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Consensus is the appropriate decision strategy for the most important team decisions. Every member of your team needs to understand what consensus reall

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

y means. A common misconception of consensus is that it means everyone agrees with the decision 100 percent.

If a team adopted this definition as the b

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

Examples of combination products may in

sis for all of its decisions, what would happen?

- The team would never be able to make a decision.

- The team would jump to a decision too quickly.

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

Unimportant matters would be over-discussed.

Consensus means that everyone in the team can live with and fully support the decision. A win-win solutio

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

n -- everyone feels that the best solution has been reached, team member positions were heard, and no one had to give in on any strongly held conviction

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

Combination pro

or needs.

So what's the downside? Consensus decision making is time- and energy-consuming. It should be reserved for important decisions requiring str

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

ng team member support from those that will implement them.

How Do You Decide Which Strategy To Use?

It really depends on the decision being made and

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

the size of your team. Below are some guidelines to determine when consensus should be used.

- When the decision affects all members of the team.

- Wh

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

n the decision will have a long-term impact on the team's performance.

- When the implementation of the solution requires coordination among team membe

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

s.

- When the decision requires the experience and skills of many team members.

- When the decision involves a critical work challenge requiring the f

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

ll commitment of the team.

- When the team is not working under emergency conditions and has the time to make the decision.

Use Caution -- Watch For G

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

Following aspects would a

roupthink

We can't leave decision strategies without touching on Groupthink, a negative strategy.

Groupthink occurs when team members try so hard to a

dd to the challenges in developing combination products:

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

hieve harmony and quick, efficient decisions that they fall into the habit of agreeing with one another too quickly.

This method discourages questionin

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

and divergent thinking, hinders creativity, and usually leads to an inferior decision.

Team embers should attempt to explore alternatives. What should

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

you do when a team is falling into Goupthink?

- Ask the team to come up with the pros and cons for the decision they have come up with. Weaknesses and

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

concerns which may have been glossed over before will be brought out.

- Get the team to table the decision for now and come back with other alternative

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

Professional from academic institutions, pharmaceutical industries, health care indust

at the next meeting.

Common Thread

Regardless of the decision strategy adopted by a team, there's one common thread. All team decisions must be suppo

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

rted by the individual team members.

How can you tell after the decision has been made whether the team truly supported it? It is not supported when:

.

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

People complain about or demean the decision after the fact.

- Team members do not follow through with actions to implement the decision.

One of the

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

Companies that provide selfless information through particip

ost significant contributions you can make if you are building a team is to help them come up with their own answers by using a proper decision strategy

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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Learn about how to create the chiropractic practice of your dreams using a few simply strategies. If you want to love what you do, help as many people as possible, and make a healthy six figure income in the process, you should read this article.

As Freud cautioned, it's insanity to keep doing the same thing and expect different results. You know things have to change. Business as usual is a guarantee to fail. Your boss supports you, but is fairly lukewarm about resources and time commitments. Your staff agrees but then claim they are too busy. Activity traps, inertia, disinterest, ambivalence, fear… people fabricate (consciously or unconsciously) lots of reasons to avoid making change. This is a frequent organizational dilemma: a needed change stalls before you even get started.

Companies follow different strategies in order to articulate their unique selling propositions. Often times, if a company has not gone through a go-to-market strategy or a strategic planning marketing process it makes sense to start there by gathering your team together and looking in-depth at the elements of your go-to market strategy.

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