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How many times have you heard a loan officer say (including yourself) that everything will be better as soon as I get THERE? There is usually the closing of a diff

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

icult deal, the week after vacation, a new loan program, a change in employers, etc. Only to realize that getting “there” didn’t change anything. The key to succes

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

Examples of combination products may in

in the mortgage business is first to maximize the opportunity immediately in front of you. You have to focus your efforts on continuing to develop strategies that

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

will enable you to overcome adversity in ANY situation. NOT continuing to hope that you will find yourself in a situation with no adversity. WE all know that there

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

is no such thing.

The ability to manipulate a set of circumstances to your advantage (regardless of the circumstances or situation) is a direct function of your w

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

Combination pro

illingness to deal with adversity, to work through difficult situations and see things through to completion. This is the concept of continued learning. People who

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

are committed to continued learning are constantly upgrading their skill sets and ultimately increasing their earning potential.

Success seems to come easy to the

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

e people when in fact it is the exact opposite.

It just looks easier because people who are committed to continued learning take an aggressive proactive approach

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

o achieving their goals, instead of waiting for the “right circumstances” to put forth their best effort.

In effect they are bringing their “there”, HERE. In othe

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

r words there is no need for them to say “everything will be better once I get there.” They are already “there” as a result of hard work over a sustained period of

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

time. Circumstances are rapidly changing in the mortgage business. Guidelines are changing HOURLY. Take a step back and evaluate how you are reacting to these chan

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

Following aspects would a

es. Are you in problem solving mode or are you hoping for a miracle? Are you finding your self surprised by the same problems over and over? Or do you draw on past

dd to the challenges in developing combination products:

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

experiences to minimize the impact of the problem? In other words are you learning from your mistakes or continuing to make them over and over?

Some experts recom

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

mend keeping a journal of situations in which you’ve had to overcome adversity and record what worked and what didn’t. At the very least you need to keep a mental

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

ournal of your past successful and unsuccessful approaches to problem solving. Every time you overcome a problem you add to your existing knowledge base.

“The mes

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

age of success is not whether you have a tough problem to deal with, but whether it is the same problem you had last year.” John Foster Dulles

Challenge-

Take a

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

Professional from academic institutions, pharmaceutical industries, health care indust

inute to set up a way to track your conversion rates on different types of loans. This is different from how you “feel” about certain types of loans; it’s a way to

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

measure what’s actually working for you. You may surprise yourself with what you find out. Maybe referrals are worth the effort; maybe you should buy internet lea

.

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

s. The key is to set up a system to track the actual results. This is where you greatest chance for improvement lies.

Lastly, be willing to look outside yourself

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

Companies that provide selfless information through particip

r your company for answers to difficult challenges. The investment you make may help you unlock your true potential. And that juice is definitely worth the squeeze

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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