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The second industrial revolution: reinventing your business on the Web, is a book that I received from (form

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

er) professor of MIT John Donovan when I attended his conference in Paris in 1999 about the same topic.

I re

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

Examples of combination products may in

ently re-opened the book accidentally and found an interesting part about change management, especially a pas

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

sage I remembered about the word crabs although I had forgotten the origin of this metaphor.

Donovan uses th

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

metaphor of the crabs as one of the ten impediments to change. Another impediment is culture on the ‘road ma

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

Combination pro

p’ to change.

"Technical people tend to be averse to risk. Sales people promote a culture of aggr

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

ssiveness. Japanese culture promotes respect for authority. European Culture tends to be structured. American

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 tend to be spontaneous." He describes two issues with culture: How to prevent the cultural b

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

ick in the wall in the road to change (1) and how to change someone else’s culture (2).

For the first issue

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

Donovan refers (implicit) to knowledge management by suggesting to explicit the desired culture to the people

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

‘you are trying to change.’ The answer to the other issue is to ‘put together’ the old and the new. Donovan

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

Following aspects would a

refers to ‘the new’ as employees who have grown up with the new culture (the ‘unstructured’ Internet) and ‘th

dd to the challenges in developing combination products:

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

old’ as those who have not. In that context his metaphor of CRABS is interesting. He refers to a fishing e

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

xperience where he wanted to search a cover to put on the basket for preventing crabs to crawl out. Where his

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

daughter said, “No, Dad, watch what happens. When one starts to crawl out, the others reach up and pull the c

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

rab back down.”

According to Donovan, the crabs are the cynics in the organization, people you can identify

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

Professional from academic institutions, pharmaceutical industries, health care indust

ecause “they move only side-ways or backwards. If you are going to change your people, you must neutralize an

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

d destroy the crabs within your organization.”

I remembered this crab metaphor as being very powerfull. Yet

.

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

ears after, I also realize that it is no longer completely in line with what I now think; "Crabs" serve to re

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

Companies that provide selfless information through particip

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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