Habit: A consistent behavior you perform so frequently that it is automatic.

For example, if you learned to drive a car with a standard transmission, the first few lessons were pretty jerky while you learned to synchronize the clutch with the accelerat

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

or pedal. If you released the clutch too fast, the car would stall. If you pressed the accelerator too fast without releasing the clutch, you raced the engine ­ but you and the car were still sitting there! However, with practice, practice, and more practice, you learned to synchronize

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

Examples of combination products may in

control of the clutch with control of the accelerator so that you don’t even think about it any more. It is now a habit.

All habits consist of knowledge combined with skill from practice. What all this means is that you can learn new habits to replace those that are no longer working

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

or you. You have to change what you’re doing, how you’re doing it, and the choices you make in order to change your business results.

If you keep doing what you’ve always done, you’ll keep getting what you’ve always gotten.

That means that if your b

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

siness is not headed in the direction you desire right now, you must make new choices and start new habits to ensure you ultimately get the results you want.

Your choices of habits, determine your success.

That may seem harsh to you. Especially if you’

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

Combination pro

like credit for having “Good Intentions.” The fact is that your intentions, however good, are immaterial until they are supported by your behaviors. In fact, good intentions that are not actualized will drain you of the energy necessary to take effective action. Remember, the only que

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

tion of significance is “What's working and What's not?”

Every habit has its consequences. Habits that are working for you create positive consequences; habits that are not working for you create negative consequences ­ every time. You may not like that your habits create consequences

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

­ but you’ll still receive those consequences just the same. Whether or not you like it isn't a factor. The fact is that as you keep on repeating a behavior you will get repeatable, predictable results.

Up to 90 percent of your current behavior is based on habits.

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

ockquote>

By and large, these habits work for you. They save you from the tedium of having to make new decisions each day. Wouldn’t it be boring and a waste of energy if each day you decided to brush your teeth, but then had to decide where, with what toothbrush, with what of the

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

00’s of toothpastes now available, for how long, with what type of action on the toothbrush, and so forth. It's much easier to go into automatic and let your neural net take charge ­ freeing you to plan for that important meeting with your big client at 2 PM.

Habits are part of being

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

uman; we all have them. We use them to conserve energy and effort; to provide familiarity/security; to free up energy for other things; to improve and fine-tune our skills; and to assist in avoiding physical and/or mental pain. Often, a particular habit can lose its usefulness. Yet, be

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

Following aspects would a

ause we are human we tend to continue the habit, knowingly or unknowingly. Only with awareness and a strong reason or motivation to change can we initiate and sustain change.

Habits tap into the nearly human obsession to be (and to appear) consistent with what we have already done. On

dd to the challenges in developing combination products:

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

e we have made a choice or taken a stand, we encounter personal and interpersonal pressures to behave consistently with that commitment. For good or for ill, the drive to be (and to look) consistent constitutes a highly potent weapon of change.

To understand why consistency is so powe

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

ful a motive, it is important to recognize that in most circumstances consistency is valued and adaptive. Inconsistency is commonly thought to be an undersirable personality trait. The person whose beliefs, words, and actions don’t match may be seen as indecisive, confused, two-faced,

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

r worse.

On the other side, a high degree of consistency is normally associated with personal and intellectual strength. Certainly, then, the personal consistency brought by habits is highly valued because it provides us with a reasonable and gainful orientation to the world. Most of

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

he time we are well served by habits... without them our lives and our businesses are difficult, erratic, and disjointed.

By superimposing a new habit on top of an existing habit, you can create a new way of doing things. In other words, you start replacing old negative habits with ne

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

Professional from academic institutions, pharmaceutical industries, health care indust

positive habits.

For example, if you always show up late for meetings, your stress levels are probably high and you feel unprepared. To improve this you might decide to develop a new habit of arriving five minutes early for every appointment, including meetings. If you take on this c

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

allenge you might notice:

- The first month or so of the new behavior is tough. In fact, you’ll find yourself reverting to the old behavior during times of stress or unawareness ­ this is normal because it is in compliance with our need to be consistent with our prior behavior. Howev

.

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

r, don’t resort to self-recriminations for the backsliding. Just pick yourself up and recommit to the desired new behavior!

- The more you activate the desired new behavior, the easier it becomes. Eventually, it will be become just as strong as the old habit you are replacing ­ then i

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

Companies that provide selfless information through particip

will supersede the old behavior. Employ the principle of consistency to help you build your new habit.

By systematically replacing your negative habits with new positive habits ­ one at a time ­ you can dramatically change all aspects of your business.

Copyright 2004, Rose Hill, In

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products