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Just Other Articles - Communications: I Never Seem To Say It Right
The ability to effectively communicate with employees is key to the success of the manager and the organization. Clear, concise communication, delivered with understanding, honesty and oft
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
en empathy, can make the difference between whether the manager’s message is received or not. When dealing with a difficult situation with an employee, whether it is a coaching session or
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
a performance appraisal interview, the words the manager chooses and the manner in which the message is delivered make a tremendous difference.
Beyond the delivery of the message, it is e
Beyond the delivery of the message, it is e
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ually important that the manager listen carefully to the employee’s response. The manager must understand exactly what the employee means, looking beyond the mere words. The true meaning o
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
f the messages is not always found in the spoken words. It is often found in the intonation of the message, the body language or the tone.
As an example, in the two conversations outlined
As an example, in the two conversations outlined
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
below, the manager, Tom, made very inappropriate responses to the situation presented. He “heard” the words that the employees were saying but never “listened” for their meaning.
In the f
In the f
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
irst situation, Tom had to address a missed deadline with Mary, a good employee who was generally prompt about meeting all customer demands. Mary’s response to Tom’s inquiry about the prob
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
lem went as follows:
Mary: “Well, you know, Tom, things are always hectic around here. We keep getting changes all the time.”
Tom: “But some of these changes are predictable. You just do
Mary: “Well, you know, Tom, things are always hectic around here. We keep getting changes all the time.”
Tom: “But some of these changes are predictable. You just do
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
’t plan well.”
In the second situation, Tom had to follow-up with another employee, Larry, who was supposed to take care of a customer complaint about a quality issue. Tom was upset becau
In the second situation, Tom had to follow-up with another employee, Larry, who was supposed to take care of a customer complaint about a quality issue. Tom was upset becau
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
se he thought the issue had been resolved earlier.
Tom: “Didn’t we talk about this before?”
Larry: “Yes, but this is a little different.”
Tom: “Frankly, I’m surprised that I had to call
Tom: “Didn’t we talk about this before?”
Larry: “Yes, but this is a little different.”
Tom: “Frankly, I’m surprised that I had to call
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
you in again. I assumed you took care of this problem months ago.”
After both exchanges, the employees walked away very upset and angry. Tom felt that he had properly addressed the proble
After both exchanges, the employees walked away very upset and angry. Tom felt that he had properly addressed the proble
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ms, but wondered why the conversations were so one sided, abrupt, and lacked real, open dialogue.
In Tom’s exchange with Mary, Tom quickly made her very defensive. His statement that she
In Tom’s exchange with Mary, Tom quickly made her very defensive. His statement that she
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
did not plan very well was judgmental and failed to determine the real problem. It would have been better if Tom reflected upon the content of Mary’s statement and was more empathetic to h
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
r feelings. He might have said “It’s all the changes, then, that you feel are causing the missed deadlines.” By stating this, Mary would not have been so defensive and a discussion about t
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
he problem would have ensued.
In the second exchange with Larry, Tom again was being judgmental and was impatient with his statement “Frankly, I’m a bit surprised....” Tom could have impr
In the second exchange with Larry, Tom again was being judgmental and was impatient with his statement “Frankly, I’m a bit surprised....” Tom could have impr
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
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
ved the situation by finding out why Larry felt this case was a little different. He could have stated simply “Different? In what way?”
Though you can never exactly plan what you are goin
Though you can never exactly plan what you are goin
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
g to say in advance, some basic coaching guidelines should be followed:
Approach the situation with a positive, helpful attitude
Avoid being judgmental
Be aware of your tone
Focus on t
Approach the situation with a positive, helpful attitude
Avoid being judgmental
Be aware of your tone
Focus on t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
he employee’s behavior, not their personality
Always maintain your objectivity
Listen carefully to what the employee is saying
Demonstrate to the employee that your goal is to help
Rea
Always maintain your objectivity
Listen carefully to what the employee is saying
Demonstrate to the employee that your goal is to help
Rea
.
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
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
h a consensus
Get commitment from the employee to a specific action plan
Tom was correct in addressing the issues with both Mary and Larry. His problems began with his approach and attit
Get commitment from the employee to a specific action plan
Tom was correct in addressing the issues with both Mary and Larry. His problems began with his approach and attit
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ude. He did not listen for the true meaning of their message and simply reacted. If done differently, incorporating the basic coaching guidelines, Tom would have experienced better 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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