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I’ve heard that the definition of an optimist is a person who does the same activity time after ti

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

me, but expecting (or perhaps hoping for) better results. Being an optimist is similar to the per

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

Examples of combination products may in

son who keeps hitting his head against the wall because it feels so good when he stops. The optimi

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

st and the person with the massive headache are resistant to change, yet they want or need better

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

results and don’t know how to go about improving.

Clearly neither approach to making things bette

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

Combination pro

r is having the desired effect, and in order to get those better results they have to change their

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

method of going after them. Maybe they need to become pessimists and tell themselves, “This just

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

isn’t working. I better change my methods and maybe then I’ll get the results I want.”

Managing

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

change is learning to understand how to analyze the way they are currently doing the task, measur

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

e the results, and then consider all the variables and possibilities that can possibly obtain the

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

desired results.

A warning. At this stage there is a tendency to want to make sweeping changes,

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

Following aspects would a

starting with the veritable “clean sheet of paper” and often this is an invitation to chaos. Chan

dd to the challenges in developing combination products:

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

ging many facets of the task all at once doesn’t allow for discovering which changes make a marked

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

improvement or which are actually counterproductive. Usually the improvement doesn’t happen beca

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

use there is no way of measuring effectiveness of each component.

The only way to discover what w

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

orks is to try different methods, one-by-one, and measure the results. Integrate the successful a

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

Professional from academic institutions, pharmaceutical industries, health care indust

ctivities, those that improve the process into the larger task.

So if you need to improve (and do

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

n’t we all?) stop banging your head against the wall, stop doing the task the same old way. Start

.

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

analyzing, innovating, and integrating the parts that work better into the task at hand. In time

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

Companies that provide selfless information through particip

, the positive results will be there and that feels a whole lot better than that massive headache.

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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While referrals are one of the most important sources of new clients for therapists and coaches, how to get them seems to be something of a mystery. Here is a five-step referral strategy that can switch on your referral faucet, or turn a trickle into a steady flow.

So much to do, so little time, is a constant refrain heard from those seeking work. Everyone gives lots of advice (including me): send out resumes, apply on the Internet, read the Classified, go to job fairs, and network, network, network. Some of us become so overwhelmed with all that we need to do that we can't figure out where to start so end up doing nothing at all.

Do your customers love buying from you? How could you make the buying experience so pleasurable that customers come back time after time?

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