Useful Advices - Business

The American economy is the growth engine of the industrial world and will continue to be so, as long a steady stream of innovative, divergent products is successfully created. The history of capitalism is replete with cycles of unique, needed advances that exponentially expand the eco

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

nomic base and evolve into completely new industry categories. No country comes close to America in dynamism, creativity and energy in pursuing cutting edge new growth opportunities.

Why is this so? Many other countries have a much longer historical pedigree with features of freedom a

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

Examples of combination products may in

d capitalism as significant foundations of their heritage. Old Europe has been trading, exploring and investing for centuries before Jamestown and Plymouth were settled. The Dutch, British, Venice, Swiss and Spanish have wondrous commercial histories. The Japanese and Chinese were comm

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

ercial powerhouses before the Europeans. And yet, none has left a commercial footprint like the United States in just over two centuries of enterprise.

Why? The answer is the constant curiosity, drive and ingenuity inherent in America’s unique form of capitalism. This is most clearly

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

eflected in the risk/reward benefits gleaned from an almost endless stream of product inventions. Hugely significant new industries are in existence solely because of the divergent nature of the product, technology or service created.

A divergent product or service is one that did not

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

Combination pro

exist before its invention. The wheel was a divergent product. The radio was a divergent product, as was the airplane. Computers, lasers, McDonalds and hearing aids are examples of products that were divergent and first to market movers.

Today we take the radio for granted. However, w

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

hen invented it was an amazing device, truly divergent, revolutionary, a breakthrough. Many refinements, improvements, and new features have been added to the original radio apparatus. Radios have been enhanced with clocks, alarms, lights, FM, placed in cars, portable and satellite del

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

very. These new benefits and performance embellishments are dependent on the original ground breaking radio product platform and are convergent products. All add to the usability of the radio and generate income, but, without the original invention, they would be of little consequence.

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

The radio was, and is, the home run product.

The result of the continual creation of divergent products and technologies is to continually fertilize and grow these industry segments with ancillary convergent business opportunities. The computer begets the software. The software attra

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

ts bugs and security services are required. New retail categories are required to sell the computers, software, security and accessories. Service companies evolve. A whole new industry has been developed on the shoulders of the original divergent invention.

Critics of the American cap

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

talist model rarely consider the huge benefits modern society enjoys from the creation of these divergent technologies. One elemental example: the light bulb. Light bulbs provide safety and the opportunity for people everywhere to more productively utilize evening hours. Light bulbs ar

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

Following aspects would a

e manufactured in dozens of countries, providing jobs and sustenance. Bulbs are made for innumerable uses. They must be transported, warehoused, marketed and sold. The result is a complete supply chain benefiting every human utilizing this simple, but amazing divergent product. This is

dd to the challenges in developing combination products:

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

a fantastic benefit of capitalism and divergent technologies.

When Thomas Edison invented the light bulb he had no real knowledge of the potential universality of the product at that time. There was as yet no power system available to deliver the electricity required to light the bulb

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

. He was seeking to solve a problem, answer a need and make a profit. He could have failed, and he did so many times. However, he kept trying and his effort was rewarded.

American capitalism rewards effort, drive and, of course, success. Uniquely, in America, failure is allowed. Failu

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

e is not regarded as finality. Americans are encouraged to try, and if they fall down, get up and try again. Almost every other society punishes failure with a different outcome, a very negative outcome. The result is a lack of creative risk taking, a lack of dynamism.

Virtually no ne

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

job growth has been created in Europe in the last 20 years. European states place huge barriers in the way of starting a business, commercializing a product or organizing capital. The successful Japanese model of the 1970’s and 1980’s has declined precipitously, and was largely based

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

Professional from academic institutions, pharmaceutical industries, health care indust

on manufacturing clones of convergent products created in America.

Korea, India and China are currently under political and media scrutiny for the imbalances they enjoy in trading with the United States. However, name a single divergent technology, product or service proprietary to an

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

of these countries. There are none. They are formidable competitors for resources, but they are not inventors and will not, at least yet, be competitive in creativity. Low cost, low margin production, product duplication and industrial theft are not long term strategies the United Sta

.

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

tes should fear.

Rigid socialist, centrally planned economies by their very nature can not be creative. The free flowing nature of American capitalism is a blessing for this country, and the few other countries (Hong Kong, Canada, Singapore) willing to let humans do what humans do bes

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

Companies that provide selfless information through particip

: enjoy freedom and seek personal opportunity. Much like the food chain, where the ox-pecker lives off the ox, we need divergent product advances to feed the desire of convergent enterprises for fresh growth opportunities. No country approaches America in industry pioneering and growth

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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