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Digg It - Help Required - Apply Within
When we lead and manage a team, whether we are business owners, run a department or just supervise a group of people in our business, we are on show.
Part of our make up ensures that we 'lead f
Part of our make up ensures that we 'lead f
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
rom the front' and take all that the world throws at us - after all, that's what we are paid for - isn't it?
This is where many managers struggle, with the pride factor. And pride can cause man
This is where many managers struggle, with the pride factor. And pride can cause man
; 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
y pitfalls because we might feel obliged to battle on fending off every issue that comes our way, day after day.
Or, we could ask for help sometimes.
You see asking for help makes a difference
Or, we could ask for help sometimes.
You see asking for help makes a difference
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
to your people in a number of wonderful ways, makes your life a whole lot easier and sets the scene for a lot less fire-fighting to go on.
Asking for help literally by saying, 'Julie, I need yo
Asking for help literally by saying, 'Julie, I need yo
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ur help' is a strong request. It tugs at the emotions and whatever relationship you have had in the past with the person in question, you now have their buy in. Because someone asking for 'help'
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
is a strong appeal they will find had to resist.
This works in all sorts of directions. You can use this up the 'line' too. Asking your own boss for 'help' is not usually heard as a desperate c
This works in all sorts of directions. You can use this up the 'line' too. Asking your own boss for 'help' is not usually heard as a desperate c
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
ry from someone incapable.
You may well be pleasantly surprised at the buzz your boss gets from it as well as you will when people ask it of you.
The appeal for help comes with some caution. Y
You may well be pleasantly surprised at the buzz your boss gets from it as well as you will when people ask it of you.
The appeal for help comes with some caution. Y
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
ou have to behave yourself if you are appealing to this level of emotion. It is vital that you show trust and respect as a whole to all in your team (and beyond). You can't play the 'I need your
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
help' card without ties yourself. And you can't play it too often.
You can even use this appeal with groups. Imagine a CEO asking, even via an e-mail newsletter that 'I need your help' to thous
You can even use this appeal with groups. Imagine a CEO asking, even via an e-mail newsletter that 'I need your help' to thous
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
ands of his people. It still has a ties in (as long as the conditions in the previous paragraph are met).
That CEO really does have to mean it, and show that he means it, especially from a dist
That CEO really does have to mean it, and show that he means it, especially from a dist
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nce. So all interactions one-to-one he has with his people must demonstrate the qualities so vital to maintain the relationship the appeal starts to create.
Why does this work? Here are a few o
Why does this work? Here are a few o
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
f the reasons:-
1. It appeals to the emotional side of anyone who hears it.
2. It builds a belief that the manager is a real, breathing human being and therefore feels the same sort of thing t
1. It appeals to the emotional side of anyone who hears it.
2. It builds a belief that the manager is a real, breathing human being and therefore feels the same sort of thing t
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
hat mere mortals do.
3. It builds the confidence of those being asked that they are capable of helping at their boss's level.
4. Being asked to 'help' expands capabilities too, as it often wor
3. It builds the confidence of those being asked that they are capable of helping at their boss's level.
4. Being asked to 'help' expands capabilities too, as it often wor
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
s best where those asked have a strength that the manager might not have.
5. Being asked to 'help' raises awareness of contributions that might be made alongside the 'day job' and that awarenes
5. Being asked to 'help' raises awareness of contributions that might be made alongside the 'day job' and that awarenes
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
s helps things get fixed before the boss becomes aware of it.
6. The manager has more time for the constructive things in their work as the help given takes them away from the minutiae of their
6. The manager has more time for the constructive things in their work as the help given takes them away from the minutiae of their
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
work.
7. The occasional use, spread across a team, helps generate team spirit. When asked to 'help', people are more likely to:-
a. Ask people themselves as well b. Recognise that help may be
7. The occasional use, spread across a team, helps generate team spirit. When asked to 'help', people are more likely to:-
a. Ask people themselves as well b. Recognise that help may be
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
needed before being asked - and not just by the boss
8. The manager asking becomes more capable of seeing themselves honestly and builds their awareness of their weaknesses and the strengths a
8. The manager asking becomes more capable of seeing themselves honestly and builds their awareness of their weaknesses and the strengths a
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
round them.
9. The manager/employee dialogue opens up - the heart of all business relationship building. Conversations spring up where in the past there may have been none.
10. Culture shifts
9. The manager/employee dialogue opens up - the heart of all business relationship building. Conversations spring up where in the past there may have been none.
10. Culture shifts
.
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
rom an isolating 'I'm all right, Jack' to a supportive team-based success culture - one which is more sustainable at a core level.
Saying those words, 'I need your help' is a constructive, hone
Saying those words, 'I need your help' is a constructive, hone
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
st and developmental way for organisations to evolve. The place to start is a manager asking those words, just once, to set that ball rolling.
You will be surprised at the benefits you will see
You will be surprised at the benefits you will see
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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