Cases - Business

You've heard the sob stories.

Seems like every business owner has his or her own story of working 18+ hours a day, seven days a week to get there bus

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

iness off the ground. If you get a group of business owners together, they all start moaning about how hard they work.

"I haven't had a day off in f

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

Examples of combination products may in

ve years." one says.

"80 hours is a good week." another complains.

Does it really have to be that way? Is that your business vision? The big quest

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

ion is, are you self-employed, or are you a business owner? They are not the same thing. If you are self-employed, your business depends on you.

Yo

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

are the person doing the work that brings in the money that pays the bills so that you can work even harder to do the work and pay the bills and on a

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

Combination pro

d on and on. If you are self-employed, don't be surprised if you are working more than employees.

After all, you not only do the work of an employee

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

, you also are responsible for all the support tasks that make that work possible. And that takes time.

There is another way.

Most likely, you star

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

ed your business because you felt you had better skills or a better idea than other businesses out there. But you do not have to be your business. I

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

fact, your business will not be able to grow unless you make it a point to get "you" out of the picture.

Your business vision should allow for you t

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 become the owner, not self-employed. From the beginning, focus on setting up systems and procedures, so your business can run your way, without you

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

doing the work.

I know it is "easier" to do it yourself, so it's done right. But if you are the only one who can do it, how is your business ever go

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

Following aspects would a

ng to be able to run without you?

For this week, keep a notebook handy, and write down everything you do. At the end of the week, take a look at how

dd to the challenges in developing combination products:

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

you are spending your time.

How many of your daily tasks are truly things that only you can do?

How much of your time is spent "fixing" things, bec

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

use things are not done the same each time?

How much of your time is spent on tasks that don't even really have to be done, or can be outsourced to o

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

hers?

If you truly want to stop working so "hard", you have to learn to work smart. Find the one item in your log that either annoys you the most, o

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

r that you feel is the biggest time waster.

Fix it. Repeat.

Sounds simple, but most of us keep doing the same things over and over, and then wonder

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

Professional from academic institutions, pharmaceutical industries, health care indust

why things aren't getting better. The only thing that you, as the business owner, have to do is provide the vision and direction for your business.

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

hat truly is your only irreplaceable task.

As long as your business depends on you to get the work done, you will work long hours. You will be tired

.

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

. You will feel like you are working harder this year to make the same income. After all, you are self-employed.

Is that your business vision?

Do

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

Companies that provide selfless information through particip

ou want to keep working harder and harder, until you finally crack? If not, it's time to take the "you" out of your business.

One task at a time.

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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There is much truth to this statement. If you buy a used watch on Ebay for $10, consider yourself lucky if it comes with a wristband- or hands. If you buy a jalopy for a hundred bucks from a used car salesman named Guido, cross your fingers before you turn that key. And how about that 6-day, 5-night getaway cruise to the Bahamas, for $200? It is probably nothing more than a ferry boat ride and a tour of roach motels. In one sense, you do get what you pay for.

Here are some interesting ideas pertaining to marketing and advertising. Can you fit them into your cattle business?

Newsletters remain a powerful marketing tool because they are targeted, specific, and often eagerly welcomed communications from you directly to your customers. Your newsletter mailing list can be pure gold, and the quality of your newsletter can help retain customers. However, few companies produce newsletters nowadays. They seem old-fashioned. However, newsletters still work today.

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