Advice You - Business

Recently, while visiting a friend's office, he began to tell me his business was a mess. It wasn't fun anymore. "The problem with this business," he said, "

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

is that the manager (ME) is the worst person for the job. I have no training in management. My partner just wants to come to work, do his job and leave the

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

Examples of combination products may in

management chores to me. Frankly, I don't have any great desire to be the boss, either. Personnel problems, cash problems, meeting sales quotas – I do it al

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

l. It's everyday and it's a drag."

Sound familiar? You have a lot of company. In every business, however, "somebody" has to be the boss. You may not have

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

the training, the desire or the patience but you have the job. Is there any way to make it less painful?

YES! First recognize that every business is in two

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

Combination pro

businesses. You do what you do -- plumb, build, sell, manufacture, etc. -- that's your first business. Your customers ultimately decide how well you practi

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

ce this business by the sales they give you. If you serve their needs, you continue to get their support. If you don’t give them what they want, they won’t

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

support you, you won't long have a business to worry about.

Your second business is the business of staying in business. You may be great at what you do, b

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

t if you fail to run your business properly, you can run yourself out of business -- FAST. This is my friend's problem. He feels overwhelmed by "being in bu

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

siness."

Being in business, though, doesn't have to be a stressful and draining. Here are three strategies you can use to help you be a better manager of yo

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

ur business:

1. Start by thinking through why you are in business. If you haven’t already, write down your clear business goals with a deadline for their a

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

Following aspects would a

ttainment and write them in terms of results. Write down what you have to do to meet your goals. (For example: Use PostIt(TM) Notes to list each step of how

dd to the challenges in developing combination products:

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

your work flows, starting with getting prospects and ending with getting paid. What paperwork do you have to generate? How many sales calls have to be made?

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

What are your production quotas? What controls are needed? Etc.)

2. Let your people know (in writing) what is expected of them in terms of results and d

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

eadlines. Agree with your partner, if you have one, what you can expect from one another. Don't leave any gaps in your expectations. Measure every action a

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

nd person in the business against those goals. Do not tolerate any action inconsistent with the goals.

3. In terms of day-to-day management skills, rely on

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

Professional from academic institutions, pharmaceutical industries, health care indust

good old common sense. If an action doesn't meet a common sense test, it is probably bad management theory, as well. Always keep in mind that when the work

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

flow flows and your policies and procedures are working and when people know what they are supposed to do and are allowed to do it, there is very little need

.

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

for additional management. You will still need to be the manager -- when things don't work. But if your company's goals are clearly stated, and everybody

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

Companies that provide selfless information through particip

is pulling in one direction, that won't happen often. And isn't that the kind of management you for that matter, can live with.

Copyright 2006 John J Reddis

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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When it comes to electricity, small and medium size enterprises can never assume they are getting a good deal. In fact, it's safe to say that - as the market stands today - businesses should assume the opposite is true, and that they are being taken for a ride by the 'big six' energy providers.

Many who thrive in the workplace are those bursting with drive and determination. These folks who are motivated by their jobs. Every person who works has personal reasons for working. While most work for money, others work because they love their jobs and because experience a sense of fulfillment. Some work because they desire to aid others or to feel distinguished in a field. People work because they are motivated by certain reasons.

The old hardware stores have now changed into huge DIY empires. What purpose do they now have?

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