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Just Other Articles - Team Dysfunction: The Roots of Resistance
Why does doing something new or different bring out such defenses in certain people? Is it insecurity? Or, fear maybe? But what could possibly be so scar
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
y about exploring new ways of doing things, especially if it means we discover ways to improve? So often when I am hired to train groups and teams I hear,
; 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
“No, that won’t work. We’ve already tried it.” I just don’t get it.
How can people think they know everything about everything all the time? It’s one thi
How can people think they know everything about everything all the time? It’s one thi
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ng for aspiring fortune tellers, but professional business people? I don’t think so.
Maybe it’s a simple matter of the world being made up of two types of
Maybe it’s a simple matter of the world being made up of two types of
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
people: the ones who say, “why not?” and the others who say, “why bother?” But I doubt that too.
No matter how many groups of open-minded, optimistic, an
No matter how many groups of open-minded, optimistic, an
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
d confident people there are, there always seems to be one who isn’t. The problem is that the hijinks of one negative person who thinks he or she knows mor
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
e than other people, is enough to sabotage just about any organizational effort.
As consultants, we're hired to improve organizational issues and effective
As consultants, we're hired to improve organizational issues and effective
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
ess. Notice, the operative word here is “improve.” But when one rotten apple is able to distract others from matters at hand, they head those very opportu
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
nities off at the pass.
On the surface, it's hard to know if there is "problem" among us. That is, until we hear the first “tsk” come from the back of the
On the surface, it's hard to know if there is "problem" among us. That is, until we hear the first “tsk” come from the back of the
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
meeting room. But since the culprit blends in so well and never - ever sits in plain view, it's still hard to know at first who he or she is.
So when his
So when his
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
or her rolling eyes and heavy sighs graduate to note passing and whispering, “the one” has made him or herself known. In no time, if left to their own dev
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
ices, these people will suck every last bit of energy from the room. The real challenge for trainers and managers alike is to figure out what to do about i
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
t.
The way I see it, we have a few choices:
1) we can remove them;
2) we can ignore them;
3) we can confront them and demand that they stop; or
The way I see it, we have a few choices:
1) we can remove them;
2) we can ignore them;
3) we can confront them and demand that they stop; or
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
> 4) we can try to help them understand their own issues in hopes to stretch them beyond their blinkered views.
Now I know that the first three seem to be
Now I know that the first three seem to be
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 most direct, but they are also the least effective. Not to mention the fact that it is more humane to give someone a chance than to make snap judgments.
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
If we aren’t open to understanding what makes these people so annoying, then we are as guilty as they are for being closed-minded.
So to really know the
So to really know the
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
know-it-all and the degree to which he or she is afflicted, is to simply ask the question: Why is he or she doing it? Doing so will reveal the crucial answ
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
er: Can they or can’t they change? Once his or her willingness to improve is determined, a proper strategy can be decided upon and implemented.
The thing
The thing
.
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
is, that we will never know how high “high” is if we don’t have the courage to admit that existing efforts might not be right or good enough, and that an op
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
en mind is the only way to challenge what we think we know. At least then the money invested in employees can show unhindered returns - now there’s an idea
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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