Advice You - Business

Americans are loosing jobs and corporate America is showing no signs of stopping this trend!!! Untill now all corporates invested heavily in the US universities. Now Intel, AMD and even Google is setting up R&D labs around the world. They need qualified people to work in these labs. And places like India, China and Mex

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

ico are able to give it at a lower cost.

Over the last three years I have heard so much about outsourcing benefits and defects that I think I can write an entire book on this subject now.

First let us start with the definitions

outsource

v : obtain goods or services from an outside supplier; to contract

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

Examples of combination products may in

work out; "Many companies outsource and hire consultants rather in order to maintain a flexible workforce"

outsourcing

Paying another company to provide services which a company might otherwise have employed its own staff to perform, e.g. software development.

Most o

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

my views would be based on my experiences and sites I visit often. This particular write-up is more from what I have read on SFGate which is a local San Francisco paper. One of my clients in the Bay Area had once sent a link to me about an article on outsourcing from SFGate. From then on, I have been a regular with th

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

is paper. What I like about this paper is that when CNN reports about Iraq Prisoners abuse, SFGate reports on the Ford Mustang turning 40. It is a welcome break to see this. Ofcourse they carry regular news of death and war too.

SFGate is carrying out a special report of outsourcing. I'll pick some of the good ones he

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

Combination pro

e. Let's start with Straight from the mouth: Executives speak out which has views of some of the CEO's of companies in the Bay Area. The best I liked was the comment from Scott McNealy -

You sound like a piano player in the old days when there were 35,000 piano players playing in the front of every movie theater when

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

they had silent movies. You're saying, 'Who's going to employ all of us now that they have sound embedded in the films?' Gang, we've got brains. There will be lots to do. What's an American company? We do half our business internationally. Does that make us an international company or a U.S. company?Global companies g

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

row globally. Shouldn't India be a little upset that we have most of their software programmers here? Who's making the value judgments here?

Scott McNealy Chairman and CEO Sun Microsystems

He has made some very good points - 1) Creative destruction and 2) Think global. One has to be competitive globally and not l

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

cally which in the end means using resources all around the world to get the best products and services at the best price. Creative destruction is a phenomenon which takes place in every industry. All chariot makers lost their jobs, due the emergence of the auto industry. The floppy drive industry is almost dead. Opt

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

ical media has more dominance and it is a matter of time before the magnetic media completely dies. Every industry goes through this shift and so would the software industry. In the software industry, the market is still alive but to get competitive, the delivery model has changed to a combination on offshore and onsit

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

.

Most of the bigger companies today in the US are global giants and not local companies. They have clients and offices all around the world. When they get revenues from all parts of the world, how does one expect them to spend it only in the US. This is something that is true for all cooperates. Toyota for example ha

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

Following aspects would a

s factories in the US. The Toyotas sold in the US are made by Americans. However, Toyota is a Japanese company. Now if the Japanese complain that the manufacturing should be done in Japan, then Toyota would cease to grow at the rate it is today. All my childhood I used to think that brands like colgate, dettol , bata a

dd to the challenges in developing combination products:

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

re Indian. That is the extent to which most of the companies have localized today. Software is no exception. MS has a windows version in German for the German market for which they need Germans.

Bottom line ... One has to sell and source globally in today's world.

Another important aspect which in my opinion is a maj

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

r problem in the US today is higher education. US has some of the best universities in the world. But most of the Americans do not have degrees.

".....Truthfully, over the long term, the greater threat is the source of well-educated labor. And if you look at the number of college- educated students that China graduate

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

s every year, it's close to 40 million. The law of large numbers is fairly compelling." Carly Fiorina Chairman and CEO Hewlett-Packard

This is something every American should be worried about. Take a look at the the National Institute of Literacy and one would get a fair idea. Here is a white paper for 1999 Nationa

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

Literacy Forum.

There was a time when the US needed doctors but not many Americans went to med. schools. As a result most of the doctors in the US are of foreign origin. The same has happened in many other professions. The IT industry faced the same problem but it has one difference the company does not have to get t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he foreigners to work in their office in the US. All they have to do is outsource.

I am sure even today there would be no Berkeley or MIT engineer who is jobless. Even a total outsourcing company would grab such people who are talented whatever be their race or color. The US gave to the world BSD but Finland gave to t

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

he world Linux.

Let's see the picture in another way. India got independence in 1947. Back then we lacked doctors, engineers ... well we had one of the lowest literacy rates in the world. The result was everything in India was imported. How could we make cars without engineers. The things remained the same for many ye

.

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

rs and all we had on Indian Roads was a Morris, Fiat and Jeep modified. We outsourced the entire technology sector those days. Indians did not stop the import of technology. However, we did focus on improving education in India. With time Indians got the expertise to make our own cars and today we have quite a few cars

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

Companies that provide selfless information through particip

which are made from scratch in India.

Bottom line... when the demand cannot be met locally it has to source it globally.

There are so many points that we can pick up when we discuss outsourcing and I really don't think I can pick it up in one session. So I'll be writing a series of articles on this topic exclusively

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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In July 2005, I wrote an E-Zine with the headline “High Definition – When?” At the time we saw little demand for HDCAM equipment aside from some clients in the U.S. Seven months later, the situation has changed dramatically. With this increase in demand, we recently hired Paul Wheeler BSC, a highly experienced film and digital cinematographer to do some workshops for us. While he was here, I interviewed him.

Buying wholesale, and selling retail is the normal way to make a profit online. But if you have an online store, the easiest way to make a profit through wholesale is to align yourself with a drop ship wholesaler.

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