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It’s clear to me that a workplace is a better place when employees truly work in teams, but the most familiar team models we have are those that are created to win wars and games. We have a commander or a coach who gives orders, and the soldiers or the players use those instructions to defeat the opponent. Mediator Bill Ury says, “People are realizing that adversarial, win–lose attitudes in an increasingly interdependent world, whe

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

re I depend on you and you depend on me, just don’t work anymore. Using those tactics is like asking, ‘Who’s winning this marriage?’”

Who’s winning this company? Wrong question.

Consensus decision-making is a powerful tool for building nonhierarchical teams that can produce the best possible collaborative thinking. I am not suggesting leaderless teams and open-ended processes with no controls. Quite the opposite. I’m suggesting w

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

Examples of combination products may in

ll-led processes that invite, engage, and expand capability and that lead to an effective and just way to make decisions, develop initiatives, and solve problems.

The prevailing method for conducting meetings and making decisions, Robert’s Rules of Order, comes from military beginnings and relies on rigid structure, rules of conduct, and strict adherence to the rule of the majority. Often nearly half the people at a meeting disagr

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

e with a decision that has been reached. In many cases, by using a more open process that encourages dialogue and participation, we can arrive at decisions that are supported, at least to some degree, by everyone affected.

Consensus is a process of synthesizing the wisdom of all participants into the best decision possible at the time. It is not unanimous agreement, and in fact, participants may consent to a decision that they dis

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

gree with, but that they recognize meets the needs of the group or the situation. The root of consensus is consent, which means to give permission to. When you consent to a decision, you are giving your permission for the group to go ahead with the decision.

Consensus is about accommodation, but, more important, it’s about nobody having to accept that to which they are vehemently opposed.

The cooperative nature of consensus yield

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

Combination pro

a different mind-set from the competitive nature of majority voting. Key attributes of successful participation include humility, willingness to listen to others and see their perspectives, and willingness to share ideas without insisting they are the best ones.

Some describe consensus as a transformational process. When we use the accumulation of several peoples’ ideas and weld them together, the final product is better than wha

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

anyone could have devised on his or her own. The idea of consensus is not to eliminate conflict but to transform it.

At South Mountain Company we have used consensus decision making for seventeen years to run our business. At Island Cohousing, where I live, we have used consensus decision making for four years of development and five years of living. As the chair of the Island Affordable Housing Fund, and in many other facilitati

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

n situations, I use the consensus process even when it is not explicitly stated that we are doing so.

How Does Consensus Decision Making Work?

Consensus can be divided into five parts or stages:

Expression of an initial idea;
Discussion of the idea;
Synthesis of reactions and creation of a proposal;
Testing of the proposal within the group, and modification if necessary; and
Implementation and evaluation

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

f the decision.

The fundamental difference between consensus and majority vote is that in a consensus process a single person can block a decision. Consensus empowers each individual in a way that majority voting does not. Majority voting can accomplish decision making quickly, but it also can strain relationships and the sense of community. In achieving a majority of votes, expediency can become more important than relationship.

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

hat one individual thinks may not matter unless that individual has sufficient power. Consensus often requires more creativity, and it often results in more complete solutions.

Because consensus can become paralyzed by one difficult, powerful, or dysfunctional individual, I advocate a backup voting mechanism to be used when consensus cannot be reached after a specified amount of discussion. In the organizations with which I am mos

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

familiar, this mechanism has been essential but rarely used. Aside from its practical utility, its existence assures more adherence to the consensus process— when someone is being stubbornly disagreeable, that individual knows that he or she is likely to be outvoted if he or she doesn’t find a way to compromise.

Occasions do arise in which individuals are consistently argumentative for the sake of argument. They often characteriz

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

Following aspects would a

e their behavior as “playing the devil’s advocate.” I once heard a facilitator respond to someone who was “just being the devil’s advocate” as follows: “Thanks for your sentiments, but I think the devil has all the help he needs.”

Consensus is a conservative process. Because it takes a new consensus to replace an existing decision, decisions tend to stand once made. Some people are uncomfortable with this conservatism because it c

dd to the challenges in developing combination products:

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

n be hard to change a decision. To address this, some consensus proposals include a review period or a sunset clause. Requiring that the decision be renewed after some time has passed can encourage a group to experiment with new ideas without fear of being locked into a risky or unfamiliar path. It also provides an easy mechanism for incorporating new learning, over time.

One way to ensure that group time is not spent reconsiderin

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

previously made decisions when only one person—or a few—wants to do so is to require that reopening a consensus decision have a minimum number of supporters, say 10 or 20 percent of the group.

There are some issues for which consensus may not be an effective process. A classic example is style issues or color or design choices. Choosing the color scheme for corporate headquarters may not be the best decision to put to a group con

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

ensus process, because there is no best choice between blue or green; they are simply personal preferences. In these cases, using a weighted voting system on a number of choices may be a more effective way to get the job done.

Consent does not mean agreement. The goal of consensus is to come to a decision that everyone will give permission to, at least for a while. Supporters of a decision usually include true supporters of that p

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

sition, those who don’t really care either way, and those who don’t fully support the position but don’t wish to stand in the way.

Blocking is appropriate only if a participant strongly believes that a proposed decision is going to be bad for the whole group or to violate the mission of the group. If a participant blocks a group decision because of his or her personal values, that individual is essentially demanding that the whole

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

Professional from academic institutions, pharmaceutical industries, health care indust

group subscribe to his or her values. It is the facilitator’s job to be clear about this and to remind participants of the powerful responsibilities that come with the ability to block decisions.

There are ways of objecting to a proposal without blocking consensus:

Nonsupport—I don’t agree with this decision but I will go along with it. Reservations—I think this decision is a mistake because _________, but I’ll live with it.

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

all for a later review—I would like this decision reviewed after ________

I am sometimes asked whether it is perilous for the employees to make the decisions for a business. What do they know? Isn’t it inefficient and potentially paralyzing for decisions to be made by consensus by a diverse group? Shouldn’t we leave the decision making to skilled management?

I speak primarily from my particular experience. South Mountain’s govern

.

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

nce system is a democracy with clear divisions of responsibility and authority. Much of the authority to act is delegated to management. This delegation comes easily, because this was the established mode of operation before the ownership of the company was shared. The difference is that there is now a clear mechanism for discussion, debate, and change. The comfortable delegation of authority may be one of the advantages of a compa

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

Companies that provide selfless information through particip

y converting to worker ownership and control, and consensus decision making, rather than starting that way. Once the entrepreneurial leap of starting a new business has been achieved, adoption of consensus-based decision making becomes a part of the maturation process. In our case, consensus decision making has only broadened our view; it has not watered down our decisions or derailed our ability to make them in any discernible way

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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Entrepreneurs have personality traits that make them ideal people to work for themselves. These same traits, while helpful as an entrepreneur can be irritating and dangerous for normal on-the-job relationships with bosses, managers, and supervisors.

I do not believe that unethical behavior can unknowingly occur if a leader has proper values and intentions. A leader who is ethically based will not knowingly break laws, deny rights, endanger lives or deceive or exploit employees, customers, stake holders or society.

The most unusual franchise opportunity that I have come across specialises in cleaning mattresses! They have turned this business into an art form. The way I clean my mattresses is by taking them out on a cold day and hitting them with a hard brush. The brush dislodges all the loose material whilst the cold kills any bed bugs.

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