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In some ways this article is a continuation of Managaging Your Team (Part 4) in that 'influencers from a position of authority or expertise may be guilty (consciously or unconsciously) of ignoring inputs from team members or,

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

just as damaging, putting down / under-valuing the contribution made and the contributor who made it.

Unfortunately, all of us may be guilty of this behaviour from time to time and often this attitude and behaviour will be

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

Examples of combination products may in

ccompanied with...

"C'mon, I was only joking! Don't be so sensitive"

One of the main root causes of this behaviour, as I have touched on previously is based on our value system.

We live, breath, and act our

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

u>own values - they are who we are and, therefore, are extremely important to each of us whether we are fully aware of them or not.

In context, think of some practical examples...

Never being late for meetings or ap

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

pointments.

Always prepared to listen and not talk over others.

If a commitment is made, it is kept.

Mobile 'phones remain switched off in team meetings.

Treat others as you would wish

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

Combination pro

hem to treat you.

You've guessed it, not surprisingly, these are values that are very important to me in both my personal and business lives. Yours may be the same or totally different. To illustrate the point...

Pun

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

tuality is extremely important to you, it is one of your primary values. So, how do you feel when team members regularly turn up late to your meetings? How do those who turn up on time feel when you wait until everyo

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

ne has arrived before you start the meeting? What message are you sending out?

NOW, let's say you have just given your views, made a suggestion to the group and it is completely ignored. How do you feel?

Who's guilt

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

of plopping - you are - you've just plopped! Everyone else continues with the group discussion which bears no relevance to the inputs you've made.

You're left sitting there (or worse standing there) wondering wha

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

the heck has just happened.

O.K. in the overall scheme of things it will happen to all of us at some time and by understanding that fact, we won't get things out of perspective or over-react.

However, we do need to

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

ocus on the challenge or issue when a team member is ignored or under-valued repeatedly by the rest of the team or one individual frequently under-values other team members

You could argue that the title of this article

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

Following aspects would a

should be...

Who's Guilty of Making Me Plop?"

Just maybe...

I did not make my inputs clear enough

Actually, what I said was somewhat irrelevant to the main point

Other team members mis

dd to the challenges in developing combination products:

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

nderstood what I meant

I was guilty of interrupting someone else and breaking their flow

My action caused someone else to 'plop' or feel discounted

So, one theme you'll find in a number of these arti

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

les is our duty of care to our fellow team members. It is encumbent on all of us to guide our team colleagues, respect their contributions, seek clarification if necessary - don't discount it or them, and where approp

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

riate, provide constructive feedback to those who are consciously or unconsciously undervaluing other team members.

And, what can I do as team leader?

Training can be beneficial at any time. However, if the team

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

is newly formed or there are some mew members, training in techniques such as effective listening, giving and receiving feedback, and other positive behavioural change courses will definitely help.

All team members

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

Professional from academic institutions, pharmaceutical industries, health care indust

hould reach consensus on what the 'ground rules' are for their team sessions and agree that it is legitimate to point out (constructively) when any of these rules are broken.

Be there for the under-valued person - s

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

upport them visibly in the team setting - again, constructively. Please don't support the person who has been ignored or under-valued by then under-valuing someone else in the group. Simple example of support without

.

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

ointing the finger...

"Before we move on, I think what Joe said is worth consideration so let's spend some more time discussing it"

If this is a behaviour used frequently by one individual, the appropriate a

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

Companies that provide selfless information through particip

tion is NOT to confront them in the team setting. Arrange to talk to them one-on-one using the techniques learned in giving constructive feedback.

Managing Your Team (Part 6) will look at "You Two, Stop Fighting"

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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Links

E-Folder - Managing Your Team (Part 5) - Who's Guilty of Plopping?

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