Advice You - Business

Challenging conventional wisdom...what a concept! How few of us are willing to risk moving out of our comfort zone, learning to push convention

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

al wisdom aside and grow. Why is it called conventional wisdom anyway? Why; Perhaps, because the very idea of it is associated with being safe

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

Examples of combination products may in

and secure. Is that where we really want to be?

In today's fast-changing and ever-shrinking world, new ideas, methods, and processes are being

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

conceived, installed and operated at breakneck speed like never before. There is little room for conventional wisdom anymore, unless of course

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

you are content with living in a bubble, with little direction or growth intentions. I like the old adage, "if you are not growing, you are dy

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

Combination pro

ing." Marketing and sales, as well as many other fields, require constant movement and adjustment.

The term “conventional wisdom” reminds me t

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

he old excuse “because that’s the way we have always done it.” This overly-used phrase is nothing more than a crude crutch for countless person

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

s. Did you know that someone, in totally-blind ignorance, once had the audacity to say publicly that “all the inventions that will ever be inve

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

nted had already been invented? There is no need for the patent office anymore.” As ridiculous as that notion appears today, that particular st

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

atement was made at the turn of the 20th century. If anything, we can only dare to imagine the discoveries and advancements that will be made i

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

the next 5 years, let alone the next century! Think Star Wars or the Jetsons.

Certainly, there are instances where conventional wisdom is qui

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

Following aspects would a

te appropriate, such as well-accepted norms of behavior, testing procedures and religious practices. I challenge however, the notion of accepti

dd to the challenges in developing combination products:

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

ng conventional wisdom at the expense of personal and intellectual growth. That is where the element of fear enters in and restricts so many pe

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

ople. Generally, most fear at this level is simply imagined in our minds-eye, thus creating barriers to our progress, self-development and care

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

er advances. Although appearing and feeling quite real, it is not. At this point, we need to train ourselves to be conscious of our actual circ

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

umstances and work through this fear to find the rewards awaiting us. Franklin D. Roosevelt spoke in his first inaugural address “The only thin

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

Professional from academic institutions, pharmaceutical industries, health care indust

g we have to fear is fear itself.” He truly understood people and human nature. FDR would never settle for accepting conventional wisdom, and n

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

either should you.

In the world of selling your own ideas, products and services, we must be continuously growing beyond our comfort zone, cha

.

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

llenging conventional wisdom along the way. Our ability to persuade others to our point of view as well as our ability to match our goods and s

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

Companies that provide selfless information through particip

ervices to the needs and wants of others, depends upon living and working in a dynamic environment, not the static world of conventional wisdom

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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