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Just Other Articles - 10 Questions To Consider When Growing Your Business
Here's a provocation for the coming year, decade, century or millennium.
By now, you've set a working direction for the year, established clear-cut objectives. Your first-iteration plan to reach them should be in place. This now seems like an ideal time to rethink the whole thing, doesn't it? After all, one of the effects of internet time is that plans are subject to change just as soon as - or perhaps even before - they ar
By now, you've set a working direction for the year, established clear-cut objectives. Your first-iteration plan to reach them should be in place. This now seems like an ideal time to rethink the whole thing, doesn't it? After all, one of the effects of internet time is that plans are subject to change just as soon as - or perhaps even before - they ar
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
e written.
Along these lines of thinking, perhaps there are some items you missed. Maybe there are issues you didn't have time to consider, or even things your mind touched on, but quickly passed over to deal with more urgent and pressing events. If you are off-cycle, and on the verge of a new period, you can use this exercise ex ante, rather than ex post. To help you stimulate your neural pathways and hopefully create an idea or two, I o
Along these lines of thinking, perhaps there are some items you missed. Maybe there are issues you didn't have time to consider, or even things your mind touched on, but quickly passed over to deal with more urgent and pressing events. If you are off-cycle, and on the verge of a new period, you can use this exercise ex ante, rather than ex post. To help you stimulate your neural pathways and hopefully create an idea or two, I o
; 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
fer the following thoughts for your consideration. These
"considerations" are not sequenced in order of importance. I think they are
important.
1. How far in the distance is your planning horizon? Most companies today plan 12-24 months out, calling anything beyond that "vision." Internet time implies a shortened time frame for activities, but does that time-collapse extend to a shortened vision as well? How much have you thought about wha
1. How far in the distance is your planning horizon? Most companies today plan 12-24 months out, calling anything beyond that "vision." Internet time implies a shortened time frame for activities, but does that time-collapse extend to a shortened vision as well? How much have you thought about wha
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
you will
accomplish this decade? What will be your company's impact on the millennium? (OK
- perhaps millennium is too far out. What about the century?) You may say you have
more pressing fish to fry. Your investors would like to see increased returns sooner
than that. While this might be true enough, taking the long view can inform the
short view, leading to greater returns for years to come. What do you see when you
take the long view
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
2. How are your prospects' needs going to change? How is their world affected by the dramatic increases in connectivity and the compression of time? What are you doing to understand their changing environment - their changing business issues? What are you doing to improve your customer's business under these slippery conditions? To take it one step further, what do your customers' customers want? While you are at it, you might stop to co
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
sider how your suppliers' needs are
changing? Could those changes open up new opportunities for you, or darkly
portend changes downstream totally derailing your business model? What about
your distributors? Is their world shifting? Can you both benefit?
3. Who in your organization simply isn't contributing? As they say, your mileage may vary from individual to individual but everyone has the responsibility to go some distance, to make som
3. Who in your organization simply isn't contributing? As they say, your mileage may vary from individual to individual but everyone has the responsibility to go some distance, to make som
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
thing valuable happen. Not everyone will make good on that
implied promise. The often observed 80-20 rule applies to your staff as well: 20% of
your people will produce 80% of the value.
That leaves 80% producing only 20%. Do the math: the bottom 10% of your organization produces almost nothing.
Who isn't making the cut? Should you be doing something about it? You may think it beneficent to provide that bottom percent with a paying job - d
That leaves 80% producing only 20%. Do the math: the bottom 10% of your organization produces almost nothing.
Who isn't making the cut? Should you be doing something about it? You may think it beneficent to provide that bottom percent with a paying job - d
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't. It isn't. The
non-performers know who they are, but they won't cut the cord on their own. Do
what you can to help them reach the bar, but if after a while they don't make it, set
them free to find an environment in which they can succeed. Free up your own
resources for people who make a difference.
4. Are you creating solutions to today's problems? What about next week's, next year's, or the problems of several years from now? How ar
4. Are you creating solutions to today's problems? What about next week's, next year's, or the problems of several years from now? How ar
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
you figuring out what
those problems are going to be, way out there on the time horizon? Because the
solution you sell today should certainly address today's problems, but the solutions
on today's drawing board better not. Who in your organization is responsible for
trend-tracking and forecasting?
Are you building scenarios for the future? What about prospect focus groups, or some other market-based feedback mechanism? Who is your reside
Are you building scenarios for the future? What about prospect focus groups, or some other market-based feedback mechanism? Who is your reside
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
t futurist?
5. What do you believe about the business you are in? For most people this is a strange question - we rarely spend time thinking about our own beliefs. The collection of beliefs you hold about your business - what the Germans call Weltanschauung - is decisive in most of the choices you make. How much risk to take. What's risky and what isn't. What projects and initiatives to undertake. What kind of resources you need and whom
5. What do you believe about the business you are in? For most people this is a strange question - we rarely spend time thinking about our own beliefs. The collection of beliefs you hold about your business - what the Germans call Weltanschauung - is decisive in most of the choices you make. How much risk to take. What's risky and what isn't. What projects and initiatives to undertake. What kind of resources you need and whom
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
o hire.
Whom to partner with, or should you have partners at all?
Cooperate or compete. How to treat your team. What your customers should expect from you. How hard do you expect people to work?
All these decisions stem from your beliefs, and it will help you to make them explicit. Once you surface those beliefs, you can start to distinguish which are useful beliefs and which are not.
