Main Subject - Business

Most of us have found ourselves working on a team at one time or another. That means we have been asked to attend, and even participate, in lots of meetings. Unfor

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

tunately, few of us found these meetings to be particularly effective. Many in fact are a complete waste of valuable time and resources.

The difficulty with most m

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

Examples of combination products may in

etings is that they are typically planned and run by extroverts, who do not take into account the needs of the introverts. Why is this important? Because a key diff

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

ntiating characteristic between extroverts and introverts is in the way they process information.

Extroverts will tend to "think out loud." They verbally walk thems

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

lves through the thinking process. Introverts however want to process new information on their own, in their heads, before commenting or vocalizing their thoughts.

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

Combination pro

And that's just the beginning of the problem. Extroverts do not take into account the needs of the Introverts or the way in which they prefer to process the informat

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

on to be shared or discussed. Because Introverts require time on their own to process information, they are not prepared (or willing) to make decisions on items tha

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

are only being discussed fo the first time in a current meeting. All too often Extroverts bring a new topic up in a meeting, even if it's not on the agenda, and ex

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

ect everyone to get engaged and act on it right away. Because the Introverts are processing the new information, they may not comment. To the Extrovert, no news i

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

good news and this only means the Introverts must be on board.

Decision-making bias is highlighted when the meeting is controlled by the Extrovert. Extroverts view

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

the quieter more contemplative members as:

"I just assumed that they weren't interested."
"I thought they had nothing to share or say.
"I figured they wer

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

Following aspects would a

e a bit stuck up, stand-offish."

But let's not blame the Extroverts for all our meeting problems. Because Introverts prefer to process new information before speak

dd to the challenges in developing combination products:

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

ng, they may plan the agenda and arrive at meetings thinking their decisions are foregone conclusions without ever engaging others for input or discussion. In fact,

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

if the normally self-sufficient and reserved Introvert had his way, all meetings would occur by telephone or web conferencing or even email. The electronic meeting

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

inimize the extra-curricular comments and diversions that occur when you put a bunch of Extroverts in a room. But like the Introvert who needs time to process, Extr

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

verts need the opportunity to talk out loud and see who is doing the talking.

Now let's take a peek inside the Introverts' heads. What are they thinking about thei

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

Professional from academic institutions, pharmaceutical industries, health care indust

group-oriented, outgoing Extroverted colleagues?

"They're all blow-hards."

"Not one of them has a clear thought in their heads."

"They don't know what they're ta

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

king about."

You can see how valuable insights might be ignored or interpersonal conflicts arise when personality and behavioral styles aren't considered. When oth

.

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

r people's behavior patterns do not match our own, it is not unusual for us to begin to "make up stuff" about why others agree or disagree.

Don't fall into the trap

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

Companies that provide selfless information through particip

of making stuff up about others without even knowing you're doing it. Understand your personal style, then understand how style differences drive and bias decisions

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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People like to do business with people that they know. It is vital that as a business owner you and your staff are engaged in the business of building relationships with your customers. Through the process of building dynamic relationships with your clients, your business will continue to grow and reach new levels of profitability. So how do you do this? This is a great time of year to host an open house.

In the sixties, professor sir Michael Marmot analyzed the information about health conditions of the government workers that are living in London. He discovered an interesting fact:

No, it’s certainly not enthusiasm. There’s usually more than enough of that to go around. And it’s certainly not a lack of ideas. Would-be business owners can pop those out faster than fireworks exploding on the 4th of July. And by now most wannabes seem to realize the importance of a written business plan, whether using their own money or they anticipate a need to borrow, so it’s not that. The key ingredient most start-ups lack is a Professional Support Team.

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