Others - Home Based Business

(Being the Boss may not be all that's cracked up to be)

Whether you are starting your own business with or without employees or maybe you have just been promoted to

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

management, this article applies to you.

Do you think it's that easy to be the boss?

Working as an employee gives you a very one sided view into the business world. All your pr

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

Examples of combination products may in

oblems and solutions are from an employees' perspective. No matter how much they are stressing you out, at the end of the day, you clock out and go home only to do it all over agai

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

n the next day.

As an employee, I spent as much time with the other employee's complaining about management and their problems and insensitivity to our needs.

"Why ca

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

nt we get more sick time?"

"So what if I was a few minutes late?"

"Who cares if I take a few office supplies home, they can afford it"

"When am I getting a raise? Management do

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

Combination pro

esn't understand that I have bills to pay"

YADA YADA YADA

In between that all of management has no privacy. Every aspect of their life is being gossiped about becau

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

se they are our bosses and too bad if they can't take the heat.

One day you get that call telling you that you have been moved up into management. Or even better, you finally get

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

your business license and you are ready to go. Hooray.

BUT WAIT,

Life is completely different now. You can no longer clock in and clock out. You have work to do. You have to fix

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

all the errors, all the screw ups. You thought it was bad when your boss chewed you out, wait until you are a manager. You really get chewed out from the owners. You have to micro

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

manage everyone, you have to listen to all their problems and you are expected to solve them.

YOU LITERALLY FEEL LIKE AN ADULT BABYSITTER.

"Can you lend me a few buc

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

ks, my lights got cut off"

"Is it okay if I take off Friday early, my tax check came in"

"Well I'm sorry if I didn't finish the file, I figured you might finish it up for me"

"Y

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

Following aspects would a

es I know about the dress code but this outfit looked so cute, can you bend the rules this one time?"

When there is a problem between employees it is up to you to med

dd to the challenges in developing combination products:

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

iate and resolve the situation. You pay their taxes, their insurance, you contribute to their 401K. etc.

Remember when you used to laugh with your co workers talking about your bo

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

ss and complaining whenever they did something that you didn't like.

Well, The Shoe Is On The Other Foot Now

The Voodoo Doll Now Has Your Name On It...

Now wait a minute, before

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

you start saying that employees are not like this, and managers are not like that, just keep reading

The whole point of this article is to let you know that you can't expect that

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

because you are a manager or business owner that it gets easier, it gets harder. You used to wait for a paycheck on Fridays', now if you don't complete the payroll, no one is get

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

Professional from academic institutions, pharmaceutical industries, health care indust

ting paid Friday. If you need more office supplies who is going to order them? Duh You

In order to improve your business, your job, yourself, understand what every persons' role i

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

s in a business and appreciate their job and in turn they will appreciate yours.

If you are a one person business like I am then just look in the mirror and complain to the boss

.

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

about your hours!!

Please note, I am not talking about the bosses that are not worthy to be called manager. The ones who can't understand why you need to take a day off for a very

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

Companies that provide selfless information through particip

sick child. The ones who expect you to come back early from maternity leave. The ones who think your only purpose in life is to do their bidding.

No I am not talking about those.

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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