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At about 3:00 on Thursday, Jack the division program manager says to the four members of his team,

"Have your proposals ready for discussion by Friday afternoon."

What did the employees hear him saying? What did they do as a result?

The following day Jack

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

called the team members one by one and asked that they come to his office with proposal in hand.

Employee #1 arrived with a 5-page typed budget proposal on the department’s annual giving campaign.
Employee #2 stepped in and told his manager tha

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

Examples of combination products may in

t he thought the proposals were due next Friday

Employee #3 handed Jack two-pages of analysis about the giving campaign.

Employee #4 greeted Jack with, "I’m glad we’re finally going to sit down and talk about this…I have some great ideas about what w

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

can do."

Obviously something went wrong. Were they listening? Was the message clear?

Many will say that Jack was not clear in communicating expectations -- partially true. Don’t underestimate the role of the listener. Whether through verbal or non-v

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

erbal cues, it is the listener that actually directs the conversation.

In the example Jack said what he wanted to say and with no questions, objections or comments he had no way of knowing that there was any disconnect. Well… not until time had been spent an

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

Combination pro

he was still without the important campaign information.

The listener has a responsibility to check in with the person speaking. Not one of the employees asked a question for clarification. Why not? They thought they heard what Jack was saying (assumed) and

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

understood what he wanted in return.

The speaker can have his say but if the listener can not accurately interpret what the speaker is trying to convey there is no communication. The best communicator with great verbal skills can not overcome the failure o

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

f a poor listener. Dialogue quickly becomes a monologue. Conversely in a conversation between a great listener and a poor speaker, the listener will work with the speaker to draw out and clarify the message.

Think of how many times you have misinterpreted i

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

structions, heard a problem incorrectly, or missed out on business opportunities. Poor listening can lead to challenges in relationships, lack of credibility, lost contacts, inaccurate reporting, rework, dissatisfied customers and lowered productivity.

Did y

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

ou know...?

It is estimated that more than 50% of our work time is spent listening.
Immediately following a 10-minute presentation the average person retains about half of what they hear and only one quarter of what they hear 48 hours later.
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
>60% of all management problems are related to listening.
We misinterpret, misunderstand or change 70 to 90% of what we hear.

When misunderstandings occur the implication is that whoever was delivering the message somehow missed the mark, that th

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

Following aspects would a

e speaker didn’t deliver a clear message. But, communication is not just is said it is what you hear someone saying. Listening is considered the most frequently used but least exercised and effective communication skill.

More Than Words Can Say
dd to the challenges in developing combination products:

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

We've talked about the listener's role in relation to the speaker but there is a third component of communication -- the message itself. It is said that the 500 most commonly used words in English have over 14,000 different dictionary definitions. As I
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
aid earlier, communication is a two-way street but it has many off ramps.

Using a simple word like "office" filtered through differing:

perceptions,
assumptions,
exposure,
experiences,
relationships,
knowledge,
agenda
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
, or
attention

might cause one to envision corporate headquarters, cubicles, corner suites with a great view, a position held, a government agency or even a team of workers.

Even under the best circumstances, the path of communication is not a dire
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
ct shot between the speaker and the listener. The speaker sends a message that is filtered by the listener and sent back again. As this path continues without clarification and stop points the message becomes muddled and strays further from the original inten
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
. Extra effort is spent trying to figure out how the message was sidetracked, frustrations rise and meaning is lost or distorted.

Listening is Priceless.

There are no shortcuts to becoming a great listener and the price tag for poor listeni
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ng is high. Listening well can cut down on misunderstandings, miscues, damaged relationships, missed opportunity and disagreements while building strong alliances, increasing knowledge and delivering better results faster.

To truly listen is priceless becaus
.

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
listening is the key to another’s thoughts, motivation,and behaviors. Dealing with customers, employees and managers, it is the listener’s responsibility to make the adjustments toward understanding. Whether your next interaction is with a customer, a frien
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
d, or a co-worker remember how easily a misunderstanding can occur. Focus on the goal of the communication and build toward the message.

The better your listen, the more you allow both people to develop shared meaning, learning, agreement and improved results

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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