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Maybe you find yourself in a new team environment and leading a team for the first time, or maybe you have been working with and leading teams forever. Either way, the keys

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

in this article – whether as new information or a fresh reminder – can make a world of difference in morale, productivity and results from teams.

Help the team ide

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

Examples of combination products may in

tify its purpose. People work more effectively when they understand the goals they are trying to achieve. As a leader it is your job to help the team see the desir

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

ed outcome of their efforts and help them set specific goals and milestones along the way.

Set the scope and boundaries. Teams need to know what they sho

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

ld tackle and what is “too big” or not their responsibility. By helping teams manage the scope of their work you will keep them more focused and on target to reach the goal

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

Combination pro

s more quickly.

Show your belief. If you don’t believe in the team concept, you won’t effectively lead teams. If you do believe both in the concept an

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

in a particular team’s potential, you need to let them know that. Show through both your words and actions that you believe in them. Once they have purpose and goals and y

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

our belief, they are on their way to success.

Define your role. Your role is to lead, not to do the work or make all of the decisions. Let the team know

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

what you role is and isn’t. Help them see how you are relying on their experience, knowledge and intellect in the completion of the team’s work.

Be a supporter.

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

Support the team with your actions. Don’t just delegate the work to the team and be gone. Teams will experience obstacles and road blocks and it is your job to r

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

move those roadblocks, find additional resources, and generally provide support. It is like a hike. If you are in front of a group on a hike, you will do your best to remov

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

Following aspects would a

e impediments that might slow down or injure those that follow. Your role on a business team of any sort is just the same.

Be a facilitator. Help the te

dd to the challenges in developing combination products:

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

m succeed. Provide guidance when needed. Keep your hands off as much as you can. Let the team succeed and develop themselves towards greater future achievement at the same

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

time. To facilitate means “to make easier” and that is your role. Remember that you chose to use a team to accomplish the task, so let them do it.

Keep your mout

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

shut. Teams often look to leaders to make the final decisions or assume that the leader has veto power on any decision in the end. If you really buy the team appr

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

oach - that you want and need everyone’s input – you have to keep quiet. If you are the first person to talk on a subject, the overall amount of discussion and idea flow wi

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

Professional from academic institutions, pharmaceutical industries, health care indust

l drop. Team members will subconsciously assume that your word is golden – whether they agree or not. Because of your position, you must abstain from the early part of a di

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

alogue on any issue, and share your thoughts nearer the close of the conversation.

Each of these things alone will help you build and lead more effective teams. But 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

aken together, significant progress can be made.

Look at the list above while you think both about your skills and behaviors and the needs of your current teams. Then, pu

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

Companies that provide selfless information through particip

t a check mark (mental or literal) next to the one item you will work on today.

By getting started NOW you can become a significantly more effective team leader right away

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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