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More and more smart business people are finding the value of writing articles and putting them online in order to propel their expert status in their field

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

. From this they develop a clientele base, which will patronize their businesses. One anonymous author has debated the number of articles one individual ca

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

Examples of combination products may in

n write as an actual expert. Is there really a limit? Can it be possible to write 1000 articles on one subject? I believe it is possible and let me tell yo

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

u why.

I started and founded a mobile car wash business, built it up and then set up franchises in 23 states, it took many years to do this. It took count

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

ess hours and along the way I encountered many experiences; each new experience each day could be summarized in a short story or article on the industry. T

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

Combination pro

his means after 20 years you could have, if you had kept track of all these experiences over 7300 articles; one for each day. Wow, well that is a lot indee

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

d. Some authors and in particular a new critic of my article writing is, well let’s just call him Ed as whoever it really is refuses to identify their true

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

identity.

Now before you say that there is no way to write that many articles, let me point out where you maybe sadly mistaken. First in any business th

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

re are countless rules and regulations. Each regulation is many pages. The OSHA laws are actually 47 stories high if you were to stack them on top of one a

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

nother; page-by-page. If each one were the an article then in fact you might have some

Each foot is 10,000 pages times 8 feet per story times 47 stories i

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

s over 3.5 million articles. That my friends is only one agency which governs the business world. What about the environmental laws, building codes, ADA, e

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

Following aspects would a

mployment laws? In my car wash business we dealt with laws in 23 states plus the fed. Imagine how many articles one could write? A lot is an understatement

dd to the challenges in developing combination products:

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

So what is the upper limits of articles you can write on a business model? I say it is unlimited. It is not is not 50, it is not 500, it is not 1000 and

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

it is not 7300; in fact it could be over 100,000 or half a million. In building my company, we had to write manuals for our franchisees. We could not make

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

them too awfully complex as people would not be able to read them all. When I finished my set of manuals, which is needed to run a mobile car wash business

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

; we had over 1000 pages, each one have a different topic or sub topic. Then I wrote manuals of how to clean boats, aircraft, trucks and concrete. Each ove

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

Professional from academic institutions, pharmaceutical industries, health care indust

500 pages; think about how simple the mobile washing business is? If you read books like the E-Myth you will see that the first step to take a business pa

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

st step one is to systematize it, organize it and set up procedures which can be duplicated. Anyone who has done this in real life could easily write 1000

.

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

articles on the subject if they really set their minds to it and committed themselves to write it all down.

Moral of the story: Anyone who limits them sel

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

Companies that provide selfless information through particip

ves in life to an artificial barrier of the mind, has in fact limited their potential. Are you limiting yourself? If so, why do you do that? Think about it

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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