What is the benefit of a particular belief? Is this bel
Whom to partner with, or should you have partners at all?
Cooperate or compete. How to treat your team. What your customers should expect from you. How hard do you expect people to work?
All these decisions stem from your beliefs, and it will help you to make them explicit. Once you surface those beliefs, you can start to distinguish which are useful beliefs and which are not.
What is the benefit of a particular belief? Is this bel
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
ef relevant to your current world,
or is it a holdover from some past part of life? Then, when you are ready, you can
experiment with new beliefs.
6. What are the obstacles to proceeding along your current path? Yes - you've set a plan in motion, and you are taking steps toward its achievement. But what roadblocks may rise up to stop you? What things could get in your way - foreseen and unforeseen? (I know, if it's unforeseen how are you
6. What are the obstacles to proceeding along your current path? Yes - you've set a plan in motion, and you are taking steps toward its achievement. But what roadblocks may rise up to stop you? What things could get in your way - foreseen and unforeseen? (I know, if it's unforeseen how are you
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
oing to see it? Use your
imagination, that's the point of this exercise.)
Rank these obstacles in terms of likelihood, then rank them in terms of severity. Consider how you might deal with them if they come up. The value of this is a) like the Boy Scouts, you are better prepared; b) you may illuminate issues you have been trying to sweep under the rug; and c) you just may invent a whole new approach to get where you are going, and it just
Rank these obstacles in terms of likelihood, then rank them in terms of severity. Consider how you might deal with them if they come up. The value of this is a) like the Boy Scouts, you are better prepared; b) you may illuminate issues you have been trying to sweep under the rug; and c) you just may invent a whole new approach to get where you are going, and it just
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
might be better than what you are doing now.
7. What, if you only knew how, would you be doing? What would you do now if you had additional resources - and should the lack of resources be stopping you? What, if you were sure it would be successful, would you jump on right away? What would you begin immediately, if your resources were limitless? (Yes, limitless can be relative.) What are you betting the future of your company on? What would
7. What, if you only knew how, would you be doing? What would you do now if you had additional resources - and should the lack of resources be stopping you? What, if you were sure it would be successful, would you jump on right away? What would you begin immediately, if your resources were limitless? (Yes, limitless can be relative.) What are you betting the future of your company on? What would
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
ou be
willing to bet the future of your company on?
8. What are the most important issues, right now? Make separate lists for issues in your market and issues in your company.
Which of these issues are you dealing with, which ones are on the backburner, and which ones aren't even in the kitchen? What are the processes you use to deal with these issues? Which issues are you ignoring, or hoping will go away?
What breakthroughs might be poss
8. What are the most important issues, right now? Make separate lists for issues in your market and issues in your company.
Which of these issues are you dealing with, which ones are on the backburner, and which ones aren't even in the kitchen? What are the processes you use to deal with these issues? Which issues are you ignoring, or hoping will go away?
What breakthroughs might be poss
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
ble by addressing or resolving issues in the
latter category? Where are you "resolving" issues by compromising? What
possibilities are available by refusing to compromise, or by breaking your
compromises? What old stories or old ways of looking at things make these
compromises seem inevitable? Where could new technologies (either material,
virtual, or societal) be applied to break these compromises?
9. What are you sacrificing to accompli
9. What are you sacrificing to accompli
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
h your current objectives? The definition of
sacrifice is giving up something of value for something of even greater value. Did
you intend to give up that thing of value, or is it a thoughtless byproduct of your
other choices? Do not dismiss this lightly.
In your business there are a number of priority-conflicting critical success factors. These include profitability, product development, new sales, customer satisfaction, recruiting and r
In your business there are a number of priority-conflicting critical success factors. These include profitability, product development, new sales, customer satisfaction, recruiting and r
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
tention, revenue growth, sufficient capital - which one gets the
most attention? And in this operating cycle - will each area get the attention it
needs? Even in a lower position of priority, these areas cannot be neglected. What
isn't getting done that needs to be done and how are you going to do it?
10. What is the purpose of your organization? I don't just mean increasing shareholder wealth that simply won't inspire your people to greatn
10. What is the purpose of your organization? I don't just mean increasing shareholder wealth that simply won't inspire your people to greatn
.
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
ss. What besides
that - a given - is the purpose of your company. Purpose is not something you
invent, it is there already - you have to uncover it. Why do you come to work each
day? What do you hope to accomplish in the long run?
What about your executive team? Your individual employees - why do they come? What do they think they are doing each day? Do you know? Have you bothered to find out? You've just completed a planning cycle, and I
What about your executive team? Your individual employees - why do they come? What do they think they are doing each day? Do you know? Have you bothered to find out? You've just completed a planning cycle, and I
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
m asking what your purpose
is! If you can't answer this question easily, now would be a great time to start.
Bonus question for consideration: Are there any questions I've listed above that you do not have easy answers to, but wish you did?
Every so often I do an exercise called the "One-Hundred Questions." Download a copy of a recent 100 questions at www.paullemberg.com/tipsandtools.html, along with how to use this simple thought-provoker
Bonus question for consideration: Are there any questions I've listed above that you do not have easy answers to, but wish you did?
Every so often I do an exercise called the "One-Hundred Questions." Download a copy of a recent 100 questions at www.paullemberg.com/tipsandtools.html, along with how to use this simple thought-provoker
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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