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One of the cornerstones of a productive and harmonious team is its ability to successfully make good decisions that impact the group. More important then that, it is critical to ge

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

t all members to buy into the decisions once they are made. Whether you are deciding on your next budget cuts, specific project deliverables, or when overtime will be mandated, the

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

Examples of combination products may in

decision process itself is as critical as the decision.

No matter how you think your team works, deep down leaders and workers both care about the fairness of the decision making p

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

rocess. In order for there to be buy-in, peace and support in your team the decision process must ultimately be perceived as fair.

Fairness is obviously a matter of who is making

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

he determination, and so there are no set rules. But over the years I have found that decisions that are perceived as fair have some common traits.

First everyone impacted by the

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

Combination pro

decision must believe they have had a real opportunity to contribute to the decision. Many fights and struggles in teams start because a decision was made without one of the member

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

s playing. How many times do you hear, “I can not believe you did that and didn’t even ask me…” If it happens a lot you need to check your process. It is probably doomed from the

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

start.

Next all sides must feel the decision maker really listened to their input and considered their point of view prior to making the decision. This is particularly true when t

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

e decision will impact team members outside of the work environment.

More then listening, all members of the team must believe they had a genuine chance to influence the decision.

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

If your team has developed to the point where certain decisions are made by the group, this is very important to stress. Team members need to understand that along with the abilit

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

y to make decisions for themselves and others comes the responsibility to listen openly and weigh input. If you have modeled this behavior all along it will come naturally, so watc

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

Following aspects would a

h your actions and act consistently.

And finally, whatever the decision is everyone must understand the reason for the final choice. Early on in the process it is important to let

dd to the challenges in developing combination products:

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

everyone know if there is a pecking order to input. If there are outside forces that also will determine the choices to be made explain them up front. Help each member of the team

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

understand why their position did not prevail.

One process you might want to try looks something like this:

1. Clearly define and communicate how the decision will be made and by

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

who.

2. Next maintain an open mind set if the decision is truly open for discussion. Be very clear what the boundaries of each of the decision makers are.

3. Actively listen to a

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

ll parties involved. Encourage everyone to ask questions for clarification. Regularly provide feedback to test for understanding. Above all, everyone needs to show respect for dif

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

Professional from academic institutions, pharmaceutical industries, health care indust

ering points of view, never interrupt to stop a dissenting opinion.

4. Once it is made, explain the decision and how you evaluated the information and made the choice.

5. Explain

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

how everyone’s input was used. Clearly show how each team member contributed to the process, especially if their particular perspective didn’t prevail.

6. Last, openly and honestly

.

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

recognize and thank team members for all contributions so they will want to participate in future decisions.

Obviously this is not the only process. Experiment, make your own. Ju

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

Companies that provide selfless information through particip

st be sure to include each of the elements. If you do your decisions won’t be any easier but at least everyone on the team will understand them and believe they were treated fairly

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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