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Digg It - Management by Delegation - Frying Pan, Fire or Neither?
How tempting is it to fix things? You know, you are passing by one of your teams cubicles and they are doing something you know all abo
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
ut. So you give a hand...
And then it's fixed, and you feel a rosy glow all about how you've 'helped'. But who is this about, y
And then it's fixed, and you feel a rosy glow all about how you've 'helped'. But who is this about, y
; 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
u or them.
You see, it can be so frustrating, for someone already frustrated, when some smart-ass boss comes along to show thei
You see, it can be so frustrating, for someone already frustrated, when some smart-ass boss comes along to show thei
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
superiority. In fact, after it's fixed, all they get is a general feeling of inadequacy. And more frustration.
And next time t
And next time t
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
hey have the same problem, They can't remember what they did because you did it so fast, in such a smart-assed sort of way. They either
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
need to wait for you to pass by again or, well, struggle again.
As a boss, it's easy to do something that you know how to do. I
As a boss, it's easy to do something that you know how to do. I
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
fact it's a big psychological boost to your little own sense of self, when you've achieved something that someone else is strug
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
gling with. So it's a 'nice' feeling to be better at something when someone else isn't.
It's not your fault, in fact it's not e
It's not your fault, in fact it's not e
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
en an action you think consciously about, it just happens that way.
And with some bosses, it happens often. I know, I've done i
And with some bosses, it happens often. I know, I've done 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
myself. It comes out of another emotion too. It comes out of a sense of 'helping' someone in distress - it's the 'knight in shining ar
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
our' thing. And it feels good.
Yet, it has a big downside. Getting someone else out of their 'frying pan' gets you into another
Yet, it has a big downside. Getting someone else out of their 'frying pan' gets you into another
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
'fire'. Because if you get so good at fixing other people's problems, that's what they'll expect of you. And wait for you to do it.
S
S
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
, you frustrate the hell out of them because you fix things for them all the time and then they start waiting for you to be the problem
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
solver. Your 'fixing' everything starts to pile up on you. You then get frustrated with them because you have such 'useless' employees
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
around you.
I wonder why!
So, here's a way to try. For someone struggling with something, however small, use the 4S Method.
<
I wonder why!
So, here's a way to try. For someone struggling with something, however small, use the 4S Method.
<
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
>Show
Supervise
Stand Back
Succeed
This means that you Show them how to do something, then you watc
Supervise
Stand Back
Succeed
This means that you Show them how to do something, then you watc
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
them and Supervise as they do it, maybe they get it wrong - if so, let them analyse why. Stand Back whilst they at last
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Succeed - and then get it right forever.
This is the 'Neither'. You get the job done right, by the person whose job it is to ge
This is the 'Neither'. You get the job done right, by the person whose job it is to ge
.
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
it right and then you are freed up to do more of this.
Thus building a team of capable, fulfilled and 'motivated to learn more' indiv
Thus building a team of capable, fulfilled and 'motivated to learn more' indiv
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
duals.
No Frying Pan, no Fire and Neither of you feel bad about it.
In fact, everything is a bit rosy, after all
No Frying Pan, no Fire and Neither of you feel bad about it.
In fact, everything is a bit rosy, after all
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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