Advice You - Business

As a self-proclaimed industry analyst spanning many sub-sectors of our economy I always find it fascinating to study Industry Surveys

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

although I never seem to quite trust the data. Why you ask? Because it always seems that I will read one research paper or survey, w

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

Examples of combination products may in

hich says one thing and another, which says something different.

Occasionally, I will find that all the surveys say the same thing a

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

nd at that point generally one would assume that such particular data is indeed correct right? Not necessarily and let me tell you wh

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

. Well if the data is a little bit different at least you know whoever was doing a survey or research actually did collect data sets.

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

Combination pro

But when all the surveys say exactly the same thing you have to wonder if they have been copying each other.

Scientific research a

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

nd data being plagiarized? Well, when it comes to industry surveys yes I see a lot of that actually. Even worse when all of the dat

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

seems to point to a particular exactness from all the different researchers and surveys one has to ask why? That is when I really g

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

et suspicious especially when I consider that the data looks incorrect.

Let me take a case study that I recently found in the car wa

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

sh industry. To exact studies done by two different groups. Both of them were equipment manufacturers. The question in this survey

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

is how many locations does the average car wash owner own?

One survey said that 61% owned only one car wash and the other survey sai

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

Following aspects would a

d that 64% owned only one car wash. When it came to three or more locations one survey said 5% and the other was 6%. Now then someo

dd to the challenges in developing combination products:

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

ne has to ask the question why is there discrepancy and who is right and who is wrong? Well, another survey said that the percentage

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

s were 68% and 4%. And perhaps no one is right, they are all wrong?

Now then someone could say this is within the margin of error.

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

ut there should not be any margin of error because there are 49,000 car washes in the United States of America and there is an exact

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

number that can be known, but apparently no one wants to dig deep enough to find out what it is. Instead these companies and researc

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

Professional from academic institutions, pharmaceutical industries, health care indust

hers are using limited data sets and getting skewed results.

As an industry analyst of the car wash industry among other industries

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

ow can I trust any of the data out there? The fact is you can't and if you think you can then you'll most likely make a mistake. No

.

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

w then with that said the answer that can be known without doing your own survey would be that there is a margin of which is 10 to 15

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

Companies that provide selfless information through particip

% (quite high) and that is the best you can know even when you talk to all the experts. I just want you to consider all this in 2006

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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