Future is this: “Focus on your Preferred Future, but respond to the present.” In doing so, you automatically identify y

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

ur highest priorities, and complete not the easiest or next thing on the “to do” list, but rather the thing that will help you achieve your goals. Here are the five steps leading

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

to your Preferred Future:

1. Clearly define your Preferred Future. Getting a new job is not clearly defined – being in charge of the hydraulic engineering department is. If you

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

on’t know what the final picture looks like, there is no way you can assemble the pieces of the puzzle.
2. Know why this Preferred Future is important to you. Do you want t

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

Following aspects would a

he new job because of money or because of the status? If you don’t know, you might make the wrong choice for the wrong reason, and the goal is always to do the right thing at the

dd to the challenges in developing combination products:

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

right time for the right reason. You can’t do that if you don’t know why your Preferred Future is important to you.
3. Identify a small step that will open the door. Every

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

ourney has its first step, and each step leads to the next. And while all the steps are not the same and some are much harder than others, you have to find a place to begin. You

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

journey nowhere without moving your feet.
4. Monitor your progress. Keep a record. Make a daily plan. Make a monthly plan. Make a quarterly plan. Make a three-year plan. An

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

take notes. Determine what worked and what didn’t. If you don’t keep track of where you are, you won’t have any idea of where you’re going.
5. Modify your actions based on

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

Professional from academic institutions, pharmaceutical industries, health care indust

what you’ve learned. When you have the information on what worked and what didn’t, change your action steps accordingly. And consistently revise your plans. If a sailor doesn’t c

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

hange course, he can never reach his goal. The better the sailor, the more frequently he monitors his actions and the more frequently he changes course.

When you focus on your P

.

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

eferred Future, you are applying the pre-eminent law of body-building, and of life. That is, what you focus on gets stronger. When you create a clearly defined Preferred Future

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

Companies that provide selfless information through particip

and focus on it constantly, you will discover that every day you are choosing the most important puzzle pieces in your life that will best help you to build your Preferred Future

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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