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Digg It - The Primacy Of Planning
“@#$%& it! Will you quit bugging me with your planning meetings – I’ve got work to do!”
That was a statement made to me by a manager when I asked him - for the third time - to work with a group of us assigned a critical project. The project, if carried off well, would have profound effects on the long term health of the business. But it ended up fizzl
That was a statement made to me by a manager when I asked him - for the third time - to work with a group of us assigned a critical project. The project, if carried off well, would have profound effects on the long term health of the business. But it ended up fizzl
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
ing after two months. Why? Because this manager, in a crucial department, didn’t see the need for planning, and wouldn’t ‘play’.
Planning can be looked on as a pain in the neck. Often, at the very best, we do it because we know we ought to. But it’s done grudgingly, and because of that incompletely. And then when the plan doesn’t work we reinforce t
Planning can be looked on as a pain in the neck. Often, at the very best, we do it because we know we ought to. But it’s done grudgingly, and because of that incompletely. And then when the plan doesn’t work we reinforce t
; 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
e thought that planning is a waste of time. But really, is it? What are the pitfalls of not planning?
PITFALLS OF NOT PLANNING Well, first there’s the effect on the plan itself. What happens when we don’t plan at all? That’s more easily seen if we look at a good vacation. Most of us wouldn’t think of going on an extended vacation without doing sign
PITFALLS OF NOT PLANNING Well, first there’s the effect on the plan itself. What happens when we don’t plan at all? That’s more easily seen if we look at a good vacation. Most of us wouldn’t think of going on an extended vacation without doing sign
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ificant planning. Why? Because it’s precious time to us! We want results from it – results like relaxation, fun with others, rejuvenation. We judge ‘effectiveness’ in a vacation by the lack of hassle, by things coming off right, the absence of nasty surprises, the pleasantness of the surroundings, everything working like it should. And what is the fi
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
al result? A good vacation brings us back refreshed and re-created (recreation?), and makes us much better able to take up our work again. In fact, a good vacation will change our entire outlook on our work, and make it a pleasure again – especially if it had stopped being a pleasure before. So we plan our vacations. We look at where we will go, what
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
things we will do; we look at the accommodations we’ll book, and the surroundings of those accommodations. We look at resources – the money we’ll need to get there and the money we’ll have on hand for spending. Is such planning worth it? Most of us would answer “Absolutely!”.
So what about NOT planning a vacation? Well, you can look forward to one su
So what about NOT planning a vacation? Well, you can look forward to one su
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 thing in that case – surprises. Now, I like surprises. But I don’t enjoy spending hours in a destination trying to find a room. I don’t like discovering that things in my hotel don’t work, or that the place isn’t clean. One surprise we encountered on a poorly researched vacation landed us in a room where the carpets were all wet. I wondered if this
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
was because they’d just cleaned them, and further exploration yielded the fact that the toilet had a habit of backing up. Now THAT was a nasty surprise. Did we stay in that room? What do YOU think?
Lack of planning can yield similar surprises in business. Let’s look what goes into a business planning process, and how it can be done right.
PERILS O
Lack of planning can yield similar surprises in business. Let’s look what goes into a business planning process, and how it can be done right.
PERILS O
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
THE PLANNING PROCESS
Let’s face it, it’s fun to get right down to the meat of our work, and planning ain’t letting us do that! Believe it or not, that’s the number one reason leaders don’t want to plan. We are busy, and there are pressures to get things done, and planning takes time. It just seems easier and more enjoyable to do the job. But conside
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
r the surprises we set ourselves up for when we do it that way. We can find ourselves wasting time looking for data that’s hard to find, or missing completely. We find ourselves doing things over, causing rework for other parts of the business, lowering morale among staff. Ultimately, we don’t get the results we want, and the business itself suffers.
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ften, leaders look at planning they HAVE done and aren’t satisfied with the results they obtained. Such results can be a powerful negative deterrent to doing any planning at all. And while our plan may have given us poor outcomes, it’s not the planning itself that’s the problem, but most often the way it was done. Good planning will take time, and it
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
should be structured – done around certain principle areas. Let’s look at what those principal areas are.
PRINCIPLES FOR PLANNING Good planning starts with looking at the results or outcomes that are needed. Those results might include increased use of our product or service. They might include increased customer satisfaction with us, or better patie
PRINCIPLES FOR PLANNING Good planning starts with looking at the results or outcomes that are needed. Those results might include increased use of our product or service. They might include increased customer satisfaction with us, or better patie
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 outcomes. They may just be plain, old-fashioned making more money! Whatever they are, good planning begins with a clear understanding of the desired results.
Time also need to be considered, and in two important areas. First, the actual time to plan must be enough for effectiveness. This can be hard because we aren’t ‘doing’ when we’re planning.
Time also need to be considered, and in two important areas. First, the actual time to plan must be enough for effectiveness. This can be hard because we aren’t ‘doing’ when we’re planning.
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
But as we saw earlier, not taking the proper amount of time to plan can generate large amounts of wasted time later, and that wasted time affects productivity, staff morale, and ultimately business success. It’s best to take the time for planning well.
Second, planning needs to include the time needed for doing the right work to get the right outcomes.
Second, planning needs to include the time needed for doing the right work to get the right outcomes.
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
Leaders need to know how much time will be needed for critical parts of the project or business. We have to consider time needed for marketing, for interacting with the customer, the actual cycle time for producing our services or products. We need to consider the time needed for maintenance – both of equipment and of us and our staff! We need to know
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
how long it will take to get important information, and how long it takes to get it to others who need it. So planning time is a principle leaders must use in planning.
The third principle is planning for resources. This is obvious, but it has to be done systematically. We have to consider the resources necessary to bring us the very best results. T
The third principle is planning for resources. This is obvious, but it has to be done systematically. We have to consider the resources necessary to bring us the very best results. T
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
ose resources will include money: for marketing, equipment, proper staffing, space to work. They will include the materials themselves: what materials, what equipment, what kind of space, what information? And they include people: what skills will my people need? How many people? Where will the people be needed? So planning for resources is critica
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
l to a successful planning effort.
Fourth and finally, really good planning means planning for information. What information will be needed for each part of the project to work well? How quickly can I get it, and do others need it quickly from us? Planning for information means knowing where to get the information, who has it and is it the best? The
Fourth and finally, really good planning means planning for information. What information will be needed for each part of the project to work well? How quickly can I get it, and do others need it quickly from us? Planning for information means knowing where to get the information, who has it and is it the best? The
.
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
ight information at the right time in the right form is critical to effective businesses, more so now than ever before in history. So the last principle in planning is planning for information.
PRIMACY OF PLANNING To sum it up, good planning is always the foundation of good business success. Good planning involves knowing the results you want, takin
PRIMACY OF PLANNING To sum it up, good planning is always the foundation of good business success. Good planning involves knowing the results you want, takin
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
g enough time to plan, planning for the time needed to run the project or process well, planning for the resource needs, and assessing the information needs for the project.
No matter how skilled workers are, or how good leaders are, or how state-of-the-art equipment is, a poor plan – or no plan – will bring it all to nothing. Take the time to plan well
No matter how skilled workers are, or how good leaders are, or how state-of-the-art equipment is, a poor plan – or no plan – will bring it all to nothing. Take the time to plan well
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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