Advice Pool - Reference and Education

"The fox knows many little things, the hedgehog knows one big thing"

Archilochus Isaiah Berlin used

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

this fragment from the ancient Greek poet Archilochus to make a distinction between the intelligence of the fox - which knows

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

Examples of combination products may in

many little things - and that of the hedgehog - which knows one big thing.

Fox or Hedgehog? There have been

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

arguments about which is more superior, to think like a fox or a hedgehog? Jim Collins, author of the books Built to Last<

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

/em> and Good to Great, for example, indicated that from his research, leaders of good-to-great companies were essent

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

Combination pro

ally hedgehogs, and he advocated a "Hedgehog Concept" for organisations. Others, like Philip Tetlock, author of Expert Pol

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

itical Judgment and John Kay, author of The Hare & The Tortoise, argued that psychological research and experien

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

e indicated that fox-like analytical skills are needed for good judgment.

The analogy of the fox and the hedgehog summarises

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

one of my key interests: how to build a successful life marrying the qualities of fox and hedgehog thinking. I am a "fox" wher

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

my wide range of interests (some intellectual, many whimsical) lie and in my attempts to synergise myriad disciplines and thi

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

nking concepts and theories, but I am a "hedgehog" with regards to where my life should lead and where should my contributions

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

Following aspects would a

lie.

Divergence and Convergence - Hedgefox

Viewed from another angle, the fox and the h

dd to the challenges in developing combination products:

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

dgehog as a concept is related to the cognitive concept of divergence and convergence. Divergence refers to the exploration fo

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

r new ideas, knowledge, options and so on (exploring many small things); and convergence relates to finding a conclusion, answ

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

r or closure on the issue in question (finding that one big thing). But in my opinion, even the conclusion should not be stati

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

c and should be reviewed and evaluated based on emerging new information and events or a change in context. In this sense the

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

Professional from academic institutions, pharmaceutical industries, health care indust

ivergence-convergence thinking mode should be understood as a cycle, as new information need to be collected and new knowledge

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

harvested to confirm or modify or reconstruct the previously-conceived "conclusion", and the process continues. This makes th

.

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

argument of whether it is better to be a "fox" or "hedgehog" moot, for to be a successful thinker and decision-maker, we need

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

Companies that provide selfless information through particip

the skills of both, and knowing when to be a fox or a hedgehog becomes critical, in other words, we need to become "Hedgefox"

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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Advice Pool - The Fox and the Hedgehog - Ideas and Thoughts

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