Advice You - Business

I am adamant about the use of processes. I believe that everyone who is organized and interested in minimizing grief in their business

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

as well as their personal life uses processes. For me, processes are an integral part of my life. I use them everywhere and often.

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

Examples of combination products may in

ome people would say that I am too process oriented at times, and maybe I am. I, however, find that my life is simplified by processe

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

and they allow me to spend my time thinking about the important things in my life instead of the routine.

I first realized the value

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

f creating and following processes way back in my youth and have allowed them to be a part of my life ever since. When I was in the mi

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

Combination pro

itary, I found that while in basic training many of the recruits, as well as myself, were struggling to respond to verbal commands from

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

the drill instructor. He would fire these orders out rapidly and with a vengeance. "Left Face. Column right." When a recruit would

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

turn left instead of right or right instead of left the drill sergeant would get right in his face and make him look and feel like a fo

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

l for not knowing right from left.

The problem is, that when you are under stress and responding to rapid fire orders it is very easy

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

o make that type of mistake, turning the wrong way. So I realized that to keep from making that mistake, I had to create a process that

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

would allow me to turn immediately in the correct direction without having to think about it. It had to be subtle and consistent. Her

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

Following aspects would a

is what I did. While standing at attention I would slightly grip the seam of my right trousers. While marching I would grip my right

dd to the challenges in developing combination products:

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

index finger and thumb together as if I were gripping the seam of my trousers. (Because your arms move while marching, I could not kee

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

a grip on my trousers, so I gripped my fingers to get the same feel.) I then told my brain that when ever I heard an order to turn ri

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

ght I would turn in the direction of my gripped fingers. It worked, and I never had to endure the drill sergeant yelling at me for tur

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

ing the wrong direction again.

I don't know why this worked, but it did. Your brain is an amazing thing and when given a process to f

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

Professional from academic institutions, pharmaceutical industries, health care indust

llow, it will take over for you. This is why it is so important to have processes in your business as well. Your company must be able

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

to run on autopilot for all of the routine situations. This will allow you to concentrate on the important things in your business, su

.

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

h as customer service, product development, marketing strategies, etc.

If you will establish processes for all of the routines in you

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

Companies that provide selfless information through particip

usiness, amazing things will happen. So taking a lesson from my military basic training let me just say, "Get a Grip!

To Your Success

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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Have you ever consider which jobs will be in the most demand in the future? Sure you probably have guessed a few. You see, there will be many jobs in the future that will be necessary to continue to probe tell our economy and run our civilization. For instance we need more engineers right now and in the future we will need even more.

An insightful article stressing actions that management can take to ensure that they act as positive strong leaders.

Cheap sourcing is not a new game in town for procurement departments to brag about, it is in fact the oldest game in town since all empires in history were built and motivated by finding new cheaper source for labour, goods and services to please their citizens.

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Advice You - Get a Grip on Your Business

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