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The next few articles will look at different traits and characteristics that individuals bring into the team environment. For those that are less than productive, they must be deal

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 with as soon as possible.

Before we go much further, I agree that the overall responsibility lies with the team leader BUT as team members we all have a duty of care, we all car

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

Examples of combination products may in

ry the responsibility to succeed.

No brainer, but I'll ask it anyway - do you want your team to fail or be successful?

Quick point about the team leader. Although the clues and

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

ips in these articles are aimed at how the team leader can act in a positive way, if you recognise a given trait in yourself, recognise that there is something that can be done pos

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

itively to help improve the productivity of the team.

Let's meet the first of these characters - The Reluctant Team Member

Even just one can significantly impact the team

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

Combination pro

ynamic, cause distraction and delay progress.

I cannot over emphasise that if any other team member discounts or under values the inputs a reluctant team member makes, the team

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

leader runs a huge risk of increasing the reluctance, not minimising it.

Why is an individual team member struggling, reluctant to participate? Can we determine the root caus

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

e(s)?

Does he or she actually believe they are reluctant, maybe not!

"Listen when I have something to contribute, I will."

Remember, we don't all have the same values and

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

these values can drive our beliefs and actions. Also we are not talking about rights and wrongs here, just differences.

Also, in the context of being a team player, we may have di

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

ffering needs...

I normally work on my own, so I'm not comfortable in a team setting

I need to understand why I am here, what's my role?

I'm not comfortabl

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

speaking in a group

I'm not as extroverted as some of the others

I'm happy to participate but not to take the initiative

So, the issue is not that we can

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

Following aspects would a

be different with different needs. The problems arise when either as team leaders or team members we do not encourage the so-called reluctant team members to participate more (an

dd to the challenges in developing combination products:

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

d, perhaps encourage the more extrovert of us, to listen more - see part 3, coming next).

What Can The Team Leader Do Constructively?

In our job role, we all ha

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

e clearly defined and measurable objectives (hopefully). If the 'reluctant' team member is part of a project team, it may be possible to allocate specific project tasks to individu

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

al members much in the same way, with each assignment being measurable, timed and reported back to the team.

Delegate don't dump. Make sure the team member is ready 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

ble. Prepare to succeed, not fail!

Maximise strengths, eliminate or, at least, minimize weaknesses. Through individual job role appraisals and team feedback, there should

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

Professional from academic institutions, pharmaceutical industries, health care indust

be enough data to formulate an effective training needs analysis, through which team related opportunities can be identified.

The use of problem solving/decision making

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

tools such as brainstorming are a very effective way of involving the reluctant participant as long as the rules are followed correctly. For an example of conducting a successful

.

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

rainstorming session see article: How To Conduct a Successful Brainstorming Session ID: 83873

As confidence grows, as involvement increases, encourage even more particip

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

Companies that provide selfless information through particip

ation by asking the erstwhile 'reluctant' team member directly, in the team setting, for their opinion or ideas.

The next article will look at Team Members Who Dominate

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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E-Folder - Managing Your Team (Part 2) - Encouraging Reluctant Team Members

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