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“Change” has been the big topic of conversation for some time now. For the most part, the change that everyone writes about and talks about is economic change. There has been much written about the change from a manufacturing economy to a service economy and ther

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

e has been much written about the movement of manufacturing jobs off shore, but I want to concentrate on another kind of change. Willis Harman wrote a whole book about it in 1987 entitled, “Global Mind Change.” To paraphrase a line in this book, society’s experie

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

Examples of combination products may in

nce shapes its science and science shapes the experience of it’s society.

We have been educated to assume that our scientific view of reality is correct. Harman suggests that there may be other views of reality that are complementary. He continues by proposing 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.

reunion of science and metaphysics. He states, “The fundamental change that we are suggesting is happening in Western society can be put in terms of these metaphysics. Essentially, it is a shift of dominant metaphysic from M-1 to M-3.”

Where:

M-1. The basic stu

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

ff of the universe is matter-energy. Consciousness emerges out of matter. Consciousness apart from a living organism is inconceivable.

M-2. Matter-energy and mind-spirit stuff both exist in the universe. Matter-energy stuff is studied with science. Mind-spirit s

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

Combination pro

tuff must be studied in other ways.

M-3. Consciousness is the ultimate stuff of the universe and matter-energy comes in some sense out of consciousness.

Margaret Wheatley in her award-winning best seller, “Leadership and the New Science” suggests that, “we let

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

o of the machine model of organizations, and workers as replaceable cogs in the machinery of production, we begin to see ourselves in much richer dimensions, to appreciate our wholeness, and, hopefully, to design organizations that honor and make use of the great

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

gift of who we humans are.” She believes that ownership is essential and suggests that ownership is not only literal owners, but describes personal connections to the organization that inspire people to contribute. Participation in the development of a plan of a

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

ction creates ownership. In fact, we participate in the creation of everything we observe. In a sense, we are owners of everything we observe.

We have all seen the progression where raw data when properly analyzed and organized becomes information. Information i

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

turn is the basis of intelligence and intelligence the basis of wisdom. Historically, management has worked to control information. Wheatley uses scientific support to suggest that for a system to remain alive, it must have a steady flow of new information.

Muc

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

h has been written about the fact that information is exploding. We know that more information was produced between 1965 and 1995 than in the preceding 5000 years and that knowledge is now doubling every 5 years. Technology certainly has fostered the explosion, b

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

Following aspects would a

ut it has also made this information available to more people as well. It is no longer practical to use a traditional building block approach to information. We need what is described in quantum physics as relational holism.

Wheatley suggests that the new scienc

dd to the challenges in developing combination products:

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

reminds us that this is a participative universe and that nothing living lives alone. We are constantly called to be in a relationship and through relationships we co-create our world. With that in mind, we make systems stronger by connecting to more of itself.

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

Webs and networks are stronger than single connections. Participation is the key.

The May-July 2004 issue of “What is Enlightenment” has some incredible articles about collective intelligence. In an article entitled, “The Science of Collective Consciousness” Rob

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

ert Kenny provides strong evidence that collective consciousness exists and can be used to produce benefits. Another great article entitled, “Come Together” by Craig Hamilton, reports, “Call it collective consciousness, team synergy, co-intelligence or group mind

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

– a growing number of people are discovering through their own experience that wholes are indeed far more than the sum of their parts; that when individuals come together with a shared intention, in a conducive environment, something mysterious can come into bein

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

Professional from academic institutions, pharmaceutical industries, health care indust

g, with capacities and intelligences that far transcend those of the individuals involved.”

While we may not yet be able to exactly define collective wisdom or how it works, it is working. There are a bunch of collective intelligence initiatives underway includi

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

ng: World Caf?, Laboratory for Social Intervention, Open Space Technology, National Coalition for Dialogue and Deliberation, Dynamic Facilitation, Deep Dialogue, Appreciative Inquiry, Global Leadership Initiative and others. This is not the product of some well-m

.

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

aning, goody-goody types, but rather the output of some of the most influential organizational minds in the world.

My own experience using World Caf?, Open Space Technology and Appreciative Inquiry to address complex and chaotic situations from a holistic approa

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

Companies that provide selfless information through particip

ch has convinced me that collective intelligence and in turn collective wisdom are real and offer incredible potential for all organizations in this time of information overload and complexity.

Copyright Bob Cannon/The Cannon Advantage, 2003. All rights reserved

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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