Digg It - Business

There are papers on the floor, across the desk and resting on the keyboard. Piles of files are all around. Magazines, newspapers…you name

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

it. Just about anything can be found in this office. You've seen it in your own organization. You know what I am talking about.

Several y

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

Examples of combination products may in

ears ago an employee called me because her performance review included items relating to the disorganized state of her office. When I arri

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

ed, her office was piled high with papers. I began asking questions. Are you late with assignments? Does it take you more than 15 seconds

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

to find information? Do you tend to completely lose information? With each question the answer was 'No'.

Probing a little further, I di

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

Combination pro

covered that her supervisor needed to walk past her office every time she wanted to get to the front of the building. So he passed by her

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

cubicle several times a day. Each and every time he walked by, he mentally noted the condition of her office. It seemed her true work perf

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

ormance was not in question… the concern was about her organizing skills. Why? For many people, a messy desk is a messy mind. And the con

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

ern with a messy mind is that work isn’t getting done.

Whether we like it or not, appearances do matter. An employee with a messy desk an

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

d office is often perceived as out of control, non-caring, ineffective and inefficient. It can cause the person to be passed over for a pr

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

motion. As a manager, you are also a role model. Direct reports are watching. And forming their own impressions.

On a wider scale, I reme

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

Following aspects would a

mber a client company that hired me to coach some of their employees on time management. The company had a 'Clean Desk' policy, which mean

dd to the challenges in developing combination products:

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

t that before employees left for the day, desktops were to be free of loose papers. I was assured the policy was enforced. In fact, employ

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

es had been seen dumpster-diving to find loose papers they left on their desk the night before which had been thrown out by the cleaning c

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

rew.

Although I don't necessarily advocate this particular type of policy or enforcement, it seems that a more organized and effective wa

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

to face each new day would be to end the previous day by taking a few moments to place loose papers in a container. Storing papers on the

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

Professional from academic institutions, pharmaceutical industries, health care indust

floor is never a good idea, so try keeping them 'above sea level'. A letter tray, a box, a basket… anything to containerize the papers an

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

d create a clear space on your desktop. Loose file folders can be put in their own container or in the front of a filing cabinet drawer.

.

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

et in the habit of taking a few minutes every day to keep the desktop organized. It will help prevent the judgment and negative impressio

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

Companies that provide selfless information through particip

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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