We have a problem with today's college students, when they graduate from college a

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

nd go to work for large or medium sized companies; they think they know it all. Th

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

Examples of combination products may in

ey run off at the mouth with lots of big buzz-words and prove that they do not kno

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

w what on Earth they are talking about. Then they insult the other party or vendor

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

with some stupid question such as:

Is this your strength?

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

Combination pro

te>

Which is the exact question I was asked recently about my knowledge or expert

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

ise in the Auto Detailing Industry, since I happened to have run a franchising com

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

any in that industry sub-sector many years the prior. However as a franchisor ther

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

e are many aspects to the business model, than just how to detail cars or how to r

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

un an auto-detailing company. Of course I felt like saying:

Oh, I see

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

I am now limited to the "mobile auto detailing" business as my "one" strength?

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

Following aspects would a

ockquote>

That is like asking Sam Walton if his strength is in selling "back to s

dd to the challenges in developing combination products:

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

chool supplies." Although he probably would have known more about selling school s

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

upplies than any other competitor who had ever walked said planet? Or like asking

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

ay Kroc founder of McDonalds if his expertise is in French Fries? If you hire a fr

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

esh out of school kid to work for your company you should probably tell them not g

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

Professional from academic institutions, pharmaceutical industries, health care indust

o around insulting entrepreneurs like that, it makes them look like a college stud

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

nt fresh out of MBA school who has never done anything in their lives, but has so

.

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

many buzz-words in their vocabulary they cannot think. Of course, if they cannot m

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

Companies that provide selfless information through particip

ake it in the real world there is always some inefficient bureaucracy to hire them

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products