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Main Subject - The Most Misused Tool in Meetings
Lisa came to the meeting ready to participate. She had some specific ideas that she wanted to share – ideas that she thought would help the team move forward on the problem they were discussing. The meeting got off to a good start and everyone was involved in the discussion.
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
At what seemed like the appropriate time, Lisa shared her idea.
People didn’t seem as enthused about it as she thought they might. So she talked a bit more about it, hoping they would understand. Some other people didn’t think her idea was quite on track with the discussion,
People didn’t seem as enthused about it as she thought they might. So she talked a bit more about it, hoping they would understand. Some other people didn’t think her idea was quite on track with the discussion,
; 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
but some others became more interested and asked questions about her idea and the issues that would surround it if it were implemented.
Soon the facilitator suggested that Lisa’s idea was a good one, but that she was going to put her idea in the Issue Bin – so that we could g
Soon the facilitator suggested that Lisa’s idea was a good one, but that she was going to put her idea in the Issue Bin – so that we could g
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
t on with the meeting agenda – and that the group could get back to her idea later.
Lisa’s heart sank. She’d seen this happen before. In the last company she worked for they called this Issue Bin thing a Parking Lot. Once your idea got put in the Parking Lot, it was gone fo
Lisa’s heart sank. She’d seen this happen before. In the last company she worked for they called this Issue Bin thing a Parking Lot. Once your idea got put in the Parking Lot, it was gone fo
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
rever. In fact, in her mind she’d quit calling it a Parking Lot and started calling it the Black Hole – a place where ideas go, never to be seen again. . .
The Tool
In case you’ve never been to a meeting where an Issue Bin or a Parking Lot is used, let me explain. Of
The Tool
In case you’ve never been to a meeting where an Issue Bin or a Parking Lot is used, let me explain. Of
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
en groups or individuals will get off track – a new topic will come up or an idea will begin to be discussed that isn’t the main focus of the meeting, or might be better discussed later on. At that point whoever is facilitating the meeting would suggest that this topic or issu
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 be placed in the Issue Bin. They would then go to a chart on the wall labeled Issue Bin and write a brief description of the issue so that the idea won’t be lost. In other words, the goal of this tool is to keep a group on track with their agenda.
Beyond that though, the Is
Beyond that though, the Is
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
ue Bin is a way to help a group “hold that thought” so that the idea isn’t lost – and can be discussed later when the time is right.
The Misuse
The most common misuse of this valuable tool is exactly what Lisa had experienced in her previous company. Facilitators put
The Misuse
The most common misuse of this valuable tool is exactly what Lisa had experienced in her previous company. Facilitators put
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
items into the Issue Bin or Parking Lot with no real plan to revisit them – they are using the Bin as a place to put stuff they don’t really want to talk about at all.
Or, facilitators do have good intentions, but when the meeting runs long (how many meetings have you been to
Or, facilitators do have good intentions, but when the meeting runs long (how many meetings have you been to
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
hat didn’t go long?), and time is short, the Issue Bin item(s) get lost in the rush to finish the meeting.
So, regardless of the intention or best-laid plans of the facilitator, the Parking Lot becomes a sham and a manipulation, never achieving the desired result of capturing
So, regardless of the intention or best-laid plans of the facilitator, the Parking Lot becomes a sham and a manipulation, never achieving the desired result of capturing
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
the idea and holding it for later exploration.
Given this, it is no surprise that the Lisa and people with a similar experience bring up their item again and again – because they are afraid the idea will get lost.
The Best Use
Think of an Issue Bin as TiVo for your me
Given this, it is no surprise that the Lisa and people with a similar experience bring up their item again and again – because they are afraid the idea will get lost.
The Best Use
Think of an Issue Bin as TiVo for your me
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
etings. If you have a TiVo connected to your TV you can easily record any television show and watch it later. This allows you to watch the show at a time more convenient for you and, much to the disappointment of advertisers, skip through the commercials easily so that the ov
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
rall time spent in watching the show is reduced.
Just like TiVo, a well used Issue Bin allows you “timeshift” an issue or idea to discuss it at the time most convenient or productive for the team. And just like TiVo may reduce your watching time, often when the issue is held
Just like TiVo, a well used Issue Bin allows you “timeshift” an issue or idea to discuss it at the time most convenient or productive for the team. And just like TiVo may reduce your watching time, often when the issue is held
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
for later, the ideas and actions discussed in the interim may reduce the amount of time or energy required to effectively discuss or explore the issue.
It isn’t hard to use an Issue Bin effectively. It just requires a process and a bit of discipline.
1. Make sure that everyo
It isn’t hard to use an Issue Bin effectively. It just requires a process and a bit of discipline.
1. Make sure that everyo
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
e knows the function of the Issue Bin.
2. Capture items to the Issue Bin as appropriate.
3. Schedule time in the agenda (typically 2-3 minutes is all that is required) to review the Issues near the end of the meeting. This review should answer three questions:
Is this still
2. Capture items to the Issue Bin as appropriate.
3. Schedule time in the agenda (typically 2-3 minutes is all that is required) to review the Issues near the end of the meeting. This review should answer three questions:
Is this still
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
an issue (or has it been resolved since it was placed in the Bin?)
Is there an action item that can be created from this issue? If so, what is it?
Is this a topic that needs to be on a future meeting agenda? 4. Don’t leave the Issue Bin until something is done with each iss
Is there an action item that can be created from this issue? If so, what is it?
Is this a topic that needs to be on a future meeting agenda? 4. Don’t leave the Issue Bin until something is done with each iss
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
e. If nothing can be done with it at this time, consider saving the issue and having it reside on the Issue Bin at the start of your next meeting.
The bottom line? Do something with every one of them! Taking this simple approach to using this tool will make your meetings run
The bottom line? Do something with every one of them! Taking this simple approach to using this tool will make your meetings run
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
more productively and make sure that all of the best ideas and issues are both raised and considered.
Just like any tool, it is wonderfully valuable when used correctly. And just like any other tool, it can be damaging and counterproductive when it isn’t.
Back to Lisa
Lisa was pleased at the end of the meeting that the facilitator asked the group what they should do with Lisa’s idea. The group decided it warranted more discussion – they encouraged Lisa to work on some aspects of the idea a bit and it was agreed that this would be the firs
Just like any tool, it is wonderfully valuable when used correctly. And just like any other tool, it can be damaging and counterproductive when it isn’t.
Back to Lisa
.
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
Lisa was pleased at the end of the meeting that the facilitator asked the group what they should do with Lisa’s idea. The group decided it warranted more discussion – they encouraged Lisa to work on some aspects of the idea a bit and it was agreed that this would be the firs
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
t agenda topic for the next meeting.
From that day forward, Lisa felt more comfortable contributing to the team – and she now knew that the Issue Bin or Parking Lot or whatever you want to call it, didn’t have to be a Black Hole – that it could be a useful tool for any meeting
From that day forward, Lisa felt more comfortable contributing to the team – and she now knew that the Issue Bin or Parking Lot or whatever you want to call it, didn’t have to be a Black Hole – that it could be a useful tool for any meeting
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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