Main Subject - Business

The US Government has just released last month’s job creation figures. It was the lowest number in two years. This is a revealing and disturbing snapshot of what is actually happening in the real economy, not the one artificially created for t

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

he headlines. Our US GNP or Gross National Product, is based upon manufactured durable goods. Unfortunately, the manufacturing economy in the US has not yet recovered from the devastating collapse it saw commence in the spring of 2000. The rec

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

Examples of combination products may in

nt improvements in jobs and growth are substantially confined to the service sector. Manufacturing is what drives the US economy and it is suffering.

Do you work in this market segment? Are you comfortable? Do you feel stable? Have you yet re

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

lized that there is no such thing as job security anymore? That concept is gone. Unlike our parents and their parents before them who could count on working in a selected field for a given employer for life and then retire, we of this generati

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

on, working in any aspect of manufacturing have no such luxury. Our job, or even the company we work for, could change overnight or possibly be gone in a heartbeat. The face of the Fortune 500 is drastically different than it was just 10 years

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

Combination pro

ago. Many companies are gone forever or have been acquired other firms or holding companies. Many have split up and others are now manufacturing off-shore in China or India. So where is your security?

What is it that you can count on during t

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

is period of instability? Where is your value as an employee? Unlike our ancestors who relied on a strong back to work the fields or do heavy labor, we rely on our knowledge and skills. Our value, what we have to offer employers, is located be

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

tween our ears.

Aside from your intrinsic value as a human being, a creation of God, do you offer enough real value your employer so that when the tough employment decisions have to be made, you are one of the people who stay? Do you offer en

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

ugh value to demand that a new employer will hire you if you are not so fortunate? These are tough questions. We do not really like to examine these possibilities, but examine them we must, for there is no more job security.

I recently spoke

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

ith a man that I had not seen in some time. He is the Quality Assurance Manager for a large, well-known manufacturer of consumer audio goods. He said that business was great, but he was fearful of his long-term prospects with his employer of 8

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

years because scuttlebutt had it that the company was quietly building their first plant in China, due to open in late-2006. He realizes that even though their products are technical in nature and superbly crafted, the plant’s operations were

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

Following aspects would a

basically assembly and packaging, and those functions could easily be done as well overseas at a much lower cost. Over the past year, he wisely reviewed his options, studied for and acquired his real estate license, and has begun selling home

dd to the challenges in developing combination products:

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

part-time. He saw that he had little choice but to take action now, well in advance of what may occur to the plant next year.

He woke up and decided to learn something new. Such a need exists for almost everyone else as well. This manager de

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

ided that if he was to maintain his lifestyle and have a promising future, he had to take charge now. He had to learn new skills, because the skills he had been trained in would possibly soon be rendered useless, at least to his existing emplo

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

yer.

Could he locate to another position in a similar capacity at another company somewhere nearby? Possibly, but what guarantee would he have that they same thing would not happen there. There are no guarantees. He was forced to take action

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

and expand his skills now.

Some people are not as fortunate, and we hear about them everyday in the news. This plant is closing their doors. That company is reducing employment by 60%. Another company is expected to only hire 15 people instea

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

Professional from academic institutions, pharmaceutical industries, health care indust

of the 45 that they originally thought. It goes on and on. What do these people do now? They have to act fast. They typically have to learn new skills so as to be able to offer value to a new employer somewhere else.

The bottom line is that

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

since we no longer have any real job security, life-long learning is more important than ever. What is this life-long learning? It is the concept of continuous learning. Many people go through primary and high school, possibly college and decl

.

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

re that their education is over. It does not work that way anymore. We must at least be continuously learning additional skills in our chosen field and possibly even expanding our skills into new fields. In this manner, we offer maximum value

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

Companies that provide selfless information through particip

o our employer or possible a future employer who may even operate in a different industry.

Wake up and learn something new. Sitting idle and dormant will surely prove costly to you. There is no other real alternative. You need to get busy now

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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Do you wonder how your medical billing software works? This installment is going to give you an introduction to finding out just what goes on behind the scenes of your medical billing software.

Myspace layouts backgrounds music codes and more interactive stuff is all the rave currently online. From teens to young adults and yes even businesses on and off the web are venturing into Myspace for their share of the online experience and profits.

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