Advice Pool - Business

You may remember being told as a child, "Keep quiet!" "Children should be seen, not heard," and "You talk too much." You were a "good" kid if you kept quiet. However, bei

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

ng quiet when you are little causes big problems later in life.

As an adult, you may have been punished for communicating. For example, if you admit you committed a crim

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

Examples of combination products may in

e and are sorry about it, no one cares. You still go to jail. If you honestly tell your spouse you are thinking about an affair, your marriage suffers if your spouse is n

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

ot very understanding. If you tell someone you feel a little crazy, who knows what might happen. So you learn to keep your mouth shut.

However, businesses fail when manag

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

ers do not talk to employees or employees do not talk to customers. Everyone mistakenly believes telepathy is working. "I thought you knew I was unhappy with your perform

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

Combination pro

ance." "You should have known I was overworked."

Marriages are ruined by poor communication. Rather than openly discuss sex, money, body problems or whatever, couples hi

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

nt about their concerns or simply say nothing. But without support and understanding from your primary teammate, you do not go as far. In fact, a bad marriage can ruin ev

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

erything in your life. Both parties in a successful marriage are able to give and receive communication from their spouse on any subject.

Life is miserable if you have n

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

o one to openly communicate with. Friendships are based on communication. The lack of friends or a spouse to communicate with often leads to mental problems.

So the firs

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

t communication skill you need is to get out there and talk.

Unfortunately, on some topics, you’ve learned to watch what you say, to keep it under your hat, to zip it up.

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

"So that is the basic lesson that anybody learns in this universe. They learn to keep their mouth shut, and it’s the wrong lesson. When in doubt, talk. When in doubt, c

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

Following aspects would a

ommunicate." — L. Ron Hubbard

Whenever you have doubts about something, COMMUNICATE! Talk, talk, talk until the problem resolves. When you feel stress, disagreement or re

dd to the challenges in developing combination products:

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

sistance between you and someone near you, the wrong thing to do is ignore the problem. Instead, start communicating.

When you know you should say something, say it! For

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

example, an employee knows another employee is embezzling money and so says something to the employee and/or boss. A doctor knows he must talk to a about the patient’s r

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

ude behavior to the office staff. An employer knows she must discuss poor performance issues with some employees.

Take the bull by the horns. Move ahead in life. Spit it

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

out.

If you’re worried about the consequences of saying something, you can ask first. Examples:

"Lisa, I want to say something about your driving to help keep you out o

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

Professional from academic institutions, pharmaceutical industries, health care indust

f accidents, but I don’t want to upset you. Can I tell you what I think or should I keep my mouth shut?"

"Boss, should I tell you if I think you are giving me bad advice

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

?"

"John, our marriage means so much to me I don’t want to say anything that would jeopardize it. But I have done something wrong and I’m sorry I did it. I think it woul

.

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

d be good for our relationship if I told you. Don’t you think it’s best if we are 100% honest with each other?"

"Can you listen to something unfortunate I have to say an

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

Companies that provide selfless information through particip

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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