Advice You - Business

It really is about motivation. After all, what impels someone to climb a mountain, or go to college, or save for a car, or learn a new language o

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

r anything of a thousand things? What is it that moves someone to action from a position of comfortable stasis? The answer is motivation. Motivation is th

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

Examples of combination products may in

e process of stimulating you to action. It takes a need, desire or some other impulse and incites a response. Motivation is the high-octane fuel of succes

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

s and, as such, it’s vital that individuals and teams capitalize on its power.

Often motivation seems to occur spontaneously -- the result of appa

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

rently random events. But random motivation isn’t the stuff of greatness - to say the least of profitability, innovation and success. It’s imperative that

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

Combination pro

team makers and leaders cultivate and nurture motivation throughout the life of a project. Fortunately, motivation is relatively easy to create. In fact,

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

it can be reduced to a formula: M = (D+ A)U. That is, motivation equals dissonance plus accountability, multiplied by urgency. This is the DNA of motivat

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

ion. It’s the essence of what will fire individual imagination and resiliently drive action. Contained within this simple formula are the seeds of phenome

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

nal success.

Beyond the DNA of motivation, bringing clarity to a project is one of the fundamental challenges of team makers and leaders. The most succ

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

essful teams will always operate with a lively, yet focused motivation. In some ways, motivation is like turning on a light bulb. Light from the bulb inst

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

antly floods the room. The same light, however, when focused, becomes a laser with vastly more powerful applications. The ability to create this laser-lik

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

Following aspects would a

e focus determines who will reach the summit and who will simply mark time in the base camp.

The single best way to achieve focus is to set realistic

dd to the challenges in developing combination products:

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

goals. Interestingly, the word, “goal,” is one of the oldest in the English language. Originally it meant, “barrier,” or, “boundary.” Today we think of a

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

goal as an objective or purpose to which we direct our energy. The older version, however, imparts a fuller flavor to the concept of Fifth Station goals.

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

At the Fifth Station, goals always follow motivation. That is, they are always set at the far boundaries of our capabilities because they reflect not only

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

where we are, but also where we want to be.

We’ve looked at the DNA of motivation and at how goals can provide laser-like focus, but what about implem

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

Professional from academic institutions, pharmaceutical industries, health care indust

entation. How do we actually go about achieving our goals? The answer is through planning. This should come as no surprise, as every goal contains a nasce

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

nt plan. Since goals tell us where we are going and provide an objective measure of success, they suggest the strategy that we’ll need to follow. With ver

.

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

y simple goals, plan and goal are synonymous. However, as the complexity of the goal increases, the requirement for a separate plan grows as well.

Team

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

Companies that provide selfless information through particip

makers and leaders can foster success by consciously applying the DNA of motivation, building clear goals and by promoting appropriate team planning.

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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