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Main Subject - Managing Your Team (Part 8) - Why Can't We Just Get This Finished?
Whereas the previous article 'Why Can't We Stay On track' looked at the dangers of digressing and losing focus due to the reluctance of some team members to move forward, this article looks at the team dynamic almost from the opposite perspective - rushing to completion whic
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
h can be equally damaging if not managed effectively and kept in check.
However, let's deal with the 'realists' and 'sceptics' first...
Just Do It!
Yes, there are times when the most appropriate action is to make a decision quickly (even when there is a lack
However, let's deal with the 'realists' and 'sceptics' first...
Just Do It!
Yes, there are times when the most appropriate action is to make a decision quickly (even when there is a lack
; 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
of data) and move on as long as that decision is monitored closely and there are contingencies in case the decision does not deliver the results expected or anticipated.
There will be times when the team's consensus is to gather more data, analyse the situation again, then
There will be times when the team's consensus is to gather more data, analyse the situation again, then
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
decide on the next action.
This is not about wasting time or procrastinating. It's about recognizing that, as team leaders, we have the responsibility to ensure the appropriate action is taken. It's also about the duty of care we have for our team members.
Finally, remem
This is not about wasting time or procrastinating. It's about recognizing that, as team leaders, we have the responsibility to ensure the appropriate action is taken. It's also about the duty of care we have for our team members.
Finally, remem
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ber that we are measured not just on what was achieved but how it was achieved.
Rushing To Completion
This behaviour can be quite common. The team may find itself being pressurized by one or more team members who are totally unwilling to work to the agreed meeting agenda
Rushing To Completion
This behaviour can be quite common. The team may find itself being pressurized by one or more team members who are totally unwilling to work to the agreed meeting agenda
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
or project structure / process
"Why Can't We Just Get This Finished?"
The analogy of the tortoise and the hare is probably over used but the point is that if we are really after quality and long-lasting results, whatever the objectives are, it takes time, it takes constant
"Why Can't We Just Get This Finished?"
The analogy of the tortoise and the hare is probably over used but the point is that if we are really after quality and long-lasting results, whatever the objectives are, it takes time, it takes constant
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
commitment from our team members.
Let me put it another way, what are the chances of the team being successful, of following through, of delivering the action plan if true consensus wasn't reached?
Before we look at the behaviours you may have recognized in one of your teams whe
Let me put it another way, what are the chances of the team being successful, of following through, of delivering the action plan if true consensus wasn't reached?
Before we look at the behaviours you may have recognized in one of your teams whe
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
n certain individuals seem to be impatient and really not into reaching consensus, we have all probably heard of the term 'hidden agendas'.
In those situations where we are managing a cross functional or multi departmental team, certain team members may be under pressure themselve
In those situations where we are managing a cross functional or multi departmental team, certain team members may be under pressure themselve
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s. Maybe expectations have already been 'suggested' by department heads or other influential people. The official team objectives or 'agenda' have been published but these unfortunate team members may feel they have absolutely no option but to bring this 'hidden' agenda to the next
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
session.
What would you do?
There you are, part of a team. You enjoy the sessions, it's a great group to belong to. So far consensus has never been an issue. But now, you are on your way to the next meeting or session and you have basically been told what the outcome needs to b
What would you do?
There you are, part of a team. You enjoy the sessions, it's a great group to belong to. So far consensus has never been an issue. But now, you are on your way to the next meeting or session and you have basically been told what the outcome needs to b
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
. So, what would you do?
Typical Behaviours
Appears individual has already reached a decision, decided the solution to the problem before it has even been discussed
Discourages any further analysis or discussion by other team members
Hastily pushes
Typical Behaviours
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
the team to make decisions
Body language or nonverbal behaviour definitely shows their unwillingness to follow the process
Other inputs are discounted by throw away comments or statements directed at the other team members
Tough one, isn't it!
Maybe. Howe
Tough one, isn't it!
Maybe. Howe
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
ver, it is important to be aware that this kind of pressure can lead to an unwillingness by other team members to go along with the decision / solution; actions may be seen as disorganized and unsystematic; and, ultimately lead to a dysfunctional team.
So, what's a team leader
So, what's a team leader
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
to do?
When facilitating team sessions or development workshops, one flipchart which was always posted on the wall and in full view was the one displaying the ground rules we ALL had agreed to at the stage the group or team formed. If the 'rush to completion' is just a natura
When facilitating team sessions or development workshops, one flipchart which was always posted on the wall and in full view was the one displaying the ground rules we ALL had agreed to at the stage the group or team formed. If the 'rush to completion' is just a natura
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
l impatience by a team member because they want to see "some progress", remind team members of the ground rules, why they are important, and that they cannot be compromised.
It may well be that the apparent hasty decision / solution is a really good one. No problem. Just u
It may well be that the apparent hasty decision / solution is a really good one. No problem. Just u
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
se the agreed process so that everyone understands the benefits, why it makes sense, and reach consensus.
When this rush is caused by external pressure or influence, and the decision doesn't make sense to you and the team, it may be more appropriate to discuss this with the team m
When this rush is caused by external pressure or influence, and the decision doesn't make sense to you and the team, it may be more appropriate to discuss this with the team m
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
ember(s) offline, try to understand why the pressure has been brought to bear. It may mean discussing this with those who are applying the pressure, get them to explain why the decision makes sense.
Be creative. In the context of the team's objectives, ask the influencer to pres
Be creative. In the context of the team's objectives, ask the influencer to pres
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ent a brief overview, as much as they are able to, as to why it makes sense to run with the decision or suggested solution. Discuss this openly, following your agreed team process and decide how to move forward. Again, make sure the ongoing results of the decision are closely moni
.
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
tored.
Even better, be proactive. Once bitten, twice shy. When team members report into different departmental or functional heads, get the inputs from those who can bring influence to bear on the team's decisions. Understand where they are coming from and ensure they know that t
Even better, be proactive. Once bitten, twice shy. When team members report into different departmental or functional heads, get the inputs from those who can bring influence to bear on the team's decisions. Understand where they are coming from and ensure they know that t
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
heir inputs will form a key part of the discussion process within the team.
Oh, one last thing, just make sure it's not you, as team leader, that is adopting this rush to completion behaviour!
Managing Your Team (Part 9) will look at Is That a Fact or Just an Opinion
Oh, one last thing, just make sure it's not you, as team leader, that is adopting this rush to completion behaviour!
Managing Your Team (Part 9) will look at Is That a Fact or Just an Opinion
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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