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Why is it that, in a team setting, some participants seem to hold more influence than others even though they may not be team leader?

Where does this influence or power come from?

What impact do these people have on the team? If the effect is being detrim

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

ental to the team's well-being or holding back progress, then why have them on the team?

Let's take, for example a continuous improvement team, a task force, perhaps a project team developing a new product.

It is healthy and, sometimes, maybe even necessa

; 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 to include team members who are invited because they are in a position of authority or have a great deal of expertise in / experience of the team's key objectives.

WHY?

Credibility. These influencers can be just that. They are in the ideal posi

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

ion to influence others outside the group if, for example, additional backing or approval is needed. Perhaps they will form part of the main presentation team, lending their skills or authority to help to ensure the success of the team.

Approval. It

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

may be that the person of authority is involved because their approval is a mandatory part of team making progress from one stage to another.

Help. Perhaps the team is struggling and needs help to move forward.

Information. Maybe addition

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

Combination pro

l information or hard data is needed. Perhaps it's feedback from a presentation or inputs based on technical know-how.

Training. The team may need specific training in new skills or techniques to enable them to make progress.

I'm sure you can

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

think of a whole bunch of other reasons why these people of influence can and do add value. However, challenges may arise when the individual with authority or relevant expertise...

Tends to undervalue the inputs and suggestions from other team members. T

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 knock-on effect of this action and attitude can be quite significant in that it undermines the participants' confidence which can lead to those team members questioning why they are involved at all. Not only that, the other team members will rapidly get the f

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

eeling that it's better to shut up and say nothing. At least, in that way, they won't be seen as naive or even stupid.

Creates taboo areas. This may or may not be intentional. This person has been invited because of their knowledge. Problem is, may

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

e they are so used to talking to their peers who already have an understanding of the subject, that they almost automatically use a lot of technical terms that just go over the heads of the rest of the team. Sadly, sometimes this can be intentional - "Don'

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

t go there, I know what I'm talking about, you don't".

Lives in the past. "Been there, done it, got the T-shirt". The It did not work twenty years ago so it won't work now attitude is not as uncommon as you may think. Although this als

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

Following aspects would a

o can damage the confidence of team members, it can, potentially, damage the credibility of the 'expert' who is less than open minded and maybe even somewhat afraid of trying something new.

Blocks inputs or suggestions. It may be obvious that all the

dd to the challenges in developing combination products:

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

e points are inter-linked and if the person in authority believes or has decided that something isn't going to fly, they may actually attempt to block any further discussion as wasting everyone's time including their own.

So, how can we handle these si

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

tuations?

I feel, as I have mentioned in previous articles, it's a case of restoring balance. These team members are present because, without them, life could be extremely difficult.

Balance needs to be restored because we want to ensure that the contrib

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

tion of ALL team members continues to be valued. Of course some ideas won't work, some suggestions won't get the support needed, some projects or tasks will need more work to be done.

However, as much as it is appropriate that team members respect the influen

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

ce that comes with authority or expertise, it is also encumbent upon the 'influencers' to use their position wisely and appropriately.

This is not about the WHAT or the WHY, it is about the HOW

Encourage an open-minded approach by everyone involved

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

Professional from academic institutions, pharmaceutical industries, health care indust

/li>

Ensure the 'influencers' understand the ground rules the team has for sharing information and making decisions

There are or should not be any taboo areas in the context of the project or team's objectives. If necessary, this approach can be

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

discussed in advance and outside the team setting, making sure this is agreed to.

Always use a structured approach. What is the data telling us? What additional analysis can the 'expert' provide? What suggestions does the expert have in moving forwa

.

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

Be prepared. The more the 'influencers' co-operate with a positive, open-minded attitude, the more successful the team will be AND the more enjoyable the experience will be for EVERYONE. To be prepared it may mean spending more time with the perso

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

Companies that provide selfless information through particip

n in authority or the expert to ensure they understand how the team works, how they can co-operate, and, as team leader, even how you would wish them to 'behave' in the team setting.

Managing Your Team (Part 5) will look at Who's Guilty of Plopping?

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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Digg It - Managing Your Team (Part 4) - Who's Exerting a Disproportionate Amount of Influence?

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